CIPROBAY 500MG TABLETS
Active substance(s): CIPROFLOXACIN HYDROCHLORIDE MONOHYDRATE
Ref: 1273/120517/1/F
Ciproxin ® 500 mg Tablets
(ciprofloxacin)
Patient Information Leaflet
Read all of this leaflet carefully before you start taking this medicine
because it contains important information for you.
* Keep this leaflet. You may need to read it again.
* If you have any further questions, ask your doctor or pharmacist.
* This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them, even if their signs of illness are the same as
yours.
* If you get any side effects, talk to your doctor or pharmacist. This includes
any possible side effects not listed in this leaflet. See section 4.
Your medicine is called Ciproxin 500mg Tablets but will be referred as
Ciproxin throughout this leaflet.
What is in this leaflet
1 What Ciproxin is and what it is used for
2 What you need to know before you take Ciproxin
3 How to take Ciproxin
4 Possible side effects
5 How to store Ciproxin
6 Contents of the pack and other information
1
What Ciproxin is and what it is used for
Ciproxin contains the active substance ciprofloxacin. Ciprofloxacin is an
antibiotic belonging to the fluoroquinolone family. Ciprofloxacin works by
killing bacteria that cause infections. It only works with specific strains of
bacteria.
Adults
Ciproxin is used in adults to treat the following bacterial infections:
* respiratory tract infections
* long lasting or recurring ear or sinus infections
* urinary tract infections
* genital tract infections in men and women
* gastro-intestinal tract infections and intra-abdominal infections
* skin and soft tissue infections
* bone and joint infections
* to prevent infections due to the bacterium Neisseria meningitidis
* anthrax inhalation exposure
* If you suffer from epilepsy or other neurological conditions such as
cerebral ischemia or stroke, you may experience side effects associated
with the central nervous system. If seizure happens, stop taking Ciproxin
and contact your doctor immediately.
* You may experience symptoms of neuropathy such as pain, burning,
tingling, numbness and/or muscle weakness. If this happens, stop taking
Ciproxin and contact your doctor immediately.
* You may experience psychiatric reactions the first time you take
Ciproxin. If you suffer from depression or psychosis, your symptoms
may become worse under treatment with Ciproxin. In rare cases,
depression or psychosis can progress to thoughts of suicide, suicide
attempts, or completed suicide. If this happens, contact your doctor
immediately.
* Hypoglycemia has been reported most often in diabetic patients,
predominantly in elderly population. If this happens, contact your doctor
immediately.
* Diarrhoea may develop while you are taking antibiotics, including Ciproxin,
or even several weeks after you have stopped taking them. If it becomes
severe or persistent or you notice that your stool contains blood or mucus,
stop taking Ciproxin and contact your doctor immediately, as this can be
life-threatening. Do not take medicines that stop or slow down bowel
movements.
* If your eyesight becomes impaired or if your eyes seem to be otherwise
affected, consult an eye specialist immediately.
* Your skin becomes more sensitive to sunlight or ultraviolet (UV) light
when taking Ciproxin. Avoid exposure to strong sunlight, or artificial UV
light such as sunbeds.
* Tell the doctor or laboratory staff that you are taking Ciproxin if you have to
provide a blood or urine sample.
* If you suffer from kidney problems, tell the doctor because your dose may
need to be adjusted.
* Ciproxin may cause liver damage. If you notice any symptoms such as
loss of appetite, jaundice (yellowing of the skin), dark urine, itching, or
tenderness of the stomach, contact your doctor immediately.
* Ciproxin may cause a reduction in the number of white blood cells and
your resistance to infection may be decreased. If you experience an
infection with symptoms such as fever and serious deterioration of
your general condition, or fever with local infection symptoms such as sore
throat/pharynx/mouth or urinary problems you should see your doctor
immediately. A blood test will be taken to check possible reduction of
white blood cells (agranulocytosis). It is important to inform your doctor
about your medicine.
Other medicines and Ciproxin
Tell your doctor or pharmacist if you are taking, have recently taken or might
take any other medicines.
Ciprofloxacin may be used in the management of patients with low white
blood cell counts (neutropenia) who have a fever that is suspected to be due
to a bacterial infection.
Do not take Ciproxin together with tizanidine, because this may cause
side effects such as low blood pressure and sleepiness (see Section 2: Do
not take Ciproxin).
If you have a severe infection or one that is caused by more than one type
of bacterium, you may be given additional antibiotic treatment in addition to
Ciproxin.
The following medicines are known to interact with Ciproxin in your body.
Taking Ciproxin together with these medicines can influence the therapeutic
effect of those medicines. It can also increase the probability of experiencing
side effects.
Children and adolescents
Ciproxin is used in children and adolescents, under specialist medical
supervision, to treat the following bacterial infections:
* lung and bronchial infections in children and adolescents suffering from
cystic fibrosis
* complicated urinary tract infections, including infections that have reached
the kidneys (pyelonephritis)
* anthrax inhalation exposure
Ciproxin may also be used to treat other specific severe infections in
children and adolescents when your doctor considered this necessary.
2
What you need to know before you take Ciproxin
Do not take Ciproxin:
* if you are allergic to the active substance, to other quinolone drugs or to
any of the other ingredients of this medicine (listed in Section 6)
* if you are taking tizanidine (see Section 2: Other medicines and Ciproxin)
Warnings and precautions
Talk to your doctor before taking Ciproxin
* if you have ever had kidney problems because your treatment may need to
be adjusted.
* if you suffer from epilepsy or other neurological conditions.
* if you have a history of tendon problems during previous treatment with
antibiotics such as Ciproxin.
* if you are diabetic because you may experience a risk of hypoglycaemia
with ciprofloxacin.
* if you have myasthenia gravis (a type of muscle weakness) because
symptoms can be exacerbated.
* if you have heart problems. Caution should be taken when using
Ciprofloxacin, if you were born with or have family history of prolonged QT
interval (seen on ECG, electrical recording of the heart), have salt
imbalance in the blood (especially low level of potassium or magnesium in
the blood), have a very slow heart rhythm (called ‘bradycardia’), have a
weak heart (heart failure), have a history of heart attack (myocardial
infarction), you are female or elderly or you are taking other medicines that
result in abnormal ECG changes (see section 2: Other medicines and
Ciproxin).
* if you or a member of your family is known to have a deficiency in
glucose-6-phosphate dehydrogenase (G6PD), since you may experience a
risk of anaemia with ciprofloxacin.
For the treatment of some genital tract infections, your doctor can prescribe
another antibiotic in addition to ciprofloxacin. If there is no improvement in
symptoms after 3 days of treatment, please consult your doctor.
While taking Ciproxin
Tell your doctor immediately, if any of the following occurs while taking
Ciproxin. Your doctor will decide whether treatment with Ciproxin needs to
be stopped.
* Severe, sudden allergic reaction (an anaphylactic reaction/shock,
angio-oedema). Even with the first dose, there is a small chance that you
may experience a severe allergic reaction with the following
symptoms: tightness in the chest, feeling dizzy, sick or faint, or
experiencing dizziness when standing up.
If this happens, stop taking Ciproxin and contact your doctor
immediately.
* Pain and swelling in the joints and tendinitis may occur occasionally,
particularly if you are elderly and are also being treated with
corticosteroids. Inflammation and ruptures of tendons may occur even
within the first 48 hours of treatment or up to several months after
discontinuation of Ciproxin therapy. At the first sign of any pain or
inflammation stop taking Ciproxin, contact your doctor and rest the painful
area. Avoid any unnecessary exercise, as this might increase the risk of a
tendon rupture.
Tell your doctor if you are taking:
* Vitamin K antagonists (e.g. warfarin, acenocoumarol, phenprocoumon or
fluindione) or other oral anticoagulants (to thin the blood)
* probenecid (for gout)
* methotrexate (for certain types of cancer, psoriasis, rheumatoid arthritis)
* theophylline (for breathing problems)
* tizanidine (for muscle spasticity in multiple sclerosis)
* olanzapine (an antipsychotic)
* clozapine (an antipsychotic)
* ropinirole (for Parkinson’s disease)
* phenytoin (for epilepsy)
* metoclopramide (for nausea and vomiting)
* cyclosporin (for skin conditions, rheumatoid arthritis and in organ
transplantation)
* other medicines that can alter your heart rhythm: medicines that belong to
the group of anti-arrhythmics (e.g. quinidine, hydroquinidine, disopyramide,
amiodarone, sotalol, dofetilide, ibutilide), tricyclic antidepressants, some
antimicrobials (that belong to the group of macrolides), some
antipsychotics.
* zolpidem (for sleep disorders)
Ciproxin may increase the levels of the following medicines in your blood:
* pentoxifylline (for circulatory disorders)
* caffeine
* duloxetine (for depression, diabetic nerve damage or incontinence)
* lidocaine (for heart conditions or anaesthetic use)
* sildenafil (e.g. for erectile dysfunction)
* agomelatine (for depression)
Some medicines reduce the effect of Ciproxin. Tell your doctor if you take or
wish to take:
* antacids
* omeprazole
* mineral supplements
* sucralfate
* a polymeric phosphate binder (e.g. sevelamer or lanthanum carbonate)
* medicines or supplements containing calcium, magnesium, aluminium or
iron
If these preparations are essential, take Ciproxin about two hours before or
no sooner than four hours after them.
Ciproxin with food and drink
Unless you take Ciproxin during meals, do not eat or drink any dairy
products (such as milk or yoghurt) or drinks with added calcium when you
take the tablets, as they may affect the absorption of the active substance.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are
planning to have a baby, ask your doctor or pharmacist for advice before
taking this medicine.
It is preferable to avoid the use of Ciproxin during pregnancy.
Do not take Ciproxin during breast-feeding because ciprofloxacin is excreted
in breast milk and can be harmful for your child.
Driving and using machines
Ciproxin may make you feel less alert. Some neurological adverse events
can occur. Therefore, make sure you know how you react to Ciproxin before
driving a vehicle or operating machinery. If in doubt, talk to your doctor.
Ref: 1273/120517/1/B
Ciproxin 500 mg Tablets
®
(ciprofloxacin)
Patient Information Leaflet (continued)
3
How to take Ciproxin
Your doctor will explain to you exactly how much Ciproxin you will have to
take as well as how often and for how long. This will depend on the type of
infection you have and how bad it is.
Tell your doctor if you suffer from kidney problems because your dose may
need to be adjusted.
The treatment usually lasts from 5 to 21 days, but may take longer for
severe infections. Always take this medicine exactly as your doctor has told
you. Check with your doctor or pharmacist if you are not sure how
many tablets to take and how to take Ciproxin.
a. Swallow the tablets with plenty of fluid. Do not chew the tablets because
they do not taste nice.
b. Do try to take the tablets at around the same time every day.
c. You can take the tablets at mealtimes or between meals. Any calcium you
take as part of a meal will not seriously affect uptake. However, do not
take Ciproxin tablets with dairy products such as milk or yoghurt or with
fortified fruit juices (e.g. calcium-fortified orange juice).
Remember to drink plenty of fluids while you are taking this medicine.
If you take more Ciproxin than you should
If you take more than the prescribed dose, get medical help immediately. If
possible, take your tablets or the box with you to show the doctor.
If you forget to take Ciproxin
Take the normal dose as soon as possible and then continue as prescribed.
However, if it is almost time for your next dose, do not take the missed dose
and continue as usual. Do not take a double dose to make up
for a forgotten dose. Be sure to complete your course of treatment.
If you stop taking Ciproxin
It is important that you finish the course of treatment even if you begin to
feel better after a few days. If you stop taking this medicine too soon, your
infection may not be completely cured and the symptoms of the infection
may return or get worse. You might also develop resistance to the antibiotic.
If you have any further questions about the use of this medicine, ask your
doctor or pharmacist.
4
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following section contains the most serious side effects that you can
recognize yourself:
Stop taking Ciproxin and contact your doctor immediately in order to
consider another antibiotic treatment if you notice any of the following serious side effects:
Rare (may affect up to 1 in 1,000 people)
- Seizure (see Section 2: Warnings and precautions)
Very rare (may affect up to 1 in 10,000 people)
- Severe, sudden allergic reaction with symptoms such as tightness in the
chest, feeling dizzy, sick or faint, or experience dizziness when standing
up (anaphylactic reaction/shock) (see Section 2: Warnings and
precautions)
- Muscle weakness, inflammation of the tendons which could lead to rupture
of the tendon, particularly affecting the large tendon at the back of the
ankle (Achilles tendon) (see Section 2: Warnings and precautions)
- A serious life-threatening skin rash, usually in the form of blisters or ulcers
in the mouth, throat, nose, eyes and other mucous membranes such as
genitals which may progress to widespread blistering or peeling of the skin
(Stevens-Johnson syndrome, toxic epidermal necrolysis).
Not known (frequency cannot be estimated from the available data)
- Unusual feelings of pain, burning tingling, numbness or muscle weakness
in the extremities (neuropathy) (see Section 2: Warnings and precautions)
- A drug reaction that causes rash, fever, inflammation of internal organs,
hematologic abnormalities and systemic illness (DRESS Drug Reaction
with Eosinophilia and Systemic Symptoms, AGEP Acute Generalised
Exanthematous Pustulosis).
Other side effects which have been observed during treatment with Ciproxin
are listed below by how likely they are:
Common: (may affect up to 1 in 10 people)
- nausea, diarrhoea
- joint pain and joint inflammation in children
Uncommon (may affect up to 1 in 100 people)
- joint pain in adults
- fungal superinfections
- a high concentration of eosinophils, a type of white blood cell
- decreased appetite
- hyperactivity or agitation
- headache, dizziness, sleeping problems, or taste disorders
- vomiting, abdominal pain, digestive problems such as stomach upset
(indigestion/heartburn), or wind
- increased amounts of certain substances in the blood (transaminases
and/or bilirubin)
- rash, itching, or hives
- poor kidney function
- pains in your muscles and bones, feeling unwell (asthenia), or fever
- increase in blood alkaline phosphatase (a certain substance in the blood)
Rare (may affect up to 1 in 1,000 people)
- muscle pain, inflammation of the joints, increased muscle tone and
cramping
- inflammation of the bowel (colitis) linked to antibiotic use (can be fatal in
very rare cases) (see Section 2: Warnings and precautions)
- changes to the blood count (leukopenia, leukocytosis, neutropenia,
anaemia), increased or decreased amounts of a blood clotting factor
(thrombocytes)
- allergic reaction, swelling (oedema), or rapid swelling of the skin and
mucous membranes (angio-oedema) (see Section 2: Warnings and
precautions)
- increased blood sugar (hyperglycaemia)
- decreased blood sugar (hypoglycaemia) (see Section 2: Warnings and
precautions)
- confusion, disorientation, anxiety reactions, strange dreams, depression
(potentially leading to thoughts of suicide, suicide attempts, or completed
suicide) (see Section 2: Warnings and precautions), or hallucinations
- pins and needles, unusual sensitivity to stimuli of the senses, decreased
skin sensitivity, tremors, or giddiness
- eyesight problems including double vision (see Section 2: Warnings and
precautions)
- tinnitus, loss of hearing, impaired hearing
- rapid heartbeat (tachycardia)
- expansion of blood vessels (vasodilation), low blood pressure, or fainting
- shortness of breath, including asthmatic symptoms
- liver disorders, jaundice (cholestatic icterus), or hepatitis
- sensitivity to light (see Section 2: Warnings and precautions)
- kidney failure, blood or crystals in the urine, urinary tract inflammation
- fluid retention or excessive sweating
- increased levels of the enzyme amylase
Very rare (may affect up to 1 in 10,000 people)
- a special type of reduced red blood cell count (haemolytic anaemia); a
dangerous drop in a type of white blood cells (agranulocytosis) (see
Section 2: Warnings and precautions); a drop in the number of red and
white blood cells and platelets (pancytopenia), which may be fatal; and
bone marrow depression, which may also be fatal
- allergic reaction called serum sickness-like reaction (see Section 2:
Warnings and precautions)
- mental disturbances (psychotic reactions potentially leading to thoughts of
suicide, suicide attempts, or completed suicide) (see Section 2: Warnings
and precautions)
- migraine, disturbed coordination, unsteady walk (gait disturbance),
disorder of sense of smell (olfactory disorders), pressure on the brain
(intracranial pressure and pseudotumor cerebri)
- visual colour distortions
- inflammation of the wall of the blood vessels (vasculitis)
- pancreatitis
- death of liver cells (liver necrosis) very rarely leading to life-threatening
liver failure (see Section 2: Warnings and precautions)
- small, pin-point bleeding under the skin (petechiae); various skin eruptions
or rashes
- worsening of the symptoms of myasthenia gravis (see Section 2: Warnings
and precautions)
Not known (frequency cannot be estimated from the available data)
- feeling highly excited (mania) or feeling great optimism and overactivity
(hypomania)
- abnormal fast heart rhythm, life-threatening irregular heart rhythm,
alteration of the heart rhythm (called ‘prolongation of QT interval’, seen on
ECG, electrical activity of the heart)
- influence on blood clotting (in patients treated with Vitamin K antagonists)
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This
includes any possible side effects not listed in this leaflet. You can also
report side effects directly via the Yellow Card Scheme at
www.mhra.gov.uk/yellowcard.
By reporting side effects, you can help provide more information on the
safety of this medicine.
5
How to store Ciproxin
Keep out of the sight and reach of children.
Do not use Ciproxin after the expiry date, which is stated on the blister or
carton after “EXP”: The expiry date refers to the last day of the month
concerned.
If your medicine becomes discoloured or shows any other signs of
deterioration consult your pharmacist who will tell you what to do.
Medicines should not be disposed of down the drain or with household
rubbish. Ask your pharmacist how to dispose of any medicines no longer
required. These measures will help to protect the environment.
*
*
*
*
6
Contents of the pack and other information
What Ciproxin contains
Ciproxin 500 mg film-coated tablets contain the active ingredient,
Ciprofloxacin.
Also contain microcrystalline cellulose, maize starch, crospovidone, colloidal
silicon dioxide, magnesium stearate and purified water. The tablet film-coat
consists of a mixture of hypromellose, macrogol 4000, titanium dioxide and
purified water.
What Ciproxin looks like and contents of the pack
Ciproxin are white, film-coated tablets. On one side it is marked with a break
line and CIP 500 and marked BAYER on the other. They are available in
blister packs containing 10 Tablets
Manufacturer and Licence Holder
This medicine is manufactured by Bayer Pharma AG, D-51368, Leverkusen,
Germany and is procured from within the EU and repackaged by the Product
Licence Holder: Lexon (UK) Limited, Unit 18, Oxleasow Road, East Moons
Moat, Redditch, Worcestershire, B98 0RE.
If you have any questions or are not sure about anything, ask your doctor or
pharmacist. They will have additional information about this medicine and
will be able to advise you.
POM
PL 15184/1273 Ciproxin 500mg Tablets
Ciproxin is a registered trademark of Bayer Aktiengesellschaft
Revision date: 12/05/17
Blind or partially sighted?
Is this leaflet hard to see or read?
Phone Lexon (UK) Limited,
Tel: 01527 505414 to obtain the leaflet
in a format suitable for you
Ref: 1273/120517/2/F
Ciprobay® 500 mg Tablets
(ciprofloxacin)
Patient Information Leaflet
Read all of this leaflet carefully before you start taking this medicine
because it contains important information for you.
* Keep this leaflet. You may need to read it again.
* If you have any further questions, ask your doctor or pharmacist.
* This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them, even if their signs of illness are the same as
yours.
* If you get any side effects, talk to your doctor or pharmacist. This includes
any possible side effects not listed in this leaflet. See section 4.
Your medicine is called Ciprobay 500mg Tablets but will be referred as
Ciprobay throughout this leaflet.
What is in this leaflet
1 What Ciprobay is and what it is used for
2 What you need to know before you take Ciprobay
3 How to take Ciprobay
4 Possible side effects
5 How to store Ciprobay
6 Contents of the pack and other information
1
What Ciprobay is and what it is used for
Ciprobay contains the active substance ciprofloxacin. Ciprofloxacin is an
antibiotic belonging to the fluoroquinolone family. Ciprofloaxcin works by
killing bacteria that cause infections. It only works with specific strains of
bacteria.
Adults
Ciprobay is used in adults to treat the following bacterial infections:
* respiratory tract infections
* long lasting or recurring ear or sinus infections
* urinary tract infections
* genital tract infections in men and women
* gastro-intestinal tract infections and intra-abdominal infections
* skin and soft tissue infections
* bone and joint infections
* to prevent infections due to the bacterium Neisseria meningitidis
* anthrax inhalation exposure
* If you suffer from epilepsy or other neurological conditions such as
cerebral ischemia or stroke, you may experience side effects associated
with the central nervous system. If seizure happens, stop taking Ciprobay
and contact your doctor immediately.
* You may experience symptoms of neuropathy such as pain, burning,
tingling, numbness and/or muscle weakness. If this happens, stop taking
Ciprobay and contact your doctor immediately.
* You may experience psychiatric reactions the first time you take
Ciprobay. If you suffer from depression or psychosis, your symptoms
may become worse under treatment with Ciprobay. In rare cases,
depression or psychosis can progress to thoughts of suicide, suicide
attempts, or completed suicide. If this happens, contact your doctor
immediately.
* Hypoglycemia has been reported most often in diabetic patients,
predominantly in elderly population. If this happens, contact your doctor
immediately.
* Diarrhoea may develop while you are taking antibiotics, including
Ciprobay, or even several weeks after you have stopped taking them. If it
becomes severe or persistent or you notice that your stool contains blood
or mucus, stop taking Ciprobay and contact your doctor immediately, as
this can be life-threatening. Do not take medicines that stop or slow down
bowel movements.
* If your eyesight becomes impaired or if your eyes seem to be otherwise
affected, consult an eye specialist immediately.
* Your skin becomes more sensitive to sunlight or ultraviolet (UV) light
when taking Ciprobay. Avoid exposure to strong sunlight, or artificial UV
light such as sunbeds.
* Tell the doctor or laboratory staff that you are taking Ciprobay if you have
to provide a blood or urine sample.
* If you suffer from kidney problems, tell the doctor because your dose may
need to be adjusted.
* Ciprobay may cause liver damage. If you notice any symptoms such as
loss of appetite, jaundice (yellowing of the skin), dark urine, itching, or
tenderness of the stomach, contact your doctor immediately.
* Ciprobay may cause a reduction in the number of white blood cells and
your resistance to infection may be decreased. If you experience an
infection with symptoms such as fever and serious deterioration of
your general condition, or fever with local infection symptoms such as sore
throat/pharynx/mouth or urinary problems you should see your doctor
immediately. A blood test will be taken to check possible reduction of
white blood cells (agranulocytosis). It is important to inform your doctor
about your medicine.
Other medicines and Ciprobay
Tell your doctor or pharmacist if you are taking, have recently taken or might
take any other medicines.
Ciprofloxacin may be used in the management of patients with low white
blood cell counts (neutropenia) who have a fever that is suspected to be due
to a bacterial infection.
Do not take Ciprobay together with tizanidine, because this may cause
side effects such as low blood pressure and sleepiness (see Section 2: Do
not take Ciprobay).
If you have a severe infection or one that is caused by more than one type
of bacterium, you may be given additional antibiotic treatment in addition to
Ciprobay.
The following medicines are known to interact with Ciprobay in your body.
Taking Ciprobay together with these medicines can influence the therapeutic
effect of those medicines. It can also increase the probability of experiencing
side effects.
Children and adolescents
Ciprobay is used in children and adolescents, under specialist medical
supervision, to treat the following bacterial infections:
* lung and bronchial infections in children and adolescents suffering from
cystic fibrosis
* complicated urinary tract infections, including infections that have reached
the kidneys (pyelonephritis)
* anthrax inhalation exposure
Ciprobay may also be used to treat other specific severe infections in
children and adolescents when your doctor considered this necessary.
2
What you need to know before you take Ciprobay
Do not take Ciprobay:
* if you are allergic to the active substance, to other quinolone drugs or to
any of the other ingredients of this medicine (listed in Section 6)
* if you are taking tizanidine (see Section 2: Other medicines and Ciprobay)
Warnings and precautions
Talk to your doctor before taking Ciprobay
* if you have ever had kidney problems because your treatment may need to
be adjusted.
* if you suffer from epilepsy or other neurological conditions.
* if you have a history of tendon problems during previous treatment with
antibiotics such as Ciprobay.
* if you are diabetic because you may experience a risk of hypoglycaemia
with ciprofloxacin.
* if you have myasthenia gravis (a type of muscle weakness) because
symptoms can be exacerbated.
* if you have heart problems. Caution should be taken when using
Ciprofloxacin, if you were born with or have family history of prolonged QT
interval (seen on ECG, electrical recording of the heart), have salt
imbalance in the blood (especially low level of potassium or magnesium in
the blood), have a very slow heart rhythm (called ‘bradycardia’), have a
weak heart (heart failure), have a history of heart attack (myocardial
infarction), you are female or elderly or you are taking other medicines that
result in abnormal ECG changes (see section 2: Other medicines and
Ciprobay).
* if you or a member of your family is known to have a deficiency in
glucose-6-phosphate dehydrogenase (G6PD), since you may experience a
risk of anaemia with ciprofloxacin.
For the treatment of some genital tract infections, your doctor can prescribe
another antibiotic in addition to ciprofloxacin. If there is no improvement in
symptoms after 3 days of treatment, please consult your doctor.
While taking Ciprobay
Tell your doctor immediately, if any of the following occurs while taking
Ciprobay. Your doctor will decide whether treatment with Ciprobay needs to
be stopped.
* Severe, sudden allergic reaction (an anaphylactic reaction/shock,
angio-oedema). Even with the first dose, there is a small chance that you
may experience a severe allergic reaction with the following symptoms:
tightness in the chest, feeling dizzy, sick or faint, or experiencing dizziness
when standing up.
If this happens, stop taking Ciprobay and contact your doctor
immediately.
* Pain and swelling in the joints and tendinitis may occur occasionally,
particularly if you are elderly and are also being treated with
corticosteroids. Inflammation and ruptures of tendons may occur even
within the first 48 hours of treatment or up to several months after
discontinuation of Ciprobay therapy. At the first sign of any pain or
inflammation stop taking Ciprobay, contact your doctor and rest the painful
area. Avoid any unnecessary exercise, as this might increase the risk of a
tendon rupture.
Tell your doctor if you are taking:
* Vitamin K antagonists (e.g. warfarin, acenocoumarol, phenprocoumon or
fluindione) or other oral anticoagulants (to thin the blood)
* probenecid (for gout)
* methotrexate (for certain types of cancer, psoriasis, rheumatoid arthritis)
* theophylline (for breathing problems)
* tizanidine (for muscle spasticity in multiple sclerosis)
* olanzapine (an antipsychotic)
* clozapine (an antipsychotic)
* ropinirole (for Parkinson’s disease)
* phenytoin (for epilepsy)
* metoclopramide (for nausea and vomiting)
* cyclosporin (for skin conditions, rheumatoid arthritis and in organ
transplantation)
* other medicines that can alter your heart rhythm: medicines that belong to
the group of anti-arrhythmics (e.g. quinidine, hydroquinidine, disopyramide,
amiodarone, sotalol, dofetilide, ibutilide), tricyclic antidepressants, some
antimicrobials (that belong to the group of macrolides), some
antipsychotics.
* zolpidem (for sleep disorders)
Ciprobay may increase the levels of the following medicines in your blood:
* pentoxifylline (for circulatory disorders)
* caffeine
* duloxetine (for depression, diabetic nerve damage or incontinence)
* lidocaine (for heart conditions or anaesthetic use)
* sildenafil (e.g. for erectile dysfunction)
* agomelatine (for depression)
Some medicines reduce the effect of Ciprobay. Tell your doctor if you take
or wish to take:
* antacids
* omeprazole
* mineral supplements
* sucralfate
* a polymeric phosphate binder (e.g. sevelamer or lanthanum carbonate)
* medicines or supplements containing calcium, magnesium, aluminium or
iron
If these preparations are essential, take Ciprobay about two hours before or
no sooner than four hours after them.
Ciprobay with food and drink
Unless you take Ciprobay during meals, do not eat or drink any dairy
products (such as milk or yoghurt) or drinks with added calcium when you
take the tablets, as they may affect the absorption of the active
substance.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are
planning to have a baby, ask your doctor or pharmacist for advice before
taking this medicine.
It is preferable to avoid the use of Ciprobay during pregnancy.
Do not take Ciprobay during breast-feeding because ciprofloxacin is
excreted in breast milk and can be harmful for your child.
Driving and using machines
Ciprobay may make you feel less alert. Some neurological adverse events
can occur. Therefore, make sure you know how you react to Ciprobay before
driving a vehicle or operating machinery. If in doubt, talk to your doctor.
Ref: 1273/120517/2/B
®
Ciprobay 500 mg Tablets
(ciprofloxacin)
Patient Information Leaflet (continued)
3
How to take Ciprobay
Your doctor will explain to you exactly how much Ciprobay you will have to
take as well as how often and for how long. This will depend on the type of
infection you have and how bad it is.
Tell your doctor if you suffer from kidney problems because your dose may
need to be adjusted.
The treatment usually lasts from 5 to 21 days, but may take longer for
severe infections. Always take this medicine exactly as your doctor has told
you. Check with your doctor or pharmacist if you are not sure how
many tablets to take and how to take Ciprobay.
a. Swallow the tablets with plenty of fluid. Do not chew the tablets because
they do not taste nice.
b. Do try to take the tablets at around the same time every day.
c. You can take the tablets at mealtimes or between meals. Any calcium you
take as part of a meal will not seriously affect uptake. However, do not
take Ciprobay tablets with dairy products such as milk or yoghurt or with
fortified fruit juices (e.g. calcium-fortified orange juice).
Remember to drink plenty of fluids while you are taking this medicine.
If you take more Ciprobay than you should
If you take more than the prescribed dose, get medical help immediately. If
possible, take your tablets or the box with you to show the doctor.
If you forget to take Ciprobay
Take the normal dose as soon as possible and then continue as prescribed.
However, if it is almost time for your next dose, do not take the missed dose
and continue as usual. Do not take a double dose to make up
for a forgotten dose. Be sure to complete your course of treatment.
If you stop taking Ciprobay
It is important that you finish the course of treatment even if you begin to
feel better after a few days. If you stop taking this medicine too soon, your
infection may not be completely cured and the symptoms of the infection
may return or get worse. You might also develop resistance to the antibiotic.
If you have any further questions about the use of this medicine, ask your
doctor or pharmacist.
4
Possible side effects
Like all medicines, this medicine can cause side effects, although not
everybody gets them.
The following section contains the most serious side effects that you can
recognize yourself:
Stop taking Ciprobay and contact your doctor immediately in order to
consider another antibiotic treatment if you notice any of the following
serious side effects:
Rare (may affect up to 1 in 1,000 people)
- Seizure (see Section 2: Warnings and precautions)
Very rare (may affect up to 1 in 10,000 people)
- Severe, sudden allergic reaction with symptoms such as tightness in the
chest, feeling dizzy, sick or faint, or experience dizziness when standing
up (anaphylactic reaction/shock) (see Section 2: Warnings and
precautions)
- Muscle weakness, inflammation of the tendons which could lead to
rupture of the tendon, particularly affecting the large tendon at the back of
the ankle (Achilles tendon) (see Section 2: Warnings and precautions)
- A serious life-threatening skin rash, usually in the form of blisters or ulcers
in the mouth, throat, nose, eyes and other mucous membranes such as
genitals which may progress to widespread blistering or peeling of the
skin (Stevens-Johnson syndrome, toxic epidermal necrolysis).
- pins and needles, unusual sensitivity to stimuli of the senses, decreased
skin sensitivity, tremors, or giddiness
- eyesight problems including double vision (see Section 2: Warnings and
precautions)
- tinnitus, loss of hearing, impaired hearing
- rapid heartbeat (tachycardia)
- expansion of blood vessels (vasodilation), low blood pressure, or fainting
- shortness of breath, including asthmatic symptoms
- liver disorders, jaundice (cholestatic icterus), or hepatitis
- sensitivity to light (see Section 2: Warnings and precautions)
- kidney failure, blood or crystals in the urine, urinary tract inflammation
- fluid retention or excessive sweating
- increased levels of the enzyme amylase
Very rare (may affect up to 1 in 10,000 people)
- a special type of reduced red blood cell count (haemolytic anaemia); a
dangerous drop in a type of white blood cells (agranulocytosis) (see
Section 2: Warnings and precautions); a drop in the number of red and
white blood cells and platelets (pancytopenia), which may be fatal; and
bone marrow depression, which may also be fatal
- allergic reaction called serum sickness-like reaction (see Section 2:
Warnings and precautions)
- mental disturbances (psychotic reactions potentially leading to thoughts of
suicide, suicide attempts, or completed suicide) (see Section 2: Warnings
and precautions)
- migraine, disturbed coordination, unsteady walk (gait disturbance),
disorder of sense of smell (olfactory disorders), pressure on the brain
(intracranial pressure and pseudotumor cerebri)
- visual colour distortions
- inflammation of the wall of the blood vessels (vasculitis)
- pancreatitis
- death of liver cells (liver necrosis) very rarely leading to life-threatening
liver failure (see Section 2:Warnings and precautions)
- small, pin-point bleeding under the skin (petechiae); various skin eruptions
or rashes
- worsening of the symptoms of myasthenia gravis (see Section 2: Warnings
and precautions)
Not known (frequency cannot be estimated from the available data)
- feeling highly excited (mania) or feeling great optimism and overactivity
(hypomania)
- abnormal fast heart rhythm, life-threatening irregular heart rhythm,
alteration of the heart rhythm (called ‘prolongation of QT interval’, seen on
ECG, electrical activity of the heart)
- influence on blood clotting (in patients treated with Vitamin K antagonists)
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This
includes any possible side effects not listed in this leaflet. You can also
report side effects directly via the Yellow Card Scheme at
www.mhra.gov.uk/yellowcard.
By reporting side effects, you can help provide more information on the
safety of this medicine.
5
*
*
*
*
How to store Ciprobay
Keep out of the sight and reach of children.
Do not use Ciprobay after the expiry date, which is stated on the blister or
carton after “EXP”: The expiry date refers to the last day of the month
concerned.
If your medicine becomes discoloured or shows any other signs of
deterioration consult your pharmacist who will tell you what to do.
Medicines should not be disposed of down the drain or with household
rubbish. Ask your pharmacist how to dispose of any medicines no longer
required. These measures will help to protect the environment.
6
Contents of the pack and other information
Not known (frequency cannot be estimated from the available data)
- Unusual feelings of pain, burning tingling, numbness or muscle weakness
in the extremities (neuropathy) (see Section 2: Warnings and precautions)
- A drug reaction that causes rash, fever, inflammation of internal organs,
hematologic abnormalities and systemic illness (DRESS Drug Reaction
with Eosinophilia and Systemic Symptoms, AGEP Acute Generalised
Exanthematous Pustulosis).
What Ciprobay contains
Ciprobay 500 mg film-coated tablets contain the active ingredient,
Ciprofloxacin.
Also contain microcrystalline cellulose, maize starch, crospovidone, colloidal
silicon dioxide, magnesium stearate and purified water. The tablet film-coat
consists of a mixture of hypromellose, macrogol 4000, titanium dioxide and
purified water.
Other side effects which have been observed during treatment with Ciprobay
are listed below by how likely they are:
What Ciprobay looks like and contents of the pack
Ciprobay are white, film-coated tablets. On one side it is marked with a
break line and CIP 500 and marked BAYER on the other. They are available
in blister packs containing 10 Tablets.
Common: (may affect up to 1 in 10 people)
- nausea, diarrhoea
- joint pain and joint inflammation in children
Uncommon (may affect up to 1 in 100 people)
- joint pain in adults
- fungal superinfections
- a high concentration of eosinophils, a type of white blood cell
- decreased appetite
- hyperactivity or agitation
- headache, dizziness, sleeping problems, or taste disorders
- vomiting, abdominal pain, digestive problems such as stomach upset
(indigestion/heartburn), or wind
- increased amounts of certain substances in the blood (transaminases
and/or bilirubin)
- rash, itching, or hives
- poor kidney function
- pains in your muscles and bones, feeling unwell (asthenia), or fever
- increase in blood alkaline phosphatase (a certain substance in the blood)
Rare (may affect up to 1 in 1,000 people)
- muscle pain, inflammation of the joints, increased muscle tone and
cramping
- inflammation of the bowel (colitis) linked to antibiotic use (can be fatal in
very rare cases) (see Section 2: Warnings and precautions)
- changes to the blood count (leukopenia, leukocytosis, neutropenia,
anaemia), increased or decreased amounts of a blood clotting factor
(thrombocytes)
- allergic reaction, swelling (oedema), or rapid swelling of the skin and
mucous membranes (angio-oedema) (see Section 2: Warnings and
precautions)
- increased blood sugar (hyperglycaemia)
- decreased blood sugar (hypoglycaemia) (see Section 2: Warnings and
precautions)
- confusion, disorientation, anxiety reactions, strange dreams, depression
(potentially leading to thoughts of suicide, suicide attempts, or completed
suicide) (see Section 2: Warnings and precautions), or hallucinations
Manufacturer and Licence Holder
This medicine is manufactured by Bayer Pharma AG, D-51368, Leverkusen,
Germany and is procured from within the EU and repackaged by the Product
Licence Holder: Lexon (UK) Limited, Unit 18, Oxleasow Road, East Moons
Moat, Redditch, Worcestershire, B98 0RE.
If you have any questions or are not sure about anything, ask your doctor or
pharmacist. They will have additional information about this medicine and
will be able to advise you.
POM
PL 15184/1273 Ciprobay 500mg Tablets
Ciprobay is a registered trademark of Bayer Aktiengesellschaft
Revision date: 12/05/17
Blind or partially sighted?
Is this leaflet hard to see or read?
Phone Lexon (UK) Limited,
Tel: 01527 505414 to obtain the leaflet
in a format suitable for you
Ref: 1273/120517/3/F
Ciprofloxacin 500 mg Tablets
Patient Information Leaflet
Read all of this leaflet carefully before you start taking this medicine
because it contains important information for you.
* Keep this leaflet. You may need to read it again.
* If you have any further questions, ask your doctor or pharmacist.
* This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them, even if their signs of illness are the same as
yours.
* If you get any side effects, talk to your doctor or pharmacist. This includes
any possible side effects not listed in this leaflet. See section 4.
Your medicine is called Ciprofloxacin 500mg Tablets but will be referred as
Ciprofloxacin throughout this leaflet.
What is in this leaflet
1 What Ciprofloxacin is and what it is used for
2 What you need to know before you take Ciprofloxacin
3 How to take Ciprofloxacin
4 Possible side effects
5 How to store Ciprofloxacin
6 Contents of the pack and other information
1
What Ciprofloxacin is and what it is used for
Ciprofloxacin contains the active substance ciprofloxacin. Ciprofloxacin is an
antibiotic belonging to the fluoroquinolone family. Ciprofloxacin works by
killing bacteria that cause infections. It only works with specific strains of
bacteria.
Adults
Ciprofloxacin is used in adults to treat the following bacterial infections:
* respiratory tract infections
* long lasting or recurring ear or sinus infections
* urinary tract infections
* genital tract infections in men and women
* gastro-intestinal tract infections and intra-abdominal infections
* skin and soft tissue infections
* bone and joint infections
* to prevent infections due to the bacterium Neisseria meningitidis
* anthrax inhalation exposure
* If you suffer from epilepsy or other neurological conditions such as
cerebral ischemia or stroke, you may experience side effects associated
with the central nervous system. If seizure happens, stop taking
Ciprofloxacin and contact your doctor immediately.
* You may experience symptoms of neuropathy such as pain, burning,
tingling, numbness and/or muscle weakness. If this happens, stop taking
Ciprofloxacin and contact your doctor immediately.
* You may experience psychiatric reactions the first time you take
Ciprofloxacin. If you suffer from depression or psychosis, your symptoms
may become worse under treatment with Ciprofloxacin. In rare cases,
depression or psychosis can progress to thoughts of suicide, suicide
attempts, or completed suicide. If this happens, contact your doctor
immediately.
* Hypoglycemia has been reported most often in diabetic patients,
predominantly in elderly population. If this happens, contact your doctor
immediately.
* Diarrhoea may develop while you are taking antibiotics, including
Ciprofloxacin, or even several weeks after you have stopped taking them.
If it becomes severe or persistent or you notice that your stool contains
blood or mucus, stop taking Ciprofloxacin and contact your doctor
immediately, as this can be life-threatening. Do not take medicines that
stop or slow down bowel movements.
* If your eyesight becomes impaired or if your eyes seem to be otherwise
affected, consult an eye specialist immediately.
* Your skin becomes more sensitive to sunlight or ultraviolet (UV) light
when taking Ciprofloxacin. Avoid exposure to strong sunlight, or artificial
UV light such as sunbeds.
* Tell the doctor or laboratory staff that you are taking Ciprofloxacin if you
have to provide a blood or urine sample.
* If you suffer from kidney problems, tell the doctor because your dose may
need to be adjusted.
* Ciprofloxacin may cause liver damage. If you notice any symptoms such
as loss of appetite, jaundice (yellowing of the skin), dark urine, itching, or
tenderness of the stomach, contact your doctor immediately.
* Ciprofloxacin may cause a reduction in the number of white blood cells
and your resistance to infection may be decreased. If you experience
an infection with symptoms such as fever and serious deterioration of
your general condition, or fever with local infection symptoms such as sore
throat/pharynx/mouth or urinary problems you should see your doctor
immediately. A blood test will be taken to check possible reduction of
white blood cells (agranulocytosis). It is important to inform your doctor
about your medicine.
Other medicines and Ciprofloxacin
Tell your doctor or pharmacist if you are taking, have recently taken or might
take any other medicines.
Ciprofloxacin may be used in the management of patients with low white
blood cell counts (neutropenia) who have a fever that is suspected to be due
to a bacterial infection.
Do not take Ciprofloxacin together with tizanidine, because this may
cause side effects such as low blood pressure and sleepiness (see Section
2: Do not take Ciprofloxacin).
If you have a severe infection or one that is caused by more than one type
of bacterium, you may be given additional antibiotic treatment in addition to
Ciprofloxacin.
The following medicines are known to interact with Ciprofloxacin in your
body. Taking Ciprofloxacin together with these medicines can influence the
therapeutic effect of those medicines. It can also increase the probability of
experiencing side effects.
Children and adolescents
Ciprofloxacin is used in children and adolescents, under specialist medical
supervision, to treat the following bacterial infections:
* lung and bronchial infections in children and adolescents suffering from
cystic fibrosis
* complicated urinary tract infections, including infections that have reached
the kidneys (pyelonephritis)
* anthrax inhalation exposure
Ciprofloxacin may also be used to treat other specific severe infections in
children and adolescents when your doctor considered this necessary.
2
What you need to know before you take Ciprofloxacin
Do not take Ciprofloxacin:
* if you are allergic to the active substance, to other quinolone drugs or to
any of the other ingredients of this medicine (listed in Section 6)
* if you are taking tizanidine (see Section 2: Other medicines and
Ciprofloxacin)
Warnings and precautions
Talk to your doctor before taking Ciprofloxacin
* if you have ever had kidney problems because your treatment may need
to be adjusted.
* if you suffer from epilepsy or other neurological conditions.
* if you have a history of tendon problems during previous treatment with
antibiotics such as Ciprofloxacin.
* if you are diabetic because you may experience a risk of hypoglycaemia
with ciprofloxacin.
* if you have myasthenia gravis (a type of muscle weakness) because
symptoms can be exacerbated.
* if you have heart problems. Caution should be taken when using
Ciprofloxacin, if you were born with or have family history of prolonged QT
interval (seen on ECG, electrical recording of the heart), have salt
imbalance in the blood (especially low level of potassium or magnesium in
the blood), have a very slow heart rhythm (called ‘bradycardia’), have a
weak heart (heart failure), have a history of heart attack (myocardial
infarction), you are female or elderly or you are taking other medicines that
result in abnormal ECG changes (see section 2: Other medicines and
Ciprofloxacin).
* if you or a member of your family is known to have a deficiency in
glucose-6-phosphate dehydrogenase (G6PD), since you may experience a
risk of anaemia with ciprofloxacin.
For the treatment of some genital tract infections, your doctor can prescribe
another antibiotic in addition to ciprofloxacin. If there is no improvement in
symptoms after 3 days of treatment, please consult your doctor.
While taking Ciprofloxacin
Tell your doctor immediately, if any of the following occurs while taking
Ciprofloxacin. Your doctor will decide whether treatment with Ciprofloxacin
needs to be stopped.
* Severe, sudden allergic reaction (an anaphylactic reaction/shock,
angio-oedema). Even with the first dose, there is a small chance that you
may experience a severe allergic reaction with the following symptoms:
tightness in the chest, feeling dizzy, sick or faint, or experiencing dizziness
when standing up. If this happens, stop taking Ciprofloxacin and
contact your doctor immediately.
* Pain and swelling in the joints and tendinitis may occur occasionally,
particularly if you are elderly and are also being treated with
corticosteroids. Inflammation and ruptures of tendons may occur even
within the first 48 hours of treatment or up to several months after
discontinuation of Ciprofloxacin therapy. At the first sign of any pain or
inflammation stop taking Ciprofloxacin, contact your doctor and rest the
painful area. Avoid any unnecessary exercise, as this might increase the
risk of a tendon rupture.
Tell your doctor if you are taking:
* Vitamin K antagonists (e.g. warfarin, acenocoumarol, phenprocoumon or
fluindione) or other oral anticoagulants (to thin the blood)
* probenecid (for gout)
* methotrexate (for certain types of cancer, psoriasis, rheumatoid arthritis)
* theophylline (for breathing problems)
* tizanidine (for muscle spasticity in multiple sclerosis)
* olanzapine (an antipsychotic)
* clozapine (an antipsychotic)
* ropinirole (for Parkinson’s disease)
* phenytoin (for epilepsy)
* metoclopramide (for nausea and vomiting)
* cyclosporin (for skin conditions, rheumatoid arthritis and in organ
transplantation)
* other medicines that can alter your heart rhythm: medicines that belong to
the group of anti-arrhythmics (e.g. quinidine, hydroquinidine, disopyramide,
amiodarone, sotalol, dofetilide, ibutilide), tricyclic antidepressants, some
antimicrobials (that belong to the group of macrolides), some
antipsychotics.
Ciprofloxacin may increase the levels of the following medicines in your
blood:
* pentoxifylline (for circulatory disorders)
* caffeine
* duloxetine (for depression, diabetic nerve damage or incontinence)
* lidocaine (for heart conditions or anaesthetic use)
* sildenafil (e.g. for erectile dysfunction)
Some medicines reduce the effect of Ciprofloxacin. Tell your doctor if you
take or wish to take:
* antacids
* omeprazole
* mineral supplements
* sucralfate
* a polymeric phosphate binder (e.g. sevelamer or lanthanum carbonate)
* medicines or supplements containing calcium, magnesium, aluminium or
iron
If these preparations are essential, take Ciprofloxacin about two hours
before or no sooner than four hours after them.
Ciprofloxacin with food and drink
Unless you take Ciprofloxacin during meals, do not eat or drink any dairy
products (such as milk or yoghurt) or drinks with added calcium when you
take the tablets, as they may affect the absorption of the active
substance.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are
planning to have a baby, ask your doctor or pharmacist for advice before
taking this medicine.
It is preferable to avoid the use of Ciprofloxacin during pregnancy.
Do not take Ciprofloxacin during breast-feeding because ciprofloxacin is
excreted in breast milk and can be harmful for your child.
Driving and using machines
Ciprofloxacin may make you feel less alert. Some neurological adverse
events can occur. Therefore, make sure you know how you react to
Ciprofloxacin before driving a vehicle or operating machinery. If in doubt, talk
to your doctor.
Ref: 1273/120517/3/B
Ciprofloxacin 500 mg Tablets
Patient Information Leaflet (continued)
3
How to take Ciprofloxacin
Your doctor will explain to you exactly how much Ciprofloxacin you will have
to take as well as how often and for how long. This will depend on the type
of infection you have and how bad it is.
Tell your doctor if you suffer from kidney problems because your dose may
need to be adjusted.
The treatment usually lasts from 5 to 21 days, but may take longer for
severe infections. Always take this medicine exactly as your doctor has told
you. Check with your doctor or pharmacist if you are not sure how
many tablets to take and how to take Ciprofloxacin
a. Swallow the tablets with plenty of fluid. Do not chew the tablets because
they do not taste nice.
b. Do try to take the tablets at around the same time every day.
c. You can take the tablets at mealtimes or between meals. Any calcium you
take as part of a meal will not seriously affect uptake. However, do not
take Ciprofloxacin tablets with dairy products such as milk or yoghurt or
with fortified fruit juices (e.g. calcium-fortified orange juice).
Remember to drink plenty of fluids while you are taking this medicine.
If you take more Ciprofloxacin than you should
If you take more than the prescribed dose, get medical help immediately. If
possible, take your tablets or the box with you to show the doctor.
If you forget to take Ciprofloxacin
Take the normal dose as soon as possible and then continue as prescribed.
However, if it is almost time for your next dose, do not take the missed dose
and continue as usual. Do not take a double dose to make up
for a forgotten dose. Be sure to complete your course of treatment.
If you stop taking Ciprofloxacin
It is important that you finish the course of treatment even if you begin to
feel better after a few days. If you stop taking this medicine too soon, your
infection may not be completely cured and the symptoms of the infection
may return or get worse. You might also develop resistance to the antibiotic.
If you have any further questions about the use of this medicine, ask your
doctor or pharmacist.
4
Possible side effects
Like all medicines, this medicine can cause side effects, although not
everybody gets them.
The following section contains the most serious side effects that you can
recognize yourself:
Stop taking Ciprofloxacin and contact your doctor immediately in order
to consider another antibiotic treatment if you notice any of the following
serious side effects:
Rare (may affect up to 1 in 1,000 people)
- Seizure (see Section 2: Warnings and precautions)
Very rare (may affect up to 1 in 10,000 people)
- Severe, sudden allergic reaction with symptoms such as tightness in the
chest, feeling dizzy, sick or faint, or experience dizziness when standing
up (anaphylactic reaction/shock) (see Section 2: Warnings and
precautions)
- Muscle weakness, inflammation of the tendons which could lead to rupture
of the tendon, particularly affecting the large tendon at the back of the
ankle (Achilles tendon) (see Section 2: Warnings and precautions)
- A serious life-threatening skin rash, usually in the form of blisters or ulcers
in the mouth, throat, nose, eyes and other mucous membranes such as
genitals which may progress to widespread blistering or peeling of the skin
(Stevens-Johnson syndrome, toxic epidermal necrolysis).
Not known (frequency cannot be estimated from the available data)
- Unusual feelings of pain, burning tingling, numbness or muscle weakness
in the extremities (neuropathy) (see Section 2: Warnings and precautions)
- A drug reaction that causes rash, fever, inflammation of internal organs,
hematologic abnormalities and systemic illness (DRESS Drug Reaction
with Eosinophilia and Systemic Symptoms, AGEP Acute Generalised
Exanthematous Pustulosis).
Other side effects which have been observed during treatment with Ciproxin
are listed below by how likely they are:
Common: (may affect up to 1 in 10 people)
- nausea, diarrhoea
- joint pain and joint inflammation in children
Uncommon (may affect up to 1 in 100 people)
- joint pain in adults
- fungal superinfections
- a high concentration of eosinophils, a type of white blood cell
- decreased appetite
- hyperactivity or agitation
- headache, dizziness, sleeping problems, or taste disorders
- vomiting, abdominal pain, digestive problems such as stomach upset
(indigestion/heartburn), or wind
- increased amounts of certain substances in the blood (transaminases
and/or bilirubin)
- rash, itching, or hives
- poor kidney function
- pains in your muscles and bones, feeling unwell (asthenia), or fever
- increase in blood alkaline phosphatase (a certain substance in the blood)
Rare (may affect up to 1 in 1,000 people)
- muscle pain, inflammation of the joints, increased muscle tone and
cramping
- inflammation of the bowel (colitis) linked to antibiotic use (can be fatal in
very rare cases) (see Section 2: Warnings and precautions)
- changes to the blood count (leukopenia, leukocytosis, neutropenia,
anaemia), increased or decreased amounts of a blood clotting factor
(thrombocytes)
- allergic reaction, swelling (oedema), or rapid swelling of the skin and
mucous membranes (angio-oedema) (see Section 2: Warnings and
precautions)
- increased blood sugar (hyperglycaemia)
- decreased blood sugar (hypoglycaemia) (see Section 2: Warnings and
precautions)
- confusion, disorientation, anxiety reactions, strange dreams, depression
(potentially leading to thoughts of suicide, suicide attempts, or completed
suicide) (see Section 2: Warnings and precautions), or hallucinations
- pins and needles, unusual sensitivity to stimuli of the senses, decreased
skin sensitivity, tremors, or giddiness
- eyesight problems including double vision (see Section 2: Warnings and
precautions)
- tinnitus, loss of hearing, impaired hearing
- rapid heartbeat (tachycardia)
- expansion of blood vessels (vasodilation), low blood pressure, or fainting
- shortness of breath, including asthmatic symptoms
- liver disorders, jaundice (cholestatic icterus), or hepatitis
- sen
Ciproxin ® 500 mg Tablets
(ciprofloxacin)
Patient Information Leaflet
Read all of this leaflet carefully before you start taking this medicine
because it contains important information for you.
* Keep this leaflet. You may need to read it again.
* If you have any further questions, ask your doctor or pharmacist.
* This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them, even if their signs of illness are the same as
yours.
* If you get any side effects, talk to your doctor or pharmacist. This includes
any possible side effects not listed in this leaflet. See section 4.
Your medicine is called Ciproxin 500mg Tablets but will be referred as
Ciproxin throughout this leaflet.
What is in this leaflet
1 What Ciproxin is and what it is used for
2 What you need to know before you take Ciproxin
3 How to take Ciproxin
4 Possible side effects
5 How to store Ciproxin
6 Contents of the pack and other information
1
What Ciproxin is and what it is used for
Ciproxin contains the active substance ciprofloxacin. Ciprofloxacin is an
antibiotic belonging to the fluoroquinolone family. Ciprofloxacin works by
killing bacteria that cause infections. It only works with specific strains of
bacteria.
Adults
Ciproxin is used in adults to treat the following bacterial infections:
* respiratory tract infections
* long lasting or recurring ear or sinus infections
* urinary tract infections
* genital tract infections in men and women
* gastro-intestinal tract infections and intra-abdominal infections
* skin and soft tissue infections
* bone and joint infections
* to prevent infections due to the bacterium Neisseria meningitidis
* anthrax inhalation exposure
* If you suffer from epilepsy or other neurological conditions such as
cerebral ischemia or stroke, you may experience side effects associated
with the central nervous system. If seizure happens, stop taking Ciproxin
and contact your doctor immediately.
* You may experience symptoms of neuropathy such as pain, burning,
tingling, numbness and/or muscle weakness. If this happens, stop taking
Ciproxin and contact your doctor immediately.
* You may experience psychiatric reactions the first time you take
Ciproxin. If you suffer from depression or psychosis, your symptoms
may become worse under treatment with Ciproxin. In rare cases,
depression or psychosis can progress to thoughts of suicide, suicide
attempts, or completed suicide. If this happens, contact your doctor
immediately.
* Hypoglycemia has been reported most often in diabetic patients,
predominantly in elderly population. If this happens, contact your doctor
immediately.
* Diarrhoea may develop while you are taking antibiotics, including Ciproxin,
or even several weeks after you have stopped taking them. If it becomes
severe or persistent or you notice that your stool contains blood or mucus,
stop taking Ciproxin and contact your doctor immediately, as this can be
life-threatening. Do not take medicines that stop or slow down bowel
movements.
* If your eyesight becomes impaired or if your eyes seem to be otherwise
affected, consult an eye specialist immediately.
* Your skin becomes more sensitive to sunlight or ultraviolet (UV) light
when taking Ciproxin. Avoid exposure to strong sunlight, or artificial UV
light such as sunbeds.
* Tell the doctor or laboratory staff that you are taking Ciproxin if you have to
provide a blood or urine sample.
* If you suffer from kidney problems, tell the doctor because your dose may
need to be adjusted.
* Ciproxin may cause liver damage. If you notice any symptoms such as
loss of appetite, jaundice (yellowing of the skin), dark urine, itching, or
tenderness of the stomach, contact your doctor immediately.
* Ciproxin may cause a reduction in the number of white blood cells and
your resistance to infection may be decreased. If you experience an
infection with symptoms such as fever and serious deterioration of
your general condition, or fever with local infection symptoms such as sore
throat/pharynx/mouth or urinary problems you should see your doctor
immediately. A blood test will be taken to check possible reduction of
white blood cells (agranulocytosis). It is important to inform your doctor
about your medicine.
Other medicines and Ciproxin
Tell your doctor or pharmacist if you are taking, have recently taken or might
take any other medicines.
Ciprofloxacin may be used in the management of patients with low white
blood cell counts (neutropenia) who have a fever that is suspected to be due
to a bacterial infection.
Do not take Ciproxin together with tizanidine, because this may cause
side effects such as low blood pressure and sleepiness (see Section 2: Do
not take Ciproxin).
If you have a severe infection or one that is caused by more than one type
of bacterium, you may be given additional antibiotic treatment in addition to
Ciproxin.
The following medicines are known to interact with Ciproxin in your body.
Taking Ciproxin together with these medicines can influence the therapeutic
effect of those medicines. It can also increase the probability of experiencing
side effects.
Children and adolescents
Ciproxin is used in children and adolescents, under specialist medical
supervision, to treat the following bacterial infections:
* lung and bronchial infections in children and adolescents suffering from
cystic fibrosis
* complicated urinary tract infections, including infections that have reached
the kidneys (pyelonephritis)
* anthrax inhalation exposure
Ciproxin may also be used to treat other specific severe infections in
children and adolescents when your doctor considered this necessary.
2
What you need to know before you take Ciproxin
Do not take Ciproxin:
* if you are allergic to the active substance, to other quinolone drugs or to
any of the other ingredients of this medicine (listed in Section 6)
* if you are taking tizanidine (see Section 2: Other medicines and Ciproxin)
Warnings and precautions
Talk to your doctor before taking Ciproxin
* if you have ever had kidney problems because your treatment may need to
be adjusted.
* if you suffer from epilepsy or other neurological conditions.
* if you have a history of tendon problems during previous treatment with
antibiotics such as Ciproxin.
* if you are diabetic because you may experience a risk of hypoglycaemia
with ciprofloxacin.
* if you have myasthenia gravis (a type of muscle weakness) because
symptoms can be exacerbated.
* if you have heart problems. Caution should be taken when using
Ciprofloxacin, if you were born with or have family history of prolonged QT
interval (seen on ECG, electrical recording of the heart), have salt
imbalance in the blood (especially low level of potassium or magnesium in
the blood), have a very slow heart rhythm (called ‘bradycardia’), have a
weak heart (heart failure), have a history of heart attack (myocardial
infarction), you are female or elderly or you are taking other medicines that
result in abnormal ECG changes (see section 2: Other medicines and
Ciproxin).
* if you or a member of your family is known to have a deficiency in
glucose-6-phosphate dehydrogenase (G6PD), since you may experience a
risk of anaemia with ciprofloxacin.
For the treatment of some genital tract infections, your doctor can prescribe
another antibiotic in addition to ciprofloxacin. If there is no improvement in
symptoms after 3 days of treatment, please consult your doctor.
While taking Ciproxin
Tell your doctor immediately, if any of the following occurs while taking
Ciproxin. Your doctor will decide whether treatment with Ciproxin needs to
be stopped.
* Severe, sudden allergic reaction (an anaphylactic reaction/shock,
angio-oedema). Even with the first dose, there is a small chance that you
may experience a severe allergic reaction with the following
symptoms: tightness in the chest, feeling dizzy, sick or faint, or
experiencing dizziness when standing up.
If this happens, stop taking Ciproxin and contact your doctor
immediately.
* Pain and swelling in the joints and tendinitis may occur occasionally,
particularly if you are elderly and are also being treated with
corticosteroids. Inflammation and ruptures of tendons may occur even
within the first 48 hours of treatment or up to several months after
discontinuation of Ciproxin therapy. At the first sign of any pain or
inflammation stop taking Ciproxin, contact your doctor and rest the painful
area. Avoid any unnecessary exercise, as this might increase the risk of a
tendon rupture.
Tell your doctor if you are taking:
* Vitamin K antagonists (e.g. warfarin, acenocoumarol, phenprocoumon or
fluindione) or other oral anticoagulants (to thin the blood)
* probenecid (for gout)
* methotrexate (for certain types of cancer, psoriasis, rheumatoid arthritis)
* theophylline (for breathing problems)
* tizanidine (for muscle spasticity in multiple sclerosis)
* olanzapine (an antipsychotic)
* clozapine (an antipsychotic)
* ropinirole (for Parkinson’s disease)
* phenytoin (for epilepsy)
* metoclopramide (for nausea and vomiting)
* cyclosporin (for skin conditions, rheumatoid arthritis and in organ
transplantation)
* other medicines that can alter your heart rhythm: medicines that belong to
the group of anti-arrhythmics (e.g. quinidine, hydroquinidine, disopyramide,
amiodarone, sotalol, dofetilide, ibutilide), tricyclic antidepressants, some
antimicrobials (that belong to the group of macrolides), some
antipsychotics.
* zolpidem (for sleep disorders)
Ciproxin may increase the levels of the following medicines in your blood:
* pentoxifylline (for circulatory disorders)
* caffeine
* duloxetine (for depression, diabetic nerve damage or incontinence)
* lidocaine (for heart conditions or anaesthetic use)
* sildenafil (e.g. for erectile dysfunction)
* agomelatine (for depression)
Some medicines reduce the effect of Ciproxin. Tell your doctor if you take or
wish to take:
* antacids
* omeprazole
* mineral supplements
* sucralfate
* a polymeric phosphate binder (e.g. sevelamer or lanthanum carbonate)
* medicines or supplements containing calcium, magnesium, aluminium or
iron
If these preparations are essential, take Ciproxin about two hours before or
no sooner than four hours after them.
Ciproxin with food and drink
Unless you take Ciproxin during meals, do not eat or drink any dairy
products (such as milk or yoghurt) or drinks with added calcium when you
take the tablets, as they may affect the absorption of the active substance.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are
planning to have a baby, ask your doctor or pharmacist for advice before
taking this medicine.
It is preferable to avoid the use of Ciproxin during pregnancy.
Do not take Ciproxin during breast-feeding because ciprofloxacin is excreted
in breast milk and can be harmful for your child.
Driving and using machines
Ciproxin may make you feel less alert. Some neurological adverse events
can occur. Therefore, make sure you know how you react to Ciproxin before
driving a vehicle or operating machinery. If in doubt, talk to your doctor.
Ref: 1273/120517/1/B
Ciproxin 500 mg Tablets
®
(ciprofloxacin)
Patient Information Leaflet (continued)
3
How to take Ciproxin
Your doctor will explain to you exactly how much Ciproxin you will have to
take as well as how often and for how long. This will depend on the type of
infection you have and how bad it is.
Tell your doctor if you suffer from kidney problems because your dose may
need to be adjusted.
The treatment usually lasts from 5 to 21 days, but may take longer for
severe infections. Always take this medicine exactly as your doctor has told
you. Check with your doctor or pharmacist if you are not sure how
many tablets to take and how to take Ciproxin.
a. Swallow the tablets with plenty of fluid. Do not chew the tablets because
they do not taste nice.
b. Do try to take the tablets at around the same time every day.
c. You can take the tablets at mealtimes or between meals. Any calcium you
take as part of a meal will not seriously affect uptake. However, do not
take Ciproxin tablets with dairy products such as milk or yoghurt or with
fortified fruit juices (e.g. calcium-fortified orange juice).
Remember to drink plenty of fluids while you are taking this medicine.
If you take more Ciproxin than you should
If you take more than the prescribed dose, get medical help immediately. If
possible, take your tablets or the box with you to show the doctor.
If you forget to take Ciproxin
Take the normal dose as soon as possible and then continue as prescribed.
However, if it is almost time for your next dose, do not take the missed dose
and continue as usual. Do not take a double dose to make up
for a forgotten dose. Be sure to complete your course of treatment.
If you stop taking Ciproxin
It is important that you finish the course of treatment even if you begin to
feel better after a few days. If you stop taking this medicine too soon, your
infection may not be completely cured and the symptoms of the infection
may return or get worse. You might also develop resistance to the antibiotic.
If you have any further questions about the use of this medicine, ask your
doctor or pharmacist.
4
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following section contains the most serious side effects that you can
recognize yourself:
Stop taking Ciproxin and contact your doctor immediately in order to
consider another antibiotic treatment if you notice any of the following serious side effects:
Rare (may affect up to 1 in 1,000 people)
- Seizure (see Section 2: Warnings and precautions)
Very rare (may affect up to 1 in 10,000 people)
- Severe, sudden allergic reaction with symptoms such as tightness in the
chest, feeling dizzy, sick or faint, or experience dizziness when standing
up (anaphylactic reaction/shock) (see Section 2: Warnings and
precautions)
- Muscle weakness, inflammation of the tendons which could lead to rupture
of the tendon, particularly affecting the large tendon at the back of the
ankle (Achilles tendon) (see Section 2: Warnings and precautions)
- A serious life-threatening skin rash, usually in the form of blisters or ulcers
in the mouth, throat, nose, eyes and other mucous membranes such as
genitals which may progress to widespread blistering or peeling of the skin
(Stevens-Johnson syndrome, toxic epidermal necrolysis).
Not known (frequency cannot be estimated from the available data)
- Unusual feelings of pain, burning tingling, numbness or muscle weakness
in the extremities (neuropathy) (see Section 2: Warnings and precautions)
- A drug reaction that causes rash, fever, inflammation of internal organs,
hematologic abnormalities and systemic illness (DRESS Drug Reaction
with Eosinophilia and Systemic Symptoms, AGEP Acute Generalised
Exanthematous Pustulosis).
Other side effects which have been observed during treatment with Ciproxin
are listed below by how likely they are:
Common: (may affect up to 1 in 10 people)
- nausea, diarrhoea
- joint pain and joint inflammation in children
Uncommon (may affect up to 1 in 100 people)
- joint pain in adults
- fungal superinfections
- a high concentration of eosinophils, a type of white blood cell
- decreased appetite
- hyperactivity or agitation
- headache, dizziness, sleeping problems, or taste disorders
- vomiting, abdominal pain, digestive problems such as stomach upset
(indigestion/heartburn), or wind
- increased amounts of certain substances in the blood (transaminases
and/or bilirubin)
- rash, itching, or hives
- poor kidney function
- pains in your muscles and bones, feeling unwell (asthenia), or fever
- increase in blood alkaline phosphatase (a certain substance in the blood)
Rare (may affect up to 1 in 1,000 people)
- muscle pain, inflammation of the joints, increased muscle tone and
cramping
- inflammation of the bowel (colitis) linked to antibiotic use (can be fatal in
very rare cases) (see Section 2: Warnings and precautions)
- changes to the blood count (leukopenia, leukocytosis, neutropenia,
anaemia), increased or decreased amounts of a blood clotting factor
(thrombocytes)
- allergic reaction, swelling (oedema), or rapid swelling of the skin and
mucous membranes (angio-oedema) (see Section 2: Warnings and
precautions)
- increased blood sugar (hyperglycaemia)
- decreased blood sugar (hypoglycaemia) (see Section 2: Warnings and
precautions)
- confusion, disorientation, anxiety reactions, strange dreams, depression
(potentially leading to thoughts of suicide, suicide attempts, or completed
suicide) (see Section 2: Warnings and precautions), or hallucinations
- pins and needles, unusual sensitivity to stimuli of the senses, decreased
skin sensitivity, tremors, or giddiness
- eyesight problems including double vision (see Section 2: Warnings and
precautions)
- tinnitus, loss of hearing, impaired hearing
- rapid heartbeat (tachycardia)
- expansion of blood vessels (vasodilation), low blood pressure, or fainting
- shortness of breath, including asthmatic symptoms
- liver disorders, jaundice (cholestatic icterus), or hepatitis
- sensitivity to light (see Section 2: Warnings and precautions)
- kidney failure, blood or crystals in the urine, urinary tract inflammation
- fluid retention or excessive sweating
- increased levels of the enzyme amylase
Very rare (may affect up to 1 in 10,000 people)
- a special type of reduced red blood cell count (haemolytic anaemia); a
dangerous drop in a type of white blood cells (agranulocytosis) (see
Section 2: Warnings and precautions); a drop in the number of red and
white blood cells and platelets (pancytopenia), which may be fatal; and
bone marrow depression, which may also be fatal
- allergic reaction called serum sickness-like reaction (see Section 2:
Warnings and precautions)
- mental disturbances (psychotic reactions potentially leading to thoughts of
suicide, suicide attempts, or completed suicide) (see Section 2: Warnings
and precautions)
- migraine, disturbed coordination, unsteady walk (gait disturbance),
disorder of sense of smell (olfactory disorders), pressure on the brain
(intracranial pressure and pseudotumor cerebri)
- visual colour distortions
- inflammation of the wall of the blood vessels (vasculitis)
- pancreatitis
- death of liver cells (liver necrosis) very rarely leading to life-threatening
liver failure (see Section 2: Warnings and precautions)
- small, pin-point bleeding under the skin (petechiae); various skin eruptions
or rashes
- worsening of the symptoms of myasthenia gravis (see Section 2: Warnings
and precautions)
Not known (frequency cannot be estimated from the available data)
- feeling highly excited (mania) or feeling great optimism and overactivity
(hypomania)
- abnormal fast heart rhythm, life-threatening irregular heart rhythm,
alteration of the heart rhythm (called ‘prolongation of QT interval’, seen on
ECG, electrical activity of the heart)
- influence on blood clotting (in patients treated with Vitamin K antagonists)
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This
includes any possible side effects not listed in this leaflet. You can also
report side effects directly via the Yellow Card Scheme at
www.mhra.gov.uk/yellowcard.
By reporting side effects, you can help provide more information on the
safety of this medicine.
5
How to store Ciproxin
Keep out of the sight and reach of children.
Do not use Ciproxin after the expiry date, which is stated on the blister or
carton after “EXP”: The expiry date refers to the last day of the month
concerned.
If your medicine becomes discoloured or shows any other signs of
deterioration consult your pharmacist who will tell you what to do.
Medicines should not be disposed of down the drain or with household
rubbish. Ask your pharmacist how to dispose of any medicines no longer
required. These measures will help to protect the environment.
*
*
*
*
6
Contents of the pack and other information
What Ciproxin contains
Ciproxin 500 mg film-coated tablets contain the active ingredient,
Ciprofloxacin.
Also contain microcrystalline cellulose, maize starch, crospovidone, colloidal
silicon dioxide, magnesium stearate and purified water. The tablet film-coat
consists of a mixture of hypromellose, macrogol 4000, titanium dioxide and
purified water.
What Ciproxin looks like and contents of the pack
Ciproxin are white, film-coated tablets. On one side it is marked with a break
line and CIP 500 and marked BAYER on the other. They are available in
blister packs containing 10 Tablets
Manufacturer and Licence Holder
This medicine is manufactured by Bayer Pharma AG, D-51368, Leverkusen,
Germany and is procured from within the EU and repackaged by the Product
Licence Holder: Lexon (UK) Limited, Unit 18, Oxleasow Road, East Moons
Moat, Redditch, Worcestershire, B98 0RE.
If you have any questions or are not sure about anything, ask your doctor or
pharmacist. They will have additional information about this medicine and
will be able to advise you.
POM
PL 15184/1273 Ciproxin 500mg Tablets
Ciproxin is a registered trademark of Bayer Aktiengesellschaft
Revision date: 12/05/17
Blind or partially sighted?
Is this leaflet hard to see or read?
Phone Lexon (UK) Limited,
Tel: 01527 505414 to obtain the leaflet
in a format suitable for you
Ref: 1273/120517/2/F
Ciprobay® 500 mg Tablets
(ciprofloxacin)
Patient Information Leaflet
Read all of this leaflet carefully before you start taking this medicine
because it contains important information for you.
* Keep this leaflet. You may need to read it again.
* If you have any further questions, ask your doctor or pharmacist.
* This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them, even if their signs of illness are the same as
yours.
* If you get any side effects, talk to your doctor or pharmacist. This includes
any possible side effects not listed in this leaflet. See section 4.
Your medicine is called Ciprobay 500mg Tablets but will be referred as
Ciprobay throughout this leaflet.
What is in this leaflet
1 What Ciprobay is and what it is used for
2 What you need to know before you take Ciprobay
3 How to take Ciprobay
4 Possible side effects
5 How to store Ciprobay
6 Contents of the pack and other information
1
What Ciprobay is and what it is used for
Ciprobay contains the active substance ciprofloxacin. Ciprofloxacin is an
antibiotic belonging to the fluoroquinolone family. Ciprofloaxcin works by
killing bacteria that cause infections. It only works with specific strains of
bacteria.
Adults
Ciprobay is used in adults to treat the following bacterial infections:
* respiratory tract infections
* long lasting or recurring ear or sinus infections
* urinary tract infections
* genital tract infections in men and women
* gastro-intestinal tract infections and intra-abdominal infections
* skin and soft tissue infections
* bone and joint infections
* to prevent infections due to the bacterium Neisseria meningitidis
* anthrax inhalation exposure
* If you suffer from epilepsy or other neurological conditions such as
cerebral ischemia or stroke, you may experience side effects associated
with the central nervous system. If seizure happens, stop taking Ciprobay
and contact your doctor immediately.
* You may experience symptoms of neuropathy such as pain, burning,
tingling, numbness and/or muscle weakness. If this happens, stop taking
Ciprobay and contact your doctor immediately.
* You may experience psychiatric reactions the first time you take
Ciprobay. If you suffer from depression or psychosis, your symptoms
may become worse under treatment with Ciprobay. In rare cases,
depression or psychosis can progress to thoughts of suicide, suicide
attempts, or completed suicide. If this happens, contact your doctor
immediately.
* Hypoglycemia has been reported most often in diabetic patients,
predominantly in elderly population. If this happens, contact your doctor
immediately.
* Diarrhoea may develop while you are taking antibiotics, including
Ciprobay, or even several weeks after you have stopped taking them. If it
becomes severe or persistent or you notice that your stool contains blood
or mucus, stop taking Ciprobay and contact your doctor immediately, as
this can be life-threatening. Do not take medicines that stop or slow down
bowel movements.
* If your eyesight becomes impaired or if your eyes seem to be otherwise
affected, consult an eye specialist immediately.
* Your skin becomes more sensitive to sunlight or ultraviolet (UV) light
when taking Ciprobay. Avoid exposure to strong sunlight, or artificial UV
light such as sunbeds.
* Tell the doctor or laboratory staff that you are taking Ciprobay if you have
to provide a blood or urine sample.
* If you suffer from kidney problems, tell the doctor because your dose may
need to be adjusted.
* Ciprobay may cause liver damage. If you notice any symptoms such as
loss of appetite, jaundice (yellowing of the skin), dark urine, itching, or
tenderness of the stomach, contact your doctor immediately.
* Ciprobay may cause a reduction in the number of white blood cells and
your resistance to infection may be decreased. If you experience an
infection with symptoms such as fever and serious deterioration of
your general condition, or fever with local infection symptoms such as sore
throat/pharynx/mouth or urinary problems you should see your doctor
immediately. A blood test will be taken to check possible reduction of
white blood cells (agranulocytosis). It is important to inform your doctor
about your medicine.
Other medicines and Ciprobay
Tell your doctor or pharmacist if you are taking, have recently taken or might
take any other medicines.
Ciprofloxacin may be used in the management of patients with low white
blood cell counts (neutropenia) who have a fever that is suspected to be due
to a bacterial infection.
Do not take Ciprobay together with tizanidine, because this may cause
side effects such as low blood pressure and sleepiness (see Section 2: Do
not take Ciprobay).
If you have a severe infection or one that is caused by more than one type
of bacterium, you may be given additional antibiotic treatment in addition to
Ciprobay.
The following medicines are known to interact with Ciprobay in your body.
Taking Ciprobay together with these medicines can influence the therapeutic
effect of those medicines. It can also increase the probability of experiencing
side effects.
Children and adolescents
Ciprobay is used in children and adolescents, under specialist medical
supervision, to treat the following bacterial infections:
* lung and bronchial infections in children and adolescents suffering from
cystic fibrosis
* complicated urinary tract infections, including infections that have reached
the kidneys (pyelonephritis)
* anthrax inhalation exposure
Ciprobay may also be used to treat other specific severe infections in
children and adolescents when your doctor considered this necessary.
2
What you need to know before you take Ciprobay
Do not take Ciprobay:
* if you are allergic to the active substance, to other quinolone drugs or to
any of the other ingredients of this medicine (listed in Section 6)
* if you are taking tizanidine (see Section 2: Other medicines and Ciprobay)
Warnings and precautions
Talk to your doctor before taking Ciprobay
* if you have ever had kidney problems because your treatment may need to
be adjusted.
* if you suffer from epilepsy or other neurological conditions.
* if you have a history of tendon problems during previous treatment with
antibiotics such as Ciprobay.
* if you are diabetic because you may experience a risk of hypoglycaemia
with ciprofloxacin.
* if you have myasthenia gravis (a type of muscle weakness) because
symptoms can be exacerbated.
* if you have heart problems. Caution should be taken when using
Ciprofloxacin, if you were born with or have family history of prolonged QT
interval (seen on ECG, electrical recording of the heart), have salt
imbalance in the blood (especially low level of potassium or magnesium in
the blood), have a very slow heart rhythm (called ‘bradycardia’), have a
weak heart (heart failure), have a history of heart attack (myocardial
infarction), you are female or elderly or you are taking other medicines that
result in abnormal ECG changes (see section 2: Other medicines and
Ciprobay).
* if you or a member of your family is known to have a deficiency in
glucose-6-phosphate dehydrogenase (G6PD), since you may experience a
risk of anaemia with ciprofloxacin.
For the treatment of some genital tract infections, your doctor can prescribe
another antibiotic in addition to ciprofloxacin. If there is no improvement in
symptoms after 3 days of treatment, please consult your doctor.
While taking Ciprobay
Tell your doctor immediately, if any of the following occurs while taking
Ciprobay. Your doctor will decide whether treatment with Ciprobay needs to
be stopped.
* Severe, sudden allergic reaction (an anaphylactic reaction/shock,
angio-oedema). Even with the first dose, there is a small chance that you
may experience a severe allergic reaction with the following symptoms:
tightness in the chest, feeling dizzy, sick or faint, or experiencing dizziness
when standing up.
If this happens, stop taking Ciprobay and contact your doctor
immediately.
* Pain and swelling in the joints and tendinitis may occur occasionally,
particularly if you are elderly and are also being treated with
corticosteroids. Inflammation and ruptures of tendons may occur even
within the first 48 hours of treatment or up to several months after
discontinuation of Ciprobay therapy. At the first sign of any pain or
inflammation stop taking Ciprobay, contact your doctor and rest the painful
area. Avoid any unnecessary exercise, as this might increase the risk of a
tendon rupture.
Tell your doctor if you are taking:
* Vitamin K antagonists (e.g. warfarin, acenocoumarol, phenprocoumon or
fluindione) or other oral anticoagulants (to thin the blood)
* probenecid (for gout)
* methotrexate (for certain types of cancer, psoriasis, rheumatoid arthritis)
* theophylline (for breathing problems)
* tizanidine (for muscle spasticity in multiple sclerosis)
* olanzapine (an antipsychotic)
* clozapine (an antipsychotic)
* ropinirole (for Parkinson’s disease)
* phenytoin (for epilepsy)
* metoclopramide (for nausea and vomiting)
* cyclosporin (for skin conditions, rheumatoid arthritis and in organ
transplantation)
* other medicines that can alter your heart rhythm: medicines that belong to
the group of anti-arrhythmics (e.g. quinidine, hydroquinidine, disopyramide,
amiodarone, sotalol, dofetilide, ibutilide), tricyclic antidepressants, some
antimicrobials (that belong to the group of macrolides), some
antipsychotics.
* zolpidem (for sleep disorders)
Ciprobay may increase the levels of the following medicines in your blood:
* pentoxifylline (for circulatory disorders)
* caffeine
* duloxetine (for depression, diabetic nerve damage or incontinence)
* lidocaine (for heart conditions or anaesthetic use)
* sildenafil (e.g. for erectile dysfunction)
* agomelatine (for depression)
Some medicines reduce the effect of Ciprobay. Tell your doctor if you take
or wish to take:
* antacids
* omeprazole
* mineral supplements
* sucralfate
* a polymeric phosphate binder (e.g. sevelamer or lanthanum carbonate)
* medicines or supplements containing calcium, magnesium, aluminium or
iron
If these preparations are essential, take Ciprobay about two hours before or
no sooner than four hours after them.
Ciprobay with food and drink
Unless you take Ciprobay during meals, do not eat or drink any dairy
products (such as milk or yoghurt) or drinks with added calcium when you
take the tablets, as they may affect the absorption of the active
substance.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are
planning to have a baby, ask your doctor or pharmacist for advice before
taking this medicine.
It is preferable to avoid the use of Ciprobay during pregnancy.
Do not take Ciprobay during breast-feeding because ciprofloxacin is
excreted in breast milk and can be harmful for your child.
Driving and using machines
Ciprobay may make you feel less alert. Some neurological adverse events
can occur. Therefore, make sure you know how you react to Ciprobay before
driving a vehicle or operating machinery. If in doubt, talk to your doctor.
Ref: 1273/120517/2/B
®
Ciprobay 500 mg Tablets
(ciprofloxacin)
Patient Information Leaflet (continued)
3
How to take Ciprobay
Your doctor will explain to you exactly how much Ciprobay you will have to
take as well as how often and for how long. This will depend on the type of
infection you have and how bad it is.
Tell your doctor if you suffer from kidney problems because your dose may
need to be adjusted.
The treatment usually lasts from 5 to 21 days, but may take longer for
severe infections. Always take this medicine exactly as your doctor has told
you. Check with your doctor or pharmacist if you are not sure how
many tablets to take and how to take Ciprobay.
a. Swallow the tablets with plenty of fluid. Do not chew the tablets because
they do not taste nice.
b. Do try to take the tablets at around the same time every day.
c. You can take the tablets at mealtimes or between meals. Any calcium you
take as part of a meal will not seriously affect uptake. However, do not
take Ciprobay tablets with dairy products such as milk or yoghurt or with
fortified fruit juices (e.g. calcium-fortified orange juice).
Remember to drink plenty of fluids while you are taking this medicine.
If you take more Ciprobay than you should
If you take more than the prescribed dose, get medical help immediately. If
possible, take your tablets or the box with you to show the doctor.
If you forget to take Ciprobay
Take the normal dose as soon as possible and then continue as prescribed.
However, if it is almost time for your next dose, do not take the missed dose
and continue as usual. Do not take a double dose to make up
for a forgotten dose. Be sure to complete your course of treatment.
If you stop taking Ciprobay
It is important that you finish the course of treatment even if you begin to
feel better after a few days. If you stop taking this medicine too soon, your
infection may not be completely cured and the symptoms of the infection
may return or get worse. You might also develop resistance to the antibiotic.
If you have any further questions about the use of this medicine, ask your
doctor or pharmacist.
4
Possible side effects
Like all medicines, this medicine can cause side effects, although not
everybody gets them.
The following section contains the most serious side effects that you can
recognize yourself:
Stop taking Ciprobay and contact your doctor immediately in order to
consider another antibiotic treatment if you notice any of the following
serious side effects:
Rare (may affect up to 1 in 1,000 people)
- Seizure (see Section 2: Warnings and precautions)
Very rare (may affect up to 1 in 10,000 people)
- Severe, sudden allergic reaction with symptoms such as tightness in the
chest, feeling dizzy, sick or faint, or experience dizziness when standing
up (anaphylactic reaction/shock) (see Section 2: Warnings and
precautions)
- Muscle weakness, inflammation of the tendons which could lead to
rupture of the tendon, particularly affecting the large tendon at the back of
the ankle (Achilles tendon) (see Section 2: Warnings and precautions)
- A serious life-threatening skin rash, usually in the form of blisters or ulcers
in the mouth, throat, nose, eyes and other mucous membranes such as
genitals which may progress to widespread blistering or peeling of the
skin (Stevens-Johnson syndrome, toxic epidermal necrolysis).
- pins and needles, unusual sensitivity to stimuli of the senses, decreased
skin sensitivity, tremors, or giddiness
- eyesight problems including double vision (see Section 2: Warnings and
precautions)
- tinnitus, loss of hearing, impaired hearing
- rapid heartbeat (tachycardia)
- expansion of blood vessels (vasodilation), low blood pressure, or fainting
- shortness of breath, including asthmatic symptoms
- liver disorders, jaundice (cholestatic icterus), or hepatitis
- sensitivity to light (see Section 2: Warnings and precautions)
- kidney failure, blood or crystals in the urine, urinary tract inflammation
- fluid retention or excessive sweating
- increased levels of the enzyme amylase
Very rare (may affect up to 1 in 10,000 people)
- a special type of reduced red blood cell count (haemolytic anaemia); a
dangerous drop in a type of white blood cells (agranulocytosis) (see
Section 2: Warnings and precautions); a drop in the number of red and
white blood cells and platelets (pancytopenia), which may be fatal; and
bone marrow depression, which may also be fatal
- allergic reaction called serum sickness-like reaction (see Section 2:
Warnings and precautions)
- mental disturbances (psychotic reactions potentially leading to thoughts of
suicide, suicide attempts, or completed suicide) (see Section 2: Warnings
and precautions)
- migraine, disturbed coordination, unsteady walk (gait disturbance),
disorder of sense of smell (olfactory disorders), pressure on the brain
(intracranial pressure and pseudotumor cerebri)
- visual colour distortions
- inflammation of the wall of the blood vessels (vasculitis)
- pancreatitis
- death of liver cells (liver necrosis) very rarely leading to life-threatening
liver failure (see Section 2:Warnings and precautions)
- small, pin-point bleeding under the skin (petechiae); various skin eruptions
or rashes
- worsening of the symptoms of myasthenia gravis (see Section 2: Warnings
and precautions)
Not known (frequency cannot be estimated from the available data)
- feeling highly excited (mania) or feeling great optimism and overactivity
(hypomania)
- abnormal fast heart rhythm, life-threatening irregular heart rhythm,
alteration of the heart rhythm (called ‘prolongation of QT interval’, seen on
ECG, electrical activity of the heart)
- influence on blood clotting (in patients treated with Vitamin K antagonists)
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This
includes any possible side effects not listed in this leaflet. You can also
report side effects directly via the Yellow Card Scheme at
www.mhra.gov.uk/yellowcard.
By reporting side effects, you can help provide more information on the
safety of this medicine.
5
*
*
*
*
How to store Ciprobay
Keep out of the sight and reach of children.
Do not use Ciprobay after the expiry date, which is stated on the blister or
carton after “EXP”: The expiry date refers to the last day of the month
concerned.
If your medicine becomes discoloured or shows any other signs of
deterioration consult your pharmacist who will tell you what to do.
Medicines should not be disposed of down the drain or with household
rubbish. Ask your pharmacist how to dispose of any medicines no longer
required. These measures will help to protect the environment.
6
Contents of the pack and other information
Not known (frequency cannot be estimated from the available data)
- Unusual feelings of pain, burning tingling, numbness or muscle weakness
in the extremities (neuropathy) (see Section 2: Warnings and precautions)
- A drug reaction that causes rash, fever, inflammation of internal organs,
hematologic abnormalities and systemic illness (DRESS Drug Reaction
with Eosinophilia and Systemic Symptoms, AGEP Acute Generalised
Exanthematous Pustulosis).
What Ciprobay contains
Ciprobay 500 mg film-coated tablets contain the active ingredient,
Ciprofloxacin.
Also contain microcrystalline cellulose, maize starch, crospovidone, colloidal
silicon dioxide, magnesium stearate and purified water. The tablet film-coat
consists of a mixture of hypromellose, macrogol 4000, titanium dioxide and
purified water.
Other side effects which have been observed during treatment with Ciprobay
are listed below by how likely they are:
What Ciprobay looks like and contents of the pack
Ciprobay are white, film-coated tablets. On one side it is marked with a
break line and CIP 500 and marked BAYER on the other. They are available
in blister packs containing 10 Tablets.
Common: (may affect up to 1 in 10 people)
- nausea, diarrhoea
- joint pain and joint inflammation in children
Uncommon (may affect up to 1 in 100 people)
- joint pain in adults
- fungal superinfections
- a high concentration of eosinophils, a type of white blood cell
- decreased appetite
- hyperactivity or agitation
- headache, dizziness, sleeping problems, or taste disorders
- vomiting, abdominal pain, digestive problems such as stomach upset
(indigestion/heartburn), or wind
- increased amounts of certain substances in the blood (transaminases
and/or bilirubin)
- rash, itching, or hives
- poor kidney function
- pains in your muscles and bones, feeling unwell (asthenia), or fever
- increase in blood alkaline phosphatase (a certain substance in the blood)
Rare (may affect up to 1 in 1,000 people)
- muscle pain, inflammation of the joints, increased muscle tone and
cramping
- inflammation of the bowel (colitis) linked to antibiotic use (can be fatal in
very rare cases) (see Section 2: Warnings and precautions)
- changes to the blood count (leukopenia, leukocytosis, neutropenia,
anaemia), increased or decreased amounts of a blood clotting factor
(thrombocytes)
- allergic reaction, swelling (oedema), or rapid swelling of the skin and
mucous membranes (angio-oedema) (see Section 2: Warnings and
precautions)
- increased blood sugar (hyperglycaemia)
- decreased blood sugar (hypoglycaemia) (see Section 2: Warnings and
precautions)
- confusion, disorientation, anxiety reactions, strange dreams, depression
(potentially leading to thoughts of suicide, suicide attempts, or completed
suicide) (see Section 2: Warnings and precautions), or hallucinations
Manufacturer and Licence Holder
This medicine is manufactured by Bayer Pharma AG, D-51368, Leverkusen,
Germany and is procured from within the EU and repackaged by the Product
Licence Holder: Lexon (UK) Limited, Unit 18, Oxleasow Road, East Moons
Moat, Redditch, Worcestershire, B98 0RE.
If you have any questions or are not sure about anything, ask your doctor or
pharmacist. They will have additional information about this medicine and
will be able to advise you.
POM
PL 15184/1273 Ciprobay 500mg Tablets
Ciprobay is a registered trademark of Bayer Aktiengesellschaft
Revision date: 12/05/17
Blind or partially sighted?
Is this leaflet hard to see or read?
Phone Lexon (UK) Limited,
Tel: 01527 505414 to obtain the leaflet
in a format suitable for you
Ref: 1273/120517/3/F
Ciprofloxacin 500 mg Tablets
Patient Information Leaflet
Read all of this leaflet carefully before you start taking this medicine
because it contains important information for you.
* Keep this leaflet. You may need to read it again.
* If you have any further questions, ask your doctor or pharmacist.
* This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them, even if their signs of illness are the same as
yours.
* If you get any side effects, talk to your doctor or pharmacist. This includes
any possible side effects not listed in this leaflet. See section 4.
Your medicine is called Ciprofloxacin 500mg Tablets but will be referred as
Ciprofloxacin throughout this leaflet.
What is in this leaflet
1 What Ciprofloxacin is and what it is used for
2 What you need to know before you take Ciprofloxacin
3 How to take Ciprofloxacin
4 Possible side effects
5 How to store Ciprofloxacin
6 Contents of the pack and other information
1
What Ciprofloxacin is and what it is used for
Ciprofloxacin contains the active substance ciprofloxacin. Ciprofloxacin is an
antibiotic belonging to the fluoroquinolone family. Ciprofloxacin works by
killing bacteria that cause infections. It only works with specific strains of
bacteria.
Adults
Ciprofloxacin is used in adults to treat the following bacterial infections:
* respiratory tract infections
* long lasting or recurring ear or sinus infections
* urinary tract infections
* genital tract infections in men and women
* gastro-intestinal tract infections and intra-abdominal infections
* skin and soft tissue infections
* bone and joint infections
* to prevent infections due to the bacterium Neisseria meningitidis
* anthrax inhalation exposure
* If you suffer from epilepsy or other neurological conditions such as
cerebral ischemia or stroke, you may experience side effects associated
with the central nervous system. If seizure happens, stop taking
Ciprofloxacin and contact your doctor immediately.
* You may experience symptoms of neuropathy such as pain, burning,
tingling, numbness and/or muscle weakness. If this happens, stop taking
Ciprofloxacin and contact your doctor immediately.
* You may experience psychiatric reactions the first time you take
Ciprofloxacin. If you suffer from depression or psychosis, your symptoms
may become worse under treatment with Ciprofloxacin. In rare cases,
depression or psychosis can progress to thoughts of suicide, suicide
attempts, or completed suicide. If this happens, contact your doctor
immediately.
* Hypoglycemia has been reported most often in diabetic patients,
predominantly in elderly population. If this happens, contact your doctor
immediately.
* Diarrhoea may develop while you are taking antibiotics, including
Ciprofloxacin, or even several weeks after you have stopped taking them.
If it becomes severe or persistent or you notice that your stool contains
blood or mucus, stop taking Ciprofloxacin and contact your doctor
immediately, as this can be life-threatening. Do not take medicines that
stop or slow down bowel movements.
* If your eyesight becomes impaired or if your eyes seem to be otherwise
affected, consult an eye specialist immediately.
* Your skin becomes more sensitive to sunlight or ultraviolet (UV) light
when taking Ciprofloxacin. Avoid exposure to strong sunlight, or artificial
UV light such as sunbeds.
* Tell the doctor or laboratory staff that you are taking Ciprofloxacin if you
have to provide a blood or urine sample.
* If you suffer from kidney problems, tell the doctor because your dose may
need to be adjusted.
* Ciprofloxacin may cause liver damage. If you notice any symptoms such
as loss of appetite, jaundice (yellowing of the skin), dark urine, itching, or
tenderness of the stomach, contact your doctor immediately.
* Ciprofloxacin may cause a reduction in the number of white blood cells
and your resistance to infection may be decreased. If you experience
an infection with symptoms such as fever and serious deterioration of
your general condition, or fever with local infection symptoms such as sore
throat/pharynx/mouth or urinary problems you should see your doctor
immediately. A blood test will be taken to check possible reduction of
white blood cells (agranulocytosis). It is important to inform your doctor
about your medicine.
Other medicines and Ciprofloxacin
Tell your doctor or pharmacist if you are taking, have recently taken or might
take any other medicines.
Ciprofloxacin may be used in the management of patients with low white
blood cell counts (neutropenia) who have a fever that is suspected to be due
to a bacterial infection.
Do not take Ciprofloxacin together with tizanidine, because this may
cause side effects such as low blood pressure and sleepiness (see Section
2: Do not take Ciprofloxacin).
If you have a severe infection or one that is caused by more than one type
of bacterium, you may be given additional antibiotic treatment in addition to
Ciprofloxacin.
The following medicines are known to interact with Ciprofloxacin in your
body. Taking Ciprofloxacin together with these medicines can influence the
therapeutic effect of those medicines. It can also increase the probability of
experiencing side effects.
Children and adolescents
Ciprofloxacin is used in children and adolescents, under specialist medical
supervision, to treat the following bacterial infections:
* lung and bronchial infections in children and adolescents suffering from
cystic fibrosis
* complicated urinary tract infections, including infections that have reached
the kidneys (pyelonephritis)
* anthrax inhalation exposure
Ciprofloxacin may also be used to treat other specific severe infections in
children and adolescents when your doctor considered this necessary.
2
What you need to know before you take Ciprofloxacin
Do not take Ciprofloxacin:
* if you are allergic to the active substance, to other quinolone drugs or to
any of the other ingredients of this medicine (listed in Section 6)
* if you are taking tizanidine (see Section 2: Other medicines and
Ciprofloxacin)
Warnings and precautions
Talk to your doctor before taking Ciprofloxacin
* if you have ever had kidney problems because your treatment may need
to be adjusted.
* if you suffer from epilepsy or other neurological conditions.
* if you have a history of tendon problems during previous treatment with
antibiotics such as Ciprofloxacin.
* if you are diabetic because you may experience a risk of hypoglycaemia
with ciprofloxacin.
* if you have myasthenia gravis (a type of muscle weakness) because
symptoms can be exacerbated.
* if you have heart problems. Caution should be taken when using
Ciprofloxacin, if you were born with or have family history of prolonged QT
interval (seen on ECG, electrical recording of the heart), have salt
imbalance in the blood (especially low level of potassium or magnesium in
the blood), have a very slow heart rhythm (called ‘bradycardia’), have a
weak heart (heart failure), have a history of heart attack (myocardial
infarction), you are female or elderly or you are taking other medicines that
result in abnormal ECG changes (see section 2: Other medicines and
Ciprofloxacin).
* if you or a member of your family is known to have a deficiency in
glucose-6-phosphate dehydrogenase (G6PD), since you may experience a
risk of anaemia with ciprofloxacin.
For the treatment of some genital tract infections, your doctor can prescribe
another antibiotic in addition to ciprofloxacin. If there is no improvement in
symptoms after 3 days of treatment, please consult your doctor.
While taking Ciprofloxacin
Tell your doctor immediately, if any of the following occurs while taking
Ciprofloxacin. Your doctor will decide whether treatment with Ciprofloxacin
needs to be stopped.
* Severe, sudden allergic reaction (an anaphylactic reaction/shock,
angio-oedema). Even with the first dose, there is a small chance that you
may experience a severe allergic reaction with the following symptoms:
tightness in the chest, feeling dizzy, sick or faint, or experiencing dizziness
when standing up. If this happens, stop taking Ciprofloxacin and
contact your doctor immediately.
* Pain and swelling in the joints and tendinitis may occur occasionally,
particularly if you are elderly and are also being treated with
corticosteroids. Inflammation and ruptures of tendons may occur even
within the first 48 hours of treatment or up to several months after
discontinuation of Ciprofloxacin therapy. At the first sign of any pain or
inflammation stop taking Ciprofloxacin, contact your doctor and rest the
painful area. Avoid any unnecessary exercise, as this might increase the
risk of a tendon rupture.
Tell your doctor if you are taking:
* Vitamin K antagonists (e.g. warfarin, acenocoumarol, phenprocoumon or
fluindione) or other oral anticoagulants (to thin the blood)
* probenecid (for gout)
* methotrexate (for certain types of cancer, psoriasis, rheumatoid arthritis)
* theophylline (for breathing problems)
* tizanidine (for muscle spasticity in multiple sclerosis)
* olanzapine (an antipsychotic)
* clozapine (an antipsychotic)
* ropinirole (for Parkinson’s disease)
* phenytoin (for epilepsy)
* metoclopramide (for nausea and vomiting)
* cyclosporin (for skin conditions, rheumatoid arthritis and in organ
transplantation)
* other medicines that can alter your heart rhythm: medicines that belong to
the group of anti-arrhythmics (e.g. quinidine, hydroquinidine, disopyramide,
amiodarone, sotalol, dofetilide, ibutilide), tricyclic antidepressants, some
antimicrobials (that belong to the group of macrolides), some
antipsychotics.
Ciprofloxacin may increase the levels of the following medicines in your
blood:
* pentoxifylline (for circulatory disorders)
* caffeine
* duloxetine (for depression, diabetic nerve damage or incontinence)
* lidocaine (for heart conditions or anaesthetic use)
* sildenafil (e.g. for erectile dysfunction)
Some medicines reduce the effect of Ciprofloxacin. Tell your doctor if you
take or wish to take:
* antacids
* omeprazole
* mineral supplements
* sucralfate
* a polymeric phosphate binder (e.g. sevelamer or lanthanum carbonate)
* medicines or supplements containing calcium, magnesium, aluminium or
iron
If these preparations are essential, take Ciprofloxacin about two hours
before or no sooner than four hours after them.
Ciprofloxacin with food and drink
Unless you take Ciprofloxacin during meals, do not eat or drink any dairy
products (such as milk or yoghurt) or drinks with added calcium when you
take the tablets, as they may affect the absorption of the active
substance.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are
planning to have a baby, ask your doctor or pharmacist for advice before
taking this medicine.
It is preferable to avoid the use of Ciprofloxacin during pregnancy.
Do not take Ciprofloxacin during breast-feeding because ciprofloxacin is
excreted in breast milk and can be harmful for your child.
Driving and using machines
Ciprofloxacin may make you feel less alert. Some neurological adverse
events can occur. Therefore, make sure you know how you react to
Ciprofloxacin before driving a vehicle or operating machinery. If in doubt, talk
to your doctor.
Ref: 1273/120517/3/B
Ciprofloxacin 500 mg Tablets
Patient Information Leaflet (continued)
3
How to take Ciprofloxacin
Your doctor will explain to you exactly how much Ciprofloxacin you will have
to take as well as how often and for how long. This will depend on the type
of infection you have and how bad it is.
Tell your doctor if you suffer from kidney problems because your dose may
need to be adjusted.
The treatment usually lasts from 5 to 21 days, but may take longer for
severe infections. Always take this medicine exactly as your doctor has told
you. Check with your doctor or pharmacist if you are not sure how
many tablets to take and how to take Ciprofloxacin
a. Swallow the tablets with plenty of fluid. Do not chew the tablets because
they do not taste nice.
b. Do try to take the tablets at around the same time every day.
c. You can take the tablets at mealtimes or between meals. Any calcium you
take as part of a meal will not seriously affect uptake. However, do not
take Ciprofloxacin tablets with dairy products such as milk or yoghurt or
with fortified fruit juices (e.g. calcium-fortified orange juice).
Remember to drink plenty of fluids while you are taking this medicine.
If you take more Ciprofloxacin than you should
If you take more than the prescribed dose, get medical help immediately. If
possible, take your tablets or the box with you to show the doctor.
If you forget to take Ciprofloxacin
Take the normal dose as soon as possible and then continue as prescribed.
However, if it is almost time for your next dose, do not take the missed dose
and continue as usual. Do not take a double dose to make up
for a forgotten dose. Be sure to complete your course of treatment.
If you stop taking Ciprofloxacin
It is important that you finish the course of treatment even if you begin to
feel better after a few days. If you stop taking this medicine too soon, your
infection may not be completely cured and the symptoms of the infection
may return or get worse. You might also develop resistance to the antibiotic.
If you have any further questions about the use of this medicine, ask your
doctor or pharmacist.
4
Possible side effects
Like all medicines, this medicine can cause side effects, although not
everybody gets them.
The following section contains the most serious side effects that you can
recognize yourself:
Stop taking Ciprofloxacin and contact your doctor immediately in order
to consider another antibiotic treatment if you notice any of the following
serious side effects:
Rare (may affect up to 1 in 1,000 people)
- Seizure (see Section 2: Warnings and precautions)
Very rare (may affect up to 1 in 10,000 people)
- Severe, sudden allergic reaction with symptoms such as tightness in the
chest, feeling dizzy, sick or faint, or experience dizziness when standing
up (anaphylactic reaction/shock) (see Section 2: Warnings and
precautions)
- Muscle weakness, inflammation of the tendons which could lead to rupture
of the tendon, particularly affecting the large tendon at the back of the
ankle (Achilles tendon) (see Section 2: Warnings and precautions)
- A serious life-threatening skin rash, usually in the form of blisters or ulcers
in the mouth, throat, nose, eyes and other mucous membranes such as
genitals which may progress to widespread blistering or peeling of the skin
(Stevens-Johnson syndrome, toxic epidermal necrolysis).
Not known (frequency cannot be estimated from the available data)
- Unusual feelings of pain, burning tingling, numbness or muscle weakness
in the extremities (neuropathy) (see Section 2: Warnings and precautions)
- A drug reaction that causes rash, fever, inflammation of internal organs,
hematologic abnormalities and systemic illness (DRESS Drug Reaction
with Eosinophilia and Systemic Symptoms, AGEP Acute Generalised
Exanthematous Pustulosis).
Other side effects which have been observed during treatment with Ciproxin
are listed below by how likely they are:
Common: (may affect up to 1 in 10 people)
- nausea, diarrhoea
- joint pain and joint inflammation in children
Uncommon (may affect up to 1 in 100 people)
- joint pain in adults
- fungal superinfections
- a high concentration of eosinophils, a type of white blood cell
- decreased appetite
- hyperactivity or agitation
- headache, dizziness, sleeping problems, or taste disorders
- vomiting, abdominal pain, digestive problems such as stomach upset
(indigestion/heartburn), or wind
- increased amounts of certain substances in the blood (transaminases
and/or bilirubin)
- rash, itching, or hives
- poor kidney function
- pains in your muscles and bones, feeling unwell (asthenia), or fever
- increase in blood alkaline phosphatase (a certain substance in the blood)
Rare (may affect up to 1 in 1,000 people)
- muscle pain, inflammation of the joints, increased muscle tone and
cramping
- inflammation of the bowel (colitis) linked to antibiotic use (can be fatal in
very rare cases) (see Section 2: Warnings and precautions)
- changes to the blood count (leukopenia, leukocytosis, neutropenia,
anaemia), increased or decreased amounts of a blood clotting factor
(thrombocytes)
- allergic reaction, swelling (oedema), or rapid swelling of the skin and
mucous membranes (angio-oedema) (see Section 2: Warnings and
precautions)
- increased blood sugar (hyperglycaemia)
- decreased blood sugar (hypoglycaemia) (see Section 2: Warnings and
precautions)
- confusion, disorientation, anxiety reactions, strange dreams, depression
(potentially leading to thoughts of suicide, suicide attempts, or completed
suicide) (see Section 2: Warnings and precautions), or hallucinations
- pins and needles, unusual sensitivity to stimuli of the senses, decreased
skin sensitivity, tremors, or giddiness
- eyesight problems including double vision (see Section 2: Warnings and
precautions)
- tinnitus, loss of hearing, impaired hearing
- rapid heartbeat (tachycardia)
- expansion of blood vessels (vasodilation), low blood pressure, or fainting
- shortness of breath, including asthmatic symptoms
- liver disorders, jaundice (cholestatic icterus), or hepatitis
- sen
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Disclaimer
Every effort has been made to ensure that the information provided by Drugslib.com is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Drugslib.com information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Drugslib.com does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Drugslib.com's drug information does not endorse drugs, diagnose patients or recommend therapy. Drugslib.com's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners.
The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Drugslib.com does not assume any responsibility for any aspect of healthcare administered with the aid of information Drugslib.com provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.
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