SERACTIL 400MG FILM-COATED TABLETS
Active substance(s): DEXIBUPROFEN
PACKAGE LEAFLET: INFORMATION FOR THE USER
Seractil® 400mg film-coated Tablets
(dexibuprofen)
Your medicine is available using the name Seractil 400mg filmcoated Tablets but will be referred to as Seractil throughout this
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 more 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.
What is in this leaflet
1.
2.
3.
4.
5.
6.
What Seractil is and what it is used for
What you need to know before you take Seractil
How to take Seractil
Possible side effects
How to store Seractil
Contents of the pack and other information
1. What Seractil is and what it is used for
Dexibuprofen, the active ingredient in Seractil, belongs to a family
of medicines called non-steroidal anti-inflammatory drugs
(NSAIDs). NSAIDs such as dexibuprofen are used as a painkiller
and to control inflammation. They work by reducing the amount of
prostaglandins (substances that control inflammation and pain)
your body produces.
What is Seractil used for?
Seractil is used to relieve:
pain and inflammation caused by osteoarthritis (when your
joints become worn);
period (menstrual) pain;
mild to moderate pain, such as pains in the muscles and
joints and toothaches.
2. What you need to know before you take
Seractil
Do not take Seractil if:
you are allergic to dexibuprofen or any of the other
ingredients of this medicine (listed in section 6);
you are allergic to acetylsalicylic acid or other pain-killers
(your allergy may cause you to have difficulty breathing,
asthma, a runny nose, a skin rash or swelling to your face);
you previously had bleedings or perforations in your
gastrointestinal system caused by NSAIDs;
you have, or have ever had, peptic ulceration (ulcer in your
stomach or duodenum) or bleeding in your digestive tract;
you have bleedings in the brain (cerebrovascular bleedings)
or other active bleedings;
you currently have a flare up of an inflammatory disease of
the intestines (ulcerative colitis, Crohn’s disease);
you have serious heart failure or serious liver or kidney
disease;
from the beginning of the 6th month of pregnancy.
Warnings and precautions
Talk to your doctor or pharmacist before taking Seractil, if
you ever have had a stomach or duodenal ulcer;
you have had bowel ulcers, ulcerative colitis or Crohn’s
disease;
you have liver or kidney disease or you are addicted to
alcohol;
you have blood clotting disorders (also see the ‘Taking other
medicines’ section);
you have oedema (when fluid collects in your body tissues);
you have a heart disease or high blood pressure;
you have asthma or any other breathing problems;
you suffer from systemic lupus erythematosus (a disease
which affects joints, muscles and skin) or mixed collagenosis
(a collagen disease which affects connective tissues).
Seractil may make it more difficult to become pregnant. You
should inform your doctor if you are planning to become pregnant
or if you have problems becoming pregnant. Your fertility will
return to normal when you stop taking Seractil.
If you need higher doses, especially if you are over 60 or if you
had stomach or duodenal ulcers, there is an increased risk of
gastrointestinal side effects. Your doctor may consider to
prescribe protective agents together with Seractil.
Medicines such as Seractil may be associated with a small
increased risk of heart attack (“myocardial infarction”) or stroke.
Any risk is more likely with high doses and prolonged treatment.
Do not exceed the recommended dose or duration of treatment.
If you have heart problems, previous stroke or think that you
might be at risk of these conditions (for example if you have high
blood pressure, diabetes or high cholesterol or are a smoker) you
should discuss your treatment with your doctor or pharmacist.
Your doctor may need to give you regular check-ups if:
you have heart, liver or kidney problems;
you are older than 60;
you need to take this medicine for long-term treatment.
Your doctor will tell you how often you need these check-ups.
You can get a headache if you take high doses of painkillers for a
long time (off label use). In this case you must not take more
Seractil for the headache.
You should avoid taking NSAIDs if you have a varicella zoster
infection (chickenpox).
Some patients might experience a delayed onset of action if
Seractil is taken for a quick pain relief in acute pain conditions,
especially if taken with food (see also section 3).
Other medicines and Seractil
Tell your doctor or pharmacist if you are taking, have recently
taken or might take any other medicines.
You should not take the following medicines with Seractil unless
you are under close medical supervision:
Non-steroidal anti-inflammatory drugs (medicines for pain,
fever and inflammation). There is an increased risk of ulcers
and bleedings in the digestive system if you take Seractil
with other NSAIDs or acetylsalicylic acid (aspirin). Do not
take if you are taking aspirin at doses of above 75 mg daily.
Warfarin or other medicines used to thin the blood or stop
blood clots. If you take this medicine with Seractil it can
prolong bleeding time or bleeding can occur.
Lithium used to treat certain mood disorders. Seractil can
increase the effect of lithium.
Methotrexate. Seractil can increase the side effects of
methotrexate.
You may take the following medicines but for safety reasons you
should tell your doctor:
Medicines used to treat high blood pressure or heart
problems (for example, beta blockers). Seractil may reduce
the benefits of these medicines.
Certain heart medicines called ACE-inhibitors or Angiotensin
II receptor antagonists. They may increase the risk of
kidney problems in rare cases.
Diuretics (water tablets).
Corticosteroids. The risk for ulcers and bleeding may
increase.
Certain antidepressants (selective serotonin reuptake
inhibitors) may increase the risk for gastro intestinal
bleeding.
Digoxin (a heart medicine). Seractil can increase the side
effects of digoxin.
Immune suppressants like ciclosporin.
Aminoglycoside antibiotics (medicines to treat infections)
Medicines that increase potassium levels in the blood: ACE
inhibitors, angiotensin-II receptor antagonists, ciclosporin,
tacrolimus, trimethoprim and heparins.
Drugs used to stop or prevent blood clots. Seractil may
make your body take longer to stop bleeding.
Phenytoin used to treat epilepsy. Seractil may increase the
side effects of phenytoin.
Phenytoin, phenobarbital and rifampicin. Concomitant
administration may lower the effects of dexibuprofen.
Low dose aspirin (up to 75 mg). Seractil may interfere with
the effect of aspirin to thin the blood.
Sulfonylurea (certain oral anti-diabetic medicines)
Pemetrexed (a medicine to treat certain forms of cancer)
Zidovudine (a medicine to treat HIV/AIDS)
Seractil with food, drink and alcohol
You may take Seractil without food, but it is better to take it with
a meal as this may help to avoid stomach problems, particularly if
you take it for long term use.
You should limit or avoid drinking alcohol when you are taking
Seractil as this may increase gastrointestinal side effects.
Pregnancy, breastfeeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant
or are planning to have a baby, ask your doctor for advice before
taking this medicine.
You must not take Seractil from the beginning of the 6th month of
pregnancy, as this may seriously harm your unborn baby, even at
very low doses.
In the first five months of pregnancy you should only use Seractil
after consulting your doctor.
Page 1 of 2
You also should not take Seractil if you plan to become pregnant,
as the medicine may make it more difficult to become pregnant.
Only small amounts of Seractil pass into breast milk. However, if
you are breast-feeding, you should not take Seractil for long
periods or in high doses.
Driving and using machines
If you have side effects like feeling dizzy, drowsy, tired, or if you
have blurred vision after taking Seractil, you should avoid driving
or using any dangerous machines (see section 4 Possible side
effects).
3. How to take Seractil
Always take this medicine exactly as your doctor has told you.
Check with your doctor or pharmacist if you are not sure.
You should take Seractil with a glass of water or some other
liquid. Seractil works faster if you take it without food. Taking it
with food is recommended as this may help to avoid stomach
problems, particularly if you take it for long term use.
Do not take more than 1 Seractil 400mg tablet for a single dose.
Do not take more than 3 Seractil 400mg tablets a day.
For osteoarthritis
The recommended dose is 1 Seractil 400mg tablet 2 times a day
(1 in the morning and 1 in the evening). For acute symptoms,
your doctor may increase the dose to 3 Seractil 400mg tablets a
day.
For period (menstrual) pain
The recommended dose is 1 Seractil 400mg tablet 2 times a day.
For mild to moderate pain
The recommended dose is 200 mg Seractil (half a 400 mg tablet)
3 times a day. If higher doses are needed your doctor may
prescribe up to 3 Seractil 400mg tablets a day. Depending on your
symptoms, the doctor may also prescribe lower strength Seractil
tablets (300 mg).
The score lines on the tablets (see the ‘What Seractil looks like’
section) make it possible for you to split the tablets into equal
doses.
Patients with liver or kidney disease: Your doctor may have
prescribed a lower than the normal dose of Seractil. You must not
increase the dose your doctor has prescribed.
Elderly patients: If you are over 60 years old, your doctor may
have prescribed a lower dose than normal. If you are not having
problems taking Seractil, your doctor may increase your dose.
Use in children and adolescents: As there is not enough
experience in children and adolescents Seractil should not be used
below the age of 18.
If you feel that the effects of your Seractil tablets are too strong
or too weak, talk to your doctor or pharmacist.
If you take more Seractil than you should
If you have accidentally taken too many tablets, contact your
doctor straight away.
If you forget to take Seractil
Do not take a double dose to make up for a forgotten tablet.
If you have any further questions on 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.
These do not happen as often when you take a low dose or you
take Seractil for only a short time.
If you suffer from any of the following at any time during your
treatment stop taking the medicine and seek immediate
medical help:
Pass blood in your faeces (stools/motions)
Pass black tarry stools
Vomit any blood or dark particles that look like coffee
grounds.
Stop taking the medicine and tell your doctor if you experience
indigestion or heartburn, abdominal pain (pains in your stomach)
or other abnormal stomach symptoms.
Also stop taking Seractil and see a doctor,
if you have a skin rash, severe blistering or peeling of the
skin, mucosal lesions or any signs of hypersensitivity.
if you have symptoms like fever, sore throat and mouth, flu
like symptoms, feeling tired, nose and skin bleed. These
can be caused by a reduction of white blood cells in your
body (agranulocytosis).
if you have severe or persistent headache.
if you have a yellow coloration of the skin and the whites of
the eyes (jaundice).
if you have a swollen face, tongue or pharynx, difficulty to
swallow or to breathe (angioedema).
The most frequent side effects are of gastrointestinal nature like
indigestion, stomach ache, diarrhoea, being sick or feeling sick.
Some gastrointestinal side effects can be serious, although they
do not affect many people, like ulcers and bleeding in the stomach
or intestines and perforations in the digestive system (for
symptoms see “stop taking Seractil and see a doctor” above).
Other side effects are:
Common: affect 1 to 10 users in 100.
feeling exhausted or drowsy, dizziness, headaches;
a skin rash.
Uncommon: affect 1 to 10 users in 1000.
ulcers in the mouth, gastritis;
purpura (purple bruises), itching, a raised itchy rash;
swelling of the face or throat (angioedema);
problems with sleeping, restlessness, anxiety, blurred vision,
buzzing or ringing in the ears (tinnitus);
runny nose, difficulties breathing.
Rare: affect 1 to 10 users in 10000.
6. Contents of the pack and other
information
What Seractil contains
Each film coated tablet contains 400mg of the active ingredient,
dexibuprofen.
Your tablets also include the following ingredients: hypromellose,
microcrystalline cellulose, carmellose calcium, colloidal anhydrous
silica, talc, titanium dioxide (E171), glycerol triacetate and
macrogol 6000.
What Seractil looks like, and the contents of the
pack
Each tablet is white, oblong and scored on both sides.
Seractil tablets are packed in blister strips and are available in
packs of 10, 30, 50 and 60 tablets.
Manufacturer
Your tablets are manufactured by: Gebro Pharma GmbH,
Fieberbrunn, Austria.
Procured from within the EU and repackaged by: Doncaster
Pharmaceuticals Group Ltd., Kirk Sandall, Doncaster, DN3 1QR.
Product Licence holder: BR Lewis Pharmaceuticals Ltd.,
Kirk Sandall, Doncaster, DN3 1QR.
POM
PL No: 08929/0407
Leaflet revision and issue date (Ref): 09.05.13
Seractil® is a registered trademark of Gebro Pharma GmbH.
a strong allergic reaction;
psychotic reactions, depression, feeling irritable;
feeling confused, disoriented or agitated;
hearing problems;
wind, constipation, an inflamed oesophagus, flare up of
diverticular disease (small pouches in your bowels that may
become infected or inflamed), colitis or Crohn’s disease;
problems with your liver, hepatitis (inflamed liver) and
jaundice (yellowing of the skin or eyes);
blood disorders, including disorders that reduce the number
of white or red blood cells or platelets.
Very rare: affect less than 1 user in 10000.
hypersensitivity reactions, including symptoms like fever,
a rash, pain in the abdomen, headaches, feeling sick and
vomiting;
photosensitivity;
aseptic meningitis (symptoms are headache, fever, stiff neck
and generally feeling ill), serious allergic reactions (difficulty
breathing, asthma, a fast heartbeat, low blood pressure and
shock), allergic reaction with inflamed small blood vessels;
reddened skin, mucous membranes or throat;
blistering hands and feet (Stevens-Johnson syndrome);
peeling skin (epidermal necrolysis);
hair loss;
inflamed kidney, kidney disease or kidney failure;
systemic lupus erythematosus (auto immune disease);
very rare bacterial infections, which attack the tissue
covering the muscle can be aggravated.
Oedema (swollen limbs), high blood pressure and heart failure
may occur with NSAID treatment.
Medicines such as Seractil may be associated with a small
increased risk of heart attack (“myocardial infarction”) or stroke.
If you get any side effects, talk to your doctor or pharmacist. This
includes any side effects not listed in this leaflet.
5. How to store Seractil
Do not store above 25°C.
Keep out of the sight and reach of children.
Protect from light.
Store in the original package.
Don’t take the tablets after the “expiry date” shown on the pack.
If your tablets are out of date, take them to your pharmacist who
will get rid of them safely. Any unused medication should be
returned to a pharmacy for disposal.
If your tablets appear discoloured or show any other signs of
deterioration, take them to your pharmacist who will advise you.
Medicines should not be disposed of via wastewater or household
waste. Ask your pharmacist how to dispose of medicines no longer
required. These measures will help to protect the environment.
Page 2 of 2
PACKAGE LEAFLET: INFORMATION FOR THE USER
Dexibuprofen 400mg film-coated Tablets
Your medicine is available using the name Dexibuprofen 400mg
film-coated Tablets but will be referred to as Dexibuprofen
throughout this 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 more 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.
What is in this leaflet
1.
2.
3.
4.
5.
6.
What Dexibuprofen is and what it is used for
What you need to know before you take Dexibuprofen
How to take Dexibuprofen
Possible side effects
How to store Dexibuprofen
Contents of the pack and other information
1. What Dexibuprofen is and what it is used
for
Dexibuprofen, the active ingredient in Dexibuprofen, belongs to a
family of medicines called non-steroidal anti-inflammatory drugs
(NSAIDs). NSAIDs such as dexibuprofen are used as a painkiller
and to control inflammation. They work by reducing the amount of
prostaglandins (substances that control inflammation and pain)
your body produces.
What is Dexibuprofen used for?
Dexibuprofen is used to relieve:
pain and inflammation caused by osteoarthritis (when your
joints become worn);
period (menstrual) pain;
mild to moderate pain, such as pains in the muscles and
joints and toothaches.
2. What you need to know before you take
Dexibuprofen
Do not take Dexibuprofen if:
you are allergic to dexibuprofen or any of the other
ingredients of this medicine (listed in section 6);
you are allergic to acetylsalicylic acid or other pain-killers
(your allergy may cause you to have difficulty breathing,
asthma, a runny nose, a skin rash or swelling to your face);
you previously had bleedings or perforations in your
gastrointestinal system caused by NSAIDs;
you have, or have ever had, peptic ulceration (ulcer in your
stomach or duodenum) or bleeding in your digestive tract;
you have bleedings in the brain (cerebrovascular bleedings)
or other active bleedings;
you currently have a flare up of an inflammatory disease of
the intestines (ulcerative colitis, Crohn’s disease);
you have serious heart failure or serious liver or kidney
disease;
from the beginning of the 6th month of pregnancy.
Warnings and precautions
Talk to your doctor or pharmacist before taking Dexibuprofen, if
you ever have had a stomach or duodenal ulcer;
you have had bowel ulcers, ulcerative colitis or Crohn’s
disease;
you have liver or kidney disease or you are addicted to
alcohol;
you have blood clotting disorders (also see the ‘Taking other
medicines’ section);
you have oedema (when fluid collects in your body tissues);
you have a heart disease or high blood pressure;
you have asthma or any other breathing problems;
you suffer from systemic lupus erythematosus (a disease
which affects joints, muscles and skin) or mixed collagenosis
(a collagen disease which affects connective tissues).
Dexibuprofen may make it more difficult to become pregnant.
You should inform your doctor if you are planning to become
pregnant or if you have problems becoming pregnant. Your
fertility will return to normal when you stop taking Dexibuprofen.
If you need higher doses, especially if you are over 60 or if you
had stomach or duodenal ulcers, there is an increased risk of
gastrointestinal side effects. Your doctor may consider to
prescribe protective agents together with Dexibuprofen.
Medicines such as Dexibuprofen may be associated with a small
increased risk of heart attack (“myocardial infarction”) or stroke.
Any risk is more likely with high doses and prolonged treatment.
Do not exceed the recommended dose or duration of treatment.
If you have heart problems, previous stroke or think that you
might be at risk of these conditions (for example if you have high
blood pressure, diabetes or high cholesterol or are a smoker) you
should discuss your treatment with your doctor or pharmacist.
Your doctor may need to give you regular check-ups if:
you have heart, liver or kidney problems;
you are older than 60;
you need to take this medicine for long-term treatment.
Your doctor will tell you how often you need these check-ups.
You can get a headache if you take high doses of painkillers for a
long time (off label use). In this case you must not take more
Dexibuprofen for the headache.
You should avoid taking NSAIDs if you have a varicella zoster
infection (chickenpox).
Some patients might experience a delayed onset of action if
Dexibuprofen is taken for a quick pain relief in acute pain
conditions, especially if taken with food (see also section 3).
Other medicines and Dexibuprofen
Tell your doctor or pharmacist if you are taking, have recently
taken or might take any other medicines.
You should not take the following medicines with Dexibuprofen
unless you are under close medical supervision:
Non-steroidal anti-inflammatory drugs (medicines for pain,
fever and inflammation). There is an increased risk of ulcers
and bleedings in the digestive system if you take
Dexibuprofen with other NSAIDs or acetylsalicylic acid
(aspirin). Do not take if you are taking aspirin at doses of
above 75 mg daily.
Warfarin or other medicines used to thin the blood or stop
blood clots. If you take this medicine with Dexibuprofen it
can prolong bleeding time or bleeding can occur.
Lithium used to treat certain mood disorders. Dexibuprofen
can increase the effect of lithium.
Methotrexate. Dexibuprofen can increase the side effects of
methotrexate.
You may take the following medicines but for safety reasons you
should tell your doctor:
Medicines used to treat high blood pressure or heart
problems (for example, beta blockers). Dexibuprofen may
reduce the benefits of these medicines.
Certain heart medicines called ACE-inhibitors or Angiotensin
II receptor antagonists. They may increase the risk of
kidney problems in rare cases.
Diuretics (water tablets).
Corticosteroids. The risk for ulcers and bleeding may
increase.
Certain antidepressants (selective serotonin reuptake
inhibitors) may increase the risk for gastro intestinal
bleeding.
Digoxin (a heart medicine). Dexibuprofen can increase the
side effects of digoxin.
Immune suppressants like ciclosporin.
Aminoglycoside antibiotics (medicines to treat infections)
Medicines that increase potassium levels in the blood: ACE
inhibitors, angiotensin-II receptor antagonists, ciclosporin,
tacrolimus, trimethoprim and heparins.
Drugs used to stop or prevent blood clots. Dexibuprofen
may make your body take longer to stop bleeding.
Phenytoin used to treat epilepsy. Dexibuprofen may
increase the side effects of phenytoin.
Phenytoin, phenobarbital and rifampicin. Concomitant
administration may lower the effects of dexibuprofen.
Low dose aspirin (up to 75 mg). Dexibuprofen may interfere
with the effect of aspirin to thin the blood.
Sulfonylurea (certain oral anti-diabetic medicines)
Pemetrexed (a medicine to treat certain forms of cancer)
Zidovudine (a medicine to treat HIV/AIDS)
Dexibuprofen with food, drink and alcohol
You may take Dexibuprofen without food, but it is better to take it
with a meal as this may help to avoid stomach problems,
particularly if you take it for long term use.
You should limit or avoid drinking alcohol when you are taking
Dexibuprofen as this may increase gastrointestinal side effects.
Pregnancy, breastfeeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant
or are planning to have a baby, ask your doctor for advice before
taking this medicine.
You must not take Dexibuprofen from the beginning of the 6th
month of pregnancy, as this may seriously harm your unborn
baby, even at very low doses.
In the first five months of pregnancy you should only use
Dexibuprofen after consulting your doctor.
Page 1 of 2
You also should not take Dexibuprofen if you plan to become
pregnant, as the medicine may make it more difficult to become
pregnant.
Only small amounts of Dexibuprofen pass into breast milk.
However, if you are breast-feeding, you should not take
Dexibuprofen for long periods or in high doses.
Driving and using machines
If you have side effects like feeling dizzy, drowsy, tired, or if you
have blurred vision after taking Dexibuprofen, you should avoid
driving or using any dangerous machines (see section 4 Possible
side effects).
3. How to take Dexibuprofen
Always take this medicine exactly as your doctor has told you.
Check with your doctor or pharmacist if you are not sure.
You should take Dexibuprofen with a glass of water or some other
liquid. Dexibuprofen works faster if you take it without food.
Taking it with food is recommended as this may help to avoid
stomach problems, particularly if you take it for long term use.
Do not take more than 1 Dexibuprofen 400mg tablet for a single
dose.
Do not take more than 3 Dexibuprofen 400mg tablets a day.
For osteoarthritis
The recommended dose is 1 Dexibuprofen 400mg tablet 2 times a
day (1 in the morning and 1 in the evening). For acute
symptoms, your doctor may increase the dose to 3 Dexibuprofen
400mg tablets a day.
For period (menstrual) pain
The recommended dose is 1 Dexibuprofen 400mg tablet 2 times a
day.
For mild to moderate pain
The recommended dose is 200 mg Dexibuprofen (half a 400 mg
tablet) 3 times a day. If higher doses are needed your doctor may
prescribe up to 3 Dexibuprofen 400mg tablets a day. Depending
on your symptoms, the doctor may also prescribe lower strength
Dexibuprofen tablets (300 mg).
The score lines on the tablets (see the ‘What Dexibuprofen looks
like’ section) make it possible for you to split the tablets into equal
doses.
Patients with liver or kidney disease: Your doctor may have
prescribed a lower than the normal dose of Dexibuprofen. You
must not increase the dose your doctor has prescribed.
Elderly patients: If you are over 60 years old, your doctor may
have prescribed a lower dose than normal. If you are not having
problems taking Dexibuprofen, your doctor may increase your
dose.
Use in children and adolescents: As there is not enough
experience in children and adolescents Dexibuprofen should not
be used below the age of 18.
If you feel that the effects of your Dexibuprofen tablets are too
strong or too weak, talk to your doctor or pharmacist.
If you take more Dexibuprofen than you should
If you have accidentally taken too many tablets, contact your
doctor straight away.
If you forget to take Dexibuprofen
Do not take a double dose to make up for a forgotten tablet.
If you have any further questions on 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.
These do not happen as often when you take a low dose or you
take Dexibuprofen for only a short time.
If you suffer from any of the following at any time during your
treatment stop taking the medicine and seek immediate
medical help:
Pass blood in your faeces (stools/motions)
Pass black tarry stools
Vomit any blood or dark particles that look like coffee
grounds.
Stop taking the medicine and tell your doctor if you experience
indigestion or heartburn, abdominal pain (pains in your stomach)
or other abnormal stomach symptoms.
Also stop taking Dexibuprofen and see a doctor,
if you have a skin rash, severe blistering or peeling of the
skin, mucosal lesions or any signs of hypersensitivity.
if you have symptoms like fever, sore throat and mouth, flu
like symptoms, feeling tired, nose and skin bleed. These
can be caused by a reduction of white blood cells in your
body (agranulocytosis).
if you have severe or persistent headache.
if you have a yellow coloration of the skin and the whites of
the eyes (jaundice).
if you have a swollen face, tongue or pharynx, difficulty to
swallow or to breathe (angioedema).
The most frequent side effects are of gastrointestinal nature like
indigestion, stomach ache, diarrhoea, being sick or feeling sick.
Some gastrointestinal side effects can be serious, although they
do not affect many people, like ulcers and bleeding in the stomach
or intestines and perforations in the digestive system (for
symptoms see “stop taking Dexibuprofen and see a doctor”
above).
Other side effects are:
Common: affect 1 to 10 users in 100.
feeling exhausted or drowsy, dizziness, headaches;
a skin rash.
Uncommon: affect 1 to 10 users in 1000.
ulcers in the mouth, gastritis;
purpura (purple bruises), itching, a raised itchy rash;
swelling of the face or throat (angioedema);
problems with sleeping, restlessness, anxiety, blurred vision,
buzzing or ringing in the ears (tinnitus);
runny nose, difficulties breathing.
6. Contents of the pack and other
information
What Dexibuprofen contains
Each film coated tablet contains 400mg of the active ingredient,
dexibuprofen.
Your tablets also include the following ingredients: hypromellose,
microcrystalline cellulose, carmellose calcium, colloidal anhydrous
silica, talc, titanium dioxide (E171), glycerol triacetate and
macrogol 6000.
What Dexibuprofen looks like, and the contents of
the pack
Each tablet is white, oblong and scored on both sides.
Dexibuprofen tablets are packed in blister strips and are available
in packs of 10, 30, 50 and 60 tablets.
Manufacturer
Your tablets are manufactured by: Gebro Pharma GmbH,
Fieberbrunn, Austria.
Procured from within the EU and repackaged by: Doncaster
Pharmaceuticals Group Ltd, Kirk Sandall, Doncaster, DN3 1QR.
Product Licence holder: BR Lewis Pharmaceuticals Ltd.,
Kirk Sandall, Doncaster, DN3 1QR.
POM
PL No: 08929/0407
Leaflet revision and issue date (Ref): 09.05.13
Rare: affect 1 to 10 users in 10000.
a strong allergic reaction;
psychotic reactions, depression, feeling irritable;
feeling confused, disoriented or agitated;
hearing problems;
wind, constipation, an inflamed oesophagus, flare up of
diverticular disease (small pouches in your bowels that may
become infected or inflamed), colitis or Crohn’s disease;
problems with your liver, hepatitis (inflamed liver) and
jaundice (yellowing of the skin or eyes);
blood disorders, including disorders that reduce the number
of white or red blood cells or platelets.
Very rare: affect less than 1 user in 10000.
hypersensitivity reactions, including symptoms like fever,
a rash, pain in the abdomen, headaches, feeling sick and
vomiting;
photosensitivity;
aseptic meningitis (symptoms are headache, fever, stiff neck
and generally feeling ill), serious allergic reactions (difficulty
breathing, asthma, a fast heartbeat, low blood pressure and
shock), allergic reaction with inflamed small blood vessels;
reddened skin, mucous membranes or throat;
blistering hands and feet (Stevens-Johnson syndrome);
peeling skin (epidermal necrolysis);
hair loss;
inflamed kidney, kidney disease or kidney failure;
systemic lupus erythematosus (auto immune disease);
very rare bacterial infections, which attack the tissue
covering the muscle can be aggravated.
Oedema (swollen limbs), high blood pressure and heart failure
may occur with NSAID treatment.
Medicines such as Dexibuprofen may be associated with a small
increased risk of heart attack (“myocardial infarction”) or stroke.
If you get any side effects, talk to your doctor or pharmacist. This
includes any side effects not listed in this leaflet.
5. How to store Dexibuprofen
Do not store above 25°C.
Keep out of the sight and reach of children.
Protect from light.
Store in the original package.
Don’t take the tablets after the “expiry date” shown on the pack.
If your tablets are out of date, take them to your pharmacist who
will get rid of them safely. Any unused medication should be
returned to a pharmacy for disposal.
If your tablets appear discoloured or show any other signs of
deterioration, take them to your pharmacist who will advise you.
Medicines should not be disposed of via wastewater or household
waste. Ask your pharmacist how to dispose of medicines no longer
required. These measures will help to protect the environment.
Page 2 of 2
Seractil® 400mg film-coated Tablets
(dexibuprofen)
Your medicine is available using the name Seractil 400mg filmcoated Tablets but will be referred to as Seractil throughout this
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 more 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.
What is in this leaflet
1.
2.
3.
4.
5.
6.
What Seractil is and what it is used for
What you need to know before you take Seractil
How to take Seractil
Possible side effects
How to store Seractil
Contents of the pack and other information
1. What Seractil is and what it is used for
Dexibuprofen, the active ingredient in Seractil, belongs to a family
of medicines called non-steroidal anti-inflammatory drugs
(NSAIDs). NSAIDs such as dexibuprofen are used as a painkiller
and to control inflammation. They work by reducing the amount of
prostaglandins (substances that control inflammation and pain)
your body produces.
What is Seractil used for?
Seractil is used to relieve:
pain and inflammation caused by osteoarthritis (when your
joints become worn);
period (menstrual) pain;
mild to moderate pain, such as pains in the muscles and
joints and toothaches.
2. What you need to know before you take
Seractil
Do not take Seractil if:
you are allergic to dexibuprofen or any of the other
ingredients of this medicine (listed in section 6);
you are allergic to acetylsalicylic acid or other pain-killers
(your allergy may cause you to have difficulty breathing,
asthma, a runny nose, a skin rash or swelling to your face);
you previously had bleedings or perforations in your
gastrointestinal system caused by NSAIDs;
you have, or have ever had, peptic ulceration (ulcer in your
stomach or duodenum) or bleeding in your digestive tract;
you have bleedings in the brain (cerebrovascular bleedings)
or other active bleedings;
you currently have a flare up of an inflammatory disease of
the intestines (ulcerative colitis, Crohn’s disease);
you have serious heart failure or serious liver or kidney
disease;
from the beginning of the 6th month of pregnancy.
Warnings and precautions
Talk to your doctor or pharmacist before taking Seractil, if
you ever have had a stomach or duodenal ulcer;
you have had bowel ulcers, ulcerative colitis or Crohn’s
disease;
you have liver or kidney disease or you are addicted to
alcohol;
you have blood clotting disorders (also see the ‘Taking other
medicines’ section);
you have oedema (when fluid collects in your body tissues);
you have a heart disease or high blood pressure;
you have asthma or any other breathing problems;
you suffer from systemic lupus erythematosus (a disease
which affects joints, muscles and skin) or mixed collagenosis
(a collagen disease which affects connective tissues).
Seractil may make it more difficult to become pregnant. You
should inform your doctor if you are planning to become pregnant
or if you have problems becoming pregnant. Your fertility will
return to normal when you stop taking Seractil.
If you need higher doses, especially if you are over 60 or if you
had stomach or duodenal ulcers, there is an increased risk of
gastrointestinal side effects. Your doctor may consider to
prescribe protective agents together with Seractil.
Medicines such as Seractil may be associated with a small
increased risk of heart attack (“myocardial infarction”) or stroke.
Any risk is more likely with high doses and prolonged treatment.
Do not exceed the recommended dose or duration of treatment.
If you have heart problems, previous stroke or think that you
might be at risk of these conditions (for example if you have high
blood pressure, diabetes or high cholesterol or are a smoker) you
should discuss your treatment with your doctor or pharmacist.
Your doctor may need to give you regular check-ups if:
you have heart, liver or kidney problems;
you are older than 60;
you need to take this medicine for long-term treatment.
Your doctor will tell you how often you need these check-ups.
You can get a headache if you take high doses of painkillers for a
long time (off label use). In this case you must not take more
Seractil for the headache.
You should avoid taking NSAIDs if you have a varicella zoster
infection (chickenpox).
Some patients might experience a delayed onset of action if
Seractil is taken for a quick pain relief in acute pain conditions,
especially if taken with food (see also section 3).
Other medicines and Seractil
Tell your doctor or pharmacist if you are taking, have recently
taken or might take any other medicines.
You should not take the following medicines with Seractil unless
you are under close medical supervision:
Non-steroidal anti-inflammatory drugs (medicines for pain,
fever and inflammation). There is an increased risk of ulcers
and bleedings in the digestive system if you take Seractil
with other NSAIDs or acetylsalicylic acid (aspirin). Do not
take if you are taking aspirin at doses of above 75 mg daily.
Warfarin or other medicines used to thin the blood or stop
blood clots. If you take this medicine with Seractil it can
prolong bleeding time or bleeding can occur.
Lithium used to treat certain mood disorders. Seractil can
increase the effect of lithium.
Methotrexate. Seractil can increase the side effects of
methotrexate.
You may take the following medicines but for safety reasons you
should tell your doctor:
Medicines used to treat high blood pressure or heart
problems (for example, beta blockers). Seractil may reduce
the benefits of these medicines.
Certain heart medicines called ACE-inhibitors or Angiotensin
II receptor antagonists. They may increase the risk of
kidney problems in rare cases.
Diuretics (water tablets).
Corticosteroids. The risk for ulcers and bleeding may
increase.
Certain antidepressants (selective serotonin reuptake
inhibitors) may increase the risk for gastro intestinal
bleeding.
Digoxin (a heart medicine). Seractil can increase the side
effects of digoxin.
Immune suppressants like ciclosporin.
Aminoglycoside antibiotics (medicines to treat infections)
Medicines that increase potassium levels in the blood: ACE
inhibitors, angiotensin-II receptor antagonists, ciclosporin,
tacrolimus, trimethoprim and heparins.
Drugs used to stop or prevent blood clots. Seractil may
make your body take longer to stop bleeding.
Phenytoin used to treat epilepsy. Seractil may increase the
side effects of phenytoin.
Phenytoin, phenobarbital and rifampicin. Concomitant
administration may lower the effects of dexibuprofen.
Low dose aspirin (up to 75 mg). Seractil may interfere with
the effect of aspirin to thin the blood.
Sulfonylurea (certain oral anti-diabetic medicines)
Pemetrexed (a medicine to treat certain forms of cancer)
Zidovudine (a medicine to treat HIV/AIDS)
Seractil with food, drink and alcohol
You may take Seractil without food, but it is better to take it with
a meal as this may help to avoid stomach problems, particularly if
you take it for long term use.
You should limit or avoid drinking alcohol when you are taking
Seractil as this may increase gastrointestinal side effects.
Pregnancy, breastfeeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant
or are planning to have a baby, ask your doctor for advice before
taking this medicine.
You must not take Seractil from the beginning of the 6th month of
pregnancy, as this may seriously harm your unborn baby, even at
very low doses.
In the first five months of pregnancy you should only use Seractil
after consulting your doctor.
Page 1 of 2
You also should not take Seractil if you plan to become pregnant,
as the medicine may make it more difficult to become pregnant.
Only small amounts of Seractil pass into breast milk. However, if
you are breast-feeding, you should not take Seractil for long
periods or in high doses.
Driving and using machines
If you have side effects like feeling dizzy, drowsy, tired, or if you
have blurred vision after taking Seractil, you should avoid driving
or using any dangerous machines (see section 4 Possible side
effects).
3. How to take Seractil
Always take this medicine exactly as your doctor has told you.
Check with your doctor or pharmacist if you are not sure.
You should take Seractil with a glass of water or some other
liquid. Seractil works faster if you take it without food. Taking it
with food is recommended as this may help to avoid stomach
problems, particularly if you take it for long term use.
Do not take more than 1 Seractil 400mg tablet for a single dose.
Do not take more than 3 Seractil 400mg tablets a day.
For osteoarthritis
The recommended dose is 1 Seractil 400mg tablet 2 times a day
(1 in the morning and 1 in the evening). For acute symptoms,
your doctor may increase the dose to 3 Seractil 400mg tablets a
day.
For period (menstrual) pain
The recommended dose is 1 Seractil 400mg tablet 2 times a day.
For mild to moderate pain
The recommended dose is 200 mg Seractil (half a 400 mg tablet)
3 times a day. If higher doses are needed your doctor may
prescribe up to 3 Seractil 400mg tablets a day. Depending on your
symptoms, the doctor may also prescribe lower strength Seractil
tablets (300 mg).
The score lines on the tablets (see the ‘What Seractil looks like’
section) make it possible for you to split the tablets into equal
doses.
Patients with liver or kidney disease: Your doctor may have
prescribed a lower than the normal dose of Seractil. You must not
increase the dose your doctor has prescribed.
Elderly patients: If you are over 60 years old, your doctor may
have prescribed a lower dose than normal. If you are not having
problems taking Seractil, your doctor may increase your dose.
Use in children and adolescents: As there is not enough
experience in children and adolescents Seractil should not be used
below the age of 18.
If you feel that the effects of your Seractil tablets are too strong
or too weak, talk to your doctor or pharmacist.
If you take more Seractil than you should
If you have accidentally taken too many tablets, contact your
doctor straight away.
If you forget to take Seractil
Do not take a double dose to make up for a forgotten tablet.
If you have any further questions on 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.
These do not happen as often when you take a low dose or you
take Seractil for only a short time.
If you suffer from any of the following at any time during your
treatment stop taking the medicine and seek immediate
medical help:
Pass blood in your faeces (stools/motions)
Pass black tarry stools
Vomit any blood or dark particles that look like coffee
grounds.
Stop taking the medicine and tell your doctor if you experience
indigestion or heartburn, abdominal pain (pains in your stomach)
or other abnormal stomach symptoms.
Also stop taking Seractil and see a doctor,
if you have a skin rash, severe blistering or peeling of the
skin, mucosal lesions or any signs of hypersensitivity.
if you have symptoms like fever, sore throat and mouth, flu
like symptoms, feeling tired, nose and skin bleed. These
can be caused by a reduction of white blood cells in your
body (agranulocytosis).
if you have severe or persistent headache.
if you have a yellow coloration of the skin and the whites of
the eyes (jaundice).
if you have a swollen face, tongue or pharynx, difficulty to
swallow or to breathe (angioedema).
The most frequent side effects are of gastrointestinal nature like
indigestion, stomach ache, diarrhoea, being sick or feeling sick.
Some gastrointestinal side effects can be serious, although they
do not affect many people, like ulcers and bleeding in the stomach
or intestines and perforations in the digestive system (for
symptoms see “stop taking Seractil and see a doctor” above).
Other side effects are:
Common: affect 1 to 10 users in 100.
feeling exhausted or drowsy, dizziness, headaches;
a skin rash.
Uncommon: affect 1 to 10 users in 1000.
ulcers in the mouth, gastritis;
purpura (purple bruises), itching, a raised itchy rash;
swelling of the face or throat (angioedema);
problems with sleeping, restlessness, anxiety, blurred vision,
buzzing or ringing in the ears (tinnitus);
runny nose, difficulties breathing.
Rare: affect 1 to 10 users in 10000.
6. Contents of the pack and other
information
What Seractil contains
Each film coated tablet contains 400mg of the active ingredient,
dexibuprofen.
Your tablets also include the following ingredients: hypromellose,
microcrystalline cellulose, carmellose calcium, colloidal anhydrous
silica, talc, titanium dioxide (E171), glycerol triacetate and
macrogol 6000.
What Seractil looks like, and the contents of the
pack
Each tablet is white, oblong and scored on both sides.
Seractil tablets are packed in blister strips and are available in
packs of 10, 30, 50 and 60 tablets.
Manufacturer
Your tablets are manufactured by: Gebro Pharma GmbH,
Fieberbrunn, Austria.
Procured from within the EU and repackaged by: Doncaster
Pharmaceuticals Group Ltd., Kirk Sandall, Doncaster, DN3 1QR.
Product Licence holder: BR Lewis Pharmaceuticals Ltd.,
Kirk Sandall, Doncaster, DN3 1QR.
POM
PL No: 08929/0407
Leaflet revision and issue date (Ref): 09.05.13
Seractil® is a registered trademark of Gebro Pharma GmbH.
a strong allergic reaction;
psychotic reactions, depression, feeling irritable;
feeling confused, disoriented or agitated;
hearing problems;
wind, constipation, an inflamed oesophagus, flare up of
diverticular disease (small pouches in your bowels that may
become infected or inflamed), colitis or Crohn’s disease;
problems with your liver, hepatitis (inflamed liver) and
jaundice (yellowing of the skin or eyes);
blood disorders, including disorders that reduce the number
of white or red blood cells or platelets.
Very rare: affect less than 1 user in 10000.
hypersensitivity reactions, including symptoms like fever,
a rash, pain in the abdomen, headaches, feeling sick and
vomiting;
photosensitivity;
aseptic meningitis (symptoms are headache, fever, stiff neck
and generally feeling ill), serious allergic reactions (difficulty
breathing, asthma, a fast heartbeat, low blood pressure and
shock), allergic reaction with inflamed small blood vessels;
reddened skin, mucous membranes or throat;
blistering hands and feet (Stevens-Johnson syndrome);
peeling skin (epidermal necrolysis);
hair loss;
inflamed kidney, kidney disease or kidney failure;
systemic lupus erythematosus (auto immune disease);
very rare bacterial infections, which attack the tissue
covering the muscle can be aggravated.
Oedema (swollen limbs), high blood pressure and heart failure
may occur with NSAID treatment.
Medicines such as Seractil may be associated with a small
increased risk of heart attack (“myocardial infarction”) or stroke.
If you get any side effects, talk to your doctor or pharmacist. This
includes any side effects not listed in this leaflet.
5. How to store Seractil
Do not store above 25°C.
Keep out of the sight and reach of children.
Protect from light.
Store in the original package.
Don’t take the tablets after the “expiry date” shown on the pack.
If your tablets are out of date, take them to your pharmacist who
will get rid of them safely. Any unused medication should be
returned to a pharmacy for disposal.
If your tablets appear discoloured or show any other signs of
deterioration, take them to your pharmacist who will advise you.
Medicines should not be disposed of via wastewater or household
waste. Ask your pharmacist how to dispose of medicines no longer
required. These measures will help to protect the environment.
Page 2 of 2
PACKAGE LEAFLET: INFORMATION FOR THE USER
Dexibuprofen 400mg film-coated Tablets
Your medicine is available using the name Dexibuprofen 400mg
film-coated Tablets but will be referred to as Dexibuprofen
throughout this 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 more 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.
What is in this leaflet
1.
2.
3.
4.
5.
6.
What Dexibuprofen is and what it is used for
What you need to know before you take Dexibuprofen
How to take Dexibuprofen
Possible side effects
How to store Dexibuprofen
Contents of the pack and other information
1. What Dexibuprofen is and what it is used
for
Dexibuprofen, the active ingredient in Dexibuprofen, belongs to a
family of medicines called non-steroidal anti-inflammatory drugs
(NSAIDs). NSAIDs such as dexibuprofen are used as a painkiller
and to control inflammation. They work by reducing the amount of
prostaglandins (substances that control inflammation and pain)
your body produces.
What is Dexibuprofen used for?
Dexibuprofen is used to relieve:
pain and inflammation caused by osteoarthritis (when your
joints become worn);
period (menstrual) pain;
mild to moderate pain, such as pains in the muscles and
joints and toothaches.
2. What you need to know before you take
Dexibuprofen
Do not take Dexibuprofen if:
you are allergic to dexibuprofen or any of the other
ingredients of this medicine (listed in section 6);
you are allergic to acetylsalicylic acid or other pain-killers
(your allergy may cause you to have difficulty breathing,
asthma, a runny nose, a skin rash or swelling to your face);
you previously had bleedings or perforations in your
gastrointestinal system caused by NSAIDs;
you have, or have ever had, peptic ulceration (ulcer in your
stomach or duodenum) or bleeding in your digestive tract;
you have bleedings in the brain (cerebrovascular bleedings)
or other active bleedings;
you currently have a flare up of an inflammatory disease of
the intestines (ulcerative colitis, Crohn’s disease);
you have serious heart failure or serious liver or kidney
disease;
from the beginning of the 6th month of pregnancy.
Warnings and precautions
Talk to your doctor or pharmacist before taking Dexibuprofen, if
you ever have had a stomach or duodenal ulcer;
you have had bowel ulcers, ulcerative colitis or Crohn’s
disease;
you have liver or kidney disease or you are addicted to
alcohol;
you have blood clotting disorders (also see the ‘Taking other
medicines’ section);
you have oedema (when fluid collects in your body tissues);
you have a heart disease or high blood pressure;
you have asthma or any other breathing problems;
you suffer from systemic lupus erythematosus (a disease
which affects joints, muscles and skin) or mixed collagenosis
(a collagen disease which affects connective tissues).
Dexibuprofen may make it more difficult to become pregnant.
You should inform your doctor if you are planning to become
pregnant or if you have problems becoming pregnant. Your
fertility will return to normal when you stop taking Dexibuprofen.
If you need higher doses, especially if you are over 60 or if you
had stomach or duodenal ulcers, there is an increased risk of
gastrointestinal side effects. Your doctor may consider to
prescribe protective agents together with Dexibuprofen.
Medicines such as Dexibuprofen may be associated with a small
increased risk of heart attack (“myocardial infarction”) or stroke.
Any risk is more likely with high doses and prolonged treatment.
Do not exceed the recommended dose or duration of treatment.
If you have heart problems, previous stroke or think that you
might be at risk of these conditions (for example if you have high
blood pressure, diabetes or high cholesterol or are a smoker) you
should discuss your treatment with your doctor or pharmacist.
Your doctor may need to give you regular check-ups if:
you have heart, liver or kidney problems;
you are older than 60;
you need to take this medicine for long-term treatment.
Your doctor will tell you how often you need these check-ups.
You can get a headache if you take high doses of painkillers for a
long time (off label use). In this case you must not take more
Dexibuprofen for the headache.
You should avoid taking NSAIDs if you have a varicella zoster
infection (chickenpox).
Some patients might experience a delayed onset of action if
Dexibuprofen is taken for a quick pain relief in acute pain
conditions, especially if taken with food (see also section 3).
Other medicines and Dexibuprofen
Tell your doctor or pharmacist if you are taking, have recently
taken or might take any other medicines.
You should not take the following medicines with Dexibuprofen
unless you are under close medical supervision:
Non-steroidal anti-inflammatory drugs (medicines for pain,
fever and inflammation). There is an increased risk of ulcers
and bleedings in the digestive system if you take
Dexibuprofen with other NSAIDs or acetylsalicylic acid
(aspirin). Do not take if you are taking aspirin at doses of
above 75 mg daily.
Warfarin or other medicines used to thin the blood or stop
blood clots. If you take this medicine with Dexibuprofen it
can prolong bleeding time or bleeding can occur.
Lithium used to treat certain mood disorders. Dexibuprofen
can increase the effect of lithium.
Methotrexate. Dexibuprofen can increase the side effects of
methotrexate.
You may take the following medicines but for safety reasons you
should tell your doctor:
Medicines used to treat high blood pressure or heart
problems (for example, beta blockers). Dexibuprofen may
reduce the benefits of these medicines.
Certain heart medicines called ACE-inhibitors or Angiotensin
II receptor antagonists. They may increase the risk of
kidney problems in rare cases.
Diuretics (water tablets).
Corticosteroids. The risk for ulcers and bleeding may
increase.
Certain antidepressants (selective serotonin reuptake
inhibitors) may increase the risk for gastro intestinal
bleeding.
Digoxin (a heart medicine). Dexibuprofen can increase the
side effects of digoxin.
Immune suppressants like ciclosporin.
Aminoglycoside antibiotics (medicines to treat infections)
Medicines that increase potassium levels in the blood: ACE
inhibitors, angiotensin-II receptor antagonists, ciclosporin,
tacrolimus, trimethoprim and heparins.
Drugs used to stop or prevent blood clots. Dexibuprofen
may make your body take longer to stop bleeding.
Phenytoin used to treat epilepsy. Dexibuprofen may
increase the side effects of phenytoin.
Phenytoin, phenobarbital and rifampicin. Concomitant
administration may lower the effects of dexibuprofen.
Low dose aspirin (up to 75 mg). Dexibuprofen may interfere
with the effect of aspirin to thin the blood.
Sulfonylurea (certain oral anti-diabetic medicines)
Pemetrexed (a medicine to treat certain forms of cancer)
Zidovudine (a medicine to treat HIV/AIDS)
Dexibuprofen with food, drink and alcohol
You may take Dexibuprofen without food, but it is better to take it
with a meal as this may help to avoid stomach problems,
particularly if you take it for long term use.
You should limit or avoid drinking alcohol when you are taking
Dexibuprofen as this may increase gastrointestinal side effects.
Pregnancy, breastfeeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant
or are planning to have a baby, ask your doctor for advice before
taking this medicine.
You must not take Dexibuprofen from the beginning of the 6th
month of pregnancy, as this may seriously harm your unborn
baby, even at very low doses.
In the first five months of pregnancy you should only use
Dexibuprofen after consulting your doctor.
Page 1 of 2
You also should not take Dexibuprofen if you plan to become
pregnant, as the medicine may make it more difficult to become
pregnant.
Only small amounts of Dexibuprofen pass into breast milk.
However, if you are breast-feeding, you should not take
Dexibuprofen for long periods or in high doses.
Driving and using machines
If you have side effects like feeling dizzy, drowsy, tired, or if you
have blurred vision after taking Dexibuprofen, you should avoid
driving or using any dangerous machines (see section 4 Possible
side effects).
3. How to take Dexibuprofen
Always take this medicine exactly as your doctor has told you.
Check with your doctor or pharmacist if you are not sure.
You should take Dexibuprofen with a glass of water or some other
liquid. Dexibuprofen works faster if you take it without food.
Taking it with food is recommended as this may help to avoid
stomach problems, particularly if you take it for long term use.
Do not take more than 1 Dexibuprofen 400mg tablet for a single
dose.
Do not take more than 3 Dexibuprofen 400mg tablets a day.
For osteoarthritis
The recommended dose is 1 Dexibuprofen 400mg tablet 2 times a
day (1 in the morning and 1 in the evening). For acute
symptoms, your doctor may increase the dose to 3 Dexibuprofen
400mg tablets a day.
For period (menstrual) pain
The recommended dose is 1 Dexibuprofen 400mg tablet 2 times a
day.
For mild to moderate pain
The recommended dose is 200 mg Dexibuprofen (half a 400 mg
tablet) 3 times a day. If higher doses are needed your doctor may
prescribe up to 3 Dexibuprofen 400mg tablets a day. Depending
on your symptoms, the doctor may also prescribe lower strength
Dexibuprofen tablets (300 mg).
The score lines on the tablets (see the ‘What Dexibuprofen looks
like’ section) make it possible for you to split the tablets into equal
doses.
Patients with liver or kidney disease: Your doctor may have
prescribed a lower than the normal dose of Dexibuprofen. You
must not increase the dose your doctor has prescribed.
Elderly patients: If you are over 60 years old, your doctor may
have prescribed a lower dose than normal. If you are not having
problems taking Dexibuprofen, your doctor may increase your
dose.
Use in children and adolescents: As there is not enough
experience in children and adolescents Dexibuprofen should not
be used below the age of 18.
If you feel that the effects of your Dexibuprofen tablets are too
strong or too weak, talk to your doctor or pharmacist.
If you take more Dexibuprofen than you should
If you have accidentally taken too many tablets, contact your
doctor straight away.
If you forget to take Dexibuprofen
Do not take a double dose to make up for a forgotten tablet.
If you have any further questions on 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.
These do not happen as often when you take a low dose or you
take Dexibuprofen for only a short time.
If you suffer from any of the following at any time during your
treatment stop taking the medicine and seek immediate
medical help:
Pass blood in your faeces (stools/motions)
Pass black tarry stools
Vomit any blood or dark particles that look like coffee
grounds.
Stop taking the medicine and tell your doctor if you experience
indigestion or heartburn, abdominal pain (pains in your stomach)
or other abnormal stomach symptoms.
Also stop taking Dexibuprofen and see a doctor,
if you have a skin rash, severe blistering or peeling of the
skin, mucosal lesions or any signs of hypersensitivity.
if you have symptoms like fever, sore throat and mouth, flu
like symptoms, feeling tired, nose and skin bleed. These
can be caused by a reduction of white blood cells in your
body (agranulocytosis).
if you have severe or persistent headache.
if you have a yellow coloration of the skin and the whites of
the eyes (jaundice).
if you have a swollen face, tongue or pharynx, difficulty to
swallow or to breathe (angioedema).
The most frequent side effects are of gastrointestinal nature like
indigestion, stomach ache, diarrhoea, being sick or feeling sick.
Some gastrointestinal side effects can be serious, although they
do not affect many people, like ulcers and bleeding in the stomach
or intestines and perforations in the digestive system (for
symptoms see “stop taking Dexibuprofen and see a doctor”
above).
Other side effects are:
Common: affect 1 to 10 users in 100.
feeling exhausted or drowsy, dizziness, headaches;
a skin rash.
Uncommon: affect 1 to 10 users in 1000.
ulcers in the mouth, gastritis;
purpura (purple bruises), itching, a raised itchy rash;
swelling of the face or throat (angioedema);
problems with sleeping, restlessness, anxiety, blurred vision,
buzzing or ringing in the ears (tinnitus);
runny nose, difficulties breathing.
6. Contents of the pack and other
information
What Dexibuprofen contains
Each film coated tablet contains 400mg of the active ingredient,
dexibuprofen.
Your tablets also include the following ingredients: hypromellose,
microcrystalline cellulose, carmellose calcium, colloidal anhydrous
silica, talc, titanium dioxide (E171), glycerol triacetate and
macrogol 6000.
What Dexibuprofen looks like, and the contents of
the pack
Each tablet is white, oblong and scored on both sides.
Dexibuprofen tablets are packed in blister strips and are available
in packs of 10, 30, 50 and 60 tablets.
Manufacturer
Your tablets are manufactured by: Gebro Pharma GmbH,
Fieberbrunn, Austria.
Procured from within the EU and repackaged by: Doncaster
Pharmaceuticals Group Ltd, Kirk Sandall, Doncaster, DN3 1QR.
Product Licence holder: BR Lewis Pharmaceuticals Ltd.,
Kirk Sandall, Doncaster, DN3 1QR.
POM
PL No: 08929/0407
Leaflet revision and issue date (Ref): 09.05.13
Rare: affect 1 to 10 users in 10000.
a strong allergic reaction;
psychotic reactions, depression, feeling irritable;
feeling confused, disoriented or agitated;
hearing problems;
wind, constipation, an inflamed oesophagus, flare up of
diverticular disease (small pouches in your bowels that may
become infected or inflamed), colitis or Crohn’s disease;
problems with your liver, hepatitis (inflamed liver) and
jaundice (yellowing of the skin or eyes);
blood disorders, including disorders that reduce the number
of white or red blood cells or platelets.
Very rare: affect less than 1 user in 10000.
hypersensitivity reactions, including symptoms like fever,
a rash, pain in the abdomen, headaches, feeling sick and
vomiting;
photosensitivity;
aseptic meningitis (symptoms are headache, fever, stiff neck
and generally feeling ill), serious allergic reactions (difficulty
breathing, asthma, a fast heartbeat, low blood pressure and
shock), allergic reaction with inflamed small blood vessels;
reddened skin, mucous membranes or throat;
blistering hands and feet (Stevens-Johnson syndrome);
peeling skin (epidermal necrolysis);
hair loss;
inflamed kidney, kidney disease or kidney failure;
systemic lupus erythematosus (auto immune disease);
very rare bacterial infections, which attack the tissue
covering the muscle can be aggravated.
Oedema (swollen limbs), high blood pressure and heart failure
may occur with NSAID treatment.
Medicines such as Dexibuprofen may be associated with a small
increased risk of heart attack (“myocardial infarction”) or stroke.
If you get any side effects, talk to your doctor or pharmacist. This
includes any side effects not listed in this leaflet.
5. How to store Dexibuprofen
Do not store above 25°C.
Keep out of the sight and reach of children.
Protect from light.
Store in the original package.
Don’t take the tablets after the “expiry date” shown on the pack.
If your tablets are out of date, take them to your pharmacist who
will get rid of them safely. Any unused medication should be
returned to a pharmacy for disposal.
If your tablets appear discoloured or show any other signs of
deterioration, take them to your pharmacist who will advise you.
Medicines should not be disposed of via wastewater or household
waste. Ask your pharmacist how to dispose of medicines no longer
required. These measures will help to protect the environment.
Page 2 of 2
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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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