SKUDEXA 75 MG/25 MG FILM-COATED TABLETS

R00670 _01

PACKAGE LEAFLET: INFORMATION FOR THE USER

Skudexa 75 mg/25 mg film-coated tablets
tramadol hydrochloride/dexketoprofen
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.
• 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. This includes any possible side effects not listed in
this leaflet. See section 4.
What is in this leaflet
1. What Skudexa is and what it is used for
2. What you need to know before you take
Skudexa
3. How to take Skudexa
4. Possible side effects
5. How to store Skudexa
6. Contents of the pack and other information
1. What Skudexa is and what it is used for
Skudexa contains the active substances
tramadol hydrochloride and dexketoprofen.
Tramadol hydrochloride is a pain killer belonging
to a group of medicines called opioids that act
on the central nervous system. It relieves pain
by acting on specific nerve cells of the brain and
spinal cord.
Dexketoprofen is a pain killer and it belongs to
a group of medicines called non-steroidal antiinflammatory drugs (NSAIDs).
Skudexa is used for the symptomatic short term
treatment of moderate to severe acute pain in
adults.
You must talk to a doctor if you do not feel better
or if you feel worse.
2. What you need to know before you take
Skudexa
Do not take Skudexa:
• if you are allergic to dexketoprofen, to
tramadol hydrochloride or any of the other
ingredients of this medicine (listed in
section 6)
• if you are allergic to acetylsalicylic acid
(aspirin) or to other NSAIDs
• if you have asthma or have suffered attacks
of asthma, acute allergic rhinitis (a short
period of inflamed lining of the nose), nasal
polyps (lumps in the nose due to allergy),
urticaria (skin rash), angioedema (swollen
face, eyes, lips, or tongue, or respiratory
distress) or wheezing in the chest after
taking acetylsalicylic acid or other nonsteroidal anti-inflammatory medicines
• if you have had photoallergic or phototoxic
reactions (reddening and/or blistering of
the skin exposed to sunlight) while taking
ketoprofen (a NSAID) or fibrates (drugs
used to lower the level of fats in the blood)
• if you have a peptic ulcer, stomach or
bowel bleeding or if you have suffered in
the past from stomach or bowel bleeding,
ulceration or perforation, including that due
to previous use of NSAIDs
• if you have chronic digestive problems (e.g.
indigestion, heartburn)
• if you have bowel disease with chronic
inflammation (Crohn’s disease or ulcerative
colitis)
• if you have serious heart failure, moderate
or serious kidney problems or serious liver
problems
• if you have a bleeding disorder or a blood
clotting disorder
• if you are severely dehydrated (have lost a
lot of body fluids) due to vomiting, diarrhoea
or insufficient intake of fluids
• if you have acute poisoning with alcohol,
sleeping pills, pain relievers, or medicines
that affect mood and emotions
• if you are also taking monoamine oxidase
inhibitors (MAOIs) (certain medicines
used for the treatment of depression) or
have taken them in the last 14 days before
treatment with this medicine (see “Other
medicines and Skudexa”)
• if you have epilepsy of suffer from fits,
because the risk of a fit may increase
• if you are breathing with difficulty
• if you are pregnant or breast feeding.
Warnings and precautions
Talk to your doctor before taking Skudexa:
• if you have an allergy, or if you have had
allergy problems in the past
• if you have kidney, liver or heart problems
(hypertension and/or heart failure) as well
as fluid retention, or have suffered from any
of these problems in the past
• if you are taking diuretics
• 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;
medicines such as this medicine 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 are elderly: you may be more likely
to suffer from side effects (see section 4).
If any of these occur, consult your doctor
immediately
• if you are a woman with fertility problems:
this medicine may affect your fertility,
therefore you should not take it if you are
planning to become pregnant or you are
having fertility tests
• have a disorder in the formation of blood
and blood cells
• if you have systemic lupus erythematosus
or mixed connective tissue disease
(immune system disorders that affect
connective tissue)
• if you have suffered in the past from a
chronic inflammatory disease of the bowel
(ulcerative colitis, Crohn’s disease)
• if you have or have suffered in the past from
other stomach or bowel problems
• if you have varicella (chickenpox), since
NSAIDs could worsen the infection, albeit
rarely
• if you are taking other medicines that
increase the risk of peptic ulcer or bleeding,
e.g. oral steroids, some antidepressants
(those of the SSRI type, i.e. Selective
Serotonin Reuptake Inhibitors), drugs that
prevent blood clots such as acetylsalicylic
acid or anticoagulants such as warfarin.
In such cases, consult your doctor before
taking this medicine: he/she may want you
to take an additional medicine to protect
your stomach
• if you are taking other medicines containing
the same active substances in this
medicine, do not exceed the maximum
daily doses of dexketoprofen or tramadol
• if you think that you are addicted to other
pain relievers (opioids)
• if you have consciousness disorders (if you
feel that you are going to faint)
• if you are in a state of shock (cold sweat
may be a sign of this)
• if you have increased pressure in the
brain (possibly after a head injury or brain
disease)
• if you are breathing with difficulty
• if you have porphyria.
Tramadol may lead to physical and psychological
addiction. When this medicine is taken for a long
time, its effect may decrease, so that higher
doses have to be taken (tolerance development).
In patients with a tendency to abuse medicines
or who are dependent on medicines, treatment
with Skudexa should only be carried out for short
periods and under strict medical supervision.
Tell your doctor if any of these problems occurs
during Skudexa treatment or if they applied in
the past.
Children and adolescents
This medicine has not been studied in children
and adolescents. Therefore, safety and efficacy
have not been established and the product
should not be used in children and adolescents.
Other medicines and Skudexa
Tell your doctor if you are taking, have recently
taken or might take any other medicines,
including medicines obtained without a
prescription. Some medicines should not be
taken together and others may need their doses
to be altered when taken together.
Always inform your doctor if you are using or

receiving any of the following medicines in
addition to Skudexa:
Use with Skudexa is not recommended:
• Acetylsalicylic acid, corticosteroids or other
anti-inflammatory drugs
• Warfarin, heparin or other medicines used
to prevent blood clots
• Lithium, used to treat certain mood
disorders
• Methotrexate, used for rheumatoid arthritis
and cancer
• Hydantoins and phenytoin, used for
epilepsy
• Sulfamethoxazole, used for bacterial
infections
• Monoamine oxidase inhibitors (MAOIs)
(medicines for the treatment of depression).
Use with Skudexa requires precautions:
• ACE inhibitors, diuretics, beta-blockers and
angiotensin II antagonists, used for high
blood pressure and heart problems
• Pentoxifylline, used to treat chronic venous
ulcers
• Zidovudine, used to treat viral infections
• Chlorpropamide and glibenclamide, used
for diabetes
• Aminoglycoside antibiotics, used to treat
bacterial infections.
Use with Skudexa requires care:
• Quinolone antibiotics (e.g. ciprofloxacin,
levofloxacin) used for bacterial infections
• Ciclosporin or tacrolimus, used to treat
immune system diseases and in organ
transplant
• Streptokinase and other thrombolytic or
fibrinolytic medicines, i.e. medicines used
to break up blood clots
• Probenecid, used in gout
• Digoxin, used to treat chronic heart failure
• Mifepristone, used to terminate a pregnancy
• Antidepressants of the selective serotonin
reuptake inhibitors type (SSRIs)
• Anti-platelet agents used to reduce platelet
aggregation and the formation of blood
clots
• Tenofovir, deferasirox, pemetrexed.
The pain-relieving effect of tramadol may be
reduced, and the length of time it acts may be
shortened, if you also take medicines containing:
• Carbamazepine (for epileptic fits)
• Buprenorphine, nalbuphine, or pentazocine
(pain relievers)
• Ondansetron (prevents nausea).
The risk of side effects increases
• if you take tranquillizers, sleeping pills,
other pain relievers such as morphine
and codeine (also as cough medicine), or
alcohol while you are taking Skudexa. You
might feel drowsier or feel that you might
faint. If this happens tell your doctor
• if you are taking medicines which may
cause convulsions (fits), such as certain
antidepressants or antipsychotics. The
risk of having a fit may increase if you take
Skudexa at the same time. Your doctor will
tell you whether Skudexa is suitable for you
• if you are taking certain antidepressants.
Skudexa may interact with these medicines
and you may experience symptoms such
as involuntary, rhythmic contractions
of muscles (including the muscles that
control movement of the eye), agitation,
excessive sweating, tremor, exaggeration
of reflexes, increased muscle tension, body
temperature above 38°C
• if you take anticoagulants (medicines for
blood thinning), e.g. warfarin, together with
this medicine. The effect of these medicines
on blood clotting may be affected and
bleeding may occur.
Skudexa with alcohol
Do not drink alcohol during treatment with
Skudexa as it may increase the effect of the
medication. For the instruction how to take
Skudexa see section 3.
Pregnancy, breast-feeding 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.
The use of Skudexa is contraindicated in
pregnancy as well as during breast-feeding.
Driving and using machines
Skudexa may affect your ability to drive and
handle machines, due to the possibility of
dizziness, blurred vision or drowsiness as side
effects of treatment. This applies particularly
when Skudexa is taken with medicines that
affect mood and emotions, or alcohol.
If you are affected, do not drive or use machines
until the symptoms wear off.
3. How to take Skudexa
Always use this medicine exactly as your doctor
has told you. Check with your doctor if you are
not sure.
The dose of Skudexa that you need depends on
the type, severity and duration of your pain. Your
doctor will tell you how many tablets you must
take daily, and for how long.
The recommended dose is generally 1
film-coated tablet (corresponding to 75 mg
of tramadol hydrochloride and 25 mg of
dexketoprofen) every 8 hours, with no more
than 3 film-coated tablets daily (corresponding
to 225 mg of tramadol hydrochloride and 75 mg
of dexketoprofen) and not exceeding 5 days of
treatment.
Use in children and adolescents
Skudexa is not suitable for children and
adolescents.
Elderly patients
If you are aged 75 years or over, your doctor
may recommend prolonging the dosage interval
because your body may handle the drug more
slowly.
Severe liver or kidney disease (insufficiency)/
dialysis patients:
Patients with severe liver and/or kidney
insufficiency should not take Skudexa.
In case of renal dysfunction, if in your case
the insufficiency is mild, your doctor may
recommend prolonging the dosage interval.
In case of hepatic dysfunction, if in your case
the insufficiency is mild or moderate, your doctor
may recommend prolonging the dosage interval.
Swallow the tablet with a sufficient amount of
fluid (preferably with a glass of water).
Food delays the absorption of Skudexa, so for
a faster effect take the tablet at least 30 minutes
before meals. The score line is to help you break
the tablet if you have difficulty swallowing it
whole.
If you take more Skudexa than you should
If you use too much of this medicine, tell your
doctor immediately or go to the emergency
department of your nearest hospital. Please
remember to take this medicine pack or this
leaflet with you.
The symptoms of an overdose of this medicine
are:
• vomiting, loss of appetite, stomach
pain,
drowsiness,
dizziness/spinning
sensation, disorientation, headache (for
dexketoprofen)
• contraction of the pupil, vomiting, heart
failure, loss of consciousness, convulsions
and difficulty in breathing (for tramadol).
If you forget to take Skudexa
Do not take a double dose to make up for a
forgotten tablet. Take the next regular dose when
it is due (see section 3 “How to take Skudexa”).
If you stop taking Skudexa
Generally there will be no after-effects when
treatment with Skudexa is stopped.
However, on rare occasions, patients who have
been taking Skudexa tablets for some time may
feel unwell if they stop taking them abruptly. They
may feel agitated, anxious, nervous or shaky, be
confused, hyperactive, have difficulty sleeping
and have stomach or bowel disorders. Rarely,

people may get panic attacks, hallucinations,
delusions, paranoia or feel a loss of identity.
They may experience unusual perceptions such
as itching, tingling and numbness, and ringing in
the ears (tinnitus). Further unusual symptoms, i.e.
confusion, delusions, feeling as though you are
detached from yourself (depersonalization), and
change in perception of reality (derealisation)
and delusion of persecution (paranoia) have
been seen very rarely. If you experience any
of these complaints after stopping Skudexa,
please consult your doctor.
If you have any further questions on the use of
this medicine, ask your doctor.
4. Possible side effects
Like all medicines, this medicine can cause side
effects, although not everybody gets them.
Possible side effects are listed below according
to how likely they are to occur.
You should see a doctor immediately if you
experience symptoms of an allergic reaction
such as swollen face, tongue and/or throat, and/
or difficulty swallowing or hives together with
difficulties in breathing.
Stop using Skudexa as soon as you notice the
appearance of a skin rash, or any lesion inside
the mouth or on mucous membranes, or any
sign of an allergy.
Very common (may affect more than 1 in 10
people):
• nausea/feeling sick
• dizziness.
Common side effects (may affect up to 1 in 10
people):
• vomiting
• stomach pain
• diarrhoea
• digestive problems
• headaches
• drowsiness, fatigue
• constipation
• dry mouth
• increased sweating.
Uncommon side effects (may affect up to 1 in
100 people):
• increase in the number of blood platelets
• effects on the heart and blood circulation
(pounding of the heart, fast heart beat,
feeling faint or collapse), low blood
pressure. These adverse effects may occur
particularly when patients are in an upright
position or under physical strain.
• high or very high blood pressure
• swelling in the voice-box (laryngeal
oedema)
• reduced potassium in the blood
• psychotic disorder
• swelling next to the eye
• shallow or slow breathing
• discomfort, abnormal feeling
• blood in urine
• spinning sensation
• sleeplessness or difficulty falling asleep
• nervousness/anxiety
• flushing
• flatulence
• tiredness
• pain
• feeling feverish and shivering, generally
feeling unwell
• abnormal blood tests
• urge to vomit (retching)
• feeling of pressure in the stomach, bloating
• inflammation of the stomach
• skin reactions (e.g. itching, rash)
• facial swelling.
Rare side effects (may affect up to 1 in 1,000
people):
• swelling of the lips and throat
• peptic ulcer, peptic ulcer perforation or
bleeding, which may be seen as vomiting
blood or black stools
• prostate problems
• liver inflammation (hepatitis), liver damage
• acute kidney failure
• slow heartbeat
• epileptic fits
• allergic/anaphylactic
reactions
(e.g.
difficulty breathing, wheezing, swelling of
the skin) and shock (sudden circulatory
failure)
• transient loss of consciousness (syncope)
• hallucinations
• water retention or swollen ankles
• loss of appetite, changes in appetite
• acne
• back pain
• passing urine frequently, or less than
normal, with difficulty or pain
• menstrual disorders
• abnormal sensations (e.g. itching, tingling,
numbness)
• trembling, muscle twitches, uncoordinated
movement, weak muscles
• confusion
• sleep disorders and nightmares
• disturbed perception
• blurred vision, contraction of the pupil
• shortness of breath.
Psychological side effects may occur after
treatment with Skudexa. Their intensity and
nature may vary (according to the patient’s
personality and length of therapy):
• change in mood (mostly high spirits,
occasionally irritation)
• changes in activity (slowing down but
sometimes an increase in activity)
• being less aware
• less able to make decisions, which may
lead to errors in judgement.
Worsening of asthma has been reported.
If Skudexa is taken over a long period of time
dependence may occur, although the risk is very
low. When treatment is stopped abruptly signs of
withdrawal may appear (see “If you stop taking
Skudexa”).
Epileptic fits have occurred mainly at high doses
of tramadol or when tramadol was taken at
the same time as other medicines which may
induce fits.
Very rare (may affect up to 1 in 10,000 people):
• inflammation of the pancreas
• kidney problems
• reduced
white
blood
cell
count
(neutropenia)
• fewer
platelets
in
the
blood
(thrombocytopenia)
• open sores on skin, mouth, eyes and
genital areas (Stevens Johnson and Lyell’s
syndromes)
• breathlessness due to narrowing of the
airways
• ringing in the ears (tinnitus)
• sensitive skin
• sensitivity to light.
Not known (frequency cannot be estimated
from the available data):
• speech disorders
• extreme pupil dilatation
• decrease in blood sugar levels.
Tell your doctor immediately if you experience
stomach/bowel side effects at the start of
treatment (e.g. stomach pain, heartburn or
bleeding), if you have previously suffered from
any such side effects due to long-term use of
anti-inflammatory drugs, and especially if you
are elderly.
The most common side effects during treatment
with Skudexa are nausea and dizziness, which
occur in more than 1 out of 10 patients.
During treatment with NSAIDs, fluid retention
and swelling (especially in the ankles and legs),
increased blood pressure and heart failure have
been reported.
Medicines such as Skudexa may be associated
with a small increased risk of heart attack or
stroke.
In patients with immune system disorders
that affect connective tissue (systemic lupus
erythematosus or mixed connective tissue
disease), anti-inflammatory medicines may
rarely cause fever, headache and neck stiffness.
Reporting of side effects
If you get any side effects, talk to your doctor.
This includes any possible side effects not listed
in this leaflet. You can also report side effects
directly via the Yellow Card Scheme. Website:
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 Skudexa
Keep this medicine out of the sight and reach
of children.

Do not use this medicine after the expiry date
which is stated on the carton and on the blister
after EXP.
The expiry date refers to the last day of that
month.
This medicine does not require any special
temperature storage conditions.
Store in the original package, in order to protect
from light.
Do not throw away any medicines via wastewater
or household waste. Ask your pharmacist how to
throw away medicines you no longer use. These
measures will help protect the environment.
6. Contents of the pack and other
information
What Skudexa contains
• The active substances are tramadol
hydrochloride and dexketoprofen. Each
tablet contains: 75 mg of tramadol
hydrochloride and 25 mg dexketoprofen.
• The other ingredients are the following:
Tablet core: microcrystalline cellulose,
pregelatinised
maize
starch,
croscarmellose sodium, sodium stearyl
fumarate, anhydrous silica colloidal.
Film-coating: polyvinyl alcohol, titanium
dioxide, Macrogol/PEG 3350, talc.
What Skudexa looks like and contents of the
pack
Almost white to slightly yellow, oblong, filmcoated tablets with a break-mark on one side
and debossed “M” on the other side in plastic/
aluminium push-through pill packs.
Skudexa is supplied in packs containing 2,
4, 10, 15, 20, 30, 50, 100 film-coated tablets
and in multipacks comprising 5 cartons, each
containing 100 film-coated tablets.
Not all pack sizes may be marketed.
Marketing
Authorisation
Holder
and
Manufacturer
Marketing Authorisation Holder:
Menarini International Operations Luxembourg
S.A.
1 Avenue de La Gare
L-1611 Luxembourg
Manufacturer:
Menarini – Von Heyden GmbH
Leipziger Strasse 7-13
01097 Dresden
Germany
This medicinal product is authorised in
the Member States of the EEA under the
following names:
Austria, Belgium, Bulgaria, Croatia, Cyprus,
Czech Republic, Denmark, Estonia, Finland,
Germany, Greece, Hungary, Ireland, Iceland,
Latvia, Liechtenstein, Lithuania, Luxembourg,
Malta, The Netherlands, Norway, Poland,
Portugal, Romania, Slovak Republic, Slovenia,
Sweden, United Kingdom: Skudexa
France: Skudexum
Italy: Lenizak
Spain: Enanplus
This leaflet was last revised in 12/2016.