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SKUDEXA 75 MG/25 MG FILM-COATED TABLETS

Active substance(s): DEXKETOPROFEN / TRAMADOL HYDROCHLORIDE

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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
anti-inflammatory 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 to any of the
other ingredients of this medicine (listed in section 6)
 if you are allergic to acetylsalicylic acid or to other NSAID
 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 non-steroidal 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)
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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 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
acethylsalicil 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 have difficulty in breathing
 if you have porphyria.
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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 (aspirin), 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:
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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 food, drink and alcohol
Do not drink alcohol during treatment with Skudexa as it may increase the effect of the
medication.
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
Use in adults
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 tablet (75 mg/25 mg) every 8 hours, with no more
than 3 tablets daily (225 mg/75 mg) 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.
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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, people 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):
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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).
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
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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)
 facial swelling
 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.

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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, film-coated 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, 20, 30, 50 or 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

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This medicinal product is authorised in the Member States of the EEA under the
following names:
Austria: Skudex 75 mg/25 mg Filmtabletten
Belgium: Skudexa 75 mg/25 mg film-coated tablets
Bulgaria: Skudex
Croatia: Skudex 75 mg/25 mg filmom obložene tablete
Cyprus: Skudex 75 mg/25 mg film-coated tablets
Czech Republic: Skudex 75 mg/25 mg potahované tablety
Denmark: Skudex
Estonia: Skudex
Finland: Skudex 75 mg/25 mg film-coated tablets
France: Skudexum 75 mg/25 mg film-coated tablets
Germany: Skudexa 75 mg/25 mg Filmtabletten
Greece: Skudex 75 mg/25 mg film-coated tablets
Hungary: Skudex 75 mg/25 mg film-coated tablets
Ireland: Skudexa 75 mg/25 mg film-coated tablets
Iceland: Skudex 75 mg/25 mg film-coated tablets
Italy: Skudo 75 mg/25 mg compresse rivestite con film
Latvia: Skudex 75 mg/25 mg film-coated tablets
Liechtenstein: Skudex 75 mg/25 mg film-coated tablets
Lithuania: Skudex 75 mg/25 mg film-coated tablets
Luxembourg: Skudexa 75 mg/25 mg film-coated tablets
Malta: Skudex 75 mg/25 mg film-coated tablets
Netherlands: Skudexa 75 mg/25 mg film-coated tablets
Norway: Skudex 75 mg/25 mg film-coated tablets
Poland: Skudex
Portugal: Skudex 75 mg/25 mg film-coated tablets
Romania: Skudex 75 mg/25 mg comprimate filmate
Slovak Republic: Skudex 75 mg/25 mg filmom obalené tablety
Slovenia: Skudex 75 mg/25 mg filmsko obložene tablete
Spain: Skudex 75 mg/25 mg film-coated tablets
Sweden: Skudex 75 mg/25 mg film-coated tablets
United Kingdom: Skudexa 75 mg/25 mg film-coated tablets
This leaflet was last revised in 01/2016.

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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