SKUDEXA

Patient Information Leaflet

Skudexa 75 mg + 25 mg, coated tablets
Tramadoli hydrochloridum + Dexketoprofenum
Please read all of this leaflet carefully before taking this medicine because it contains
important information for you.

• Keep this leaflet as you may need to read it again.
• If you have any further questions, please ask your doctor.
• This medicine has been prescribed for you personally. Do not pass it on to others. It may harm other people, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor. See section 4.

Table of contents

1. What Skudexa is and what it is used for
2. Important information before taking 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 tramadol hydrochloride and dexketoprofen as active substances.
Tramadol hydrochloride is a pain-relieving medicine belonging to a group of medicines called
opioids, which act on the central nervous system. It relieves pain by acting on specific nerve cells in the brain and spinal cord.
Dexketoprofen is a pain-relieving medicine belonging to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs).
Skudexa is used for the short-term symptomatic treatment of moderate to severe acute pain in adults.
Tell your doctor if you do not feel better or feel worse after taking this medicine.

2. Important information before using Skudexa

When not to use Skudexa:

• if the patient is allergic to dexketoprofen, tramadol hydrochloride, or any of the other ingredients of this medicine (listed in section 6)
• if the patient has hypersensitivity to acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (NSAIDs)
• if the patient has asthma or a history of asthma attacks, acute allergic rhinitis (a short-term inflammatory condition of the nasal mucosa), nasal polyps (growths inside the nose caused by allergy), urticaria (skin rash), angioedema (swelling of the face, eyes, lips or tongue, or respiratory failure), or wheezing after taking acetylsalicylic acid or another NSAID
• if the patient has previously experienced photosensitivity reactions: photoallergic or phototoxic reactions (particularly manifesting as redness and/or blisters on skin exposed to sunlight) while taking ketoprofen (an NSAID) or fibrates (medicines used to lower blood lipid levels)
• if the patient has gastric or duodenal ulcer disease and/or gastrointestinal bleeding, or a history of gastrointestinal bleeding, ulceration, or perforation, including cases due to prior use of NSAIDs
• if the patient has chronic gastrointestinal disorders (e.g. indigestion, heartburn)
• if the patient has inflammatory bowel diseases (Crohn's disease or ulcerative colitis)
• if the patient has severe heart failure, moderate or severe renal impairment, or severe hepatic impairment
• if the patient has bleeding disorders or coagulation disorders
• if the patient is severely dehydrated (excessive loss of body fluids) due to vomiting, diarrhoea, or inadequate fluid intake
• in cases of acute alcohol intoxication, sedatives, painkillers, or medicines affecting mood and emotions
• if the patient is also taking monoamine oxidase inhibitors (MAOIs) (some medicines used to treat depression) or has taken them within the last 14 days before starting treatment with this medicine (see "Skudexa with other medicines")
• if the patient has epilepsy or seizures, as seizure risk may increase
• if the patient has breathing difficulties
• if the patient is pregnant or breastfeeding.

Warnings and precautions
Before starting Skudexa, discuss with your doctor:

• if the patient has allergies or a history of allergic conditions
• if the patient has impaired kidney, liver, or heart function (hypertension and/or heart failure), fluid retention, or if any of these conditions occurred previously
• in patients taking diuretics (medicines that increase urine production)
• if the patient has heart disease, history of stroke, or suspicion of being in a high-risk group for these conditions (e.g. high blood pressure, diabetes, high cholesterol, or smoking). In such cases, consult your doctor before using Skudexa. Taking medicines such as Skudexa may be associated with a small increased risk of heart attack (myocardial infarction) or stroke. This risk increases with long-term use of high doses. Do not exceed recommended doses or duration of treatment
• if the patient is elderly: increased risk of adverse effects (see section 4). In such cases, contact your doctor immediately
• in women experiencing difficulty conceiving: this medicine may impair female fertility and is not recommended for women planning pregnancy or undergoing infertility treatment
• if the patient has blood cell formation or blood cell disorders
• if the patient has systemic lupus erythematosus or mixed connective tissue disease (immune system disorders affecting connective tissue)
• if the patient has a history of chronic inflammatory bowel diseases (ulcerative colitis, Crohn's disease)
• if the patient has or has had other stomach or intestinal diseases
• if the patient has an infection – see below, section titled "Infections"
• if the patient is taking other medicines that increase the risk of gastric or duodenal ulcer disease and/or bleeding, e.g. oral corticosteroids, certain antidepressants (SSRIs, i.e. selective serotonin reuptake inhibitors), anticoagulants such as acetylsalicylic acid or anticoagulant medicines such as

warfarin. In such cases, consult your doctor before taking the medicine, who
may decide to prescribe an additional medicine to protect the stomach

• if the patient has depression and is taking antidepressants, as some of these may interact with tramadol (see "Skudexa with other medicines")
• if the patient is taking other medicines containing the same active substances, do not exceed the maximum daily dose of dexketoprofen or tramadol
• if the patient believes they are dependent on other painkillers (opioids)
• if the patient has disturbances of consciousness (if the patient feels they may faint)
• if the patient is in shock (cold sweat may be a symptom)
• if the patient has increased intracranial pressure (e.g. due to head injury or brain disease)
• if the patient has breathing difficulties
• if the patient has porphyria (a disorder involving disturbances in heme metabolism).

Tolerance, dependence, and abuse
This medicine contains tramadol, which is an opioid medicine. Repeated use of opioids
may lead to reduced effectiveness of the medicine (the patient becomes accustomed to the medicine, known
as tolerance). Repeated use of Skudexa may also lead to dependence, abuse, and addiction, which may result in life-threatening
overdose. The risk of these adverse effects may increase with higher doses and
longer duration of use.
Dependence may cause the patient to lose control over the dose or frequency of medicine intake.
The risk of dependence varies among individuals. The risk of dependence on Skudexa may
be higher if:
the patient or a family member has ever abused or been dependent on
alcohol, prescription medicines, or illegal drugs ("addiction");
the patient smokes tobacco;
the patient has ever had mood disorders (depression, anxiety, or
personality disorders) or has been treated by a psychiatrist for other mental illnesses.
If any of the following symptoms occur during treatment with Skudexa, this may
indicate dependence:
the patient needs to take the medicine longer than prescribed by the doctor
the patient needs to take a higher dose than recommended
the patient feels a need to continue taking the medicine despite it not helping
to relieve pain
the patient uses the medicine for reasons other than recommended, e.g. "to calm down"
or "to help sleep"
the patient has made repeated, unsuccessful attempts to stop or control medicine use
after stopping the medicine, the patient feels unwell and feels better after
re-taking the medicine ("withdrawal effects")
If any of these symptoms occur, talk to your doctor to discuss the best treatment approach, including when and how to discontinue the medicine safely (see section 3. "Discontinuing Skudexa").
Tramadol may lead to physical and psychological dependence. If used for a long time, the medicine's effect may weaken, requiring higher doses (development of tolerance). In patients with a tendency to drug abuse or dependence, treatment with Skudexa should be short-term and under strict medical supervision.
Inform your doctor if any of these problems occur during treatment with Skudexa or have occurred in the past.
If any of the following symptoms occur during treatment with Skudexa, inform your doctor: excessive fatigue, loss of appetite, severe abdominal pain, nausea, vomiting, or low blood pressure. These may indicate adrenal insufficiency (low cortisol levels). If such symptoms occur, contact your doctor, who will decide whether hormone replacement is necessary.
Tramadol is metabolized in the liver by an enzyme. Some individuals have a genetic variation of this enzyme, which may lead to different effects. In some people, pain relief may be insufficient, while in others, severe adverse effects are more likely.
Discontinue the medicine and contact your doctor immediately if any of the following adverse effects occur: slowed or shallow breathing, confusion, drowsiness, pinpoint pupils, nausea or vomiting, constipation, or loss of appetite.
There is a small risk of serotonin syndrome when tramadol is taken with certain antidepressants or tramadol alone. If any symptoms of this serious syndrome occur, the patient should seek immediate medical advice (see section 4 "Possible side effects").
Sleep-related breathing disorders
Skudexa may cause sleep-related breathing disorders, such as sleep apnoea (pauses in breathing during sleep) and sleep-related hypoxemia (low blood oxygen levels).
Symptoms may include pauses in breathing during sleep, nocturnal awakenings due to breathlessness, difficulty maintaining sleep, or excessive daytime sleepiness. If the patient or another person observes these symptoms, contact the doctor. The doctor may recommend reducing the dose.
Infections
Skudexa may mask symptoms of infection, such as fever and pain. Therefore, Skudexa may delay appropriate treatment of infection and consequently increase the risk of complications. This has been observed in bacterial pneumonia and bacterial skin infections associated with varicella (chickenpox). If the patient takes this medicine during an existing infection and symptoms persist or worsen, seek immediate medical advice.
Avoid using this medicine during varicella (chickenpox).
Kounis syndrome
During use of dexketoprofen, symptoms of allergic reaction to this medicine have been reported, including breathing difficulties, facial and neck swelling (angioedema), and chest pain. If any of these symptoms occur, discontinue Skudexa immediately and contact your doctor or emergency services without delay.
Children and adolescents
The use of this medicine has not been studied in children and adolescents. Safety and efficacy have not been established, and therefore, the medicine should not be used in children and adolescents.
Use in children with breathing disorders
Tramadol is not recommended in children with breathing disorders, as tramadol toxicity symptoms may be intensified in them.
Skudexa with other medicines
Inform your doctor about all medicines currently or recently taken, as well as any medicines the patient plans to take, including over-the-counter medicines.
Some medicines should not be used together with Skudexa, while others may require dose adjustments when used concurrently.
Always inform your doctor if taking any of the following medicines together with Skudexa:
Not recommended for concomitant use:

• Acetylsalicylic acid, corticosteroids, or other anti-inflammatory medicines
• Warfarin, heparin, or other anticoagulant medicines
• Lithium used to treat certain mood disorders
• Methotrexate used to treat rheumatoid arthritis and cancer
• Hydantoin derivatives and phenytoin used to treat epilepsy
• Sulfamethoxazole used to treat bacterial infections
• Monoamine oxidase inhibitors (MAOIs) (medicines used to treat depression).

Concomitant use requiring caution:

• ACE inhibitors, diuretics, beta-blockers, and angiotensin II antagonists used to treat high blood pressure and heart disease
• Pentoxifylline used to treat ulcers in chronic venous insufficiency
• Zidovudine used to treat viral infections
• Chlorpropamide and glibenclamide used to treat diabetes
• Aminoglycoside antibiotics used to treat bacterial infections.
• Concomitant use of Skudexa with sedatives such as benzodiazepines or other medicines acting similarly to benzodiazepines may increase the risk of drowsiness, breathing difficulties (respiratory depression), coma, and may be life-threatening. Therefore, concomitant use should only be considered when no other treatment options are possible. If the treating doctor prescribes Skudexa to be used concomitantly with sedatives, the dose and duration of treatment should be limited by the doctor. Inform your doctor about all sedative medicines taken and strictly follow the treating doctor's instructions. It may be helpful to inform friends and family that the above-mentioned symptoms may occur. Contact the treating doctor if such symptoms occur.

Concomitant use requiring special consideration:

• Quinolone antibiotics (e.g. ciprofloxacin, levofloxacin) used to treat bacterial infections
• Cyclosporine and tacrolimus used to treat immune system disorders and in transplant patients
• Streptokinase and other thrombolytic or fibrinolytic medicines, i.e. medicines used to dissolve blood clots
• Probenecid used to treat gout
• Digoxin used to treat chronic heart failure
• Mifepristone used as a medicine to terminate pregnancy
• Selective serotonin reuptake inhibitors (SSRIs), a class of antidepressants
• Antiplatelet medicines used to reduce platelet aggregation and blood clot formation
• Tenofovir, deferasirox, pemetrexed

The pain-relieving effect of tramadol may be reduced and its duration shortened when the patient
also takes medicines containing:

• Carbamazepine (due to seizures)
• Buprenorphine, nalbuphine, or pentazocine (painkillers)
• Ondansetron (to prevent nausea).

The risk of adverse effects increases:

• if the patient takes gabapentin or pregabalin for epilepsy or nerve-related pain (neuropathic pain)
• if the patient takes sedatives, sleeping pills, other painkillers such as morphine and codeine (also for cough), or alcohol while using Skudexa. The patient may feel drowsy or feel faint. If this occurs, inform the doctor
• if the patient takes medicines that may cause seizures (convulsions), such as certain antidepressants or antipsychotics. The risk of seizures may increase due to concomitant use of Skudexa. The doctor will decide whether Skudexa is suitable for the patient
• if the patient takes certain antidepressants. Skudexa may interact with these medicines and cause serotonin syndrome (see section 4 "Possible side effects")
• if the patient takes anticoagulants (blood-thinning medicines), e.g. warfarin, together with this medicine. The effect of these medicines on blood clotting may be disturbed, leading to bleeding.

Use with alcohol
Do not drink alcohol while being treated with Skudexa, as it may intensify the medicine's effects.
Instructions for use of Skudexa – see section 3.
Pregnancy, breastfeeding, and effects on fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor before using this medicine.
Dexketoprofen may cause kidney and heart problems in the unborn child.
This medicine may increase the tendency to bleed in both the patient and the child and may delay or prolong labour. From the 20th week of pregnancy, dexketoprofen may cause kidney problems in the unborn child – this may lead to reduced amniotic fluid volume surrounding the child (oligohydramnios) or narrowing of a blood vessel (ductus arteriosus) in the child's heart.
Tramadol is excreted in breast milk.
Use of Skudexa is contraindicated during pregnancy and while breastfeeding.
Driving and operating machinery
Skudexa may affect the ability to drive and operate machinery due to possible side effects such as dizziness, visual disturbances, or drowsiness during treatment. This is particularly relevant when Skudexa is taken with medicines affecting mood and emotions or with alcohol.
If such symptoms occur, do not drive or operate machinery until symptoms subside.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. the medicine is considered "sodium-free".

3. How to use Skudexa

This medicine should always be taken exactly as prescribed by the doctor. In case of doubt, consult
your doctor.
The lowest effective dose should be used for the shortest duration necessary to relieve symptoms.
If, during an infection, its symptoms (such as fever and pain) persist or worsen, consult your doctor
immediately (see section 2).
Your doctor will inform you about the dose of Skudexa, which will depend on the type, severity, and
duration of your pain. Before starting treatment and regularly during treatment, your doctor will
discuss with you what to expect from using Skudexa, how many tablets to take per day, when and
for how long to take it, when to contact your doctor, and when to discontinue the medicine (see also
Stopping Skudexa).
The recommended daily dose is usually 1 coated tablet (equivalent to 75 mg tramadol hydrochloride
and 25 mg dexketoprofen) every 8 hours. The total daily dose should not exceed 3 coated tablets
(equivalent to 225 mg tramadol hydrochloride and 75 mg dexketoprofen), and treatment should not
last longer than 5 days.
Use in children and adolescents
Skudexa must not be used in children and adolescents.
Elderly patients
In patients aged 75 years or older, your doctor may recommend longer intervals between doses,
because the body may metabolize the medicine more slowly.
Patients with severe liver or kidney disease (renal failure)/patients on dialysis
Patients with severe liver disease and/or renal failure must not use Skudexa.
In case of impaired kidney function, if the patient has mild renal impairment, the doctor may
recommend extending the interval between doses.
In case of impaired liver function, if the patient has mild or moderate liver impairment, the doctor
may recommend extending the interval between doses.
Skudexa tablets should be swallowed with sufficient fluid (preferably a glass of water).
Food delays the absorption of Skudexa; therefore, to achieve a faster effect, the tablet should be
taken at least 30 minutes before a meal. The break line visible on the tablet will help to split it in case
of difficulty swallowing the tablet whole.
Taking more Skudexa than recommended
If you take more Skudexa than recommended, contact your doctor or go immediately to the
emergency department of your nearest hospital. Remember to bring the medicine packaging or the
patient leaflet with you.
Symptoms of overdose include:

• vomiting, loss of appetite, abdominal pain, drowsiness, dizziness/vertigo, disorientation, headache (due to dexketoprofen)
• pinpoint pupils, vomiting, cardiac failure, loss of consciousness, seizures, and breathing difficulties (due to tramadol).

Missing a dose of Skudexa
Do not take a double dose to make up for a missed dose. Take the next dose according to the
prescribed dosing schedule (see section 3 "How to use Skudexa").
Stopping Skudexa
Withdrawal effects after stopping Skudexa are unlikely.
However, in rare cases, patients who have taken Skudexa for some time may feel unwell if treatment
is stopped abruptly. They may experience restlessness, anxiety, nervousness, feel uneasy, confused,
hyperactive, have sleep disturbances, or gastrointestinal disorders. Rarely, patients may experience
panic attacks, hallucinations, delusions, paranoia, or loss of identity. Unusual sensations such as
itching, tingling, numbness, and ringing in the ears (tinnitus) may occur. Very rarely, additional
unusual symptoms such as confusion, delusions, feelings of depersonalization, changes in the
perception of reality (derealization), and persecutory delusions (paranoia) have been observed. If any
of these symptoms occur after stopping Skudexa, consult your doctor.
If you have any further questions about the use of this medicine, consult your doctor.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
The possible adverse effects are listed below and are categorized according to their likelihood of occurrence.
Contact a doctor immediately if symptoms of an allergic reaction occur, such as swelling of the face, tongue and/or throat, and/or difficulty swallowing or hives accompanied by breathing difficulties.
Stop taking Skudexa as quickly as possible if the patient notices the appearance of a rash or any changes inside the oral cavity or mucous membranes, or any symptoms of allergy.

Very common adverse effects (may occur in more than 1 in 10 people):

• nausea
• dizziness

Common adverse effects (may occur in up to 1 in 10 people):

• vomiting
• abdominal pain
• diarrhoea
• indigestion
• headache
• drowsiness, fatigue
• constipation
• dry mouth
• excessive sweating

Uncommon adverse effects (may occur in up to 1 in 100 people):

• increased platelet count
• effects on the heart and circulation (palpitations, rapid heartbeat, feeling faint or collapse), low blood pressure. These adverse effects may occur especially when the patient is in an upright position or during physical exertion.
• high or very high blood pressure
• swelling of the vocal cords (laryngeal oedema)
• decreased potassium levels in the blood
• psychotic disorders
• eye area swelling
• shallow or slow breathing
• discomfort, abnormal sense of well-being
• blood in urine
• sensation of spinning
• insomnia or difficulty falling asleep
• nervousness/anxiety
• hot flushes
• bloating
• fatigue
• pain
• feeling feverish and chills, general malaise
• abnormal blood test results
• tendency to vomit (vomiting reflex)
• feeling of pressure in the stomach, bloating
• gastritis
• skin reactions (e.g. itching, rash)
• memory impairment
• facial swelling

Rare adverse effects (may occur in up to 1 in 1,000 people):

• swelling of lips and throat
• peptic ulcer of the stomach and/or duodenum, perforation or bleeding, which may present as vomiting blood or black stools
• prostate disorders
• liver inflammation (hepatitis), liver damage
• acute kidney failure
• slow heartbeat
• seizures
• allergic/anaphylactic reactions (e.g. difficulty breathing, wheezing, skin swelling) and shock (sudden circulatory failure)
• transient loss of consciousness (fainting)
• hallucinations
• fluid retention or ankle swelling
• loss of appetite, changes in appetite
• acne
• back pain
• frequent urination or less than usual, with difficulties or pain
• menstrual disorders
• sensory disturbances (e.g. itching, tingling, numbness)
• tremor, muscle spasms, uncoordinated movements, weak muscles
• confusion
• sleep disturbances and nightmares
• disturbances in perception
• blurred vision, pinpoint pupils
• shortness of breath

Psychiatric disorders may occur during treatment with Skudexa. Their intensity and nature may vary (depending on the patient's personality and duration of treatment) and may include:

• mood changes (mostly elevated mood, sometimes irritability)
• changes in activity (slowing down, but sometimes increased activity)
• feeling less aware
• reduced decision-making ability, which may lead to errors in judgment.

Worsening of asthma has been reported.
Withdrawal symptoms may occur after abrupt discontinuation of treatment (see "Stopping Skudexa").
Seizures occurred mainly after administration of high doses of tramadol or when tramadol was used simultaneously with other medicines that may provoke seizures.

Very rare adverse effects (may occur in up to 1 in 10,000 people):

• pancreatitis
• kidney disorders
• reduced white blood cell count (neutropenia)
• reduced platelet count (thrombocytopenia)
• skin, lip, eye and genital area ulceration (Stevens-Johnson syndrome and Lyell's syndrome)
• shortness of breath due to airway constriction
• ringing in the ears (tinnitus)
• skin hypersensitivity
• light sensitivity

Frequency not known (frequency cannot be estimated from available data):

• Kounis syndrome. Chest pain, which may be a symptom of a potentially severe allergic reaction called Kounis syndrome
• erythema multiforme. An allergic skin reaction known as erythema multiforme, whose symptoms may include circular or oval areas of redness and swelling of the skin, blister formation and itching. Darkening of the skin in affected areas may also occur, which may persist after healing. Erythema multiforme usually recurs in the same location(s) upon re-exposure to the drug
• serotonin syndrome, which may present with changes in mental state (e.g. agitation, hallucinations, coma), as well as other symptoms such as fever, rapid heartbeat, unstable blood pressure, involuntary muscle contractions, muscle rigidity, lack of coordination and/or gastrointestinal symptoms (e.g. nausea, vomiting, diarrhoea) (see section 2. Important information before taking Skudexa)
• speech disorders
• extreme dilation of the pupils
• decreased blood sugar levels
• hiccups

Inform the doctor if the patient observes any adverse effects affecting the stomach or intestines at the beginning of treatment (e.g. stomach pain, heartburn or bleeding), especially if the patient has previously experienced similar adverse effects due to long-term use of anti-inflammatory medicines, particularly in elderly individuals.

The most common adverse effects during treatment with Skudexa are nausea and dizziness, occurring in more than 1 in 10 patients.

During administration of non-steroidal anti-inflammatory drugs, fluid retention and oedema (especially of the ankles and legs), increased blood pressure and heart failure may occur.

Taking medicines such as Skudexa may be associated with a small increased risk of heart attack (myocardial infarction) or stroke.

In patients with immune system disorders affecting connective tissue (systemic lupus erythematosus or mixed connective tissue disease), administration of anti-inflammatory medicines may rarely cause fever, headache and neck stiffness.

Reporting of adverse effects

If any adverse effects occur, including any adverse effects not listed in this leaflet, inform a doctor, pharmacist or nurse.

Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:

Al. Jerozolimskie 181C
02-222 Warsaw
Tel.: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl

Adverse effects can also be reported to the marketing authorization holder.

Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Skudexa

Keep this medicine out of sight and reach of children.
This medicine should be stored in a safe place where others cannot access it.
It may cause serious harm or be fatal to people for whom it has not been prescribed.
Do not use this medicine after the expiry date stated on the outer carton and on the
blister after "EXP". The expiry date refers to the last day of the stated month.
This medicine does not require any special storage temperature conditions. Store blisters
in the outer packaging to protect from light.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist
how to dispose of medicines no longer required. 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 of dexketoprofen.
• Other ingredients are:
  Tablet core: microcrystalline cellulose, maize pregelatinized starch, sodium croscarmellose, sodium stearyl fumarate, colloidal anhydrous silica.
  Tablet coating: Opadry II white 85F18422 consisting of: polyvinyl alcohol, titanium dioxide (E 171), macrogol/PEG 3350, talc.

What Skudexa looks like and contents of the pack
Skudexa tablets are almost white to slightly yellowish, oblong coated tablets with a division line on one side and embossed "M" on the other side.
Pack contents: 4, 10, 15, 20, 30, 50 or 100 coated tablets, and a collective pack containing 5 packs of 100 coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Menarini International Operations Luxembourg S.A.
1, Avenue de la Gare, L-1611 Luxembourg
Luxembourg

Manufacturer
Menarini – Von Heyden GmbH
Leipziger Strasse 7-13
01097 Dresden
Germany

This medicinal product is authorised in the European Economic Area countries under the following names:
Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Estonia, Finland, Greece, Hungary, Ireland, Latvia, Liechtenstein, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, United Kingdom (Northern Ireland): Skudexa
France: Skudexum
Spain: Enanplus
Italy: Lenizak

For further information, please contact the local representative of the Marketing Authorisation Holder:
Berlin-Chemie/Menarini Polska Sp. z o.o.
Tel.: (22) 566 21 00
Fax: (22) 566 21 01