Skudexa

Package leaflet: Information for the patient

Skudexa, 75 mg + 25 mg, granules for oral solution
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 a specific individual. Do not pass it on to others. It may harm someone else, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor. See section 4.

Table of contents

1. What Skudexa is and what it is used for
2. What you need to know 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 an analgesic 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 an analgesic 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.

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 has previously experienced asthma attacks, acute allergic rhinitis (a short period of inflammation 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 photoallergic or phototoxic reactions (such as redness and/or blisters on sun-exposed skin) 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 has previously experienced 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 with chronic inflammation (Crohn's disease or ulcerative colitis)
• if the patient has severe heart failure, moderate or severe kidney dysfunction, or severe liver dysfunction
• if the patient has bleeding disorders, coagulation disorders, or other active bleeding
• if the patient is severely dehydrated (excessive loss of body fluids) due to vomiting, diarrhoea, or inadequate fluid intake
• in case of acute alcohol intoxication, sedatives, painkillers, or medicines affecting mood and emotions
• if the patient is currently 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 and other medicines")
• if the patient has epilepsy or seizures, as the risk of seizures may increase
• if the patient has breathing difficulties
• if the patient is pregnant or breastfeeding.

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

• if the patient has allergies or has previously had allergy-related conditions
• if the patient has kidney, liver, or heart problems (hypertension and/or heart failure), fluid retention, or if any of these conditions occurred in the past
• in patients taking diuretics (medicines that increase urine production)
• if the patient has heart disease, has had a stroke, or is suspected to be at risk for these conditions (e.g. in case of high blood pressure, diabetes, high cholesterol levels, or if the patient smokes). In such cases, consult your doctor before taking this medicine; 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 the recommended dose or duration of treatment
• if the patient is elderly: there is an increased risk of adverse effects (see section 4). In such cases, contact your doctor immediately
• in women with difficulty becoming pregnant: 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 previously had chronic inflammatory bowel diseases (ulcerative colitis, Crohn's disease)
• if the patient currently has or has previously 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 ulceration or bleeding, e.g. oral corticosteroids, certain antidepressants (SSRIs, i.e. selective serotonin reuptake inhibitors), anticoagulants such as acetylsalicylic acid, or antithrombotic medicines such as warfarin. In such cases, consult your doctor before taking this medicine; the doctor may decide to prescribe an additional medicine to protect the stomach
• if the patient has depression and is taking antidepressants, as some of them may interact with tramadol (see "Skudexa and 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 in consciousness (if the patient feels they may faint)
• if the patient is in shock (cold sweat may be a sign of this condition)
• if the patient has increased intracranial pressure (e.g. due to head injury or brain disease)
• if the patient has breathing difficulties or has porphyria (a disorder affecting haem metabolism).

Tolerance, dependence, and addiction
This medicine contains tramadol, which is an opioid medicine. Repeated use of opioids may result in reduced effectiveness of the medicine (the patient becomes accustomed to the medicine, known as tolerance). Repeated use of Skudexa may also lead to dependence, misuse, 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 someone in their family has ever misused 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, even though it does not help relieve pain
the patient takes 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 taking it again ("withdrawal effects")
If any of these symptoms occur, talk to your doctor to discuss the best treatment approach, including when and how to stop the medicine safely (see section 3. "Stopping treatment with Skudexa").
Tramadol may lead to physical and psychological dependence. If used for a long time, the effect of the medicine may weaken, requiring higher doses (development of tolerance). In patients with a tendency to misuse medicines or who are already dependent on medicines, 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, tell your doctor: excessive fatigue, loss of appetite, severe abdominal pain, nausea, vomiting, or low blood pressure. This 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 people have a variation of this enzyme, which may have different effects. In some individuals, pain relief may be insufficient, while in others, severe adverse effects are more likely. Stop taking the medicine and contact your doctor immediately if any of the following adverse effects occur: slowed or shallow breathing, confusion, drowsiness, constricted 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 the patient experiences any symptoms of this serious syndrome, they 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 hypoxia (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 someone else 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 chickenpox. If the patient takes this medicine during an existing infection and infection symptoms persist or worsen, consult a doctor immediately.
Avoid using this medicine during chickenpox.

Kounis syndrome
During the 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, stop taking 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. The safety and efficacy of this medicine have not been established, and therefore it 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 and other medicines
Tell your doctor about all medicines the patient is currently taking or has 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 taken together with Skudexa. Always inform your doctor if any of the following medicines are being taken together with Skudexa:

Not recommended to use together:

• 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 and other sulfonamides
• Monoamine oxidase inhibitors (MAOIs) (medicines used to treat depression)

Use together with caution:

• ACE inhibitors, diuretics, angiotensin II antagonists used to treat high blood pressure and heart diseases
• Pentoxifylline used to treat ulcers in chronic venous insufficiency
• Zidovudine used to treat viral infections
• Sulfonylurea derivatives such as chlorpropamide and glibenclamide used to treat diabetes
• Aminoglycoside antibiotics used to treat bacterial infections
• Concurrent 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, concurrent use should only be considered if no other treatment options are possible. If your doctor prescribes Skudexa to be used together with sedatives, the dose and duration of treatment should be limited by the doctor. Inform your doctor about all sedative medicines you are taking and strictly follow your doctor's instructions. It may be helpful to inform friends and family that the above-mentioned symptoms may occur. Contact your doctor if such symptoms occur.

Use together with special consideration:

• Quinolone antibiotics (e.g. ciprofloxacin, levofloxacin) used to treat bacterial infections
• Cyclosporine and tacrolimus used to treat immune system diseases and in transplantations
• 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) used as antidepressants
• Antiplatelet medicines used to reduce platelet aggregation and blood clot formation
• Tenofovir, deferasirox, pemetrexed
• Beta-adrenolytic medicines used to treat high blood pressure and heart diseases

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

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

The risk of adverse effects increases:

• if the patient is taking gabapentin or pregabalin for epilepsy or nerve-related pain (neuropathic pain)
• if the patient is taking sedatives, sleeping medicines, 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 is taking medicines that may cause seizures (convulsions), such as certain antidepressants or antipsychotics. The risk of seizures may increase due to concurrent use of Skudexa. The doctor will decide whether Skudexa is suitable for the patient
• if the patient is taking certain antidepressants. Skudexa may interact with these medicines and cause serotonin syndrome (see section 4 "Possible side effects")
• if the patient is taking 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 of Skudexa with alcohol
Do not drink alcohol during treatment with Skudexa, as it may intensify the effect of this medicine.
Instructions for use of Skudexa – see section 3.

Pregnancy, breastfeeding, and effect on fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans to have a child, she should consult a 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.
The use of Skudexa is contraindicated during pregnancy and breastfeeding.

Driving and operating machinery
Skudexa may affect the ability to drive and operate machinery due to the possibility of dizziness, visual disturbances, or drowsiness as adverse effects during treatment. This is particularly important 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.

Skudexa contains sucrose
Skudexa contains 2.7 g of sucrose per dose. This should be taken into account in patients with diabetes.
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should contact the doctor before taking the medicine.

3. How to use Skudexa

This medicine should always be taken as directed by the doctor. If in doubt, consult the 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, medical advice should be sought immediately (see section 2).
The dose of Skudexa will depend on the type, severity, and duration of pain experienced by the patient.
Before starting treatment and regularly during treatment, the doctor will discuss with the patient what to expect from using Skudexa, how many tablets should be taken per day, when and for how long the medicine should be taken, when to contact the doctor, and when to discontinue treatment (see also information on stopping Skudexa).

The recommended daily dose is usually 1 sachet (equivalent to 75 mg of tramadol hydrochloride and 25 mg of dexketoprofen) every 8 hours, not exceeding 3 sachets per day (equivalent to 225 mg of tramadol hydrochloride and 75 mg of 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
For patients aged 75 years or older, the doctor may recommend longer intervals between doses, as the body may metabolize the medicine more slowly.

Patients with severe liver or kidney disease (failure)/dialysis patients
Patients with severe liver disease and/or kidney failure must not use Skudexa.
In case of renal function impairment, if the patient has mild kidney failure, the doctor may recommend extending the interval between doses.
In case of hepatic function impairment, if the patient has mild or moderate liver failure, the doctor may recommend extending the interval between doses.

The contents of the sachet should be dissolved in a glass of water and stirred thoroughly to aid dissolution.
The resulting solution should be taken immediately after preparation.
Food delays the absorption of Skudexa; therefore, to achieve faster action, the granules for oral solution in sachets should be taken at least 30 minutes before a meal.

Taking more than the recommended dose of Skudexa
If a patient takes more than the recommended dose, a doctor should be contacted immediately or the nearest hospital emergency department should be visited. Remember to bring the medicine packaging or patient leaflet with you.
Symptoms of overdose include:

• vomiting, loss of appetite, abdominal pain, drowsiness, dizziness/vertigo, disorientation, headache (due to dexketoprofen)
• constricted 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. The next dose should be taken according to the prescribed dosing schedule (see section 3 "How to use Skudexa").

Stopping treatment with 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 abruptly discontinued. They may experience agitation, anxiety, nervousness, feelings of unease, confusion, hyperactivity, sleep disturbances, or gastrointestinal disturbances. 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 rare cases have included confusion, delusions, depersonalization, perceptual disturbances (derealization), and persecutory delusions (paranoia). If any of these symptoms occur after stopping Skudexa, consult a doctor.
If there are any further doubts regarding the use of this medicine, consult a 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 grouped 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 together with breathing difficulties.
Treatment with Skudexa should be stopped as quickly as possible if the patient notices the appearance of a rash or any changes inside the mouth or on 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 blood 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 with 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 heart rate
• seizures
• allergic/anaphylactic reactions (e.g. breathing difficulties, wheezing, skin swelling) and shock (sudden circulatory failure)
• transient loss of consciousness (fainting)
• hallucinations
• fluid retention or ankle swelling
• loss of appetite, appetite changes
• acne
• back pain
• frequent urination or less than usual, with difficulty or pain
• menstrual disorders
• sensory disturbances (e.g. itching, tingling, numbness)
• tremor, muscle spasms, uncoordinated movements, weak muscles
• confusion
• sleep disturbances and nightmares
• perceptual disturbances
• blurred vision, pinpoint pupils
• shortness of breath.

Psychiatric disorders may occur after 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 assessing situations.

Worsening of asthma has been reported.
Symptoms of withdrawal may occur when treatment is stopped abruptly (see "Discontinuation of 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 ulceration (Stevens-Johnson syndrome and Lyell's syndrome)
• shortness of breath due to narrowing of the airways
• 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, the symptoms of which may include circular or oval areas of redness and swelling of the skin, blister formation and itching. Skin darkening 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 medicine
• serotonin syndrome, which may present with mental status changes (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 pupil dilation
• decreased blood sugar levels
• hiccups.

Patients should inform their doctor if they experience any adverse effects affecting the stomach or intestines at the beginning of treatment (e.g. stomach pain, heartburn or bleeding), especially if they have previously experienced similar adverse effects due to long-term use of anti-inflammatory medicines, particularly in elderly patients.

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

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

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

In patients with immunological 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 not listed in this leaflet, tell your 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 authorisation 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.
Store this medicine in a safe place where others cannot access it.
It may cause serious harm and can be fatal to individuals for whom it has not been prescribed.
Do not use this medicine after the expiry date stated on the outer carton and on the sachet after "EXP". The expiry date refers to the last day of the stated month.
There are no special requirements regarding storage temperature.
Store in the original 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. Such measures will help protect the environment.

6. Contents of the package and other information

What Skudexa contains

• The active substances in this medicine are tramadol hydrochloride and dexketoprofen. Each sachet contains 75 mg of tramadol hydrochloride and 25 mg of dexketoprofen (as dexketoprofen trometamol).
• Other ingredients are: sucrose, lemon flavour, acesulfame potassium (E 950).

What Skudexa looks like and contents of the pack
White to almost white granules for oral solution, available in thermoformed sachets made of multilayer foil: Paper/Aluminium/PE (in the form of a copolymer with vinyl acetate), packed in a cardboard box.
Pack sizes contain 2, 3, 10, 15, 20, 50, 100 and 500 sachets.
Not all pack sizes may be marketed.

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

Manufacturer
E-Pharma Trento S.p.A.
Frazione Ravina – Via Provina, 2
38123 Trento (TN)
Italy

This medicinal product is authorised in the European Economic Area countries under the following names:
Austria, Belgium, 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
Italy: Lenizak
Spain: Enanplus

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