Vimpat 10 mg/ml syrup
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the patient
Vimpat 10 mg/ml oral syrup
lacosamide
Read all of this leaflet carefully before you start 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 questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, because it may harm them.
- If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.
Contents of the leaflet
- What Vimpat is and what it is used for
- What you need to know before taking Vimpat
- How to take Vimpat
- Possible side effects
- How to store Vimpat
- Contents of the pack and other information
1. What Vimpat is and what it is used for
What Vimpat is
Vimpat contains lacosamide, which belongs to a group of medicines called "antiepileptic drugs". These medicines are used to treat epilepsy.
- You have been prescribed this medicine to reduce the number of seizures you experience.
What Vimpat is used for
-
Vimpat is used:
-
alone or in combination with other antiepileptic medicines in adults, adolescents, and children from 2 years of age to treat a certain type of epilepsy characterized by partial-onset seizures with or without secondary generalization. In this type of epilepsy, seizures affect only one side of the brain. However, they may then spread to larger areas on both sides of the brain;
-
in combination with other antiepileptic medicines in adults, adolescents, and children from 4 years of age to treat primary generalized tonic-clonic seizures (major seizures, with loss of consciousness) in patients with idiopathic generalized epilepsy (a type of epilepsy believed to have a genetic origin).
2. What you need to know before starting to take Vimpat
Do not take Vimpat
- if you are allergic to lacosamide or to any of the other ingredients of this medicine (listed in section 6). If you are unsure whether you are allergic, consult your doctor.
- if you have a heart rhythm problem called second- or third-degree AV block.
Do not take Vimpat if either of the above applies to you. If you are unsure, consult your doctor or pharmacist before taking this medicine.
Warnings and precautions
Talk to your doctor before starting to use Vimpat if:
- you have thoughts of self-harm or suicide. A small number of people taking antiepileptic medicines such as lacosamide have had thoughts about harming themselves or suicide. If you have these thoughts at any time, contact your doctor immediately.
- you have a heart condition affecting your heartbeat and your pulse is often particularly slow, fast, or irregular (such as AV block, atrial fibrillation, or atrial flutter).
- you have severe heart disease such as heart failure or have had a myocardial infarction (heart attack).
- you frequently feel dizzy or fall. Vimpat may cause dizziness, which could increase the risk of accidental injury or falls. This means you should be cautious until you are accustomed to the effects of this medicine.
If any of the above apply to you (or you are unsure), consult your doctor or pharmacist before taking Vimpat.
If you are taking Vimpat, consult your doctor if you experience a new type of seizure or worsening of existing seizures.
If you are taking Vimpat and experience symptoms of abnormal heartbeat (such as slow, fast, or irregular heartbeat, palpitations, dyspnea (difficulty breathing), dizziness, or fainting), contact your doctor immediately (see section 4).
Children
Vimpat is not recommended for children under 2 years of age with epilepsy characterized by partial-onset seizures, and is not recommended for children under 4 years of age with primary generalized tonic-clonic seizures. This is because it is not yet known whether it is effective and safe in children of this age group.
Other medicines and Vimpat
Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
In particular, inform your doctor or pharmacist if you are taking any of the following medicines that affect the heart, as Vimpat may also affect the heart:
- medicines used to treat heart problems;
- medicines that may increase the "PR interval" on a heart test (ECG or electrocardiogram), such as medicines for epilepsy or pain called carbamazepine, lamotrigine, or pregabalin;
- medicines used to treat certain types of arrhythmia or heart failure.
If any of the above apply to you (or you are unsure), speak with your doctor or pharmacist before taking Vimpat.
Also inform your doctor or pharmacist if you are taking any of the following medicines, as they may increase or decrease the effect of Vimpat in your body:
- antifungal medicines such as fluconazole, itraconazol, or ketoconazole;
- medicines for HIV such as ritonavir;
- antibiotics such as clarithromycin or rifampicin;
- a herbal remedy used to treat mild anxiety and depression called St. John’s wort.
If any of the above apply to you (or you are unsure), speak with your doctor or pharmacist before taking Vimpat.
Taking Vimpat with alcohol
As a safety precaution, do not take Vimpat with alcohol.
Pregnancy and breastfeeding
Women of childbearing age should discuss the use of contraception with their doctor.
If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.
Taking Vimpat during pregnancy is not recommended, as the effects of Vimpat on pregnancy and the fetus are unknown.
Breastfeeding is not recommended while taking Vimpat, because Vimpat passes into breast milk.
Seek immediate advice from your doctor if you are pregnant or planning to become pregnant. Your doctor will help you decide whether or not to take Vimpat.
Do not stop treatment without first talking to your doctor, as this could increase seizures. Worsening of your condition may also harm the fetus.
Driving and using machines
You must not drive, ride a bicycle, or operate tools or machinery until you know how this medicine affects you. This is because Vimpat may cause dizziness or blurred vision.
Vimpat contains sorbitol, sodium, sodium methyl parahydroxybenzoate, aspartame, propylene glycol, and potassium
- Sorbitol (a type of sugar). This medicine contains 187 mg of sorbitol per ml. Sorbitol is a source of fructose. If your doctor has told you that you (or your child) have an intolerance to certain sugars or have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disorder in which the body cannot break down fructose, consult your doctor before taking or administering (or allowing your child to take or receive) this medicine. Sorbitol may cause gastrointestinal discomfort and a mild laxative effect.
- Sodium (salt). This medicine contains 1.42 mg of sodium (the main component of table/cooking salt) per ml. This corresponds to 0.07% of the maximum daily recommended sodium intake for an adult.
- Sodium methyl parahydroxybenzoate (E219) may cause allergic reactions (possibly delayed).
- Aspartame (E951). This medicine contains 0.032 mg of aspartame per ml. Aspartame is a source of phenylalanine, which may be harmful if you have phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body cannot properly eliminate it.
- Propylene glycol (E1520). This medicine contains 2.14 mg of propylene glycol per ml.
- Potassium. This medicine contains potassium, less than 1 mmol (39 mg) per 60 ml; this is essentially “potassium-free”.
3. How to take Vimpat
Follow exactly the dosing instructions for this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.
Taking Vimpat
- Take Vimpat twice daily, approximately 12 hours apart.
- Try to take it at about the same times each day.
- You may take Vimpat with or without food.
Normally, you will start with a low daily dose, and your doctor will gradually increase the dose over several weeks. When you reach the dose that works well for you, called the “maintenance dose,” you will continue taking the same amount each day. Vimpat is used as a long-term treatment.
You should continue taking Vimpat until your doctor tells you to stop.
What amount to take
The following are the normal recommended doses of Vimpat for different age and weight groups.
Your doctor may prescribe you a different dose if you have kidney or liver problems.
Use the 10 ml oral syringe (with black graduation marks) or the 30 ml dosing cup supplied in the outer carton, as appropriate, according to the required dose. See instructions for use below.
Adolescents and children weighing 50 kg or more, and adults
When taking Vimpat alone:
The usual starting dose is 50 mg (5 ml), twice daily.
Your doctor may prescribe a starting dose of 100 mg (10 ml) of Vimpat twice daily.
Your doctor may increase your twice-daily dose by 50 mg (5 ml) each week until reaching a maintenance dose between 100 mg (10 ml) and 300 mg (30 ml) twice daily.
When taking Vimpat with other antiepileptic medicines:
The usual starting dose is 50 mg (5 ml) twice daily.
Your doctor may increase your twice-daily dose by 50 mg (5 ml) each week until reaching a maintenance dose between 100 mg (10 ml) and 200 mg (20 ml) twice daily.
If you weigh 50 kg or more, your doctor may decide to start Vimpat treatment with a single “loading” dose of 200 mg (20 ml). You would then begin taking the regular maintenance dose 12 hours later.
Children and adolescents weighing less than 50 kg
- In the treatment of partial-onset seizures: note that Vimpat is not recommended for children under 2 years of age.
- In the treatment of primary generalized tonic-clonic seizures: note that Vimpat is not recommended for children under 4 years of age.
When taking Vimpat alone:
- Your doctor will determine the Vimpat dose based on your body weight.
- The usual starting dose is 1 mg (0.1 ml) per kilogram (kg) of body weight, twice daily.
- Your doctor may increase your twice-daily dose by 1 mg (0.1 ml) per kg of body weight each week until reaching the maintenance dose.
- Dosing tables with the recommended maximum doses are shown below.
- These doses are for informational purposes only. Your doctor will calculate the correct dose for you.
To be used twice daily in children from 2 years of age weighing from 10 to less than 40 kg
Weight | Week 1 Initial dose: 0.1 ml/kg | Week 2 0.2 ml/kg | Week 3 0.3 ml/kg | Week 4 0.4 ml/kg | Week 5 0.5 ml/kg | Week 6 Maximum recommended dose: 0.6 ml/kg |
Use of the 10 ml syringe (black graduation marks) for a volume between 1 ml and 20 ml
| ||||||
10 kg | 1 ml | 2 ml | 3 ml | 4 ml | 5 ml | 6 ml |
15 kg | 1.5 ml | 3 ml | 4.5 ml | 6 ml | 7.5 ml | 9 ml |
20 kg | 2 ml | 4 ml | 6 ml | 8 ml | 10 ml | 12 ml |
25 kg | 2.5 ml | 5 ml | 7.5 ml | 10 ml | 12.5 ml | 15 ml |
30 kg | 3 ml | 6 ml | 9 ml | 12 ml | 15 ml | 18 ml |
35 kg | 3.5 ml | 7 ml | 10.5 ml | 14 ml | 17.5 ml | 21 ml* |
Take twice daily, for adolescents and children who weigh from 40 kg to less than 50 kg
Weight | Week 1 Starting dose: 0.1 ml/kg | Week 2 0.2 ml/kg | Week 3 0.3 ml/kg | Week 4 0.4 ml/kg | Week 5 Maximum recommended dose: 0.5 ml/kg |
Use the 10 ml syringe (black graduation marks) for a volume between 1 ml and 20 ml
| |||||
40 kg | 4 ml | 8 ml | 12 ml | 16 ml | 20 ml |
45 kg | 4.5 ml | 9 ml | 13.5 ml | 18 ml | 22.5 ml* |
When taking Vimpat with other antiepileptic medicines
- Your doctor will determine the Vimpat dose according to your body weight.
- The usual initial dose is 1 mg (0.1 ml) per kilogram (kg) of body weight, twice daily.
- Your doctor may increase your twice-daily dose by 1 mg (0.1 ml) per kg of body weight each week, until the maintenance dose is reached.
- The dosing tables below show the recommended maximum doses.
- These doses are for informational purposes only. Your doctor will calculate the correct dose for you.
To be taken twice daily for children from 2 years of age who weigh from 10 kg to less than 20 kg
Week | Week 1 Initial dose: 0.1 ml/kg | Week 2 0.2 ml/kg | Week 3 0.3 ml/kg | Week 4 0.4 ml/kg | Week 5 0.5 ml/kg | Week 6 Maximum recommended dose: 0.6 ml/kg |
Use of the 10 ml syringe (black graduation marks) for a volume between 1 ml and 20 ml | ||||||
10 kg | 1 ml | 2 ml | 3 ml | 4 ml | 5 ml | 6 ml |
12 kg | 1.3 ml | 2.4 ml | 3.6 ml | 4.8 ml | 6 ml | 7.2 ml |
14 kg | 1.4 ml | 2.8 ml | 4.2 ml | 5.6 ml | 7 ml | 8.4 ml |
15 kg | 1.5 ml | 3 ml | 4.5 ml | 6 ml | 7.5 ml | 9 ml |
16 kg | 1.6 ml | 3.2 ml | 4.8 ml | 6.4 ml | 8 ml | 9.6 ml |
18 kg | 1.8 ml | 3.6 ml | 5.4 ml | 7.2 ml | 9 ml | 10.8 ml |
Take twice daily, for adolescents and children weighing 20 kg to less than 30 kg:
Weight | Week 1 Starting dose: 0.1 ml/kg | Week 2 0.2 ml/kg | Week 3 0.3 ml/kg | Week 4 0.4 ml/kg | Week 5 Maximum recommended dose: 0.5 ml/kg |
Use of the 10 ml syringe (black graduation marks) for a volume between 1 ml and 20 ml | |||||
20 kg | 2 ml | 4 ml | 6 ml | 8 ml | 10 ml |
22 kg | 2.2 ml | 4.4 ml | 6.6 ml | 8.8 ml | 11 ml |
24 kg | 2.4 ml | 4.8 ml | 7.2 ml | 9.6 ml | 12 ml |
25 kg | 2.5 ml | 5 ml | 7.5 ml | 10 ml | 12.5 ml |
26 kg | 2.6 ml | 5.2 ml | 7.8 ml | 10.4 ml | 13 ml |
28 kg | 2.8 ml | 5.6 ml | 8.4 ml | 11.2 ml | 14 ml |
Take twice daily, for adolescents and children weighing from 30 kg to less than 50 kg
Weight | Week 1 Starting dose: 0.1 ml/kg | Week 2 0.2 ml/kg | Week 3 0.3 ml/kg | Week 4 Maximum recommended dose: 0.4 ml/kg |
Use of the 10 ml syringe (black graduation marks) for a volume between 1 ml and 20 ml | ||||
30 kg | 3 ml | 6 ml | 9 ml | 12 ml |
35 kg | 3.5 ml | 7 ml | 10.5 ml | 14 ml |
40 kg | 4 ml | 8 ml | 12 ml | 16 ml |
45 kg | 4.5 ml | 9 ml | 13.5 ml | 18 ml |
Instructions for use
It is important to use the correct device to measure your dose. Your doctor or pharmacist will advise you which device to use, depending on the dose prescribed for you.
10 ml Oral Dosage Syringe | 30 ml Measuring Cup |
The 10 ml oral syringe has black graduations in 0.25 ml increments. If the required dose is between 1 ml and 10 ml, you should use the 10 ml oral syringe and the adapter provided in this package. If the required dose is between 10 ml and 20 ml, you should use the 10 ml syringe twice. | The 30 ml measuring cup has black graduations in 5 ml increments. If the required dose is greater than 20 ml, you should use the 30 ml measuring cup included in this package. |
Usage instructions: measuring cup
- Shake the bottle well before use.
- Fill the measuring cup up to the prescribed millilitre (ml) mark as directed by your doctor.
- Swallow the syrup dose.
- Then drink some water.
Usage instructions: oral syringe
Your doctor will show you how to use the oral syringe before you use it for the first time. If you have any questions, consult your doctor or pharmacist.
Shake the bottle well before use.
Open the bottle by pressing down on the cap while turning it counterclockwise (Figure 1).
Follow these steps the first time you take Vimpat:
- Remove the adapter from the oral syringe (Figure 2).
- Place the adapter onto the top of the bottle (Figure 3). Make sure it is securely attached. It is not necessary to remove the adapter after use.
Follow these steps each time you take Vimpat:
- Insert the oral syringe into the opening of the adapter (Figure 4).
- Turn the bottle upside down (Figure 5).
- Hold the bottle upside down with one hand and use the other hand to fill the oral syringe.
- Pull the plunger down to draw a small amount of solution into the oral syringe (Figure 6).
- Push the plunger up to expel any air bubbles (Figure 7).
- Pull the plunger down to the dose mark corresponding to the number of millilitres (ml) prescribed by your doctor (Figure 8). The plunger may rise slightly within the barrel during the first dose. Therefore, ensure that it remains in position until the oral syringe is disconnected from the bottle.
- Turn the bottle back to the upright position (Figure 9).
- Remove the oral syringe from the adapter (Figure 10).
There are two options for taking the medication:
- Empty the contents of the oral syringe into a small amount of water by pushing the plunger fully down (Figure 11) – in which case you must drink all the water (add just enough water to make it easier to drink) or
- Take the solution directly from the oral syringe without water (Figure 12) – drink all the contents of the oral syringe.
- Close the bottle with the plastic screw cap (it is not necessary to remove the adapter).
- To clean the oral syringe, rinse it with cold water only, moving the plunger up and down several times to draw in and expel water, without separating the two parts of the syringe (Figure 13).
- Store the bottle, oral syringe, and package leaflet in the carton.
If you take more Vimpat than you should
If you have taken more Vimpat than you should, contact your doctor immediately. Do not attempt to drive. You may experience:
- Dizziness.
- Feeling unwell (nausea) or being unwell (vomiting).
- Seizures, heart rhythm problems such as slow, fast, or irregular pulse, coma, or low blood pressure with tachycardia and sweating.
If you forget to take Vimpat
- If you forget to take a dose within 6 hours of the scheduled time, take it as soon as you remember.
- If you forget to take a dose more than 6 hours after the scheduled time, do not take the missed dose. Instead, take your next dose at the usual time.
- Do not take a double dose to make up for a forgotten dose.
If you stop taking Vimpat
- Do not stop taking Vimpat without consulting your doctor, as seizures may return or worsen.
- If your doctor decides to discontinue your treatment with Vimpat, you will be given instructions on how to gradually reduce the dose.
If you have any further questions about the use of this product, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
Nervous system effects such as dizziness may be greater after a single "loading" dose.
Inform your doctor or pharmacist if you experience any of the following effects:
Very common: may affect more than 1 in 10 people
- Headache;
- Feeling dizzy or sick (nausea);
- Double vision (diplopia).
Common: may affect up to 1 in 10 people
- Brief jerks of a muscle or group of muscles (myoclonic jerks);
- Difficulty coordinating movements or walking;
- Problems maintaining balance, tremor, tingling (paraesthesia), or muscle spasms, tendency to fall and bruise easily;
- Memory problems, difficulty thinking or finding words, confusion;
- Rapid, uncontrolled eye movements (nystagmus);
- Blurred vision;
- Sensation of dizziness (vertigo), feeling of drunkenness;
- Feeling dizzy (vomiting), dry mouth, constipation, indigestion, excessive gas in the stomach or intestines, diarrhoea;
- Reduced sensation, difficulty articulating words, attention disorder;
- Ringing in the ears such as buzzing, ringing, or hissing;
- Irritability, difficulty sleeping, depression;
- Drowsiness, tiredness or weakness (asthenia);
- Itching, rash.
Uncommon: may affect up to 1 in 100 people
- Decreased heart rate, palpitations, irregular pulse, or other changes in the heart's electrical activity (conduction disorder);
- Exaggerated feeling of well-being, seeing and/or hearing things that are not real;
- Allergic reaction to taking the medicine, hives;
- Blood tests may show abnormalities in liver function, liver damage;
- Thoughts of self-harm or suicide, or suicide attempt: inform your doctor immediately;
- Feeling angry or agitated, abnormal thoughts and/or loss of sense of reality;
- Severe allergic reactions causing swelling of the face, throat, hands, feet, ankles, or lower legs;
- Fainting;
- Abnormal involuntary movements (dyskinesia).
Frequency not known: cannot be estimated from available data
- Abnormally fast heartbeat (ventricular tachyarrhythmia);
- Sore throat, high temperature, and increased frequency of infections. Blood tests may show a severe decrease in a specific type of white blood cells (agranulocytosis);
- Serious skin reaction, which may include high temperature and other flu-like symptoms, rash on the face, widespread rash with swollen lymph nodes (enlarged lymph nodes). Blood tests may show increased levels of liver enzymes and an increase in a type of white blood cells (eosinophilia);
- A widespread rash with blisters and peeling of the skin, especially around the mouth, nose, eyes and genitals (Stevens-Johnson syndrome), and a more severe form causing skin peeling over more than 30% of the body surface (toxic epidermal necrolysis);
- Seizures.
Other adverse effects in children
Additional adverse effects observed in children were fever (pyrexia), runny nose (nasopharyngitis), sore throat (pharyngitis), eating less than usual (decreased appetite), behavioural changes, not acting as they normally do (abnormal behaviour), and lack of energy (lethargy). Sleepiness (somnolence) is a very common side effect in children and may affect more than 1 in 10 children.
Reporting of adverse effects
If you experience any adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the national reporting system included in Appendix V. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Vimpat
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and on the bottle, after CAD/EXP. The expiry date refers to the last day of the month indicated.
Do not refrigerate.
No special storage conditions are required.
After opening the syrup bottle, do not use beyond 6 months.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.
6. Contents of the pack and other information
Composition of Vimpat
- The active substance is lacosamide. 1 ml of Vimpat syrup contains 10 mg of lacosamide.
- The other components are: glycerol (E422), sodium carmellose, liquid sorbitol (crystallizable) (E420), polyethylene glycol 4000, sodium chloride, citric acid (anhydrous), potassium acesulfame (E950), sodium methyl parahydroxybenzoate (E219), strawberry flavour (contains propylene glycol, maltol), flavour masker (contains propylene glycol, aspartame (E951), acesulfame potassium (E950), maltol and deionized water), purified water.
Appearance of the medicine and contents of the pack
- Vimpat 10 mg/ml syrup is a colourless to yellowish-brown, clear, viscous solution.
- Vimpat is available in a 200 ml bottle.
The Vimpat syrup pack includes a 30 ml polypropylene dosing cup (with black graduation marks) and a 10 ml oral polyethylene/polypropylene dosing syringe (with black graduation marks) with its polyethylene adapter.
- The dosing cup is suitable for doses greater than 20 ml. Each graduation mark (5 ml) on the dosing cup corresponds to 50 mg of lacosamide (e.g., 2 graduation marks correspond to 100 mg).
The 10 ml oral dosing syringe is suitable for doses between 1 ml and 20 ml. A fully filled 10 ml oral dosing syringe corresponds to 100 mg of lacosamide. The minimum extractable volume is 1 ml, which corresponds to 10 mg of lacosamide. After this, each graduation mark (0.25 ml) corresponds to 2.5 mg of lacosamide (e.g., 4 graduation marks correspond to 10 mg).
Marketing Authorization Holder
UCB Pharma S.A., Allée de la Recherche 60, B-1070 Bruxelles, Belgium.
Manufacturer
Aesica Pharmaceuticals GmbH, Alfred-Nobel Strasse 10, D-40789 Monheim am Rhein, Germany
or
UCB Pharma SA, Chemin du Foriest, B-1420, Braine-l’Alleud, Belgium.
For more information about this medicine, please contact the local representative of the Marketing Authorization Holder:
Belgium/Belgium/Belgium UCB Pharma SA/NV Tel/Tel: + 32 / (0)2 559 92 00 | Lithuania UCB Pharma Oy Finland Tel: + 358 9 2514 4221 (Finland) |
| Luxembourg/Luxembourg UCB Pharma SA/NV Tél/Tel: + 32 / (0)2 559 92 00 (Belgium/Belgium) |
Czech Republic UCB s.r.o. Tel: + 420 221 773 411 | Hungary UCB Magyarország Kft. Tel.: + 36-(1) 391 0060 |
Denmark UCB Nordic A/S Tlf: + 45 / 32 46 24 00 | Malta Pharmasud Ltd. Tel: + 356 / 21 37 64 36 |
Germany UCB Pharma GmbH Tel: + 49 /(0) 2173 48 4848 | Netherlands UCB Pharma B.V. Tel.: + 31 / (0)76-573 11 40 |
Estonia UCB Pharma Oy Finland Tel: + 358 9 2514 4221 (Finland) | Norway UCB Nordic A/S Tlf: + 47 / 67 16 5880 |
Greece UCB Α.Ε. Tel: + 30 / 2109974000 | Austria UCB Pharma GmbH Tel: + 43 (0) 1291 80 00 |
Spain UCB Pharma, S.A. Tel: + 34 / 91 570 34 44 | Poland UCB Pharma Sp. z o.o. / VEDIM Sp. z o.o. Tel.: + 48 22 696 99 20 |
France UCB Pharma S.A. Tél: + 33 / (0)1 47 29 44 35 | Portugal UCB Pharma (Pharmaceutical Products), Lda Tel: + 351 21 302 5300 |
Croatia Medis Adria, d.o.o. Tel: +385 (0) 1 230 34 46 | Romania UCB Pharma Romania S.R.L. Tel: + 40 21 300 29 04 |
Ireland UCB (Pharma) Ireland Ltd. Tel: + 353 / (0)1-46 37 395 | Slovenia Medis, d.o.o. Tel: + 386 1 589 69 00 |
Iceland Vistor hf. Tel: + 354 535 7000 | Slovakia UCB s.r.o., organizational unit Tel: + 421 (0) 2 5920 2020 |
Italy UCB Pharma S.p.A. Tel: + 39 / 02 300 791 | Finland/Finland UCB Pharma Oy Finland Puh/Tel: + 358 9 2514 4221 |
Cyprus Lifepharma (Z.A.M.) Ltd Tel: + 357 22 05 63 00 | Sweden UCB Nordic A/S Tel: + 46 / (0) 40 29 49 00 |
Latvia UCB Pharma Oy Finland Tel: + 358 9 2514 4221 (Finland) | United Kingdom (Northern Ireland) UCB (Pharma) Ireland Ltd Tel: + 353 / (0)1-46 37 395 |
Date of the most recent review of this leaflet: {month/YYYY}.
Other sources of information
Detailed information on this medicine is available on the website of the European Medicines Agency: http://www.ema.europa.eu/.