Vimpat 10 mg/ml jarabe
Introduction
Patient Information Leaflet
Vimpat 10 mg/ml Syrup
Lacosamide
Read 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. Do not give it to others even if they have the same symptoms as you, as it may harm them.
- If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.
1. What is Vimpat and what is it used for
What is Vimpat
Vimpat contains lacosamide, which belongs to a group of medicines called “antiepileptic medicines”. These medicines are used to treat epilepsy.
- You have been prescribed this medicine to reduce the number of seizures you experience.
What is Vimpat used for
- Vimpat is used:
- alone and in combination with other antiepileptic medicines in adults, adolescents, and children aged 2 years or older to treat a certain type of epilepsy characterized by the occurrence of 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 in both sides of the brain;
- in combination with other antiepileptic medicines in adults, adolescents, and children aged 4 years or older 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 any of the other ingredients of this medicine (listed in section 6). If you are unsure if 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 any of the above applies to you. If you are unsure, consult your doctor or pharmacist before taking this medicine.
Warnings and precautions
Consult 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 of self-harm or suicide. If you ever have these thoughts, contact your doctor immediately.
- you have a heart problem that affects your heartbeat and your pulse is often very slow, fast or irregular (such as AV block, atrial fibrillation or atrial flutter)
- you have a serious heart condition such as heart failure or have had a heart attack.
- you often get dizzy or fall. Vimpat may cause dizziness, which could increase the risk of accidents or falls. This means you mustbe carefuluntil you are used to the effects of this medicine.
If any of the above applies 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 heart rhythm (such as slow, fast or irregular heartbeat, palpitations, shortness of breath, dizziness, fainting), consult your doctor immediately (see section 4).
Children
Vimpat is not recommended for children under 2 years with epilepsy characterised by the onset of partial seizures and is not recommended for children under 4 years with primary generalised tonic-clonic seizures. This is because it is not yet known if it is effective and safe for children of this age group.
Other medicines and Vimpat
Inform your doctor or pharmacist if you are taking, have taken recently or may need to take any other medicine.
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 to treat heart problems;
- medicines that may increase the "PR interval" in a heart test (ECG or electrocardiogram) such as epilepsy or pain medicines called carbamazepine, lamotrigine or pregabalin;
- medicines used to treat certain types of arrhythmia or heart failure.
If any of the above applies to you (or you are unsure), speak with your doctor or pharmacist before taking Vimpat.
Inform your doctor or pharmacist if you are taking any of the following medicines, as they may also increase or decrease the effect of Vimpat on your body:
- medicines for fungal infections such as fluconazole, itraconazole or ketoconazole;
- medicines for HIV such as ritonavir;
- medicines for bacterial infections such as clarithromycin or rifampicin;
- a medicinal plant used to treat mild anxiety and depression called St. John's Wort.
If any of the above applies to you (or you are unsure), speak with your doctor or pharmacist before taking Vimpat.
Vimpat and alcohol
As a precaution, do not take Vimpat with alcohol.
Pregnancy and breastfeeding
Women of childbearing age should discuss the use of contraceptives with their doctor.
If you are pregnant or breastfeeding, think you may be pregnant or intend to become pregnant, consult your doctor or pharmacist before using this medicine.
Do not take Vimpat if you are pregnant, as the effects of Vimpat on pregnancy and the fetus are not known.
Do not breastfeed while taking Vimpat, as Vimpat passes into breast milk.
Ask your doctor immediately if you are pregnant or planning to become pregnant. They will help you decide if you should take Vimpat or not.
Do not stop treatment without talking to your doctor, as this may increase seizures (crises). A worsening of your condition may also harm the fetus.
Driving and operating machinery
You should not drive, cycle or use any tools or operate machinery until you know if this medicine affects you. The reason is that Vimpat may cause dizziness or blurred vision.
Vimpat contains sorbitol, sodium, methyl parahydroxybenzoate, aspartame, propylene glycol and potassium
- Sorbitol (a type of sugar). This medicine contains 187 mg of sorbitol in each ml. Sorbitol is a source of fructose. If your doctor has told you that you (or your child) have a problem with certain sugars or have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disorder in which the patient cannot break down fructose, consult your doctor before taking or receiving (or your child taking or receiving) this medicine. Sorbitol may cause gastrointestinal upset and a mild laxative effect.
- Sodium (salt). This medicine contains 1.42 mg of sodium (main component of table salt/for cooking) in each ml. This is equivalent to 0.07% of the maximum daily sodium intake recommended for an adult.
- Methyl parahydroxybenzoate (E219) may cause allergic reactions (possibly delayed).
- Aspartame (E951). This medicine contains 0.032 mg of aspartame in each ml. Aspartame is a source of phenylalanine that may be harmful if you have phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body is unable to eliminate it correctly.
- Propylene glycol (E1520). This medicine contains 2.14 mg of propylene glycol in each ml.
- Potassium. This medicine contains potassium, less than 1 mmol (39 mg) per 60 ml; that is, it is essentially "potassium-free".
3. How to Take Vimpat
Follow exactly the administration instructions of this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.
Vimpat Dosage
- Take Vimpat twice a day, with an interval of approximately 12 hours.
- Try to take it more or less at the same time each day.
- You can take Vimpat with or without food.
Normally, you will start taking a low dose each day, 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 take the same amount each day. Vimpat is used as long-term treatment.
You should continue taking Vimpat until your doctor tells you to stop.
How much to take
The following are the normal recommended doses of Vimpat for different age groups and weights.
Your doctor may prescribe a different dose if you have kidney or liver problems.
Use the 10 ml oral syringe (black graduation marks) or the 30 ml measuring cup provided in the outer box, as appropriate, according to the dose needed. See the usage instructions 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 a day.
Your doctor may prescribe a starting dose of 100 mg (10 ml) of Vimpat twice a day.
Your doctor may increase the dose you take twice a day by 50 mg (5 ml) each week, until you reach the maintenance dose between 100 mg (10 ml) and 300 mg (30 ml) twice a day.
When taking Vimpat with other antiepileptic medications:
The usual starting dose is 50 mg (5 ml) twice a day.
Your doctor may increase the dose you take twice a day by 50 mg (5 ml) each week, until you reach the maintenance dose between 100 mg (10 ml) and 200 mg (20 ml) twice a day.
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). Then, you will start taking the continuous maintenance dose 12 hours later.
Children and adolescents weighing less than 50 kg
- For the treatment of partial onset seizures:Vimpat is not recommended for children under 2 years old.
- For the treatment of primary generalized tonic-clonic seizures:Vimpat is not recommended for children under 4 years old.
When taking Vimpat alone.
- Your doctor will decide the Vimpat dose according to your body weight.
- The usual starting dose is 1 mg (0.1 ml) per kilogram (kg), twice a day.
- Your doctor may increase the dose you take twice a day by 1 mg (0.1 ml) per kg of body weight each week, until you reach the maintenance dose.
- The following are the dosing tables with the maximum recommended dose.
- These doses are merely informative. Your doctor will calculate the correct dose for you.
Take twice a dayfor children from 2 years old whoweigh between 10 and less than 40 kg
Weight | Week 1 Dose initial: 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 the 10 ml oral syringe (black graduation marks) for a volume between 1 ml and 20 ml * Use the 30 ml measuring cup (black graduation marks) for a volume of more than 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 a day, for adolescents and children whoweigh between 40 kg and less than 50 kg
Weight | Week 1 Dose initial: 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 oral syringe (black graduation marks) for a volume between 1 ml and 20 ml * Use the 30 ml measuring cup (black graduation marks) for a volume of more than 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 medications:
- Your doctor will decide the Vimpat dose according to your body weight.
- The usual starting dose is 1 mg (0.1 ml) per kilogram (kg) of body weight, twice a day.
- Your doctor may increase the dose you take twice a day by 1 mg (0.1 ml) per kg of body weight each week, until you reach the maintenance dose.
- The following are the dosing tables with the maximum recommended dose.
- These doses are merely informative. Your doctor will calculate the correct dose for you.
Take twice a dayfor children from 2 years old whoweigh between 10 kg and less than 20 kg
Week | Week 1 Dose initial: 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 the 10 ml oral 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 a day,for adolescents and childrenwho weigh between 20 kg and less than 30 kg:
Weight | Week 1 Dose initial: 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 oral 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 a day,for adolescents and childrenwho weigh between 30 kg and less than 50 kg
Weight | Week 1 Dose initial: 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 the 10 ml oral 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 |
Usage instructions
It is essential to use the correct device to measure your dose. Your doctor or pharmacist will indicate which device you should use, depending on the dose prescribed.
10 ml oral syringe | 30 ml measuring cup |
The 10 ml oral syringe has black graduation marks in increments of 0.25 ml. 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 graduation marks in increments of 5 ml. If the required dose is greater than 20 ml, you should use the 30 ml measuring cup provided in this package. |
Usage instructions: measuring cup
1. Shake the bottle well before use.
2. Fill the measuring cup to the graduation mark of the milliliters (ml) prescribed by your doctor.
3. Swallow the dose of syrup.
4. Then drink a little 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 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 on the top of the bottle (figure 3). Make sure it is securely attached. You do not need to remove the adapter after use.
Follow these steps each time you take Vimpat:
- Place the oral syringe on the opening of the adapter (figure 4).
- Place 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 fill the oral syringe with a small amount of solution (figure 6).
- Pull the plunger up to remove any bubbles (figure 7).
- Pull the plunger down to the dose mark corresponding to the milliliters (ml) prescribed by your doctor (figure 8). The plunger may return to the top of the syringe in the first dose. Therefore, make sure it remains in position until the oral syringe is disconnected from the bottle.
- Turn the bottle to the correct position (figure 9).
- Remove the oral syringe from the adapter (figure 10).
You can choose one of two ways to take the medication:
- Empty the contents of the oral syringe into a little water by pressing the plunger to the bottom of the syringe (figure 11) – in which case you will need to drink all the water (add the right amount of 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 (you do not need to remove the adapter).
- To clean the oral syringe, rinse it only with cold water, moving the plunger several times up and down to collect and expel the water, without separating the two parts of the syringe (figure 13).
- Store the bottle, oral syringe, and leaflet in the box.
If you take more Vimpat than you should
If you have taken more Vimpat than you should, consult your doctor immediately. Do not drive. You may experience:
- Dizziness.
- Feeling dizzy (nausea) or being dizzy (vomiting).
- Seizures, heart problems such as slow, fast, or irregular heartbeat, coma, or low blood pressure with tachycardia and sweating.
If you forget to take Vimpat
- If you have forgotten to take a dose within 6 hours of the scheduled dose, take it as soon as you remember.
- If you have forgotten to take a dose more than 6 hours after the scheduled dose, do not take the missed dose. Instead, take Vimpat at the next scheduled time.
- Do not take a double dose to compensate for the missed doses.
If you interrupt treatment with Vimpat
- Do not stop taking Vimpat without telling your doctor, as epilepsy may recur or worsen.
- If your doctor decides to stop your treatment with Vimpat, they will give you instructions on how to gradually reduce the dose.
If you have any other questions about the use of this product, ask your doctor or pharmacist.
4. Possible Adverse Effects
Like all medicines, this medicine may cause side effects, although not everyone will experience them.
The side effects in the nervous system, such as dizziness, may be more pronounced after a single "loading" dose.
Inform your doctor or pharmacist if you experience any of the following side effects:
Very common: may affect more than 1 in 10 patients
- Headache;
- Feeling dizzy or nauseous;
- Dual vision (diplopia).
Common: may affect up to 1 in 10 patients
- Brief muscle or group of muscle spasms (myoclonic crisis);
- Difficulty coordinating movements or walking;
- Problems maintaining balance, agitation (tremor), numbness (paresthesia) or muscle spasms, easy to fall and bruise;
- Memory problems, difficulty thinking or finding words, confusion;
- Rapid and uncontrolled eye movements (nystagmus);
- Blurred vision;
- Sensation of dizziness (vertigo), feeling drunk;
- Feeling dizzy (vomiting), dry mouth, constipation, indigestion, excessive gas in the stomach or intestines, diarrhea;
- Decreased sensitivity, difficulty articulating words, attention disorder;
- Ringing in the ears like buzzing, ringing or whistling;
- Irritability, difficulty sleeping, depression;
- Drowsiness, fatigue or weakness (asthenia);
- Itching, rash.
Uncommon: may affect up to 1 in 100 patients
- Decreased heart rate, palpitations, irregular pulse or other changes in heart electrical activity (conduction disorder);
- Exaggerated feeling of well-being, seeing and/or hearing things that are not real;
- Allergic reaction to the medication, hives;
- Blood tests may show liver function abnormalities, liver damage;
- Thoughts of self-harm or suicide or attempted suicide: inform your doctor immediately;
- Feeling angry or agitated Abnormal thoughts and/or loss of sense of reality;
- Severe allergic reactions, which cause 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 heart rate (ventricular tachyarrhythmia);
- Sore throat, elevated temperature and present infections more frequently than normal. Blood tests may show a severe decrease in a specific type of white blood cell (agranulocytosis);
- Severe skin reaction, which may include elevated temperature and other pseudogripal symptoms, generalized rash with lymph node inflammation (enlarged lymph nodes). Blood tests may show an increase in liver enzymes and an increase in a type of white blood cell (eosinophilia);
- Generalized blistering with peeling of the skin, especially around the mouth, nose, eyes and genitals (Stevens-Johnson syndrome) and a more severe form that causes peeling of the skin on more than 30% of the body surface (toxic epidermal necrolysis).
- Seizures.
Other side effects in children
The additional side effects observed in children were fever (pyrexia), runny nose (nasopharyngitis), sore throat (pharyngitis), eating less than usual (decreased appetite), changes in behavior, not acting as they normally do (abnormal behavior) and lack of energy (lethargy). Drowsiness is a very common side effect in children and may affect more than 1 in 10 children.
Reporting side effects
If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through thenational reporting system included in theAppendix V. By reporting side effects, you can contribute to providing more information on the safety of this medicine.
5. Conservation of Vimpat
Keep this medication out of the sight and reach of children.
Do not use this medication after the expiration date that appears on the box and in the bottle, after CAD/EXP. The expiration date is the last day of the month indicated.
Do not refrigerate.
No special storage conditions are required.
Once the bottle of syrup is opened, do not use itafter 6 months.
Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the containers and medications you no longer need. This will help protect the environment.
6. Contents of the packaging and additional information
Composition of Vimpat
- The active ingredient is lacosamide. 1 ml of Vimpat syrup contains 10 mg of lacosamide.
- The other components are: glycerol (E422), sodium caramelose, liquid sorbitol (crystallizable) (E420), polyethylene glycol 4000, sodium chloride, anhydrous citric acid, potassium acesulfame (E950), methyl parahydroxybenzoate sodium (E219), strawberry flavor (contains propylene glycol, maltol), flavor masker (contains propylene glycol, aspartame (E951), potassium acesulfame (E950), maltol, and deionized water), purified water.
Appearance of the product and contents of the package
- Vimpat 10 mg/ml syrup is a viscous, transparent, colorless to yellowish-brown solution.
- Vimpat is available in a 200 ml bottle.
The Vimpat syrup package includes a 30 ml polypropylene measuring cup (black graduations) and a 10 ml polyethylene/polypropylene oral syringe (black graduations) with its polyethylene adapter.
- The measuring cup is suitable for doses above 20 ml. Each graduation mark (5 ml) on the measuring cup corresponds to 50 mg of lacosamide (for example, 2 graduation marks correspond to 100 mg).
The 10 ml oral syringe is suitable for doses between 1 ml and 20 ml. A full 10 ml oral 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 (for example, 4 graduation marks correspond to 10 mg).
Marketing Authorization Holder
UCB Pharma S.A., Allée de la Recherche 60, B-1070 Brussels, Belgium.
Responsible for manufacturing
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
You can request more information about this medication by contacting the local representative of the marketing authorization holder:
België/Belgique/Belgien UCB Pharma SA/NV Tel: + 32 / (0)2 559 92 00 | Lietuva UCB Pharma Oy Finland Tel: + 358 9 2514 4221 (Suomija) |
Luxembourg/Luxemburg UCB Pharma SA/NV Tél/Tel: + 32 / (0)2 559 92 00 (Belgique/Belgien) | |
Ceská republika UCB s.r.o. Tel: + 420 221 773 411 | Magyarország UCB Magyarország Kft. Tel.: + 36-(1) 391 0060 |
Danmark UCB Nordic A/S Tlf: + 45 / 32 46 24 00 | Malta Pharmasud Ltd. Tel: + 356 / 21 37 64 36 |
Deutschland UCB Pharma GmbH Tel: + 49 /(0) 2173 48 4848 | Nederland UCB Pharma B.V. Tel.: + 31 / (0)76-573 11 40 |
Eesti UCB Pharma Oy Finland Tel: + 358 9 2514 4221 (Soome) | Norge UCB Nordic A/S Tlf: + 47 / 67 16 5880 |
Ελλάδα UCB Α.Ε. Τηλ: + 30 / 2109974000 | Österreich UCB Pharma GmbH Tel: + 43 (0) 1291 80 00 |
España UCB Pharma, S.A. Tel: + 34 / 91 570 34 44 | Polska 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 (Produtos Farmacêuticos), Lda Tel: + 351 21 302 5300 |
Hrvatska Medis Adria, d.o.o. Tel: +385 (0) 1 230 34 46 | România UCB Pharma Romania S.R.L. Tel: + 40 21 300 29 04 |
Ireland UCB (Pharma) Ireland Ltd. Tel: + 353 / (0)1-46 37 395 | Slovenija Medis, d.o.o. Tel: + 386 1 589 69 00 |
Ísland Vistor hf. Simi: + 354 535 7000 | Slovenská republika UCB s.r.o., organizacná zložka Tel: + 421 (0) 2 5920 2020 |
Italia UCB Pharma S.p.A. Tel: + 39 / 02 300 791 | Suomi/Finland UCB Pharma Oy Finland Puh/Tel: + 358 9 2514 4221 |
Κύπρος Lifepharma (Z.A.M.) Ltd Τηλ: + 357 22 05 63 00 | Sverige UCB Nordic A/S Tel: + 46 / (0) 40 29 49 00 |
Latvija UCB Pharma Oy Finland Tel: + 358 9 2514 4221 (Somija) | United Kingdom (Northern Ireland) UCB (Pharma) Ireland Ltd Tel: + 353 / (0)1-46 37 395 |
Last review date of this leaflet:{month/YYYY}.
Other sources of information
Detailed information about this medication is available on the European Medicines Agency website:http://www.ema.europa.eu/.
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