Package Leaflet: Information for the Patient
Vimpat 10 mg/ml Oral Solution
lacosamide
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
Contents of the pack
What is Vimpat
Vimpat contains lacosamide, which belongs to a group of medicines called “antiepileptic medicines”. These medicines are used to treat epilepsy.
What is Vimpat used for
Do not take Vimpat
Do not take Vimpat if any of the above applies to you. If you are not sure, talk to your doctor or pharmacist before taking this medicine.
Warnings and precautions
Talk to your doctor before you start taking Vimpat if:
If any of the above applies to you (or you are not sure), talk to your doctor or pharmacist before taking Vimpat.
If you are taking Vimpat, talk to 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 beat (such as slow, fast or irregular heart beat, palpitations, shortness of breath, feeling dizzy, fainting), contact your doctor immediately (see section 4).
Children
Vimpat is not recommended in children under 2 years of age with epilepsy that causes seizures that start in one part of the brain, and is not recommended for children under 4 years of age 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
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
In particular, tell your doctor or pharmacist if you are taking any of the following medicines that affect the heart, as Vimpat may also affect the heart:
If any of the above applies to you (or you are not sure), talk to your doctor or pharmacist before taking Vimpat.
Tell your doctor or pharmacist if you are taking any of the following medicines, as they may also increase or decrease the effect of Vimpat in your body:
If any of the above applies to you (or you are not sure) talk to your doctor or pharmacist before taking Vimpat.
Taking Vimpat with alcohol
As a precaution, do not take Vimpat with alcohol.
Pregnancy and breast-feeding
Women of childbearing potential should discuss the use of contraceptives with their doctor.
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Vimpat should not be taken during pregnancy, as it is not known what effect it may have on the pregnancy or the baby.
Breast-feeding is not recommended while taking Vimpat, as Vimpat passes into breast milk.
Ask your doctor for advice immediately if you are pregnant or plan to become pregnant. Your doctor will help you decide if you should take Vimpat or not.
Do not stop treatment without first talking to your doctor, as this may increase the risk of seizures (fits). Worsening of your disease may also harm the baby.
Driving and using machines
You should not drive, ride a bicycle or use any tools or machines until you know if this medicine affects your ability to perform these activities. This is because Vimpat may cause dizziness or blurred vision.
Vimpat contains sorbitol, sodium, methyl parahydroxybenzoate, aspartame, propylene glycol and potassium
Follow your doctor's or pharmacist's administration instructions for this medication exactly. If in doubt, consult your doctor or pharmacist again.
Taking Vimpat
Normally, you will start by taking a low dose every 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 every 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 usual 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 supplied in the outer box, as appropriate, according to the necessary dose. See the instructions for use below.
Adolescents and children who weigh 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 a 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 a 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 would start taking the continuous maintenance dose 12 hours later.
Children and adolescents who weigh less than 50 kg
When taking Vimpat alone.
To be taken twice a dayby children from 2 years of age who weigh between 10 kg and 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* |
To be taken twice a dayfor adolescents and children who weigh between 40 kg and less than 50 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 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
| |||||
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
To be taken twice a dayfor children from 2 years of age who weigh between 10 kg and 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 |
To be taken twice a day, for adolescents and children who weigh between 20 kg and less than 30 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 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 |
To be taken twice a day, for adolescents and children who weigh between 30 kg and less than 50 kg
Weight | Week 1 Initial 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 that you use the correct device to measure your dose. Your doctor or pharmacist will indicate which device you should use based on the dose prescribed for you.
10 ml oral syringe | 30 ml measuring cup |
The 10 ml oral syringe has black graduations in increments of 0.25 ml. If the necessary 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 necessary 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 increments of 5 ml. If the necessary dose is more than 20 ml, you should use the 30 ml measuring cup included in this package. |
Instructions for use: measuring cup
Instructions for use: 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 using it.
Open the bottle by pressing the cap while turning it counterclockwise (figure 1).
Follow these steps the first time you take Vimpat:
Follow these steps each time you take Vimpat:
There are two ways you can choose to take the medication:
If you take more Vimpat than you should
If you have taken more Vimpat than you should, consult your doctor immediately. Do not try to drive. You may experience:
If you forget to take Vimpat
If you stop treatment with Vimpat
If you have any other questions about the use of this product, ask your doctor or pharmacist.
Like all medicines, this medicine can cause adverse effects, although not all people suffer from them.
Adverse effects on the nervous system, such as dizziness, may be greater after a single "loading" dose.
Tell your doctor or pharmacist if you experience any of the following effects:
Very common: may affect more than 1 in 10 patients
Common: may affect up to 1 in 10 patients
Uncommon: may affect up to 1 in 100 patients
Frequency not known: cannot be estimated from the available data
Other adverse effects in children
Additional adverse effects observed in children were fever (pyrexia), runny nose (nasopharyngitis), sore throat (pharyngitis), decreased appetite, behavioral changes, abnormal behavior, and lack of energy (lethargy). Drowsiness (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 type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that is not listed in this leaflet. You can also report them directly through the national reporting system included in Appendix V. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiration date that appears on the box and on 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 syrup bottle is opened, do not use it after 6 months.
Medicines should not be thrown away through wastewater or household waste. Ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.
Vimpat Composition
Product Appearance and Package Contents
The Vimpat syrup box includes a 30 ml polypropylene measuring cup (black graduation marks) and a 10 ml oral syringe made of polyethylene/polypropylene (black graduation marks) with its polyethylene adapter.
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 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.
You can request more information about this medicine 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., organizačná 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 |
Date of last revision of this leaflet:{month/YYYY}.
Other sources of information
Detailed information about this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu/.
The average price of VIMPAT 10 mg/ml SYRUP in October, 2025 is around 23.49 EUR. Prices may vary depending on the region, pharmacy, and whether a prescription is required. Always check with a local pharmacy or online source for the most accurate information.