Vimpat 10 mg/ml solution for infusion
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the patient
Vimpat 10 mg/ml solution for infusion
lacosamide
Read the entire leaflet carefully before you start using 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.
- If you experience any adverse reactions, consult your doctor or pharmacist, even if they are 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 using Vimpat
- How to use 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 medicines". 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:
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alone or in combination with other antiepileptic medicines in adults, adolescents, and children from 2 years of age for the treatment of 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 for the treatment of 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 using Vimpat
Do not use 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 certain type of heart rhythm problem called second- or third-degree AV block.
Do not use Vimpat if either of the above applies to you. If you are unsure, consult your doctor or pharmacist before starting to use 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 of self-harm or suicide. If at any time you have such thoughts, 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 often 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 starting to use 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 it is not recommended for children under 4 years of age with primary generalized tonic-clonic seizures. This is because its efficacy and safety in children of these age groups have not yet been established.
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" in a heart test (ECG or electrocardiogram), such as antiepileptic or pain medicines called carbamazepine, lamotrigine, and 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 starting to use 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, itraconazole, and ketoconazole;
- an HIV medicine such as ritonavir;
- antibiotics such as clarithromycin and 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 starting to use Vimpat.
Use of Vimpat with alcohol
As a precaution, do not use Vimpat with alcohol.
Pregnancy and breastfeeding
Women of childbearing potential 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.
Vimpat is not recommended during pregnancy, as the effects of Vimpat on pregnancy and the fetus are unknown.
Breastfeeding is not recommended while taking Vimpat, as 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 use machinery until you know how this medicine affects you. This is because Vimpat may cause dizziness or blurred vision.
Vimpat contains sodium
This medicine contains 59.8 mg of sodium (a main component of table/cooking salt) per vial. This corresponds to 3% of the maximum daily recommended sodium intake for an adult.
3. How to use Vimpat
Follow exactly the instructions given by your doctor or pharmacist for taking this medicine. If in doubt, consult your doctor or pharmacist again.
Use of Vimpat
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Treatment with Vimpat may be started:
- by taking the medicine orally, or
- by intravenous infusion (sometimes called i.v. infusion), where the doctor or nurse administers the medicine into a vein. The infusion lasts between 15 and 60 minutes.
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The i.v. infusion is normally used for a short period of time, when the medicine cannot be taken by mouth.
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Your doctor will decide for how many days you will receive infusions. Experience exists with administering Vimpat infusions twice daily for up to 5 days. For longer-term treatment, Vimpat tablets and oral solution are available.
When switching from infusion to oral administration or vice versa, the total daily amount and frequency of dosing will remain the same.
- Use Vimpat twice daily (with an interval of approximately 12 hours).
- Try to take it at about the same time each day.
What dose to use
The following are the normally recommended doses of Vimpat for different age and weight groups. Your doctor may prescribe a different dose if you have kidney or liver problems.
Adolescents and children weighing 50 kg or more, and adults
When using Vimpat as monotherapy:
The usual starting dose is 50 mg twice daily.
Treatment with Vimpat may also begin with a dose of 100 mg of Vimpat twice daily.
Your doctor may increase your twice-daily dose by 50 mg each week until reaching a maintenance dose between 100 mg and 300 mg twice daily.
When using Vimpat in combination with other antiepileptic medicines:
The usual starting dose is 50 mg twice daily.
Your doctor may increase your twice-daily dose by 50 mg each week until reaching a maintenance dose between 100 mg and 200 mg 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. You will then begin taking your 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 using Vimpat as monotherapy:
- 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.
- 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 used twice daily in children aged 2 years and older who weigh from 10 kg to less than 40 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 |
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 used twice daily, for adolescents and children weighing 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 |
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 using Vimpat with other antiepileptic medicines
- Your doctor will determine the Vimpat dose based on your body weight.
- For children and adolescents weighing from 10 kg to less than 50 kg, 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 weighing from 10 kg to less than 20 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 Recommended maximum dose: 0.6 ml/kg |
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 |
To be used twice daily, for adolescents and children weighing from 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 |
20 kg | 2 ml | 4 ml | 6 ml | 8 ml | 10 ml |
25 kg | 2.5 ml | 5 ml | 7.5 ml | 10 ml | 12.5 ml |
To be used twice daily, for adolescents and children weighing 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 |
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 |
If you stop treatment with Vimpat
If your doctor decides to stop your treatment with Vimpat, your dose will be gradually reduced step by step. This is to prevent epilepsy from recurring or worsening.
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.
Tell 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, trembling (tremor), tingling (paraesthesia), or muscle spasms, falling easily and bruising;
- Memory problems, difficulty thinking or finding words, confusion;
- Rapid, uncontrolled eye movements (nystagmus), blurred vision;
- Feeling dizzy (vertigo), sensation of drunkenness;
- Feeling dizzy (vomiting), dry mouth, constipation, indigestion, excessive gas in the stomach or intestines, diarrhoea;
- Decreased sensitivity, difficulty articulating words, attention disorder;
- Ringing in the ears such as buzzing or whistling;
- Irritability, trouble 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 the 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 a type of white blood cells (eosinophilia);
- 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 with intravenous administration
Local adverse reactions may occur.
Common: may affect up to 1 in 10 people
- Pain or discomfort at the injection site or irritation.
Uncommon: may affect up to 1 in 100 people
- Redness at the injection site.
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). Drowsiness 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 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 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 vial. The expiry date is the last day of the month indicated.
Do not store above 25 °C.
Each vial of Vimpat infusion solution is for single use only. Any unused solution must be discarded.
Only clear solutions free from particles and without colour change should be used.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging that you no longer need. This will help protect the environment.
6. Contents of the container and other information
Composition of Vimpat
- The active substance is lacosamide.
1 ml of Vimpat infusion solution contains 10 mg of lacosamide.
1 vial contains 20 ml of Vimpat infusion solution, equivalent to 200 mg of lacosamide.
- The other components are: sodium chloride, hydrochloric acid, water for injections.
Appearance of the product and contents of the container
- Vimpat 10 mg/ml infusion solution is a clear, colourless solution.
Vimpat infusion solution is available in packs containing 1 vial and 5 vials. Each vial contains 20 ml.
Only certain pack sizes may be marketed.
Marketing Authorization Holder
UCB Pharma S.A., Allée de la Recherche 60, B-1070 Bruxelles, Belgium.
Manufacturer
UCB Pharma S.A., Chemin du Foriest, B-1420 Braine-l’Alleud, Belgium
or
Aesica Pharmaceuticals GmbH, Alfred-Nobel Strasse 10, D-40789 Monheim am Rhein, Germany.
For more information about this medicinal product, 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 Hungary 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 S.A. 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. Simi: + 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/Sweden 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 last revision of this leaflet: {MM/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/.
This information is intended only for medical or healthcare professionals:
Each vial of Vimpat solution for infusion must be used only once (single use). Any unused solution must be discarded (see section 3).
Vimpat solution for infusion may be administered without further dilution, or it may be diluted with the following solutions: sodium chloride 9 mg/ml (0.9%), glucose 50 mg/ml (5%), or Ringer lactate solution.
From a microbiological standpoint, the medicine should be used immediately. If not used immediately, the in-use storage times and conditions prior to use are the responsibility of the user and must not exceed 24 hours at a temperature of 2 to 8 °C, unless the dilution was carried out under validated controlled and aseptic conditions.
Chemical and physical in-use stability has been demonstrated for 24 hours at temperatures up to 25 °C for drug products mixed with these diluents and stored in glass or PVC bags.