VIMPAT 10 mg/ml SOLUTION FOR INFUSION
How to use VIMPAT 10 mg/ml SOLUTION FOR INFUSION
Introduction
Package Leaflet: Information for the Patient
Vimpat 10 mg/ml Solution for Infusion
lacosamide
Read the entire package leaflet carefully before starting to use this medication, as it contains important information for you.
- Keep this package leaflet, as you may need to read it again.
- If you have any questions, consult your doctor or pharmacist.
- If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. See section 4.
Contents of the Package Leaflet
- What is Vimpat and what is it used for
- What you need to know before taking Vimpat
- How to take Vimpat
- Possible side effects
- Storage of Vimpat
- Contents of the pack and further information
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 have.
What is Vimpat used for
- Vimpat is used:
- alone and with other antiepileptics in adults, adolescents, and children from 2 years of age 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 can then spread to larger areas on both sides of the brain;
- with other antiepileptics 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 that is believed to have a genetic origin).
2. What you need to know before taking 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 not sure if 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 take Vimpat if any of the above applies to you. If you are not sure, consult your doctor or pharmacist before starting to take this medicine.
Warnings and precautions
Consult your doctor before starting to take Vimpat if:
- you have thoughts of self-harm or suicide. A small number of people taking antiepileptics such as lacosamide have had thoughts of self-harm or suicide. If you have these thoughts at any time, contact your doctor immediately.
- you have a heart problem that affects 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 heart attack.
- You often feel dizzy or faint. Vimpat may cause dizziness, which could increase the risk of accidental injuries or falls. This means you should be careful until you are used to the effects of this medicine.
If any of the above applies to you (or you are not sure), consult your doctor or pharmacist before starting to take 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, shortness of breath, dizziness, fainting), consult your doctor immediately (see section 4).
Children
Vimpat is not recommended for children under 2 years of age with epilepsy characterized by the occurrence of 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 if it is effective and safe for children in this age group.
Other medicines and Vimpat
Tell your doctor or pharmacist if you are using or have recently used or might use 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:
- medicines for heart problems;
- medicines that can increase the "PR interval" in a heart test (ECG or electrocardiogram) such as epilepsy or pain medicines called carbamazepine, lamotrigine, and pregabalin;
- medicines used to treat certain types of arrhythmia or heart failure.
If any of the above applies to you (or you are not sure), talk to your doctor or pharmacist before starting to take Vimpat.
Also, tell 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:
- medicines for fungal infections such as fluconazole, itraconazole, and ketoconazole;
- a medicine for HIV such as ritonavir
- medicines for bacterial infections such as clarithromycin and rifampicin;
- a herbal medicine used to treat mild anxiety and depression called St. John's Wort.
If any of the above applies to you (or you are not sure), talk to your doctor or pharmacist before starting to take Vimpat.
Using Vimpat with alcohol
As a precaution, do not use 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 plan to become pregnant, consult your doctor or pharmacist before using this medicine.
Vimpat is not recommended if you are pregnant, as its effects on pregnancy and the fetus are not known.
It is not recommended to breastfeed while taking Vimpat, as Vimpat passes into breast milk.
Ask your doctor for advice immediately if you are pregnant or plan to become pregnant. They will help you decide whether to take Vimpat or not.
Do not stop treatment without talking to your doctor first, as this could increase the risk of seizures (epilepsy). Worsening of your illness can also harm the fetus.
Driving and using machines
Do not drive, ride a bicycle, or use machines until you know if this medicine affects you. The reason is that Vimpat may cause dizziness or blurred vision.
Vimpat contains sodium
This medicine contains 59.8 mg of sodium (the main component of table salt/cooking salt) per vial. This is equivalent to 3% of the maximum recommended daily intake of sodium for an adult.
3. How to take Vimpat
Follow the instructions for administration of this medicine exactly as indicated by your doctor or pharmacist. If you are in doubt, consult your doctor or pharmacist again.
Using Vimpat
- Treatment with Vimpat may be started:
- by taking the medicine orally or
- administered as an intravenous infusion (sometimes called i.v. infusion) with which the doctor or nurse administers the medicine into a vein. The administration takes 15 to 60 minutes.
- The i.v. infusion is normally used for a short period, when the medicine cannot be taken orally.
- Your doctor will decide how many days you will be given infusions. There is experience with administration of Vimpat infusions twice a day for up to 5 days. For longer-term treatment, Vimpat tablets and syrup are available.
When switching from infusion to oral administration or vice versa, the total amount you take per day and the frequency of administration will remain the same.
- Use Vimpat twice a day (with an interval of approximately 12 hours).
- Try to use it at about the same time every day.
How much to use
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.
Adolescents and children who weigh 50 kg or more and adults
When using Vimpat alone:
The usual starting dose is 50 mg twice a day.
Treatment with Vimpat may also be started with a dose of 100 mg of Vimpat twice a day.
Your doctor may increase the dose you take twice a day by 50 mg each week, until you reach a maintenance dose between 100 mg and 300 mg twice a day.
When using Vimpat with other antiepileptic medicines:
The usual starting dose is 50 mg twice a day.
Your doctor may increase the dose you take twice a day by 50 mg each week, until you reach a maintenance dose between 100 mg and 200 mg twice a day.
If you weigh 50 kg or more, your doctor may decide to start treatment with Vimpat with a single "loading dose" of 200 mg. You will then start taking your maintenance dose 12 hours later.
Children and adolescents who weigh 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 alone
- Your doctor will decide the dose of Vimpat based on 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 for information only. Your doctor will calculate the correct dose for you.
To be taken twice a dayfor children from 2 years of age 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 taken twice a dayfor adolescents and children who weigh from 40 kg to 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 |
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 decide the dose of Vimpat based on your body weight.
- For children and adolescents who weigh from 10 kg to less than 50 kg, 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 for information only. Your doctor will calculate the correct dose for you.
To be taken twice a dayfor children from 2 years of age who weigh 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 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 |
To be taken twice a dayfor adolescents and children who weigh from 20 kg to 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 |
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 taken twice a dayfor adolescents and children who weigh from 30 kg to 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 |
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, they will gradually reduce your dose. This is to prevent epilepsy from appearing again or worsening.
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 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
- Headache;
- Feeling dizzy or sick (nausea);
- Double vision (diplopia).
Common:may affect up to 1 in 10 patients
- Brief muscle or muscle group tremors (myoclonic seizures);
- Difficulty coordinating movements or walking;
- Balance problems, agitation (tremor), tingling (paresthesia) or muscle spasms, easy falling and bruising;
- Memory problems, difficulty thinking or finding words, confusion;
- Rapid, uncontrolled eye movements (nystagmus), blurred vision;
- Dizzy sensation (vertigo), sensation of drunkenness;
- Being dizzy (vomiting), dry mouth, constipation, indigestion, excessive gas in the stomach or intestine, diarrhea;
- Decreased sensitivity, difficulty articulating words, attention disorder;
- Noise in the ears like buzzing or whistling;
- Irritability, sleep problems, depression;
- Somnolence, 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 sense of well-being, seeing and/or hearing things that are not real;
- Allergic reaction to taking the medicine, 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 the available data
- Abnormally fast heartbeat (ventricular tachyarrhythmia);
- Sore throat, elevated temperature and frequent infections. Blood tests may show a severe decrease in a specific class of white blood cells (agranulocytosis);
- Severe skin reaction, which may include elevated temperature and other flu-like symptoms, rash on the face, generalized rash with lymph node inflammation (enlarged lymph nodes). Blood tests may show an increase in liver enzyme levels and a type of white blood cell (eosinophilia);
- A generalized rash with blisters and skin peeling, especially around the mouth, nose, eyes, and genitals (Stevens-Johnson syndrome) and a more severe form that causes skin peeling on more than 30% of the body surface (toxic epidermal necrolysis);
- Seizures.
Other adverse effects of intravenous administration
Local adverse reactions may occur.
Common:may affect up to 1 in 10 patients
- Pain or discomfort at the injection site or irritation.
Uncommon:may affect up to 1 in 100 patients
- 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), decreased appetite, behavioral changes, abnormal behavior, and lack of energy (lethargy). 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 prospectus. 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.
5. Conservation of Vimpat
Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiration date that appears on the box and vial. The expiration date is the last day of the month indicated.
Do not store at a temperature above 25 ºC.
Each vial of Vimpat solution for infusion should be used only once (single use). The unused solution should be discarded.
Only clear solutions, free of particles and without color change, should be used.
Medicines should not be thrown away through wastewater or household waste. Ask your pharmacist how to dispose of the packaging and medicines that are no longer needed. This will help protect the environment.
6. Package contents and additional information
Vimpat composition
- The active ingredient is lacosamide.
1 ml of Vimpat solution for infusion contains 10 mg of lacosamide.
1 vial contains 20 ml of Vimpat solution for infusion, equivalent to 200 mg of lacosamide.
- The other components are: sodium chloride, hydrochloric acid, water for injectable preparations.
Product appearance and package contents
- Vimpat 10 mg/ml solution for infusion is a clear, colorless solution.
Vimpat solution for infusion is available in packages with 1 vial and 5 vials. Each vial contains 20 ml.
Only some package sizes may be marketed.
Marketing authorization holder
UCB Pharma S.A., Allée de la Recherche 60, B-1070 Bruxelles, Bélgica.
Manufacturer
UCB Pharma S.A., Chemin du Foriest, B-1420 Braine-l’Alleud, Bélgica
or
Aesica Pharmaceuticals GmbH, Alfred-Nobel Strasse 10, D-40789 Monheim am Rhein, Alemania.
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 Tél/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 prospectus:{month/YYYY}.
Other sources of information
Detailed information about this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu/.
This information is intended only for doctors or healthcare professionals:
Each vial of Vimpat solution for infusion should be used only once (single use). The unused solution should be discarded (see section 3).
Vimpat solution for infusion can be administered without further dilution, or it can be diluted with the following solutions: sodium chloride 9 mg/ml (0.9%), glucose 50 mg/ml (5%) or Ringer's lactate solution.
From a microbiological point of view, the medicine should be used immediately. If not used immediately, the storage times and conditions prior to use are the responsibility of the user and should not exceed 24 hours at a temperature between 2 and 8 ºC, unless the dilution has taken place in controlled and validated aseptic conditions.
The chemical and physical stability in use has been demonstrated for 24 hours at temperatures up to 25 ºC for medicines mixed with these diluents and stored in glass or PVC bags.
- Country of registration
- Active substance
- Prescription requiredYes
- Manufacturer
- CompositionCLORURO DE SODIO (0 - mg)
- This information is for reference only and does not constitute medical advice. Always consult a licensed doctor before taking any medication. Oladoctor is not responsible for medical decisions based on this content.
- Alternatives to VIMPAT 10 mg/ml SOLUTION FOR INFUSIONDosage form: TABLET, 100 mgActive substance: lacosamideManufacturer: Intas Third Party Sales 2005 S.L.Prescription requiredDosage form: TABLET, 150 mgActive substance: lacosamideManufacturer: Intas Third Party Sales 2005 S.L.Prescription requiredDosage form: TABLET, 200 mgActive substance: lacosamideManufacturer: Intas Third Party Sales 2005 S.L.Prescription required
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