Vimpat 10 mg/ml solucion para perfusion
Introduction
Package Insert: Information for the Patient
Vimpat 10 mg/ml Infusion Solution
Lacosamide
Read this entire package insert carefully before starting to use this medication, as it contains important information for you.
- Keep this package insert, as you may need to refer to it again.
- If you have any questions, consult your doctor or pharmacist.
- If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. 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 medications called “antiepileptic medications”. These medications are used to treat epilepsy.
- You have been prescribed this medication to reduce the number of seizures you experience.
What is Vimpat used for
- Vimpat is used:
- alone and in combination with other antiepileptic medications in adults, adolescents, and children aged 2 years and 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 medications in adults, adolescents, and children aged 4 years and 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 use Vimpat
Do not use Vimpat
- If you are allergic to lacosamide or any of the other ingredients in this medicine (listed in section 6). If you are unsure 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 use Vimpat if any of the above applies to you. If you are unsure, consult your doctor or pharmacist before starting to use 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 the 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 disease such as heart failure or have had a heart attack.
- You often feel dizzy or fall. Vimpat may cause dizziness, which could increase the risk of accidents 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 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 heart rhythm (such as slow, fast, or irregular heartbeat, palpitations, shortness of breath, feeling dizzy, fainting), consult your doctor immediately (see section 4).
Children
Vimpat is not recommended for children under 2 years with epilepsy characterized by the onset of partial seizures and is not recommended for children under 4 years 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
Inform your doctor or pharmacist if you are using or have used recently or may need to use any other medicine.
Particularly, 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, and 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 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 on 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 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 starting to use Vimpat.
Use of 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 to be taken if you are pregnant, as the effects of Vimpat on pregnancy and the fetus are not known.
Vimpat is not recommended to be breastfed, as Vimpat passes into breast milk.
Ask your doctor immediately if you are pregnant or plan 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 could increase seizures (crises). A worsening of your condition may also harm the fetus.
Driving and operating machines
You should not drive, ride a bike, 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 (main component of table salt/for cooking) in each vial. This is equivalent to 3% of the maximum daily sodium intake recommended for an adult.
3. How to use Vimpat
Follow exactly the administration instructions of this medication as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.
Use of Vimpat
- The treatment with Vimpat can be initiated:
- by taking the medication by mouth or
- administered as an intravenous infusion (also known as i.v. infusion) with which your doctor or nurse administers the medication through a vein. The administration lasts from 15 to 60 minutes.
- The i.v. infusion is usually used for a short period of time, when the medication cannot be taken by mouth.
- Your doctor will decide for how many days you will receive infusions. There is experience with the administration of Vimpat infusions twice a day for up to 5 days. For long-term treatment, Vimpat tablets and syrup are available.
When changing the infusion to start taking the medication by mouth or vice versa, the total amount you will take per day and the frequency of intake 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 each day.
What dose 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 weighing 50 kg or more and adults
When using Vimpat alone:
The usual starting dose is 50 mg twice a day.
Treatment with Vimpat can also begin 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 medications:
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 a single "loading" dose of 200 mg. You will then start taking your continued maintenance dose 12 hours later.
Children and adolescents weighing less than 50 kg
- In the treatment of partial onset seizures:Vimpat is not recommended for children under 2 years of age.
- In the treatment of primary generalized tonic-clonic seizures:Vimpat is not recommended for children under 4 years of age.
When using Vimpat alone
- Your doctor will decide the dose of Vimpat 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 dose tables with the maximum recommended dose.
- These doses are merely informative. Your doctor will calculate the correct dose for you.
Ato be taken twice a dayfor children aged 2 years or older whoweigh between 10 kg and 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 day,for adolescents and childrenwho 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 |
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 medications
- Your doctor will decide the dose of Vimpat according to your body weight.
- For children and adolescents who weigh between 10 kg and less than 50 kg, the usual initial 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 each week by 1 mg (0.1 ml) per kg of body weight, until you reach the maintenance dose.
- The following are the dose tables with the maximum recommended dose.
- These doses are merely informative. Your doctor will calculate the correct dose for you.
To be taken twice a dayfor children aged 2 years or older whoweigh between 10 kg and 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 day,for adolescents and childrenwho 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 Maximum recommended dose: 0.4 ml/kg |
20 kg | 2 ml | 4 ml | 6 ml | 8 ml |
25 kg | 2.5 ml | 5 ml | 7.5 ml | 10 ml |
To be taken twice a day,for adolescents and childrenwho 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 |
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 interrupt treatment with Vimpat
If your doctor decides to stop your treatment with Vimpat, they will gradually reduce your dose. This is to prevent seizures from recurring 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 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;
- Diplopia (double vision).
Common:may affect up to 1 in 10 patients
- Myoclonic seizures (brief muscle or muscle group spasms);
- Difficulty coordinating movements or walking;
- Balance problems, agitation (tremor), paresthesia (numbness), or muscle spasms, easy to fall and bruise;
- Memory problems, difficulty thinking or finding words, confusion;
- Uncontrolled rapid eye movements (nystagmus), blurred vision;
- Sensation of dizziness (vertigo), feeling drunk;
- Feeling nauseous (vomiting), dry mouth, constipation, indigestion, excessive gas in the stomach or intestines, diarrhea;
- Decreased sensitivity, difficulty articulating words, attention disorder;
- Ring in the ears like buzzing or hissing;
- 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;
- Loss of consciousness;
- Anomalous involuntary movements (dyskinesia).
Frequency not known:cannot be estimated from available data
- Abnormally fast ventricular heart rate (ventricular tachyarrhythmia);
- Sore throat, elevated temperature, and increased frequency of infections. 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 flu-like symptoms, widespread rash with lymph node inflammation (enlarged lymph nodes). Blood tests may show increased levels of liver enzymes and a type of white blood cell (eosinophilia);
- Generalized blistering and 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 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 side effects in children
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 normally (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 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 the national notification system included in theAppendix V. By reporting side effects, you can contribute to providing more information about 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 vial. The expiration date is the last day of the month indicated.
Do not store at a temperature above 25 °C.
Each vial of Vimpat infusion solution must be used only once (single use). Unused solution must be discarded.
Only clear solutions, free of particles and without color change should be used.
Medications should not be thrown down the drains or in the trash. Ask your pharmacist how to dispose of the containers and medications that 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 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 injection preparations.
Appearance of the product and contents of the package
- Vimpat 10 mg/ml infusion solution is a clear, colorless solution.
Vimpat infusion solution 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 Brussels, Belgium.
Responsible for manufacturing
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 medicine, please contact the local representative of the marketing authorization holder:
België/Belgique/Belgien UCB Pharma SA/NV Tel/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) 217348 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 thisleaflet:{month/YYYY}.
Other sources of information
Detailed information about this medicine is available on the website of the European Medicines Agency:http://www.ema.europa.eu/.
This information is intended solely for medical professionals or healthcare professionals:
Each vial of Vimpat infusion solution should be used only once (single use). Unused solution should be discarded (see section 3).
Vimpat infusion solution can be administered without additional dilution, or it can 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 point of view, the medicinal product should be used immediately. If not used immediately, the storage times in use and the conditions prior to use are the responsibility of the user and should not be greater than 24 hours at a temperature of between 2°C and 8°C, unless the dilution has taken place in validated and controlled conditions and in an aseptic environment.
The chemical and physical stability in use has been demonstrated for 24 hours at temperatures up to 25°C for medicines mixed with these diluents and stored in glass or PVC bags.
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