50 mg, 100 mg, 150 mg resp. 200 mg Film-coated tablets
Lacosamide
What Vimpat is and what it is used for
What Vimpat is
Vimpat contains lacosamide. This substance belongs to a group of medicines called “antiepileptics”. These drugs are used to treat epilepsy.
- You have been given this medicine to help you have fewer seizures (convulsions).
What Vimpat is used for
- Vimpat is used:
- as a single treatment and together with other anti-epileptic medicines in adults, adolescents, and children from 2 years of age to treat a particular form of epilepsy characterized by the occurrence of partial seizures with or without secondary generalization. In this form of epilepsy, the seizures initially affect only one hemisphere of the brain. Afterward, however, they can spread to larger areas in both brain hemispheres.
- together with other anti-epileptic medicines in adults, adolescents, and children aged 4 and over to treat primary generalized tonic-clonic seizures (bigger seizures, including loss of consciousness) in patients with idiopathic generalized epilepsy (the type of epilepsy that is thought to be hereditary).
What you need to know before you 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 not sure whether you are allergic, you should discuss it with your doctor.
- if you have a particular type of heart rhythm problem called second or third-degree (II or III) AV block.
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 taking Vimpat if:
- you have thoughts of harming yourself or committing suicide. A small number of people treated with anti-epileptic drugs such as lacosamide have had thoughts of harming themselves or committing suicide. If you ever have these thoughts, see a doctor immediately
- you have heart problems that affect your heartbeats and you often have very slow, fast, or irregular heartbeats (such as AV block, atrial fibrillation, and atrial flutter )
- you have severe heart disease such as heart failure or have had a heart attack
- you often feel dizzy or fall. Vimpat can make you dizzy – this can increase the risk of an accident or fall. This means that you should be careful until you are used to the effects that the drug can have.
If any of the above apply to you (or if 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 the seizures you already have.
If you are taking Vimpat and experience symptoms of an abnormal heart rate (such as slow, fast, or irregular heart rate, palpitations, shortness of breath, feeling dizzy, or fainting) seek medical advice immediately (see section 4).
Children
Vimpat is not recommended for children under 2 years of age with epilepsy characterized by the presence of partial seizures, nor is it recommended for children under 4 years of age with primarily generalized tonic-clonic seizures. This is because we do not yet know if it has any effect or if it is safe for children in 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.
It is especially important to talk to your doctor or pharmacist if you are taking any of the following medicines that affect your heart. This is because Vimpat can also affect your heart:
- medicines for heart problems,
- drugs that can increase the “PQ time” during an examination of the heart ( ECG, electrocardiogram ), such as anti-epileptic drugs or pain-relieving drugs such as carbamazepine, lamotrigine, or pregabalin,
- medicines to treat certain types of irregular heart rhythms or heart failure.
If any of the above apply to you (or if you are not sure), talk to your doctor or pharmacist before taking Vimpat.
Also talk to 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 against fungal infections, for example, fluconazole, itraconazole, or ketoconazole
- medicines against HIV, for example, ritonavir
- medicines to treat bacterial infections, for example, clarithromycin or rifampicin
- a (traditional) herbal medicine used to treat mild depression and mild anxiety called St. John’s wort.
If any of the above apply to you (or if you are not sure), talk to your doctor or pharmacist before taking Vimpat.
Stuck with alcohol
As a precaution, do not take Vimpat with alcohol.
Pregnancy and breastfeeding
Women who may become pregnant should discuss appropriate contraception with their doctor.
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
It is not recommended to take Vimpat if you are pregnant because the effects of Vimpat on pregnancy and the fetus are unknown.
It is not recommended that you breastfeed your baby while taking Vimpat as Vimpat passes into breast milk.
Consult a doctor immediately if you become pregnant or plan to become pregnant. The doctor will help you decide whether or not to take Vimpat.
Do not stop treatment without first talking to your doctor, as this may cause you to have more seizures (seizures). A worsening of the disease can also be harmful to your child.
Driving ability and use of machinery
You should not drive, cycle or use tools or machines until you know how the medicine affects you. The reason for this is that Vimpat can cause dizziness or blurred vision.
How to take Vimpat
Always take this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure. Other forms of this medicine may be more suitable for children, ask your doctor or pharmacist.
How to take Vimpat
- Take Vimpat 2 times each day approximately 12 hours apart.
- Try to take it at about the same time each day.
- Swallow the Vimpat tablet with a glass of water.
- You can take Vimpat with or without food.
You will usually start by taking a low dose each day, which your doctor will slowly increase over several weeks. When you reach the dose that suits you, the so-called “maintenance dose”, you will then take the same amount every day. Vimpat is used for long-term treatment. You should continue to take Vimpat until your doctor tells you to stop.
How much to take
Listed below are the doses of Vimpat that are normally recommended for different age groups and body weights. Your doctor may prescribe a different dose if you have problems with your kidneys or liver.
Young people and children weighing at least 50 kg and adults
When you take Vimpat as the only treatment
The usual starting dose of Vimpat is 50 mg twice a day.
The doctor may also prescribe a starting dose of 100 mg of Vimpat twice a day.
The doctor may increase your dose, which is taken twice daily, by 50 mg every week. This continues until you reach a maintenance dose of between 100 mg and 300 mg twice a day.
When you take Vimpat together with other medicines for epilepsy
The usual starting dose of Vimpat is 50 mg twice a day.
The doctor may increase your dose, which is taken twice daily, by 50 mg every week. This continues until you reach a so-called maintenance dose of between 100 mg and 200 mg twice a day.
If you weigh at least 50 kg, your doctor may decide to start Vimpat treatment with a single “loading dose” of 200 mg. You then start your ongoing maintenance dosage 12 hours later.
Children and young people who weigh less than 50 kg
– When treating partial seizures: Please note that Vimpat is not recommended for children under 2 years of age.
– In the treatment of primary generalized tonic-clonic seizures: Please note that Vimpat is not recommended for children under 4 years of age.
Does one depends on body weight. You usually start the treatment with syrup and only switch to tablets if the child/youth can take the tablets and get the correct dose with the different tablet strengths. The doctor will prescribe the most suitable drug form.
If you have taken too much Vimpat
If you have taken too much Vimpat, contact your doctor immediately. Do not attempt to drive.
You may suffer from:
- dizziness
- nausea or vomiting
- seizures (convulsions), heart rhythm problems such as slow, fast, or irregular heartbeats, coma or drop in blood pressure with fast heartbeats and sweating.
If you forget to take Vimpat
- If you have missed a dose and it has been less than 6 hours since the scheduled dose, take it as soon as you remember.
- If you have missed a dose and it has been more than 6 hours since the scheduled dose, do not take the missed tablet. Instead, take the next tablet at the normal time.
- Do not take a double dose to make up for a missed dose.
If you stop taking Vimpat
- Do not stop taking Vimpat without talking to your doctor as your epilepsy may come back or get worse.
- If the doctor decides to end your treatment with Vimpat, he will explain to you how to reduce the dose step by step.
If you have any further questions about this medicine, ask your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Side effects in the central nervous system, such as dizziness, may increase after a single “loading dose”.
Talk to your doctor or pharmacist if you experience any of the following:
Very common: may affect more than 1 in 10 people
- Headache
- Dizziness or nausea
- Double vision ( diplopia )
Common: may affect up to 1 in 10 people
- Rapid contractions of a muscle or group of muscles (myoclonic seizures)
- Difficulty coordinating your movements or walking
- Balance difficulties, shaking ( tremor ), tingling ( paresthesia ) or muscle spasms, easy to fall and get bruises
- Memory problems, difficulty thinking or finding words, confusion
- Rapid and uncontrolled eye movements ( nystagmus ), blurred vision
- A feeling of dizziness (vertigo), intoxication
- Vomiting, dry mouth, constipation, indigestion, excessive flatulence in the stomach or intestines, diarrhea
- Decreased sensation or sensitivity, difficulty articulating words, impaired attention
- Noises in the ears such as hissing, ringing, or whistling
- Irritability, difficulty sleeping, depression
- Drowsiness, fatigue, or weakness ( asthenia )
- Itching, rash
Uncommon: may affect up to 1 in 100 people
- Slow heartbeat, palpitations, irregular pulse, or other changes in the electrical activity of your heart (disorders in the heart’s conduction system)
- An exaggerated sense of well-being, seeing and/or hearing things that are not real
- Allergic reaction to the drug, hives
- Blood tests showing abnormalities in liver function, liver damage
- Thoughts of harming yourself or committing suicide: talk to your doctor immediately
- Anger or upset
- Abnormal thinking or lost touch with reality
- Severe allergic reaction causing swelling of the face, neck, hands, feet, ankles, or lower legs
- Fainting
- Abnormal, involuntary movements ( dyskinesia )
Not known frequency: cannot be estimated from the available data
- Abnormally fast heart rate ( ventricular tachyarrhythmia )
- Sore throat, high fever, and more infections than normal. Blood tests may show a severe reduction of a certain type of white blood cell ( agranulocytosis )
- A serious skin reaction which may include high fever and other flu-like symptoms, rash on the face, widespread skin rash, and swollen glands (enlarged lymph nodes ). Blood tests may show increased levels of liver enzymes and a type of white blood cell ( eosinophils )
- Widespread skin rash with blisters and peeling, especially around the mouth, nose, eyes, and genitals ( Stevens-Johnson syndrome ) and a more severe form causing peeling off more than 30% of the body surface ( toxic epidermal necrolysis )
- Cramps
How to store Vimpat
Keep this medicine out of the sight and reach of children.
Use before the expiry date which is stated on the carton and blister after EXP. The expiration date is the last day of the specified month.
No special storage instructions.
Medicines must not be thrown into the drain or among the household waste. Ask the pharmacist how to dispose of medicines that are no longer used. These measures will help to protect the environment.
Contents of the packaging and other information
Contents declaration
- The active substance is lacosamide.One Vimpat 50 mg tablet contains 50 mg lacosamideOne Vimpat 100 mg tablet contains 100 mg lacosamideOne Vimpat 150 mg tablet contains 150 mg lacosamideOne Vimpat 200 mg tablet contains 200 mg lacosamide
- Other ingredients are Tablet core: microcrystalline cellulose, hydroxypropyl cellulose, hydroxypropyl cellulose (low substituted), colloidal anhydrous silica, crospovidone (Polyplasdone XL-10 pharmaceutical grade), magnesium stearateTablet film: polyvinyl alcohol, polyethylene glycol, talc, titanium dioxide (E171), dyes**Colors are:50 mg tablet: red iron oxide (E172), black iron oxide (E172), indigo carmine aluminum lacquer color (E132).100 mg tablet: yellow iron oxide (E172).150 mg tablet: yellow iron oxide (E172), red iron oxide (E172), black iron oxide (E172).200 mg tablet: indigo carmine aluminum lacquer color (E132).
Appearance and package sizes of the medicine
- Vimpat 50 mg are pinkish oval film-coated tablets of approximately 10.4 mm x 4.9 mm, debossed with ‘SP’ on one side and ’50’ on the other.
- Vimpat 100 mg are dark yellow oval film-coated tablets of approximately 13.2 mm x 6.1 mm, debossed with ‘SP’ on one side and ‘100’ on the other.
- Vimpat 150 mg are salmon pink oval film-coated tablets approximately 15.1 mm x 7.0 mm, debossed with ‘SP’ on one side and ‘150’ on the other.
- Vimpat 200 mg are blue oval film-coated tablets of approximately 16.6 mm x 7.8 mm, debossed with ‘SP’ on one side and ‘200’ on the other.
Vimpat is supplied in packs of 14, 28, 56, 60, 14 x 1, and 56 x 1 film-coated tablet. Vimpat 50 mg and Vimpat 100 mg are supplied in packs of 168 film-coated tablets and Vimpat 150 mg and Vimpat 200 mg are supplied in multipacks consisting of 3 packs each containing 56 tablets. The packs of 14 x 1 and 56 x 1 film-coated tablet are supplied in the form of perforated single-dose PVC/PVDC blisters, sealed with aluminum foil. The packs of 14, 28, 56, and 168 tablets are supplied in standard PVC/PVDC blisters, sealed with aluminum foil, and the packs of 60 tablets are supplied in HDPE cans with a child-resistant closure. Not all pack sizes may be marketed.
Marketing Authorisation Holder
UCB Pharma SA, Allée de la Recherche 60, B-1070 Bruxelles, Belgium
Manufacturer
UCB Pharma SA, Chemin du Foriest, B-1420 Braine-l’Alleud, Belgium
or
Aesica Pharmaceuticals GmbH, Alfred-Nobel Strasse 10, D-40789 Monheim am Rhein, Germany