Vimpat 50 mg film-coated tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Vimpat 50 mg film-coated tablets

Vimpat 100 mg film-coated tablets

Vimpat 150 mg film-coated tablets

Vimpat 200 mg film-coated tablets

lacosamide

Read all of this leaflet carefully before you start taking 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.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of this leaflet

1. What Vimpat is and what it is used for
2. What you need to know before taking Vimpat
3. How to take Vimpat
4. Possible side effects
5. How to store Vimpat
6. 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 drugs". 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:

• alone or in combination with other antiepileptic drugs in adults, adolescents, and children from 2 years of age, to treat 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 drugs 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 believed to have a genetic origin).

2. What you need to know before starting to use Vimpat

Do not take 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 heart rhythm problem called second- or third-degree AV block.

Do not take Vimpat if either of the above applies to you. If you are unsure, consult your doctor or pharmacist before taking 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 experience such thoughts, contact your doctor immediately.
• you have a heart condition affecting your heartbeat, and often your pulse is 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 feel dizzy or fall frequently. 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 if you are unsure), consult your doctor or pharmacist before taking Vimpat.

If you are taking Vimpat, contact your doctor if you experience a new type of seizure or a 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, or for children under 4 years of age with generalized tonic-clonic seizures. This is because it is not yet known whether it is effective and safe in children of these age groups.

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 medicines for epilepsy or pain called carbamazepine, lamotrigine, or pregabalin.
• medicines used to treat certain types of arrhythmia or heart failure.

If any of the above apply to you (or if you are unsure), speak with your doctor or pharmacist before taking Vimpat.

Also inform your doctor or pharmacist if you are taking any of the following medicines, as they may either increase or decrease the effect of Vimpat in your body:

• antifungal medicines such as fluconazole, itraconazole, or ketoconazole.
• medicines for HIV such as ritonavir.
• medicines for bacterial infections such as clarithromycin or rifampicin.
• a herbal medicine used to treat mild anxiety and depression called St. John's wort.

If any of the above apply to you (or if you are unsure), speak with your doctor or pharmacist before taking Vimpat.

Taking Vimpat with alcohol

As a safety precaution, do not take 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 are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

Taking Vimpat during pregnancy is not recommended, as the effects of Vimpat on pregnancy and the fetus are not known.

Breastfeeding is not recommended while taking Vimpat, because Vimpat passes into breast milk.

Seek immediate advice from your doctor if you are pregnant or planning to become pregnant. They will help you decide whether or not you should 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 operate any tools or machinery until you know whether this medicine affects you. The reason is that Vimpat may cause dizziness or blurred vision.

3. How to take Vimpat

Follow exactly the instructions for using this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again. Another form(s) of this medicine may be more suitable for children; please consult your doctor or pharmacist.

How to take Vimpat

• Take Vimpat twice daily, 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 may take Vimpat with food or separately.

Normally, you will start with a low daily dose, and your doctor will gradually increase the dose over several weeks. When you reach the dose that works well for you, known as the “maintenance dose”, you will take the same amount every day. Vimpat is used as a long-term treatment. You should continue taking Vimpat until your doctor tells you to stop.

How much to take

Below 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 taking Vimpat as monotherapy:

The usual starting dose is 50 mg twice daily.

Your doctor may also prescribe a starting 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 taking Vimpat 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 start Vimpat treatment with a single “loading dose” of 200 mg. You would then begin taking the regular 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.

The dose depends on body weight. Treatment is usually started with the oral syrup, and only switched to tablets if the patient is able to swallow them and can achieve the correct dose using tablets of different strengths. Your doctor will prescribe the pharmaceutical form most suitable for you.

If you take more Vimpat than you should

If you have taken more Vimpat than you should, contact your doctor immediately. Do not attempt to drive. You may experience:

• dizziness;
• feeling sick (nausea) or being sick (vomiting);
• seizures (fits), heart rhythm problems such as slow, fast or irregular pulse, coma, or low blood pressure with tachycardia and sweating.

If you forget to take Vimpat

• If you forget to take a dose within 6 hours of your scheduled dose, take it as soon as you remember.
• If you forget to take a dose more than 6 hours after your scheduled dose, do not take the missed dose; instead, take your next dose at the usual 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 telling your doctor, as epilepsy may return or worsen.
• If your doctor decides to stop your treatment with Vimpat, you will be given instructions on how to gradually reduce the dose.

If you have any further questions about the use of this medicine, 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 patients

• Headache;
• Feeling dizzy or sick (nausea);
• Double vision (diplopia).

Common: may affect up to 1 in 10 patients

• Brief jerks of a muscle or group of muscles (myoclonic seizures);
• Difficulty coordinating movements or walking;
• Problems with balance, 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), feeling drunk;
• Feeling dizzy (vomiting), dry mouth, constipation, indigestion, excessive gas in the stomach or intestines, diarrhoea;
• Reduced sensation, difficulty speaking, attention disturbance;
• Ringing in the ears such as buzzing, ringing, or whistling;
• Irritability, trouble sleeping, depression;
• Drowsiness, tiredness or weakness (asthenia);
• Itching, rash.

Uncommon: may affect up to 1 in 100 patients

• Decreased heart rate, palpitations, irregular pulse, or other changes in the heart's electrical activity (conduction disorder);
• Euphoria (exaggerated feeling of well-being), seeing and/or hearing things that are not real;
• Allergic reaction to the medicine, hives;
• Blood tests may show abnormalities in liver function tests, liver damage;
• Thoughts of self-harm or suicide, or attempted suicide: inform your doctor immediately;
• Feeling angry or agitated;
• Abnormal thoughts 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 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, facial rash, widespread rash with swollen lymph nodes (enlarged lymph nodes). Blood tests may show increased liver enzyme levels and an increase in a type of white blood cells (eosinophilia);
• A 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 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 (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 adverse effect, talk to 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 detailed 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 which is stated on the carton and on the blister after CAD/EXP. The expiry date is the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging when they are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

Composition of Vimpat

• The active substance is lacosamide.

Each Vimpat 50 mg tablet contains 50 mg of lacosamide.
Each Vimpat 100 mg tablet contains 100 mg of lacosamide.
Each Vimpat 150 mg tablet contains 150 mg of lacosamide.
Each Vimpat 200 mg tablet contains 200 mg of lacosamide.

• The other components are:

Tablet core: microcrystalline cellulose, hydroxypropylcellulose, low-substituted hydroxypropylcellulose, colloidal anhydrous silica, crospovidone (poliplasdone XL-10 pharmaceutical grade), magnesium stearate.

Coating: polyvinyl alcohol, macrogol, talc, titanium dioxide (E171), colourants*

• The colourants are:

50 mg tablets: iron oxide red (E172), iron oxide black (E172), indigo carmine aluminium lake (E132).
100 mg tablets: iron oxide yellow (E172).
150 mg tablets: iron oxide yellow (E172), iron oxide red (E172), iron oxide black (E172).
200 mg tablets: indigo carmine aluminium lake (E132).

Appearance of the product and contents of the pack

• Vimpat 50 mg are pink, film-coated oval tablets, approximately 10.4 mm x 4.9 mm, marked with “SP” on one side and “50” on the other.
• Vimpat 100 mg are dark yellow, film-coated oval tablets, approximately 13.2 mm x 6.1 mm, marked with “SP” on one side and “100” on the other.
• Vimpat 150 mg are salmon-coloured, film-coated oval tablets, approximately 15.1 mm x 7.0 mm, marked with “SP” on one side and “150” on the other.
• Vimpat 200 mg are blue, film-coated oval tablets, approximately 16.6 mm x 7.8 mm, marked with “SP” on one side and “200” on the other.

Vimpat is available in packs containing 14, 28, 56, 60, 14 x 1 and 56 x 1 film-coated tablets. Vimpat 50 mg and Vimpat 100 mg are available in packs of 168 film-coated tablets. Vimpat 150 mg and Vimpat 200 mg are available in multiple packs containing 3 boxes of 56 tablets each. Packs of 14 x 1 and 56 x 1 film-coated tablets are supplied in pre-cut PVC/PVDC unit dose blisters sealed with an aluminium foil. Packs of 14, 28, 56 and 168 tablets are available in standard PVC/PVDC blisters sealed with an aluminium foil. Packs of 60 tablets are available in HDPE bottles with child-resistant safety closures. Not all pack sizes may be marketed.

Marketing Authorisation 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 further information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

Date of the most recent revision of this leaflet: {month/YYYY}.

Other sources of information

Detailed information on this medicinal product is available on the website of the European Medicines Agency: http://www.ema.europa.eu/.