VIMPAT 200 mg FILM-COATED TABLETS

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, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What is Vimpat and what is it used for
2. What you need to know before you take Vimpat
3. How to take Vimpat
4. Possible side effects
5. Storage of Vimpat
6. Contents of the pack and other 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:

• on its own 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 your brain. However, they can then spread to larger areas on both sides of your 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 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, consult your doctor.
• if you have a heart problem called second or third degree atrioventricular (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 taking this medicine.

Warnings and precautions

Consult your doctor before starting treatment with 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 at any time you have these thoughts, 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 and 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 injury 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 taking 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 in children under 2 years of age with epilepsy characterized by the occurrence of partial-onset seizures or in children under 4 years of age with primary generalized tonic-clonic seizures. This is because it is not yet known whether it is effective and 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.

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 may increase the “PR interval” in a heart test (ECG or electrocardiogram) such as epilepsy or pain medicines called carbamazepine, lamotrigine or pregabalin.
• medicines used to treat certain types of irregular heartbeat or heart failure.

If any of the above applies to you (or you are not sure) talk to your doctor or pharmacist before taking Vimpat.

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

• medicines for fungal infections 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 applies to you (or you are not sure) talk to your doctor or pharmacist before taking Vimpat.

Taking Vimpat with alcohol

As a precaution, do not take Vimpat with alcohol.

Pregnancy and breastfeeding

Women of childbearing potential should discuss the use of contraceptives 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.

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

Breastfeeding is not recommended 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 first talking to your doctor, as this may increase seizures. Worsening of your disease may also harm the fetus.

Driving and using machines

Do not drive, cycle or use any tools or machines until you know whether this medicine affects you. The reason is that Vimpat may cause dizziness or blurred vision.

3. How to take Vimpat

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. Another form of this medicine may be more suitable for children; consult your doctor or pharmacist.

Taking Vimpat

• Take Vimpat twice a day, with an interval of approximately 12 hours.
• Try to take it at about the same time each day.
• Take the Vimpat tablet with a glass of water.
• You can take Vimpat with or without food.

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

How much to take

The following are the usual 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 alone:

The usual starting dose is 50 mg twice a day.

Your doctor may also prescribe a starting 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 taking 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 start treatment with Vimpat with a single “loading dose” of 200 mg. You will then start taking the continuous 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 solution and only changed to tablets if the patient is able to take them and get the correct dose with tablets of different strengths. Your doctor will prescribe the formulation that best suits you.

If you take more Vimpat than you should

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

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

If you forget to take Vimpat

• If you have forgotten to take a dose within 6 hours of the scheduled dose, take it as soon as you remember.
• If you have forgotten to take a dose after 6 hours of the scheduled dose, do not take the missed dose. Instead, take Vimpat the next time you would normally take it.
• Do not take a double dose to make up for forgotten doses.

If you stop taking Vimpat

• Do not stop taking Vimpat without telling your doctor, as your epilepsy may come back or get worse.
• If your doctor decides to stop your treatment with Vimpat, they will give you instructions on how to gradually decrease the dose.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Side effects on the nervous system, such as dizziness, may be greater after a single “loading dose”.

Tell your doctor or pharmacist if you get any of the following side 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, shock-like jerks of a muscle or a group of muscles (myoclonic seizures);

• difficulty in coordinating movements or walking;
• problems with balance, shakiness (tremor), tingling (paresthesia) or muscle spasms, easy falling and bruising;
• memory problems, difficulty thinking or finding words, confusion;
• rapid, uncontrolled movements of the eyes (nystagmus), blurred vision;
• feeling dizzy (vertigo), feeling drunk;
• being sick (vomiting), dry mouth, constipation, indigestion, excessive gas in the stomach or intestines, diarrhea;
• decreased sensitivity, difficulty speaking, attention problems;
• ringing in the ears like buzzing, ringing or whistling;
• irritability, sleep problems, depression;
• sleepiness, tiredness or weakness (asthenia);
• itching, rash.

Uncommon:may affect up to 1 in 100 people

• slow heart rate, palpitations, irregular heartbeat or other changes in the electrical activity of the heart (conduction disorder);
• feeling extremely happy, 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: tell your doctor immediately;
• feeling angry or agitated;
• abnormal thoughts 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, high temperature and infections more often than usual. Blood tests may show a severe decrease in a specific class of white blood cells (agranulocytosis);
• severe skin reaction, which may include high temperature and other flu-like symptoms, rash on the face, widespread rash with swollen lymph nodes (lymph nodes enlarged); blood tests may show increased liver enzyme levels and an increase in a type of white blood cell (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 side effects in children

Additional side effects seen in children were fever (pyrexia), runny nose (nasopharyngitis), sore throat (pharyngitis), decreased appetite, behavioral changes, not acting as they normally do (abnormal behavior) and lack of energy (lethargy). Sleepiness (somnolence) is a very common side effect in children and may affect more than 1 in 10 children.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side 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 blister after EXP. The expiry date refers to the last day of that month.

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 no longer required. These measures will help protect the environment.

6. Packaging Contents and Additional Information

Vimpat Composition

• The active ingredient 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, anhydrous colloidal silica, crospovidone (Poliplasdone XL-10 pharmaceutical grade), magnesium stearate.

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

• The colorants are:

50 mg tablets: red iron oxide (E172), black iron oxide (E172), aluminum lake indigo carmine (E132).

100 mg tablets: yellow iron oxide (E172).

150 mg tablets: yellow iron oxide (E172), red iron oxide (E172), black iron oxide (E172).

200 mg tablets: aluminum lake indigo carmine (E132).

Product Appearance and Packaging Contents

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

Vimpat is available in packs of 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, and Vimpat 150 mg and Vimpat 200 mg are available in multiple packs containing 3 boxes of 56 tablets. The packs of 14 x 1 and 56 x 1 film-coated tablets are available in pre-cut, single-dose PVC/PVDC blisters sealed with an aluminum foil, the packs of 14, 28, 56 and 168 are available in standard PVC/PVDC blisters sealed with an aluminum foil, the packs of 60 are available in HDPE bottles with a child-resistant closure. Not all 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 further information about this medicinal product, please contact the local representative of the marketing authorization holder:

Date of Last Revision of this Leaflet:{month/YYYY}.

Other Sources of Information

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