Product 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 this entire 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. Do not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

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).

Do not take Vimpat

• If you are allergic to lacosamide or any of the other ingredients in this medicine (listed in section 6). If you are not sure if 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 any of the above applies to you. If you are unsure, consult your doctor or pharmacist before taking 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 like 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 your heartbeat and your pulse is often very slow, fast, or irregular (such as AV block, atrial fibrillation, and 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 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 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 or for children under 4 years with 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 taking, have taken recently, or may need to take any other medicine.

In particular, inform your doctor or pharmacist if you are taking any of the following heart medicines, 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, or 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 taking 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, or ketoconazole.
• Medicines for HIV such as ritonavir.
• Medicines for bacterial infections such as clarithromycin or 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 taking Vimpat.

Vimpat and alcohol

As a precaution, do not take 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.

Do not take Vimpat if you are pregnant, as the effects of Vimpat on pregnancy and the fetus are not known.

Do not breastfeed a baby while taking Vimpat, 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 machinery

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

Follow exactly the administration instructions of this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again. Other forms of this medication may be more suitable for children; consult your doctor or pharmacist.

Vimpat Dosage

• Take Vimpat twice a day, with an interval of approximately 12 hours.
• Try to take it more or less at the same time each day.
• Take the Vimpat tablet with a glass of water.
• You can take Vimpat with meals or separately.

Normally, you will start 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 should continue taking Vimpat until your doctor tells you to stop.

How much to take

The following are the normal 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 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 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 start treatment with a single "loading" dose of 200 mg. Then you will start taking the continuous 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 old.

- In the treatment of primary generalized tonic-clonic seizures:Vimpat is not recommended for children under 4 years old.

The dose depends on body weight. Treatment usually starts with the syrup and only changes to tablets if the patient is able to take them and obtain the correct dose with tablets of different concentrations. Your doctor will prescribe the pharmaceutical form that best suits you.

If you take more Vimpat than you should

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

• dizziness;
• sensation of dizziness (nausea) or dizziness (vomiting);
• seizures (crises), heart problems such as slow, fast, or irregular heartbeat, coma, or low blood pressure with tachycardia 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 more than 6 hours after the scheduled dose, do not take the missed dose, instead, take Vimpat at the next time you normally take it.
• Do not take a double dose to compensate for the missed doses.

If you interrupt treatment with Vimpat

• Do not stop taking Vimpat without telling your doctor, as epilepsy may recur or worsen.
• If your doctor decides to stop your treatment with Vimpat, they will give you instructions on how to gradually reduce the dose.

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

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

• Short muscle or group of muscles spasms (myoclonic crisis);

• Difficulty coordinating movements or walking;
• Problems maintaining balance, agitation (tremor), paresthesia (tingling) or muscle spasms, easy to fall and bruise;
• Memory problems, thinking or finding words, confusion;
• Rapid and uncontrolled 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 alteration;
• Ringing in the ears like buzzing, beeping or whistling;
• Irritability, sleep problems, 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 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, which cause swelling of the face, throat, hands, feet, ankles or lower legs;
• Loss of consciousness;
• Abnormal involuntary movements (dyskinesia).

Frequency not known:cannot be estimated from available data

• Abnormally fast ventricular heart rate (ventricular tachyarrhythmia);
• Sore throat, elevated temperature and presenting infections more frequently than normal. 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 pseudogripal symptoms, facial rash, generalized rash with lymph node inflammation (enlarged lymph nodes). Blood tests may show increased levels of liver enzymes and an increase in 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 in children

The additional side effects observed in children were fever (pyrexia), nasal congestion (nasopharyngitis), sore throat (pharyngitis), eating less than usual (decreased appetite), changes in behavior, not acting as they normally do (abnormal behavior) and lack of energy (lethargy). Drowsiness 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 thenational notification system included in theAppendix V. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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 on the blister pack after CAD/EXP. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medications should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the containers and medications that you no longer need. By doing so, you will help protect the environment.

Composition of Vimpat

• 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:

Core tablet:microcrystalline cellulose, hydroxypropyl cellulose, hydroxypropyl cellulose (low-substituted), anhydrous colloidal silica, crospovidone (poliplasdona XL-10 pharmaceutical grade), magnesium stearate.

Covering:vinyl alcohol polymer, macrogol, talc, titanium dioxide (E171), colorants*

* The colorants are:

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

Appearance of the product and contents of the package

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

Vimpat is available in packages 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 packages of 168 film-coated tablets, and Vimpat 150 mg and Vimpat 200 mg are available in multi-pack containers containing 3 packs of 56 film-coated tablets. The 14 x 1 and 56 x 1 film-coated tablets are available in pre-cut, single-dose PVC/PVDC blisters sealed with an aluminium foil, the 14, 28, 56, and 168 are available in standard PVC/PVDC blisters sealed with an aluminium foil, the 60 are available in HDPE bottles with a child-resistant safety cap. Only some package sizes may be marketed.

Marketing authorization holder

UCB Pharma S.A., Allée de la Recherche 60, B-1070 Bruxelles, 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:

Last review date of this leaflet:{month/YYYY}.

Other sources of information

Further information on this medicine is available on the website of the European Medicines Agency:http://www.ema.europa.eu/.