Vilepsia 100 mg film-coated tablets EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Vilepsia 50mg film-coated tablets EFG

Vilepsia 100mg film-coated tablets EFG

Vilepsia 150mg film-coated tablets EFG

Vilepsia 200mg film-coated tablets EFG

lacosamide

Read the 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 other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any side effects, talk to your doctor or pharmacist, even if the side effects are not listed in this leaflet. See section 4.

Leaflet Contents

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

1. What Vilepsia is and what it is used for

What Vilepsia is

Vilepsia 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 experience.

What Vilepsia is used for

• Lacosamide is used:

• as monotherapy and in combination with other antiepileptic drugs in adults, adolescents, and children from 2 years of age for the treatment of a certain type of epilepsy characterized by partial-onset seizures with or without secondary generalization. In this type of epilepsy, seizures originate in 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 for the treatment of 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 take Vilepsia

Do not take Vilepsia

• 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 known as second- or third-degree AV block.

Do not take lacosamide if either 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 lacosamide 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 have these types of thoughts, contact your doctor immediately.
• you have a heart condition affecting your heartbeat, and your pulse is often 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.
• you frequently feel dizzy or fall. Lacosamide 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 you are unsure), consult your doctor or pharmacist before taking lacosamide.

If you are taking lacosamide, consult your doctor if you experience a new type of seizure or worsening of existing seizures.

If you are taking lacosamide 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

Lacosamide is not recommended in children under 2 years of age with epilepsy characterized by partial-onset seizures, or in children under 4 years of age with generalized tonic-clonic seizures. This is because it is still unknown whether it is effective and safe in children of this age group.

Other medicines and Vilepsia

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 lacosamide 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 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 apply to you (or if you are unsure), speak with your doctor or pharmacist before taking lacosamide.

Also inform your doctor or pharmacist if you are taking any of the following medicines, as they may increase or decrease the effect of lacosamide 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 remedy 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 lacosamide.

Taking Vilepsia with alcohol

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

Lacosamide is not recommended if you are pregnant, as the effects of lacosamide on pregnancy and the fetus are unknown.

Breastfeeding is not recommended while taking lacosamide, as lacosamide passes into breast milk.

Seek immediate advice from your doctor if you are pregnant or plan to become pregnant. They will help you decide whether or not you should take lacosamide.

Do not stop treatment without first talking to your doctor, as this could increase seizures (episodes). Worsening of your condition may also harm the fetus.

Driving and operating machinery

You should not drive, ride a bicycle, or operate any tools or machinery until you know whether this medicine affects you. The reason is that lacosamide may cause dizziness or blurred vision.

3. How to take Vilepsia

Follow exactly the instructions for using this medicine given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Other presentations of this medicine may be more suitable for children; consult your doctor or pharmacist.

Taking Vilepsia

• Take lacosamide twice daily, approximately 12 hours apart.
• Try to take it at about the same times each day.
• Swallow the lacosamide tablet with a glass of water.
• You may take lacosamide with food or separately.

Normally, you will start with a low daily dose, and your doctor will gradually increase the dose over several weeks. Once you reach the dose that works well for you, called the "maintenance dose," you will continue taking the same amount each day. Lacosamide is used as a long-term treatment. You should keep taking lacosamide until your doctor tells you to stop.

How much to take

The following are the recommended normal doses of lacosamide for different age and weight groups. Your doctor may prescribe you a different dose if you have kidney or liver problems.

Adolescents and children weighing 50 kg or more and adults When taking lacosamida alone:

The usual starting dose is 50 mg twice a day.

Your doctor may also prescribe a starting dose of 100 mg of lacosamida twice a day.

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 a day.

When taking lacosamida with other antiepileptic medicines: The usual starting dose is 50 mg twice a day.

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 a day.

If you weigh 50 kg or more, your doctor may start lacosamida 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 lacosamide is not recommended for children below 2 years of age.
• In the treatment of primary generalized tonic-clonic seizures: note that

lacosamide is not recommended for children below 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 the correct dose can be achieved using tablets of different strengths. Your doctor will prescribe the pharmaceutical form best suited to the patient.

If you take more Vilepsia than you should

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

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

In case of overdose or accidental ingestion, consult your doctor or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Vilepsia

• 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 lacosamide at your next regularly scheduled time.
• Do not take a double dose to make up for a missed dose.

If you interrupt treatment with Vilepsia

• Do not stop taking lacosamide without informing your doctor, as epilepsy may recur or worsen.
• If your doctor decides to discontinue your lacosamide treatment, they will provide 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.

Adverse effects on the nervous system, 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 people

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

Common: may affect up to 1 in 10 people

• 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, thinking difficulties or trouble finding words, confusion;
• Rapid, uncontrolled eye movements (nystagmus), blurred vision;
• Feeling of dizziness (vertigo), sensation of drunkenness;
• Feeling dizzy (vomiting), dry mouth, constipation, indigestion, excessive gas in the stomach or intestines, diarrhoea;
• Decreased sensation, difficulty speaking, attention disturbance;
• Ringing in the ear 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 people

• Decreased heart rate, palpitations, irregular pulse, or other changes in the heart's electrical activity (conduction disorder);
• 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 suicide attempt: 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 getting infections more often than usual. 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, rash on the face, 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 skin peeling, 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). Feeling sleepy (drowsiness) 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 type of 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 via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Vilepsia

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the carton and blister pack after EXP. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point in your pharmacy. If you are unsure, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Vilepsia

The active substance is lacosamide.

• Each Vilepsia 50 mg tablet contains 50 mg of lacosamide.
• Each Vilepsia 100 mg tablet contains 100 mg of lacosamide.
• Each Vilepsia 150 mg tablet contains 150 mg of lacosamide.
• Each Vilepsia 200 mg tablet contains 200 mg of lacosamide.

The other components are:

• Tablet core: microcrystalline cellulose, hydroxypropylcellulose, crospovidone, low-substituted hydroxypropylcellulose, colloidal anhydrous silica, and magnesium stearate.

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

• The colourants are:

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

Vilepsia 100 mg tablets: iron oxide yellow (E172) and iron oxide black (E172).

Vilepsia 150 mg tablets: iron oxide yellow (E172), iron oxide red (E172), iron oxide black (E172), and indigo carmine aluminium lake (E132).

Vilepsia 200 mg tablets: indigo carmine aluminium lake (E132).

Appearance of the product and pack contents

• Vilepsia 50 mg are biconvex, oblong, film-coated tablets, pink in colour, marked with “50” on one side.
• Vilepsia 100 mg are biconvex, oblong, film-coated tablets, dark yellow in colour, marked with “100” on one side.
• Vilepsia 150 mg are biconvex, oblong, film-coated tablets, beige in colour, marked with “150” on one side.
• Vilepsia 200 mg are biconvex, oblong, film-coated tablets, blue in colour, marked with “200” on one side.

Vilepsia 50 mg is available in packs of 14 film-coated tablets.

Vilepsia 100 mg, Vilepsia 150 mg, and Vilepsia 200 mg are available in packs of 56 film-coated tablets.

The blisters are made of transparent PVC/PVDC sealed with an aluminium foil.

Marketing Authorisation Holder

Kern Pharma, S.L.

Venus, 72 – Pol. Ind. Colón II

08228 Terrassa – Barcelona

Spain

Manufacturer

Genepharm S.A.

18th km Marathonos Ave,

153 51 Pallini Attiki

Greece

Date of the most recent revision of this leaflet: March 2025

Detailed information on this medicine is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/.