Leaflet: information for the patient

Vilepsia 50mg film-coated tablets

Vilepsia 100mg film-coated tablets

Vilepsia 150mg film-coated tablets

Vilepsia 200mg film-coated tablets

lacosamida

Read 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. 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.

1. What is Vilepsia and what it is used for

2. What you need to know before starting Vilepsia

3. How to take Vilepsia

4. Possible side effects

5. Storage of Vilepsia

6. Contents of the pack and additional information

What isVilepsia

Vilepsiacontains 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 Vilepsia used forVilepsia

• Lacosamideis 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 takeVilepsia

• if you are allergic to lacosamide or any of the other components of this medication (listed in section 6). If you are unsure if you are allergic, consult your doctor.
• if you have a heart rhythm problem called second- or third-degree AV block.

Do not take lacosamide if any of the above applies to you. If you are unsure, consult your doctor or pharmacist before taking this medication.

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 medications such as lacosamide have had thoughts of self-harm or suicide. If you ever have these thoughts, contact your doctor immediately.
• you have a heart condition that affects heart rhythm and your pulse is often abnormally slow, fast, or irregular (such as AV block, atrial fibrillation, and atrial flutter).
• you have a serious heart condition such as heart failure or have had a heart attack.
• you often feel dizzy or fall. Lacosamide 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 medication.

If any of the above applies 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 heart rhythm (such as slow, fast, or irregular heartbeat, palpitations, shortness of breath, dizziness, or fainting), consult your doctor immediately (see section 4).

Children

Lacosamide is not recommended for children under 2 years with epilepsy characterized by partial seizure onset 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 medications and Vilepsia

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

Particularly, inform your doctor or pharmacist if you are taking any of the following medications that affect the heart, as lacosamide may also affect the heart:

• medications to treat heart problems.
• medications that may increase the "PR interval" in a heart test (ECG or electrocardiogram) such as epilepsy or pain medications called carbamazepine, lamotrigine, or pregabalin.
• medications 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 lacosamide.

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

• antifungal medications such as fluconazole, itraconazole, or ketoconazole.
• medications for HIV such as ritonavir.
• antibacterial medications 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 lacosamide.

Taking Vilepsia with alcohol

As a precaution, do not take lacosamide 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 medication.

It is not recommended to take lacosamide if you are pregnant, as the effects of lacosamide on pregnancy and the fetus are not known.

It is not recommended to breastfeed 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 if you should take lacosamide or not.

Do not stop treatment without first speaking with 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, ride a bike, or use any tools or machines until you know if this medication affects you. The reason is that lacosamide 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 presentations of this medication may be more suitable for children; consult your doctor or pharmacist.

TakingVilepsia

• Takelacosamidatwice a day, with an interval of approximately 12 hours.
• Try to take it more or less at the same time each day.
• Take thelacosamidatablet with a glass of water.
• You can takelacosamidawith 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.Lacosamidais used as long-term treatment. You will need to continue takinglacosamidauntil your doctor tells you to stop.

How much to take

The following are the normal recommended doses oflacosamidafor 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 takinglacosamidaalone:

The usual starting dose is 50 mg twice a day.

Your doctor may also prescribe a starting dose of 100 mg oflacosamidatwice 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 takinglacosamidawith 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 seizures:note thatlacosamidais not recommended for children under 2 years old.
• In the treatment of primary generalized tonic-clonic seizures:note thatlacosamidais 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 get the correct dose with tablets of different concentrations. Your doctor will prescribe the pharmaceutical form that best suits you.

If you take moreVilepsiathan you should

If you have taken morelacosamidathan 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.

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

If you forget to takeVilepsia

• 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 takelacosamidaat the next time you normally take it.
• Do not take a double dose to compensate for the missed doses.

If you interrupt treatment withVilepsia

• Do not stop takinglacosamidawithout telling your doctor, as epilepsy may recur or worsen.
• If your doctor decides to stop your treatment withlacosamida, they will give you instructions on how to gradually reduce the dose.

If you have any other questions 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 people

• Headache;
• Feeling dizzy or nauseous;
• Diplopia (double vision).

Common:may affect up to 1 in 10 people

• Brief muscle or muscle group 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, uncontrolled eye movements (nystagmus), blurred vision;
• Sensation of dizziness (vertigo), feeling drunk;
• Feeling dizzy (vomiting), dry mouth, constipation, indigestion, excessive gas in the stomach or intestines, diarrhea;
• Decreased sensitivity, difficulty articulating words, altered attention;
• Ringing in the ears like buzzing, ringing or hissing;
• Irritability, difficulty sleeping, depression;
• Drowsiness, fatigue or weakness (asthenia);
• Itching, rash.

Uncommon:may affect up to 1 in 100 people

• 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 taking 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, 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 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, 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 with 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 the Spanish System for Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es. 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. 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. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Vilepsia

The active ingredient 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:

• Core of the tablet: microcrystalline cellulose, hydroxypropyl cellulose, crospovidone, hydroxypropyl cellulose (partially substituted), anhydrous colloidal silica, and magnesium stearate.
• Covering: polyvinyl alcohol, titanium dioxide (E171), macrogol, talc, and colorants*.

*The colorants are:

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

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

Appearance of the product and contents of the package

• Vilepsia 50 mg are biconvex, oblong-shaped tablets with a pink film coating and marked with “50” on one face.
• Vilepsia 100 mg are biconvex, oblong-shaped tablets with a dark yellow film coating and marked with “100” on one face.
• Vilepsia 150 mg are biconvex, oblong-shaped tablets with a beige film coating and marked with “150” on one face.
• Vilepsia 200 mg are biconvex, oblong-shaped tablets with a blue film coating and marked with “200” on one face.

Vilepsia 50 mg is available in blister packs of 14 tablets with a film coating.

Vilepsia 100 mg, Vilepsia 150 mg, and Vilepsia 200 mg are available in blister packs of 56 tablets with a film coating.

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

Marketing authorization holder

Kern Pharma, S.L.

Venus, 72 – Pol. Ind. Colón II

08228 Terrassa – Barcelona

Spain

Responsible for manufacturing

Genepharm S.A.

18th km Marathonos Ave,

153 51 Pallini Attiki

Greece

Last review date of this leaflet:March 2025

For detailed information about this medicine, please visit the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/.