NEXILINA 150 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Nexilina 150 mg Film-Coated Tablets EFG

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 experience 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 and other information:

• 1. What Nexilina is and what it is used for
• 2. What you need to know before you take Nexilina

• 3. How to take Nexilina
• 4. Possible side effects

• 5. Storage of Nexilina
• 6. Contents of the pack and other information

1. What Nexilina is and what it is used for

What Nexilina is

This medicine 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 Nexilina is used for

Nexilina 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 (grand mal 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 you take Nexilina

Do not take Nexilina

• 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 AV block.

Do not take this medicine 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 to use this medicine if:

• you have thoughts of self-harm or suicide. A small number of people being treated

with antiepileptics such as lacosamide have had thoughts of self-harm or suicide. If

at any time you have these kinds of 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.

Si alguno de los anteriores es aplicable en su caso (o no está seguro) hable con su médico o farmacéutico antes de tomar este medicamento.

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

• you often feel dizzy or faint. Lacosamide 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 this medicine.

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

If you are taking Nexilina 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

Lacosamide 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 if it is effective and safe for children of this age group.

Other medicines and Nexilina

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 lacosamide 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.

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

• medicines used to treat certain types of arrhythmia or heart failure.

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

Tell your doctor or pharmacist if you are taking any of the following medicines, as they may also increase or decrease the effect of lacosamide 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 Nexilina.

Taking Nexilina with alcohol

As a precaution, do not take this medicine 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 are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

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

It is not recommended to breastfeed while taking Nexilina, as lacosamide 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 lacosamide or not.

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

Driving and using machines

Do not drive, ride a bike, or use any tools or machines until you know if this medicine affects you. The reason is that lacosamide may cause dizziness or blurred vision.

This medicine may cause allergic reactions because it contains Orange Yellow S (E110). It may cause asthma, especially in patients allergic to acetylsalicylic acid.

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3. How to take Nexilina

Follow exactly the administration instructions of this medicine given by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again. Another form of this medicine may be more suitable for children; consult your doctor or pharmacist.

Taking Nexilina

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

Normally, you will start by taking a low dose every 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 every day. Lacosamide is used as long-term treatment. You will need to continue taking lacosamide until your doctor tells you to stop.

How much to take

The following are the usual recommended doses of lacosamide 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 moreand adults

When taking Nexilina alone:

The usual starting dose is 50 mg twice a day.

Your doctor may also prescribe a starting dose of 100 mg of lacosamide 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 Nexilina 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 lacosamide treatment 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 lacosamide is not recommended for children under 2 years of age.
• In the treatment of primary generalized tonic-clonic seizures: note that lacosamide 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 to obtain the correct dose with tablets of different concentrations. Your doctor will prescribe the pharmaceutical form that best suits you.

If you take more Nexilina 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 sick (nausea) or being sick (vomiting);
• seizures (epilepsy), heart rhythm problems such as slow, fast, or irregular pulse, coma, or low blood pressure with rapid heartbeat and sweating.

If you forget to take Nexilina

• If you have forgotten to take a dose within the next 6 hours after the scheduled dose, take it as soon as you remember.

If you have forgotten to take a dose after the next 6 hours after the scheduled dose, do not take the missed dose. Instead, take lacosamide the next time you normally would.

• Do not take a double dose to make up for missed doses.

If you stop taking Nexilina

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

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

4. Possible side effects

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

Side effects in 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

• short, sudden muscle jerks or muscle groups (myoclonic seizures);
• difficulty coordinating movements or walking;

• difficulty keeping balance,

shaking (tremor), tingling (paresthesia), or muscle spasms, falling easily, and bruising;

• memory problems, thinking, or finding words, confusion;
• rapid, uncontrolled eye movements (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 articulating words, attention disorder;
• ringing in the ears like buzzing, whistling, or hissing;
• irritability, sleep problems, 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 heart activity (conduction disorder);

a feeling of extreme 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: 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).

Rare: may affect up to 1 in 1,000 people

• abnormally fast heart rhythm (ventricular tachyarrhythmia);
• sore throat, high temperature, and getting infections more often than normal. Blood tests may show a serious decrease in a specific type of white blood cell (agranulocytosis);

severe skin reaction, which may include high temperature and other flu-like symptoms, rash on the face, generalized rash with swollen lymph nodes (lymphadenopathy). 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 that causes 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). Drowsiness (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 Spanish Pharmacovigilance System for Human Use website: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Nexilina

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 the month shown.

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. Contents of the pack and other information

Composition of Nexilina

The active substance is lacosamide.

Each Nexilina 150 mg tablet contains 150 mg of lacosamide.

The other ingredients are:

Core of the tablet: microcrystalline cellulose, hydroxypropylcellulose, low-substituted hydroxypropylcellulose, anhydrous colloidal silica, crospovidone, magnesium stearate.

Coating: poly(vinyl alcohol), macrogol, talc, titanium dioxide (E171), yellow iron oxide (E172), and Orange Yellow S (E110).

Appearance of the product and contents of the pack

Nexilina 150 mg are film-coated, oval, orange tablets, marked with "150" on one side and smooth on the other side. Approximate dimensions: 6.6 x 14.0 mm.

Nexilina 150 mg is available in blister packs of 56 film-coated tablets.

Marketing authorization holder and

Adventia Pharma, S.L.

Calle Viera y Clavijo, 30, 2º

35002 Las Palmas de Gran Canaria (Spain)

Local representative

Atika Pharma, S.L.

Calle Viera y Clavijo, 30, 2º

35002 Las Palmas de Gran Canaria (Spain)

Manufacturer

Merckle GmbH,

Blaubeuren,

Germany

Or

TEVA Gyógyszergyár Zrt.,

Pallagi út 13

H-4042, Debrecen

Hungary

Date of last revision of this leaflet:July 2022

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