Nexilina 50 mg film-coated tablets EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Nexilina 50 mg film-coated tablets EFG

Lacosamide

Read the entire leaflet carefully before you start taking this medicine, as 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 and must not be given to other people, even if they have the same symptoms as you, because it may harm them.
• • If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents :

• 1. What Nexilina is and what it is used for
• 2. What you need to know before taking Nexilina
• 3. How to take Nexilina
• 4. Possible side effects
• 5. How to store 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.

This medicine has been prescribed for you to reduce the number of seizures you experience.

What Nexilina is used for

Nexilina is used:

• as monotherapy and in combination with other antiepileptic medicines 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 affect 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 medicines 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 taking Nexilina

Do not take Nexilina

• 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 called second- or third-degree AV block.

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

Warnings and precautions

Talk to 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 antiepileptic medicines such as lacosamide have had thoughts of self-harm or suicide. If

you experience such thoughts at any time, contact your doctor immediately.

• you have a heart condition affecting your heartbeat and your pulse is often

especially 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 (heart attack).

• you feel dizzy or fall frequently. 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 if you are unsure), 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 a worsening of existing seizures.

If you are taking Nexilina and experience symptoms of abnormal heartbeat (such as slow, fast, or irregular heartbeat, palpitations, dyspnea (difficulty breathing), dizziness, or fainting), consult your doctor immediately (see section 4).

Children

Lacosamide is not recommended for children under 2 years of age with epilepsy characterized by partial-onset seizures, or for children under 4 years of age with generalized tonic-clonic seizures. This is because it is not yet known whether it is effective and safe in children of these age groups.

Other medicines and Nexilina

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 medicines for epilepsy or pain 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 this medicine.

Also inform 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.

• 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 Nexilina.

Taking Nexilina with alcohol

As a precaution, do not take this medicine 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 during pregnancy, as the effects of this medicine on pregnancy and the fetus are not known.

Breastfeeding is not recommended while taking Nexilina, because lacosamide passes into breast milk. Seek immediate advice from your doctor if you are pregnant or planning to become pregnant. They will help you decide whether or not to take lacosamide.

Do not stop treatment without first talking to your doctor, as this could increase

seizures. Worsening of your condition may also harm the fetus.

Driving and using machines

You should not drive, ride a bicycle, or operate any tools or machinery until you know how this

medicine affects you. The reason is that lacosamide may cause dizziness or blurred vision.

3. How to take Nexilina

Follow exactly the instructions for using this medicine given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again. Another form(s) of this medicine may be more suitable for children; consult your doctor or pharmacist.

Taking Nexilina

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

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 every day. Lacosamide is used as a long-term treatment. You should continue taking lacosamide until your doctor tells you to stop.

What dose to take

The following are the normal recommended 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 Nexilina alone:

The usual starting dose is 50 mg twice daily.

Your doctor may also prescribe a starting dose of 100 mg of lacosamide twice daily. 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 daily.

When taking Nexilina with other antiepileptic medicines:

The usual starting dose is 50 mg twice daily.

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 daily.

If you weigh 50 kg or more, your doctor may start lacosamide treatment with a single “loading dose” of 200 mg. You would 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 switched to tablets if the patient is able to swallow them and can achieve the correct dose using tablets of different strengths. Your doctor will prescribe the pharmaceutical form most suitable for you.

If you take more Nexilina than you should

If you have taken more lacosamide than you should, contact your doctor immediately. Do not attempt to drive.

You may experience:

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

If you forget to take Nexilina

• 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 the next scheduled time.

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

If you stop taking Nexilina

• Do not stop taking lacosamide without telling your doctor, as epilepsy may return or worsen.
• If your doctor decides to stop your treatment with lacosamide, you will be given 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, lacosamide may cause adverse effects, although not everyone experiences them.

Nervous system effects, 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 patients

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

Common: may affect up to 1 in 10 patients

• Brief jerks of a muscle or group of muscles (myoclonic seizures);

• Difficulty coordinating movements or walking;

• Problems maintaining balance, agitation (tremor), tingling (paraesthesia), or muscle spasms, falling easily and bruising;

• Memory problems, difficulty thinking or finding words, confusion;

• Rapid, uncontrolled eye movements (nystagmus), blurred vision;

• Feeling dizzy (vertigo), sensation of drunkenness;

• Feeling dizzy (vomiting), dry mouth, constipation, indigestion, excessive gas in the stomach or intestine, diarrhoea;

• Decreased sensitivity, difficulty articulating words, attention disturbance;

• Ringing in the ear such as buzzing, ringing, or whistling;

• Irritability, sleep problems, depression;

• Drowsiness, tiredness or weakness (asthenia);

• Itching, rash.

Uncommon: may affect up to 1 in 100 patients

• 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 taking 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 normal. 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 levels of liver enzymes and an increase in a type of white blood cells (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 peeling of the skin 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), changes in behaviour, 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, consult 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 website: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Nexilina

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiry date stated on the carton and blister after CAD/EXP. The expiry date is 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 packaging at a SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Nexilina

The active substance is lacosamide.

Each Nexilina 50 mg tablet contains 50 mg of lacosamide.

The other components are:

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

Coating: poly(vinyl alcohol), macrogol, talc, titanium dioxide (E171), red iron oxide (E172), black iron oxide (E172), and yellow iron oxide (E172).

Appearance of the medicinal product and contents of the pack

Nexilina 50 mg are pink, oval, film-coated tablets, marked with "50" on one side and plain on the other. Approximate dimensions: 4.3 x 9.7 mm.

Nexilina 50 mg is available in blister packs containing 14 film-coated tablets.

Marketing Authorization Holder

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 the most recent review 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/