NEXILINA 50 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Nexilina 50 mg Film-Coated Tablets EFG

Lacosamide

Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you.

• - Keep this package leaflet, as you may need to read it again.

• - If you have any doubts, consult your doctor or pharmacist.

• - This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.

• - If you experience side effects, consult your doctor or pharmacist, even if they are side effects not listed in this package leaflet. See section 4.

Contents of the Package Leaflet:

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

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

• 5. Storage of Nexilina
• 6. Package Contents and Additional Information

1. What is Nexilina and what is it used for

What is Nexilina

This medication 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 Nexilina is used for

Nexilina is used:

• alone and with other antiepileptics in adults, adolescents, and children from 2 years of age to treat a certain type of epilepsy characterized by the onset of partial seizures with or without secondary generalization. In this type of epilepsy, seizures affect only one side of the brain. However, they can then spread to larger areas on both sides of the brain;
• with other antiepileptics in adults, adolescents, and children from 4 years of age 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).

2. What you need to know before taking Nexilina

Do not take Nexilina

• if you are allergic to lacosamide or any of the other components of this medication

(including those listed in section 6). If you are unsure, consult your doctor.

• if you have a heart rhythm problem called second- or third-degree AV block.

Do not take this medication 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 this medication 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 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.

If any of the above applies to you (or you are unsure), consult your doctor or pharmacist before taking this medication.

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

• medications for fungal infections such as fluconazole, itraconazole, or ketoconazole.

• medications for HIV such as ritonavir.
• medications 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 applies to you (or you are unsure), consult your doctor or pharmacist before taking Nexilina.

Taking Nexilina with alcohol

As a precaution, do not take this medication 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.

Lacosamide is not recommended if you are pregnant, 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 seizures (epilepsy). Worsening of your condition may also harm the fetus.

Driving and using machines

You should not drive, ride a bicycle, or use any tools or machines until you know if this

medication affects you. The reason is that lacosamide can cause dizziness or blurred vision.

3. How to take Nexilina

Follow the administration instructions for this medication exactly as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again. Another form of this medication 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 food or on an empty stomach.

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 more and 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 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 lacosamide treatment with a single "loading dose" of 200 mg. Then, you would 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 get 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 heart rate and sweating.

If you forget to take Nexilina

• 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 after 6 hours of 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 recur or worsen.
• If your doctor decides to stop your treatment with lacosamide, they will give you instructions on how to gradually decrease the dose.

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

4. Possible side effects

Like all medications, lacosamide can cause side effects, although not everyone gets them.

Side 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 patients

• headache;
• feeling dizzy or sick (nausea);
• double vision (diplopia).

Common: may affect up to 1 in 10 patients

• brief muscle jerks or muscle group jerks (myoclonic seizures);
• difficulty coordinating movements or walking;

• problems 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), having a dry mouth, constipation, indigestion, excessive gas in the

stomach or intestines, diarrhea;

• decreased sensitivity, difficulty articulating words, attention disturbance;
• ringing in the ear like a buzzing, whistling, or hissing;
• 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 taking the medication, hives;
• blood tests may show abnormalities in liver function tests, liver damage;

If you experience any of the above, consult your doctor or pharmacist.

• thoughts of self-harm or suicide or attempted suicide: inform your doctor immediately;

Also, inform your doctor or pharmacist if you experience any of the following effects:

• 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).

Frequency not known: cannot be estimated from available data

• abnormally fast heart rhythm (ventricular tachyarrhythmia);
• sore throat, elevated temperature, and frequent infections. Blood tests may show a severe

decrease in a specific class of white blood cells (agranulocytosis);

• severe skin reaction, which may include elevated temperature and other flu-like symptoms,

rash on the face, generalized rash with swollen lymph nodes (lymphadenopathy). Blood tests may show elevated 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 on more than 30% of the body surface (toxic epidermal necrolysis):

• seizures.

Other side effects in children

Additional side effects observed in children were fever (pyrexia), runny nose (nasopharyngitis), sore throat (pharyngitis), decreased appetite, behavioral changes, 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 side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are possible side effects not listed in this package leaflet. You can also report side effects directly through the Spanish Medicines Monitoring System website: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Nexilina

Keep this medication out of sight and reach of children.

Do not use this medication after the expiration date shown on the box and blister 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 via wastewater or household waste. Deposit the packaging and any unused medication in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.

6. Package Contents and Additional Information

Nexilina Composition

The active ingredient is lacosamide.

Each Nexilina 50 mg tablet contains 50 mg of lacosamide.

The other ingredients are:

Tablet core: microcrystalline cellulose, hydroxypropylcellulose, hydroxypropylcellulose (low substituted), 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 Product and Package Contents

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

Nexilina 50 mg is available in blister packs of 14 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 the last revision of this package leaflet: July 2022

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