Lacosamide Tarbis 200 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Lacosamida Tarbis 50 mg film-coated tablets EFG

Lacosamida Tarbis 100 mg film-coated tablets EFG

Lacosamida Tarbis 150 mg film-coated tablets EFG

Lacosamida Tarbis 200 mg film-coated tablets EFG

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 and must not be given to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse reactions, consult your doctor or pharmacist, even if these reactions are not listed in this leaflet. See section 4.

Leaflet contents

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

1. What Lacosamida Tarbis is and what it is used for

What is Lacosamida

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 experience.

What lacosamide is used for

Lacosamide is used:

• as monotherapy and in combination with other antiepileptic medicines to treat a certain type of epilepsy characterized by partial-onset seizures with or without secondary generalization in adults, adolescents, and children from 2 years of age. 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 to treat primary generalized tonic-clonic seizures (generalized seizures, with loss of consciousness) in adults, adolescents, and children from 4 years of age with idiopathic generalized epilepsy (a type of epilepsy believed to have a genetic origin).

2. What you need to know before taking Lacosamide Tarbis

Do not take Lacosamide

• 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, please consult your doctor.
• if you are allergic to peanuts or soya.
• 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 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 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 lacosamide, contact your doctor if you experience a new type of seizure or worsening of existing seizures.

If you are taking this medicine 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 for children under 24 years of age with epilepsy characterized by partial-onset seizures, and is not recommended for children under 4 years of age with primary generalized tonic-clonic seizures. This is because it is not yet known whether lacosamide is effective and safe in children in these age groups.

Other medicines and lacosamide

Tell 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" on a heart test (ECG or electrocardiogram), such as antiepileptic 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 this medicine.

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.
• HIV medicines such as ritonavir.
• antibacterial medicines 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 lacosamide with alcohol

As a precaution, do not take this medicine with alcohol.

Pregnancy and breastfeeding

Women of childbearing age should discuss contraception use 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, the fetus, or the newborn are not known. Breastfeeding is not recommended while taking lacosamide, as 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 you should 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 must not drive, ride a bicycle, or operate any tools or machinery until you know how this medicine affects you. This is because lacosamide may cause dizziness or blurred vision.

Lacosamide Tarbis contains soya lecithin.

If you are allergic to peanuts or soya, do not use this medicine.

3. How to take/use Lacosamida Tarbis

Follow exactly the administration instructions for this medicine given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again. There are other forms of this medicine that may be more suitable for children; please consult your doctor or pharmacist.

Taking Lacosamida

• Take lacosamida twice daily, approximately 12 hours apart.
• Try to take it at about the same time each day.
• Take the lacosamida tablet with a glass of water.
• You may take lacosamida 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, known as the “maintenance dose”, you will take the same amount every day. Lacosamida is used as a long-term treatment. You should continue taking lacosamida until your doctor tells you to stop.

What dose to take

Below are the recommended normal doses of lacosamida 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 lacosamida alone:

The usual starting dose is 50 mg twice daily.

Your doctor may also prescribe a starting dose of 100 mg of lacosamida 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 lacosamida 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 lacosamida treatment with a single "loading" dose of 200 mg. You would then start taking the regular maintenance dose 12 hours later.

Children and adolescents weighing less than 50 kg

• In the treatment of partial-onset seizures: the use of lacosamida is not recommended in children under 2 years of age.

• In the treatment of primary generalized tonic-clonic seizures: the use of lacosamida is not recommended in children under 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 can achieve the correct dose using tablets of different strengths. Your doctor will prescribe the pharmaceutical form best suited to you.

If you take more lacosamida than you should

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

You may experience:

• dizziness;
• feeling sick (nausea) or being sick (vomiting);
• seizures, 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, contact your doctor, pharmacist, or the Toxicology Information Service immediately at telephone number: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take lacosamida

• If you forget to take a dose within 6 hours of the scheduled time, take it as soon as you remember.
• If you forget to take a dose more than 6 hours after the scheduled time, do not take the missed dose; instead, take lacosamida at the next scheduled time.
• Do not take a double dose to make up for a missed dose.

If you stop taking lacosamida

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

Nervous system effects, such as dizziness, may be greater after a single "loading" dose.

Inform 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 with balance, tremor, tingling (paraesthesia), or muscle spasms, tendency to fall and bruise easily;
• Memory problems, difficulty thinking or finding words, confusion;
• Rapid and uncontrolled eye movements (nystagmus), blurred vision;
• Sensation of dizziness (vertigo), feeling of drunkenness;
• Feeling dizzy (vomiting), dry mouth, constipation, indigestion, excessive gas in the stomach or intestines, diarrhoea;
• Decreased sensitivity, difficulty articulating words, attention disturbance;
• Ringing in the ears 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 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 increased frequency of infections. 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, facial rash, widespread rash with swollen lymph nodes (enlarged lymph nodes). Blood tests may show increased liver enzymes and an increase in a type of white blood cells (eosinophilia);
• 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 skin peeling over more than 30% of the body surface (toxic epidermal necrolysis);
• Seizures.

Other adverse effects in children

Other adverse effects in children were fever (pyrexia), runny nose (nasopharyngitis), sore throat (pharyngitis), eating less than usual (decreased appetite), behavioral changes, not acting as they normally do (abnormal behavior), and lack of energy (lethargy). Feeling sleepy (somnolence) is a very common adverse effect in children and may affect more than 1 in every 10 children.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You may 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 Lacosamide Tarbis

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 after EXP/CAD. 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. Unused medicines and waste materials, including packaging, should be returned to the SIGRE point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Lacosamida Tarbis

The active substance is lacosamida.

Each film-coated tablet contains 50 mg, 100 mg, 150 mg or 200 mg of lacosamida.

The other components are:

Tablet core: microcrystalline cellulose (E460), hydroxypropylcellulose (E463), crospovidone (E1202), colloidal anhydrous silica, magnesium stearate.

Coating: polyvinyl alcohol (E1203), talc (E553b), titanium dioxide (E171), macrogol (E1521), lecithin (E322) and colourings*.

*The colourings are:

Lacosamida Tarbis 50 mg: iron oxide red (E172), iron oxide black (E172), indigo carmine aluminium lake (E132).

Lacosamida Tarbis 100 mg: iron oxide yellow (E172).

Lacosamida Tarbis 150 mg: iron oxide yellow (E172), iron oxide red (E172), iron oxide black (E172).

Lacosamida Tarbis 200 mg: indigo carmine aluminium lake (E132).

Transparent coating (all strengths):
hypromellose (E464), macrogol (E1521).

Presentation of the product and contents of the container

Lacosamida Tarbis 50 mg are film-coated tablets (approximately 10.4 mm x 4.8 mm) pink in colour, oval-shaped, biconvex, marked with 'J' on one side and '12' on the other.

Lacosamida Tarbis 100 mg are film-coated tablets (approximately 13.1 mm x 6.1 mm) yellow in colour, oval-shaped, biconvex, marked with 'J' on one side and '13' on the other.

Lacosamida Tarbis 150 mg are film-coated tablets (approximately 15.2 mm x 7.0 mm) salmon in colour, oval-shaped, biconvex, marked with 'J' on one side and '14' on the other.

Lacosamida Tarbis 200 mg are film-coated tablets (approximately 16.6 mm x 7.7 mm) blue in colour, oval-shaped, biconvex, marked with 'J' on one side and '15' on the other.

Clear PVC/PVDC-aluminium blisters containing 14, 50, 56 and 168 film-coated tablets.

Only certain pack sizes may be marketed.

Marketing Authorisation Holder

Tarbis Farma S.L.
Gran Vía Carlos III, 94
08028 Barcelona
Spain

Manufacturer

Pharmadox Healthcare Ltd.
KW20A Kordin Industrial Park
Paola, PLA 3000
Malta

Amarox Pharma B.V.
Rouboslaan 32
2252 TR Voorschoten
The Netherlands

This medicinal product is authorised in the European Economic Area member states under the following names:

Germany: Lacosamid Amarox 50mg, 100mg, 150mg, 200mg Filmtabletten

Netherlands: Lacosamide Amarox 50mg, 100mg, 150mg, 200mg filmomhulde tabletten

Spain: Lacosamida Tarbis 50mg, 100mg, 150mg, 200mg comprimidos recubiertos con película EFG

Sweden: Lakosamid Amarox 50mg, 100mg, 150mg, 200mg filmdragerade tabletter

Date of the most recent revision of this leaflet: October 2022

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