LACOSAMIDE TARBIS 100 mg FILM-COATED TABLETS

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 package leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this package 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 symptoms 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 package leaflet. See section 4.

Contents of the package leaflet

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

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

What is Lacosamida

This medicine contains lacosamida, 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 is Lacosamida used for

Lacosamida is used:

• on its own and with other antiepileptics to treat a certain type of epilepsy characterized by the occurrence of partial-onset seizures with or without secondary generalization in adults, adolescents, and children from 2 years of age. In this type of epilepsy, the 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 to treat primary generalized tonic-clonic seizures (grand mal seizures, with loss of consciousness) in adults, adolescents, and children from 4 years of age with idiopathic generalized epilepsy (a type of epilepsy that is believed to have a genetic origin).

2. What you need to know before you take Lacosamida Tarbis

Do not take Lacosamida

• if you are allergic to lacosamida or any of the other ingredients of this medicine

(listed in section 6). If you are not sure, talk to your doctor.

• If you are allergic to peanuts or soy.
• if you have a heart rhythm 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, talk to your doctor or pharmacist before taking this medicine.

Warnings and precautions

Talk to your doctor before you start taking this medicine if:

• you have thoughts of self-harm or suicide. A small number of people taking antiepileptics such as lacosamida have had thoughts of self-harm or suicide. If you have such thoughts at any time, contact your doctor immediately. you have a heart problem that affects your heartbeat and your pulse is

especially 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.
• you often feel dizzy or faint. Lacosamida 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), talk to your doctor or pharmacist before taking this medicine.

If you are taking lacosamida, talk to 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, shortness of breath, dizziness, fainting), contact your doctor immediately (see section 4).

Children

Lacosamida is not recommended in children under 24 years of age with epilepsy characterized by partial-onset seizures and is not recommended in children under 4 years of age with primary generalized tonic-clonic seizures. This is because it is not yet known whether it is effective and safe for children in this age group.

Other medicines and Lacosamida

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 lacosamida 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.

• 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 lacosamida 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 lacosamida.

Taking Lacosamida with alcohol

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

Pregnancy and breastfeeding

Women of childbearing age should consult their doctor about the use of contraceptives.

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.

Lacosamida is not recommended if you are pregnant, as it is not known whether it can harm your unborn baby. It is also not recommended to breastfeed while taking lacosamida, as lacosamida 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 lacosamida or not.

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

Driving and using machines

Do not drive, ride a bike, or use any tools or machines until you know whether this

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

Lacosamida Tarbis contains soy lecithin.

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

3. How to take/use Lacosamida Tarbis

Follow exactly the instructions for taking this medicine given by your doctor or pharmacist. If you are unsure, talk to your doctor or pharmacist again. There are other forms of this medicine that may be more suitable for children; consult your doctor or pharmacist.

Taking Lacosamida

• Take lacosamida twice a day, spaced apart by approximately 12 hours.
• Try to take it at about the same time each day.
• Take the lacosamida tablet with a glass of water.
• You can take lacosamida with or without food.

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 each day. Lacosamida is used as long-term treatment. You should continue to take lacosamida until your doctor tells you to stop.

How much to take

The following are the usual recommended 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 a day.

Your doctor may also prescribe a starting dose of 100 mg of lacosamida 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 lacosamida 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 lacosamida 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: lacosamida is not recommended in children under 2 years of age.

• In the treatment of primary generalized tonic-clonic seizures: lacosamida is not recommended in 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 take them and to get the correct dose with tablets of different strengths. Your doctor will prescribe the formulation that best suits you.

If you take more Lacosamida than you should

If you have taken more lacosamida than you should, talk to 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 rapid heartbeat and sweating.

In case of overdose or accidental ingestion, talk to your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Lacosamida

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

If you stop taking Lacosamida

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

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

4. Possible side effects

Like all medicines, lacosamida 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 sick (nausea);
• double vision (diplopia).

Common: may affect up to 1 in 10 people

• brief muscle jerks or muscle groups (myoclonic seizures);
• difficulty coordinating movements or walking;
• problems keeping balance, shakiness (tremor), tingling (paresthesia), 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), feeling drunk;
• being sick (vomiting), dry mouth, constipation, indigestion, excessive gas in the stomach or intestines, diarrhea;

• decreased sensitivity, difficulty articulating words, attention disturbance;
• 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

• slow heart rate, palpitations, irregular heartbeat, or other changes in heart 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: tell your doctor immediately;

if you experience any of these, 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).

Frequency not known: cannot be estimated from the available data

• abnormally fast heart rate (ventricular tachyarrhythmia);
• sore throat, high temperature, and infections more often than usual. Blood tests may show a severe 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 peeling of the skin on more than 30% of the body surface (toxic epidermal necrolysis):

• seizures.

Other side effects in children

Other side effects 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 that 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 package 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 Lacosamida Tarbis

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 CAD/EXP. The expiry date is the last day of the month stated.

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. Container Content and Additional Information

Composition of Lacosamida Tarbis

The active ingredient 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 colorants*.

*The colorants are:

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

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

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

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

Transparent coating (all doses)

Hypromellose (E464), macrogol (E1521).

Appearance of the Product and Container Content

Lacosamida Tarbis 50 mg are film-coated tablets (approximately 10.4 mm x 4.8 mm) of pink color, oval shape, biconvex, with the mark ‘J’ on one face and ‘12’ on the other face.

Lacosamida Tarbis 100 mg are film-coated tablets (approximately 13.1 mm x 6.1 mm) of yellow color, oval shape, biconvex, with the mark ‘J’ on one face and ‘13’ on the other face.

Lacosamida Tarbis 150 mg are film-coated tablets (approximately 15.2 mm x 7.0 mm) of salmon color, oval shape, biconvex, with the mark ‘J’ on one face and ‘14’ on the other face.

Lacosamida Tarbis 200 mg are film-coated tablets (approximately 16.6 mm x 7.7 mm) of blue color, oval shape, biconvex, with the mark ‘J’ on one face and ‘15’ on the other face.

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

Only some pack sizes may be marketed.

Marketing Authorization 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

Netherlands

This medicinal product is authorized in the Member States of the European Economic Area 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 film-coated tablets EFG

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

Date of the Last Revision of this Leaflet:October 2022

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