Prospect: information for the patient

Lacosamida Tarbis 50 mg film-coated tablets

Lacosamida Tarbis 100 mg film-coated tablets

Lacosamida Tarbis 150 mg film-coated tablets

Lacosamida Tarbis 200 mg film-coated tablets

Read this prospect carefully before starting to take this medicine, because it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed only for you, and you must not give it to other people even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect. See section 4.

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

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

3. How to take Lacosamida Tarbis

4. Possible adverse effects

5. Storage of Lacosamida Tarbis

6. Contents of the package and additional information

What is Lacosamida

This medication contains lacosamida, 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 is lacosamida used for

Lacosamida is used:

• alone and in combination with other antiepileptic medications 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 aged 2 years and older. 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 medications to treat primary generalized tonic-clonic seizures (major seizures, with loss of consciousness) in adults, adolescents, and children aged 4 years and older with idiopathic generalized epilepsy (a type of epilepsy believed to have a genetic origin).

Do not take Lacosamida

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

(see section 6). If you are unsure if you are allergic, consult 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 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 taking antiepileptic medications such as lacosamida have had thoughts of self-harm or suicide. If you ever have this type of thought, contact your doctor immediately.you have a heart problem that affects the heartbeat and your pulse is often

especially slow, fast, or irregular (such as AV block, atrial fibrillation, and atrial flutter).

• you have a serious heart disease such as heart failure or have had a myocardial infarction.
• you often feel dizzy or fall. Lacosamida may cause dizziness, which could increase the risk of accidental injuries or falls. This means you should be careful until you are accustomed to the effects of this medication.

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

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

If you are taking this medication and experience symptoms of abnormal heart rhythm (such as slow, fast, or irregular heartbeat, palpitations, shortness of breath, dizziness, fainting), consult your doctor immediately (see section 4).

Children

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

Other medications and lacosamida

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

Particularly, inform your doctor or pharmacist if you are taking any of the following medications that affect the heart, as lacosamida may also affect the heart:

• medications to treat heart problems.
• medications that may increase the "PR interval" in a heart test (ECG or electrocardiogram) such as epilepsy or pain medications called carbamazepine, lamotrigine, or pregabalin.

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

If any of the above applies to you (or you are unsure), speak with 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 increase or decrease the effect of lacosamida on your body:

• antifungal medications such as fluconazole, itraconazole, or ketoconazole.
• medications for HIV such as ritonavir.
• antibacterial medications such as clarithromycin or rifampicin.
• a medicinal plant used to treat mild anxiety and depression called St. John's Wort.

If any of the above applies to you (or you are unsure), speak with your doctor or pharmacist before taking lacosamida.

Lacosamida Tarbis contains soy lecithin.

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

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again. There are other forms of this medication that may be more suitable for children; consult your doctor or pharmacist.

Lacosamide Dosage

• Take lacosamide twice a day, separated by approximately 12 hours.
• Try to take it more or less at the same time each day.
• Take the lacosamide tablet with a glass of water.
• You can take lacosamide with meals or separately.

Normally, you will start 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, which is called the "maintenance dose," you will take the same amount each day. Lacosamide is used as long-term treatment. You should continue taking lacosamide until your doctor tells you to stop.

How much to take

Below are the normal recommended doses of lacosamide for different age groups and weights. 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 lacosamide 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 lacosamide 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 the lacosamide treatment with a single "loading dose" of 200 mg. Then you will start taking the continuous maintenance dose 12 hours later.

Children and adolescents weighing less than 50 kg

• In the treatment of initial partial seizures: lacosamide is not recommended for use in children under 2 years of age.

• In the treatment of primary generalized tonic-clonic seizures: lacosamide is not recommended for use in children under 4 years of age. The dose depends on body weight. Normally, treatment starts with the syrup and only changes to tablets if the patient is able to take them and obtain the correct dose with tablets of different concentrations. Your doctor will prescribe the pharmaceutical form that best suits you.

If you take more lacosamide than you should

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

You may experience:

• dizziness;
• sensation of dizziness (nausea) or dizziness (vomiting);
• seizures (crises), heart problems such as slow, fast, or irregular heartbeat, coma, or low blood pressure with tachycardia and sweating.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to take lacosamida

• If you forgot to take a dose within 6 hours of the scheduled dose, take it as soon as you remember.
• If you forgot to take a dose more than 6 hours after the scheduled dose, do not take the missed dose, instead, take lacosamide at the next time you normally take it.
• Do not take a double dose to compensate for the missed doses.

If you interrupt the treatment with lacosamida

• 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 reduce the dose.

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

Like all medicines, lacosamide may cause side effects, although not everyone will experience them.

The side effects in the nervous system, such as dizziness, may be more pronounced after a single "loading dose".

Inform your doctor or pharmacist if you experience any of the following side effects:

Very common: may affect more than 1 in 10 patients

• Headache;
• Feeling dizzy or nauseous;
• Diplopia (double vision).

Common: may affect up to 1 in 10 patients

• Short, involuntary muscle contractions (myoclonic crises);
• Difficulty coordinating movements or walking;
• Problems maintaining balance, agitation (tremor), paresthesia (tingling), or muscle spasms, easy to fall and bruise;
• Memory problems, difficulty thinking or finding words, confusion;
• Rapid, uncontrolled eye movements (nystagmus), blurred vision;
• Sensation of dizziness (vertigo), feeling drunk;
• Feeling nauseous (vomiting), dry mouth, constipation, indigestion, excessive gas in the stomach or intestines, diarrhea;

• Decreased sensitivity, difficulty articulating words, attention alteration;
• Ringing in the ear like a buzzing, ringing, or hissing;
• Irritability, difficulty sleeping, 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 the medication, hives;
• Blood tests may show abnormalities in liver function tests, liver damage;

• Thoughts of self-harm or suicide or attempted suicide: inform 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;

• Loss of consciousness.
• Abnormal involuntary movements (dyskinesia).

Frequency not known: cannot be estimated from available data

• Abnormally fast heart rate (ventricular tachyarrhythmia);
• Sore throat, elevated temperature, and increased frequency of infections. Blood tests may show a severe decrease in a specific type of white blood cell (agranulocytosis);

• Severe skin reaction, which may include elevated temperature and other symptoms pseudogripal, hives, generalized rash with lymph node inflammation (enlarged lymph nodes). Blood tests may show increased levels of liver enzymes and an increase in a type of white blood cell (eosinophilia);

• Generalized rash with blisters and skin peeling, 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

Other side effects in children were fever (pyrexia), nasal congestion (nasopharyngitis), sore throat (pharyngitis), eating less than usual (decreased appetite), changes in behavior, not acting normally (abnormal behavior), and lack of energy (lethargy). Drowsiness is a very common side effect in children that may affect more than 1 in 10 children.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet.You can also report directly through the Spanish System for Pharmacovigilance of Medicines for Human Use website:www.notificaRAM.es.By reporting side effects, you can contribute to providing more information on the safety of this medicine..

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the box and on the blister after CAD/EXP. The expiration date is the last day of the month indicated.

This medication does not require special conditions for conservation.

Medications should not be thrown down the drains or in the trash. Dispose of the containers and medications you no longer need at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medications you no longer need. By doing so, you will help protect the environment.

Lacosamida Tarbis Composition

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:

Core tablet:microcrystalline cellulose (E460), hydroxypropyl cellulose (E463), crospovidone (E1202), anhydrous colloidal silica, magnesium stearate.

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

*The colorants are:

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

Transparent coating (all doses)

hypromellose (E464), macrogol (E1521).

Appearance of the product and contents of the package

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-aluminium blisters containing 14, 50, 56 and 168 film-coated tablets.

Only some package sizes may be marketed.

Marketing Authorization Holder

Tarbis Farma S.L.

Gran Vía Carlos III, 94

08028 Barcelona

Spain

Responsible for manufacturing

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 with 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

Last review date of this leaflet:October 2022

The detailed and updated information on this medicinal product is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/