Lacosamide Teva 200 mg film-coated tablets EFG

Patient Information Leaflet

Introduction

Package leaflet: Information for the patient

Lacosamida Teva 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. 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 you should not give it to others, 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.

Contents of the leaflet

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

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

What Lacosamida Teva is

Lacosamida Teva contains the active substance 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 experience.

What Lacosamida Teva is used for

• It is used:
• alone or in combination with other antiepileptic medicines in adults, adolescents, and children from 2 years of age to treat a certain type of epilepsy characterized by partial-onset seizures with or without secondary generalization. In this type of epilepsy, seizures initially 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 to treat primary generalized tonic-clonic seizures (severe seizures, including loss of consciousness) in patients with idiopathic generalized epilepsy (the type of epilepsy believed to have a genetic cause).

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

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

Do not take Lacosamida if either of the above applies 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 Lacosamida if:

• you have thoughts of self-harm or suicide. A small number of people taking antiepileptic medicines such as lacosamide have had thoughts about harming themselves or suicide. If you experience such thoughts at any time, contact your doctor immediately.
• you have a heart condition affecting your heartbeat and often have a particularly slow, fast, or irregular pulse (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 you are unsure), consult your doctor or pharmacist before taking Lacosamida.

If you are taking lacosamide, speak with your doctor if you experience a new type of seizure or worsening of existing seizures.

If you are taking Lacosamida Teva 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 its efficacy and safety have not yet been established in children of these age groups.

Taking lacosamide with other medicines

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

In particular, inform your doctor or pharmacist if you are taking any of the following medicines that affect the heart. The reason is that 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 applies to you (or you are unsure), speak with your doctor or pharmacist before taking Lacosamida.

Also inform your doctor or pharmacist if you are taking any of the following medicines.

The reason is that they may also increase or decrease the effect of Lacosamida in your body:

• antifungal medicines such as fluconazole, itraconazole, ketoconazole
• medicines for HIV such as ritonavir
• antibacterial medicines 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 unsure), speak with your doctor or pharmacist before taking Lacosamida.

Taking lacosamide 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 might be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

This medicine is not recommended during pregnancy, as the effects of lacosamide on pregnancy and the fetus are unknown. 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 Lacosamida.

Do not stop treatment without first talking to your doctor, as this could increase the frequency of seizures. Worsening of your condition may also harm the fetus.

Driving and using machines

You must not drive, ride a bicycle, or operate 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 Lacosamida Teva

Follow exactly the instructions for using this medicine as given by 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.
• Swallow the lacosamida tablet with a glass of water.
• You may take lacosamida with food or on an empty stomach.

Usually, 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—called the "maintenance dose"—you will take the same amount every day. Lacosamida is used as a long-term treatment. You must continue taking lacosamida until your doctor tells you to stop.

What dose to take

Below are the normally 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 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 begin taking the regular maintenance dose 12 hours later.

Children and adolescents weighing less than 50 kg

• In the treatment of partial-onset seizures: note that lacosamida is not recommended for children under 2 years of age.
• In the treatment of primary generalized tonic-clonic seizures: note that lacosamida is not recommended for children under 4 years of age.

The dose depends on body weight. Treatment usually starts with the oral syrup, and only switches 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 prescribed, 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.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately, or call the Toxicology Information Service at telephone number: 91 562 04 20, stating the name of the medicine and the amount ingested.

It is recommended to bring the medicine packaging and leaflet to the healthcare professional.

If you forget to take lacosamida

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

If you stop taking lacosamida

Do not stop taking this medicine without speaking to your doctor, as your symptoms may return or worsen.

If your doctor decides to discontinue your lacosamida treatment, they will give you 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, this medicine can cause adverse effects, although not everybody will experience 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:

Very common: may affect more than 1 in 10 people

• Dizziness
• Feeling dizzy or sick (nausea)
• Double vision (diplopia)

Common: may affect up to 1 in 10 people

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

• Difficulty coordinating movements or walking

• Problems with balance, trembling (tremor), tingling (paraesthesia), or muscle spasms, tendency to fall and bruise easily

• Memory problems, difficulty thinking or finding words, confusion

• Rapid 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 sensation, difficulty articulating words, attention disorder

• Ringing in the ears such as buzzing or whistling

• Irritability, difficulty sleeping, depression

• Drowsiness, tiredness or weakness (asthenia)

• Itching, rash

Uncommon: may affect up to 1 in 100 people

• 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 and/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)

• Severe 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 enzyme levels and an increase in a type of white blood cells (eosinophilia)

• Widespread rash with blisters and skin peeling, 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

Additional adverse effects observed in children were fever (pyrexia), runny nose (nasopharyngitis), sore throat (pharyngitis), eating less than usual (decreased appetite), behavioural changes, not acting as they normally do (abnormal behaviour), 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 of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is an effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Lacosamide Teva

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 packaging, on the blister and on the bottle after "EXP". The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage temperature. Store in the original packaging to protect from light.

Medicines must not be disposed of via wastewater or household waste. Unused medicines and waste materials should be returned to the SIGRE point at your pharmacy. If you are unsure, please consult your pharmacist on how to dispose of medicines and containers you no longer require. This will help protect the environment.

6. Contents of the pack and other information

Composition of Lacosamida Teva

• The active substance is lacosamide.

Each film-coated tablet contains 200 mg of lacosamide.

• The other components are:

Tablet core: microcrystalline cellulose, low-substituted hydroxypropylcellulose, hydroxypropylcellulose, anhydrous colloidal silica, crospovidone (type A) and magnesium stearate.

Coating: poly(vinyl alcohol), titanium dioxide (E171), macrogol 3350, talc, brilliant blue FCF (E133) and Ponceau 4R (E124).

Appearance of the product and contents of the pack

Lacosamida Teva 200 mg are blue, oval-shaped, biconvex film-coated tablets marked with “200” on one side and plain on the other.

Lacosamida Teva 200 mg is available in blisters of 14, 56, 98, 112, 168, 200 and 210 tablets, unit-dose blisters of 56x1 and 60x1, and bottles containing 60, 100 and 200 tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Teva B.V.

Swensweg 5,

2031GA Haarlem

The Netherlands

Local representative:

Teva Pharma S.L.U.

C/ Anabel Segura, 11, Edificio Albatros B, 1st floor

28108 Alcobendas, Madrid (Spain)

Manufacturer

TEVA Gyógyszergyár Zrt.

Pallagi út 13,

4042 Debrecen

Hungary

or

Teva Operations Poland Sp. z.o.o

ul. Mogilska 80

31-546 Kraków

Poland

or

Merckle GmbH

Ludwig-Merckle-Strasse 3,

89143 Blaubeuren

Germany

This medicinal product is authorized in the Member States of the European Economic Area (EEA) under the following names:

Germany Lacosamid AbZ 200 mg Filmtabletten

Greece Lacosamide/Teva 200 mg επικαλυμμένα με λεπτό υμένιο δισκία

Spain Lacosamida Teva 200 mg comprimidos recubiertos con película EFG

France Lacosamide Teva 200 mg comprimé pelliculé

Croatia Lakozamid Pliva 200 mg filmom obložene tablete

Hungary Lacosamid Teva 200 mg filmtabletta

Poland Lacosamide Teva

Portugal Lacosamida ratiopharm

Romania Lacosamide TEVA 200mg Film-coated Tablets

Sweden Lacosamide Teva

Slovenia Lakozamid Teva 200 mg filmsko obložene tablete

Date of the most recent review of this summary: October 2022

Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (Agencia Española de Medicamentos y Productos Sanitarios, AEMPS) (http://www.aemps.gob.es/)