Lacosamide Teva 50 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Lacosamide Teva 50 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 other people, 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 Lacosamide Teva is and what it is used for
2. What you need to know before taking Lacosamide Teva
3. How to take Lacosamide Teva
4. Possible side effects
5. How to store Lacosamide 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

Lacosamida Teva is used:

• as monotherapy and 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, but 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 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 particularly 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.
• 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.

Use of 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 either increase or decrease the effect of Lacosamide in your body:

• antifungal medicines such as fluconazole, itraconazole, 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 applies to you (or you are unsure), speak with your doctor or pharmacist before taking Lacosamida.

Taking lacosamide with alcohol

As a safety 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 may 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 to 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 any 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 given by your doctor or pharmacist for taking this medicine.

Taking Lacosamida

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

What dose to take

Below are the normally 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 lacosamide alone:

The usual starting dose is 50 mg twice daily.

Your doctor may also prescribe a starting dose of 100 mg of lacosamide 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 lacosamide 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 lacosamide 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: 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 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 lacosamide than you should

If you have taken more lacosamide than you should, 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: 91 562 04 20, stating the medicine and the amount taken.

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

If you forget to take lacosamide

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

If you stop taking lacosamide

Do not stop taking this medicine without first talking to your doctor, as your symptoms may return 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 further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can produce adverse effects, although not everyone experiences them.

Adverse effects affecting 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:

Very common: may affect more than 1 in 10 patients

• Dizziness
• 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)
• Difficulties coordinating movements or walking
• Problems maintaining balance, tremor, tingling (paraesthesia), or muscle spasms, falling easily and bruising
• 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 sensitivity, difficulty articulating words, attention disorder
• Ringing in the ears such as buzzing or whistling
• 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 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
• Involuntary abnormal 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, rash on the face, 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 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

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). Feeling sleepy (drowsiness) 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, consult your doctor or pharmacist, even if it is an effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: 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 stated on the packaging, blister, and 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 it from light.

Medicines must not be disposed of via wastewater or household waste. Unused medicines and their containers should be taken to a SIGRE point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of unused medicines and containers. 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 50 mg of lacosamide.

• The other components are:

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

Coating: poly (vinyl alcohol), titanium dioxide (E171), macrogol 3350, talc, iron oxide red (E172), iron oxide black (E172) and iron oxide yellow (E172).

Appearance of the product and pack contents

Lacosamida Teva 50 mg are pink, oval-shaped, biconvex film-coated tablets, marked with "50" on one side and plain on the other.

Lacosamida Teva 50 mg is available in blisters of 14, 56, 98, 112, 168, 200 and 210 tablets, unit-dose blisters of 14x1, 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 European Economic Area member states under the following names:

Germany Lacosamid AbZ 50 mg Filmtabletten

Greece Lacosamide/Teva 50 mg επικαλυμμένα με λεπτό υμένιο δισκία

Spain Lacosamida Teva 50 mg film-coated tablets EFG

France Lacosamide Teva 50 mg comprimé pelliculé

Croatia Lakozamid Pliva 50 mg filmom obložene tablete

Hungary Lacosamid Teva 50 mg filmtabletta

Italy LACOSAMIDE TEVA

Netherlands Lacosamide Teva 50 mg filmomhulde tabletten

Poland Lacosamide Teva

Portugal Lacosamida ratiopharm

Romania Lacosamide TEVA 50mg Film-coated Tablets

Sweden Lacosamide Teva

Slovenia Lakozamid Teva 50 mg filmsko obložene tablete

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

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