LACOSAMIDE TEVA 200 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Lacosamida Teva 200 mg film-coated tablets EFG

Read all of this 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 further questions, ask your doctor or pharmacist.

• Keep this 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 signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

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

What is Lacosamida Teva

Lacosamida Teva 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 are having.

What is Lacosamida Teva used for

• It is used:
• on its own and with other antiepileptic medicines in adults, adolescents and children from 2 years of age to treat a certain type of epilepsy that causes seizures that start in one part of the brain. These seizures may then spread to other parts of the brain;
• with other antiepileptic medicines in adults, adolescents and children from 4 years of age to treat primary generalised tonic-clonic seizures (a type of seizure that affects the entire brain) in patients with idiopathic generalised epilepsy (the type of epilepsy that is thought to have a genetic cause).

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

Do not take lacosamide

• if you are allergic to lacosamide or any of the other ingredients of this medicine (listed in section 6). If you are not sure, talk to your doctor.
• if you have a heart problem called second or third degree atrioventricular (AV) block.

Do not take Lacosamida 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 Lacosamida if:

• you have thoughts of harming yourself or suicide. A small number of people taking antiepileptics, such as lacosamide, have had thoughts of harming themselves or suicide.
• you have a heart problem that affects your heart beat and your pulse is often very slow, fast or irregular (such as an 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 have fallen over. 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 Lacosamida.

If you are taking lacosamide, talk to your doctor if you experience a new type of seizure or worsening of your seizures.

If you are taking Lacosamida Teva and experience symptoms of an abnormal heart beat (such as a slow, fast or irregular heart beat, palpitations, shortness of breath, feeling dizzy, fainting), talk to your doctor immediately (see section 4).

Children

Lacosamida is not recommended for children under 2 years of age with partial-onset seizures or under 4 years of age with primary generalised tonic-clonic seizures. This is because it is not yet known if it is effective and safe for this age group.

Using lacosamide with other medicines

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. The reason is that 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 irregular heart beats or heart failure.

If any of the above applies to you (or you are not sure), talk to your doctor or pharmacist before taking Lacosamida.

Tell 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:

• medicines for fungal infections such as fluconazole, itraconazole, 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 lacosamide with alcohol

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

Pregnancy and breast-feeding

Women of childbearing potential should talk to their doctor about the use of contraceptive methods.

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

It is not recommended to take this medicine if you are pregnant, as it is not yet known what effect lacosamide has on the unborn baby. It is not recommended to breast-feed while taking lacosamide, as lacosamide passes into breast milk. Ask your doctor for advice if you are pregnant or planning to become pregnant. They will help you decide if you should take Lacosamida or not.

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

Driving and using machines

Do not drive, cycle or use any tools or machines until you know if this medicine affects you. The reason is that Lacosamida may cause dizziness or blurred vision.

3. How to take Lacosamida Teva

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Taking Lacosamida

• Take lacosamide twice a day, with an interval of about 12 hours.
• Try to take it at the same time every day.
• Take the lacosamide tablet with a glass of water.
• You can take lacosamide with or without food.

Normally, you will start with a low dose each day and your doctor will slowly increase the dose over a few weeks. When you reach the dose that works best for you, called the “maintenance dose”, you will take the same amount each day. Lacosamida is used as a long-term treatment. You will need to keep taking lacosamide until your doctor tells you to stop.

How much to take

The following are the usual 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 on its own:

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 of between 100 mg and 300 mg twice a day.

When taking lacosamide 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 of between 100 mg and 200 mg twice a day.

If you weigh 50 kg or more, your doctor may start your treatment with a single “loading dose” of 200 mg. You will then start taking the 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 generalised tonic-clonic seizures: note that lacosamide is not recommended for 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 get the right dose with tablets of different strengths. Your doctor will prescribe the formulation that best suits you.

If you take more lacosamide than you should

If you have taken more lacosamide 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 beat problems such as a slow, fast or irregular pulse, coma or low blood pressure with a fast heart rate and sweating

In case of overdose or accidental ingestion, talk to your doctor or pharmacist immediately or call the Poisons Information Centre on +34 91 562 04 20, stating the medicine and the amount taken.

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

If you forget to take lacosamide

• If you miss a dose within 6 hours of the scheduled dose, take it as soon as you remember.
• If you miss a dose more than 6 hours after the scheduled dose, do not take the missed dose. Take lacosamide at the next normal time.
• Do not take a double dose to make up for a forgotten dose.

If you stop taking lacosamide

Do not stop taking this medicine without talking to your doctor, as your seizures may return or become worse.

If your doctor decides to stop your treatment with lacosamide, they will tell you how to reduce the dose gradually.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Side effects on 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

• dizziness
• feeling sick (nausea)
• double vision (diplopia)

Common: may affect up to 1 in 10 people

• brief, shock-like jerks of a muscle or a group of muscles (myoclonic seizures)
• difficulty in coordinating movements or walking
• problems with balance, shaking (tremor), tingling (paraesthesia) or muscle spasms, falling easily and bruising easily

• memory problems, difficulty in thinking or finding words, confusion
• rapid, uncontrolled eye movements (nystagmus), blurred vision
• feeling dizzy (vertigo), feeling drunk
• being sick (vomiting), having a dry mouth, constipation, indigestion, excessive gas in the stomach or intestines, diarrhoea
• decreased sensitivity, difficulty in speaking, attention disorder
• ringing in the ears (such as tinnitus or buzzing)

• 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 the electrical activity of the heart (conduction disorder)

• feeling extremely happy, 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 attempted suicide: tell your doctor immediately
• feeling angry or agitated

• abnormal thoughts and/or loss of contact with 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 serious 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, generalised rash with swollen lymph nodes (lymphadenopathy). Blood tests may show increased liver enzymes and an increase in a type of white blood cell (eosinophilia)

• a 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 on more than 30% of the body surface (toxic epidermal necrolysis)
• seizures.

Other side effects in children

Additional side effects seen in children were fever (pyrexia), runny nose (nasopharyngitis), sore throat (pharyngitis), eating less than usual (decreased appetite), changes in behaviour, 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 side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Lacosamida 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 carton, blister and bottle after “EXP”. The expiry date refers to the last day of that month.

This medicine does not require any special storage conditions. Keep the bottle in the outer carton in order to protect from light.

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 to protect the environment.

6. Container Content and Additional Information

Composition of Lacosamida Teva

• The active ingredient is lacosamide.

Each film-coated tablet contains 200 mg of lacosamide.

• The other ingredients are:

Tablet core: microcrystalline cellulose, hypromellose (low substituted), hypromellose, colloidal anhydrous 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 Container Content

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

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

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Teva B.V.

Swensweg 5,

2031GA Haarlem

Netherlands

Local Representative:

Teva Pharma S.L.U.

C/ Anabel Segura, 11, Edificio Albatros B, 1ª planta

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 under the following names:

Germany Lacosamid AbZ 200 mg Filmtabletten

Greece Lacosamide/Teva 200 mg επικαλυμμ?να με λεπτ? υμ?νιο δισκ?α

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 Last Revision of this Leaflet:October 2022

Detailed 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/)