LACOSAMIDE TEVA 50 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Lacosamida Teva 50 mg Film-Coated Tablets EFG

Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.

• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are side effects not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

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

It is used:

• alone and in combination with other antiepileptic medications in adults, adolescents, and children from 2 years of age to treat a certain type of epilepsy characterized by the occurrence of partial-onset seizures with or without secondary generalization. In this type of epilepsy, the attacks first affect only one side of your brain. However, these can then spread to larger areas on both sides of your brain;
• in combination with other antiepileptic medications 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 that is believed to have a genetic cause).

2. What you need to know before taking Lacosamida Teva

Do not take lacosamida

• if you are allergic to lacosamida or any of the other ingredients of this medication (listed in section 6). If you are not sure if 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 any of the above applies to you. If you are not sure, consult your doctor or pharmacist before taking this medication.

Warnings and precautions

Consult your doctor before starting to use Lacosamida 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 at any time you have these thoughts, contact your doctor immediately.
• you have a heart problem that affects your heartbeat and your pulse is often particularly 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 fall. Lacosamida may cause dizziness, which could increase the risk of accidental injuries or falls. This means you should be careful until you are used to the effects of this medication.

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

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

Children

Lacosamida is not recommended in children under 2 years of age with epilepsy characterized by the occurrence of partial-onset seizures or in children under 4 years of age 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.

Use of lacosamida with other medications

Tell your doctor or pharmacist if you are taking or have recently taken or may need to take another medication.

In particular, tell your doctor or pharmacist if you are taking any of the following medications that affect the heart. The reason is that Lacosamida may also affect the heart:

• medications for heart problems.
• medications that can 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 not sure), talk to your doctor or pharmacist before taking Lacosamida.

Tell your doctor or pharmacist if you are taking any of the following medications.

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

• medications for fungal infections such as fluconazole, itraconazole, ketoconazole
• medications for HIV such as ritonavir

• medications for bacterial infections 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 not sure), talk to your doctor or pharmacist before taking Lacosamida.

Taking lacosamida with alcohol

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

Pregnancy and breastfeeding

Women of childbearing age should discuss the use of contraceptives with their doctor.

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

This medication is not recommended if you are pregnant, as the effects of lacosamida on pregnancy and the fetus are not known. 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 your symptoms may come back or worsen.

Driving and using machines

Do not drive, ride a bicycle, or use any tool or machine until you know if this medication affects you. The reason is that Lacosamida may cause dizziness or blurred vision.

3. How to take Lacosamida Teva

Follow the instructions for taking this medication exactly as indicated by your doctor or pharmacist.

Taking Lacosamida

• Take lacosamida twice a day, with an interval of approximately 12 hours.
• Try to take it more or less at the same time every day.
• Take the lacosamida tablet with a glass of water.
• You can take lacosamida with food or on an empty stomach.

Normally, you will start by taking a low dose every 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 every day. Lacosamida is used as long-term treatment. You will need to continue taking 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 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 lacosamida 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 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. Normally, treatment is started with the oral solution and only changed to tablets if the patient is able to take them and get the correct dose with tablets of different concentrations. Your doctor will prescribe the pharmaceutical form that best suits you.

If you take more lacosamida than you should

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

You may experience:

• dizziness;
• feeling dizzy (nausea) or vomiting;
• seizures (crises), 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, consult your doctor or pharmacist immediately, or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

It is recommended to take the medication packaging and package leaflet to the healthcare professional.

If you forget to take lacosamida

• If you have forgotten to take a dose within 6 hours of the scheduled dose, take it as soon as you remember.
• If you have forgotten to take a dose after 6 hours of the scheduled dose, do not take the missed dose in its place; take lacosamida the next time you normally would.
• Do not take a double dose to make up for missed doses.

If you stop taking lacosamida

Do not stop taking this medication without telling your doctor first, as your symptoms may come back or worsen.

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 other questions about the use of this medication, ask your doctor or pharmacist.

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone 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 experience any of the following effects:

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

• Short muscle jerks or muscle group jerks (myoclonic seizures)
• Difficulty coordinating movements or walking
• Difficulty maintaining balance, agitation (shaking), numbness (paresthesia), or muscle spasms, easy falling 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), having a dry mouth, constipation, indigestion, excessive gas in the stomach or intestine, diarrhea
• Numbness, difficulty articulating words, attention disorder
• Noise in the ears like ringing or whistling

• Irritability, sleep problems, depression

• Drowsiness, tiredness, or weakness (asthenia)
• Itching, rash

Uncommon: may affect up to 1 in 100 patients

• Decreased 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 medication, 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 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 available data

• Abnormally fast heartbeat (ventricular tachyarrhythmia)
• Sore throat, elevated temperature, and frequent infections. Blood tests may show a severe decrease in a specific class of white blood cells (agranulocytosis)

• Severe skin reaction, which may include elevated temperature and other flu-like symptoms, rash on the face, generalized rash with swollen lymph nodes (lymphadenopathy). Blood tests may show elevated 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 skin peeling on more than 30% of the body surface (toxic epidermal necrolysis)
• Seizures.

Other side effects in children

Additional side effects observed in children were fever (pyrexia), runny nose (nasopharyngitis), sore throat (pharyngitis), decreased appetite, behavioral changes, not acting as they normally do (abnormal behavior), 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 side effects

If you experience any side effect, consult your doctor or pharmacist, even if it is a side effect not listed in this package leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medications: https://www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Lacosamida Teva

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

Do not use this medication after the expiration date stated on the packaging, blister, and bottle after "EXP". The expiration date is the last day of the month indicated.

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

Medications should not be disposed of via wastewater or household waste. Deposit the packaging and medications you no longer need at the SIGRE collection point in your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Container Content and Additional Information

Composition of Lacosamida Teva

• The active ingredient is lacosamide.

Each film-coated tablet contains 50 mg of lacosamida.

• The other components are:

Core of the tablet: 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, red iron oxide (E172), black iron oxide (E172), and yellow iron oxide (E172).

Appearance of the Product and Container Content

Lacosamida Teva 50 mg are film-coated tablets of pink color, oval, biconvex, marked with “50” on one side and flat on the other.

Lacosamida Teva 50 mg is available in blisters of 14, 56, 98, 112, 168, 200, and 210 tablets, single-dose blisters of 14x1, 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 50 mg Filmtabletten

Greece Lacosamide/Teva 50 mg επικαλυμμ?να με λεπτ? υμ?νιο δισκ?α

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 Last Revision of thisProspect: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/)