Package Leaflet: Information for the Patient

Lacosamida Teva 200 mg Film-Coated Tablets

Read this leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, as 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. Do not pass it on to others even if their symptoms are the same as yours. It may harm them.

• If you experience any side effects, talk to your doctor or pharmacist. See section 4.

1.What Lacosamida Teva is and what it is 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

What is Lacosamida Teva

Lacosamida Teva contains 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 is Lacosamida Teva used for

• It is used for:
• alone and in association with other antiepileptic medicinesin adults, adolescents, and children aged 2 years and aboveto treat a certain type of epilepsy characterised by the occurrence of partial onset seizures with or without secondary generalisation. In this type of epilepsy, the attacks initially affect only one side of the brain. However, these may then spread to larger areas in both sides of the brain;
• in association with other antiepileptic medicinesin adults, adolescents, and children aged 4 years and aboveto treat primary generalised tonic-clonic seizures (severe seizures, including loss of consciousness) in patients with idiopathic generalised epilepsy (the type of epilepsy believed to have a genetic cause).

Do not take lacosamide

• If you are allergic to lacosamide or any of the other ingredients in this medication (listed in section 6). If you are unsure if you are allergic, consult your doctor.
• If you have a heart rhythm problem called second- or third-degree AV block.

Do not take Lacosamide 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 Lacosamide if:

• You have thoughts of self-harm or suicide. A small number of people taking antiepileptic medications like lacosamide have had thoughts of self-harm or suicide. If you ever have these thoughts, contact your doctor immediately.
• You have a heart condition that affects heart rhythm and often your pulse is abnormally slow, fast, or irregular (such as AV block, atrial fibrillation, and atrial flutter).
• You have a serious heart condition such as heart failure or have had a myocardial infarction.
• You often get dizzy or fall. Lacosamide may cause dizziness, which could increase the risk of accidents 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 unsure), consult your doctor or pharmacist before taking Lacosamide.

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

If you are taking Lacosamide Teva 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

Lacosamide is not recommended for children under 2 years with epilepsy characterized by the onset of partial seizures or for children under 4 years with 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 lacosamide with other medications

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

Particularly, inform your doctor or pharmacist if you are taking any of the following medications that affect the heart. The reason is that Lacosamide 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 medications for epilepsy or pain 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), talk to your doctor or pharmacist before taking Lacosamide.

Also inform 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 Lacosamide on 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 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), talk to your doctor or pharmacist before taking Lacosamide.

Taking lacosamide 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 during pregnancy, as the effects of lacosamide on pregnancy and the fetus are unknown. It is not recommended to breastfeed while taking lacosamide, as lacosamide passes into breast milk. Immediately ask your doctor for advice if you are pregnant or plan to become pregnant. They will help you decide if you should take Lacosamide or not.

Do not stop treatment without first talking to your doctor, as this may increase seizures (crises). A worsening of your condition may also harm the fetus.

Driving and operating machinery

You should not drive, ride a bike, or use any tools or machines until you know if this medication affects you.

The reason is that Lacosamide may cause dizziness or blurred vision.

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist.

Lacosamide Dosage

• Take lacosamide twice a day, with an interval of 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, 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 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 partial 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.

Dosage depends on body weight. Treatment usually 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 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, consult your doctor or pharmacist immediately, or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

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

If you forget to take lacosamide

• 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 more than 6 hours after the scheduled dose, do not take the missed dose, 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 treatment with lacosamide

Do not stop taking this medication without telling your doctor, as your symptoms may appear again or worsen.

If your doctor decides to stop your treatment with lacosamide, he 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, this medicine 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

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

Common: may affect up to 1 in 10 patients

• Brief muscle or group of muscle spasms (myoclonic seizures)
• Difficulty coordinating movements or walking
• Problems maintaining balance, agitation (tremor), numbness (paresthesia) or muscle spasms, easy to fall and bruise

• Memory problems, difficulty thinking or finding words, confusion
• Uncontrolled rapid eye movements (nystagmus), blurred vision
• Sensation of dizziness (vertigo), feeling drunk
• Feeling dizzy (vertigo), dry mouth, constipation, indigestion, excessive gas in the stomach or intestines, diarrhea
• Decreased sensitivity, difficulty articulating words, attention disorder
• Ringing in the ears like buzzing 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 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 heart rate (ventricular tachyarrhythmia)
• Sore throat, elevated temperature, and presenting infections more frequently than normal. Blood tests may show a severe decrease in a specific type of white blood cell (agranulocytosis)

• Severe skin reaction, which may includehigh temperature and otherflu-like symptoms, facial rash, 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 blistering and peeling of the skin, especially around the mouth, nose, eyes, and genitals (Stevens-Johnson syndrome) and a more severe form that causes peeling of the skin on more than 30% of the body surface (toxic epidermal necrolysis)
• Seizures

Other side effects in children

The additional side effects observed in children were fever (pyrexia), runny nose (nasopharyngitis), sore throat (pharyngitis), eating less than usual (decreased appetite), changes in behavior, not acting as they normally do (abnormal behavior), and lack of energy (lethargy). Drowsiness 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 that does not appear in this leaflet. You can also report them directly throughthe Spanish System for Pharmacovigilance of Medicines for Human Use: https://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 packaging, in the blister pack, and in the bottle after “CAD”. 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 thrown down the drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Lacosamida Teva

• The active ingredient is lacosamida.

Each film-coated tablet contains 200 mg of lacosamida.

• The other components are:

Core of the tablet : microcrystalline cellulose, hydroxypropylcellulose (partially substituted), hydroxypropylcellulose, anhydrous colloidal silica, crospovidone (type A), and magnesium stearate.

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

Appearance of the product and contents of the package

Lacosamida Teva 200 mg are blue film-coated, oval, biconvex tablets, marked with “200” on one face 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 package sizes may be marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Teva B.V.

Swensweg 5,

2031GA Haarlem

Netherlands

Local representative:

Teva Pharma S.L.U.

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

28108 Alcobendas, Madrid (Spain)

Responsible for manufacturing

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 medicine is authorized in the member states of the European Economic Area with 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 Tab lets

Sweden Lacosamide Teva

Slovenia Lakozamid Teva 200 mg filmsko obložene tablete

Date of the last review of this leaflet: October 2022

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