Lacosamide Teva

Package Leaflet: Information for the Patient

Lacosamide Teva, 50 mg, Film-Coated Tablets

Lacosamide Teva, 100 mg, Film-Coated Tablets

Lacosamide Teva, 150 mg, Film-Coated Tablets

Lacosamide Teva, 200 mg, Film-Coated Tablets

Lacosamide

Read the package leaflet carefully before taking the medicine, as 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.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Table of Contents of the Package Leaflet

• 1. What is Lacosamide Teva and what is it used for
• 2. Important information 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 is Lacosamide Teva and what is it used for

What is Lacosamide Teva

Lacosamide Teva contains lacosamide. It belongs to a group of medicines called antiepileptics, which are used to treat epilepsy.

• This medicine has been prescribed by your doctor to reduce the number of seizures.

What is Lacosamide Teva used for

• Lacosamide Teva is used:
• as monotherapy and adjunctive therapy with other antiepileptic medicines in adults, adolescents, and children from 2 years of age for the treatment of partial-onset seizures and generalized secondary seizures. In this type of epilepsy, seizures initially affect only one side of the brain but may then spread to other areas on both sides of the brain;
• as adjunctive therapy with other antiepileptic medicines in adults, adolescents, and children from 4 years of age for the treatment of primary generalized tonic-clonic seizures (grand mal seizures involving loss of consciousness) in patients with idiopathic generalized epilepsy (a type of epilepsy believed to have a genetic basis).

2. Important information before taking Lacosamide Teva

When not to take Lacosamide Teva

• if you are allergic to lacosamide or 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 certain type of heart rhythm disorder called atrioventricular (AV) block II or III.

If any of the above applies to you, do not take Lacosamide Teva. If you are unsure, consult your doctor or pharmacist before taking this medicine.

Warnings and precautions

Before taking Lacosamide Teva, tell your doctor if:

• you have thoughts of self-harm or suicide. Some patients taking antiepileptic medicines, such as 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 the heart rhythm - it is often slowed, accelerated, or irregular (e.g., AV block, atrial fibrillation, or atrial flutter);
• you have severe heart disease, such as heart failure or have had a heart attack;
• you often experience dizziness or falls. Lacosamide Teva may cause dizziness, which may increase the risk of accidental injury or falls. Therefore, be cautious until you are used to the effects of the medicine.

If any of the above applies to you (or if you are unsure), consult your doctor or pharmacist before taking Lacosamide Teva. If you are taking Lacosamide Teva and experience any new type of seizure or worsening of existing seizures, tell your doctor. 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, or fainting), seek medical attention immediately (see section 4).

Children

Lacosamide Teva is not recommended for children under 2 years of age with partial-onset seizures or under 4 years of age with primary generalized tonic-clonic seizures. The efficacy and safety of the medicine in children of this age group have not been established.

Lacosamide Teva with other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or might take. In particular, tell your doctor or pharmacist if you are taking any of the following medicines that affect the heart:

• medicines for heart conditions;
• medicines that may prolong the PR interval (visible on an electrocardiogram (ECG)), such as antiepileptic medicines or pain medicines, e.g., carbamazepine, lamotrigine, or pregabalin;
• medicines for certain types of irregular heart rhythms or heart failure.

If any of the above applies to you (or if you are unsure), consult your doctor or pharmacist before taking Lacosamide Teva. Also, tell your doctor or pharmacist if you are taking any of the following medicines, as they may decrease or increase the effectiveness of Lacosamide Teva:

• antifungal medicines, such as fluconazole, itraconazole, or ketoconazole;
• HIV medicines, such as ritonavir;
• antibiotics, such as clarithromycin or rifampicin;
• a herbal medicine used to treat mild anxiety and depression - St. John's Wort.

If any of the above applies to you (or if you are unsure), consult your doctor or pharmacist before taking Lacosamide Teva.

Lacosamide Teva with alcohol

For safety reasons, it is not recommended to drink alcohol while taking Lacosamide Teva.

Pregnancy and breastfeeding

Women of childbearing age should discuss the use of contraception with their doctor. If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Lacosamide Teva should not be taken during pregnancy, as its effects on pregnancy and the unborn child are not known. Breastfeeding is not recommended during treatment with Lacosamide Teva, as lacosamide passes into breast milk. If you become pregnant or plan to become pregnant, consult your doctor, who will help you decide whether to take Lacosamide Teva. Do not stop treatment without consulting your doctor, as this may increase the frequency of seizures. The severity of the mother's symptoms may also harm the child.

Driving and using machines

Do not drive a car, ride a bike, or use tools or machines until you are sure how the medicine affects you. This is because Lacosamide Teva may cause dizziness or blurred vision.

Lacosamide Teva 100 mg and 150 mg contain sunset yellow FCF (E 110)

May cause allergic reactions.

Lacosamide Teva 200 mg contains cochineal red A (E 124)

May cause allergic reactions.

3. How to take Lacosamide Teva

Always take this medicine exactly as your doctor or pharmacist has told you. If you are unsure, ask your doctor or pharmacist.

Taking Lacosamide Teva

• Take Lacosamide Teva twice a day, approximately every 12 hours.
• Take the medicine at the same time every day.
• Swallow the tablet with a glass of water.
• Lacosamide Teva can be taken with or without food.

Treatment usually starts with a low daily dose, which your doctor will gradually increase over several weeks. Once the effective dose for you is reached, called the maintenance dose, you will continue to take it daily. Lacosamide Teva is used for long-term treatment. Continue taking Lacosamide Teva until your doctor tells you to stop.

What dose to take

The recommended dose of Lacosamide Teva is as follows for patients of different age groups and body weights. Your doctor may prescribe a different dose if you have kidney or liver problems.

Adults, adolescents, and children weighing 50 kg or more, and adults

Monotherapy with Lacosamide Teva: The usual starting dose of Lacosamide Teva is 50 mg twice a day. Your doctor may also start treatment with a dose of 100 mg twice a day. Your doctor may increase the dose (given twice a day) by 50 mg every week until a maintenance dose of 100 mg to 300 mg per day, given in two divided doses, is reached. Adjunctive therapy with Lacosamide Teva: The usual starting dose of Lacosamide Teva is 50 mg twice a day. Your doctor may increase the dose (given twice a day) by 50 mg every week until a maintenance dose of 100 mg to 200 mg twice a day is reached. If you weigh 50 kg or more, your doctor may decide to start Lacosamide Teva with a single loading dose of 200 mg. After 12 hours, you will start taking the maintenance dose.

Children and adolescents weighing less than 50 kg

• Treatment of partial-onset seizures: Note that Lacosamide Teva is not recommended for children under 2 years of age.
• Treatment of primary generalized tonic-clonic seizures: Note that Lacosamide Teva is not recommended for children under 4 years of age.

The dose depends on the child's body weight. Treatment usually starts with an oral solution and is only switched to tablets if the child can swallow them and the correct dose can be achieved with the available tablet strengths. Your doctor will prescribe the medicine in the form most suitable for the child.

Taking more Lacosamide Teva than prescribed

If you take more Lacosamide Teva than prescribed, contact your doctor immediately. Do not attempt to drive. You may experience:

• dizziness;
• nausea or vomiting;
• seizures (convulsions), heart rhythm disturbances, such as slow, fast, or irregular heartbeat, coma, or low blood pressure with rapid heart rate and sweating.

Missing a dose of Lacosamide Teva

• If you miss a dose by less than 6 hours, take the missed dose as soon as possible.
• If you miss a dose by more than 6 hours, do not take the missed dose. Take the next dose of Lacosamide Teva at the usual time.
• Do not take a double dose to make up for a missed dose.

Stopping treatment with Lacosamide Teva

• Do not stop taking Lacosamide Teva without consulting your doctor, as your epilepsy may worsen or seizures may return.
• If your doctor decides to stop treatment with Lacosamide Teva, they will inform you how to gradually reduce the dose. If you have any questions about your treatment, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Lacosamide Teva can cause side effects, although not everybody gets them. Side effects from the nervous system, such as dizziness, may be stronger after taking 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

• headache;
• dizziness or nausea (nausea);
• double vision.

Common: may affect up to 1 in 10 people

• brief muscle jerks or muscle groups (myoclonic seizures);
• difficulty with coordination or walking;
• balance disturbances, tremors, tingling, or numbness (paresthesia) or muscle cramps, tendency to fall or bruise;
• memory disturbances, thinking disturbances, or problems finding words, confusion;
• rapid and uncontrolled eye movements (nystagmus), blurred vision;
• feeling of spinning, feeling drunk;
• vomiting, dry mouth, constipation, indigestion, gas in the stomach or intestines (bloating), diarrhea;
• sensory disturbances (weakness), speech disturbances (articulation disorders), attention disturbances;
• ringing in the ears (such as buzzing, ringing, or whistling);
• irritability, difficulty sleeping, depression;
• sleepiness, fatigue, or weakness (asthenia);
• itching, rash.

Uncommon: may affect up to 1 in 100 people

• slow heart rate, palpitations, irregular heartbeat, or other changes in heart activity (conduction disturbances);
• excessive well-being, seeing and/or hearing non-existent things;
• allergic reaction after taking the medicine, hives;
• abnormal liver blood test results (abnormal liver function, liver damage);
• thoughts of self-harm or suicide or attempted suicide: contact your doctor immediately;
• feeling angry or agitated;
• thinking disturbances or loss of contact with reality;
• severe allergic reactions causing swelling of the face, throat, hands, feet, ankles, or lower legs;
• fainting;
• involuntary movements (dyskinesia).

Frequency not known: cannot be estimated from the available data

• abnormal rapid heart rhythm (ventricular tachycardia);
• sore throat, high fever, and frequent infections. Blood tests may show a significant decrease in the number of a certain type of white blood cell (agranulocytosis);

widespread rash with blisters and peeling skin, mainly on the face, eyes, nose, and genitals (Stevens-Johnson syndrome) and a more severe form of rash with peeling skin on more than 30% of the body surface (toxic epidermal necrolysis);

• seizures.

Additional side effects in children

Additional side effects in children included fever, runny nose (nasopharyngitis), sore throat (pharyngitis), decreased appetite, behavioral changes, the child does not behave as usual (abnormal behavior), and lack of energy (lethargy). Sleepiness is a very common side effect in children and may occur in more than 1 in 10 children.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl. By reporting side effects, you can help provide more information on the safety of this medicine. Side effects can also be reported to the marketing authorization holder.

5. How to store 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 carton, blister, or tablet container after “EXP”. The expiry date refers to the last day of that month. The batch number is stated after “Lot”. This medicine does not require any special storage conditions. Store in the original package 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. This will help protect the environment.

6. Contents of the pack and other information

What Lacosamide Teva contains

• The active substance is lacosamide. One tablet of Lacosamide Teva, 50 mg contains 50 mg of lacosamide. One tablet of Lacosamide Teva, 100 mg contains 100 mg of lacosamide. One tablet of Lacosamide Teva, 150 mg contains 150 mg of lacosamide. One tablet of Lacosamide Teva, 200 mg contains 200 mg of lacosamide.
• The other ingredients are: Core:microcrystalline cellulose, low-substituted hydroxypropylcellulose, hydroxypropylcellulose, silicon dioxide, crospovidone (type A), magnesium stearate Coating:polyvinyl alcohol, titanium dioxide (E171), polyethylene glycol, talc. Lacosamide Teva, 50 mg tablets also contain iron oxide red (E172), iron oxide black (E172), iron oxide yellow (E172). Lacosamide Teva, 100 mg tablets also contain iron oxide yellow (E172), quinoline yellow (E104), sunset yellow FCF (E110). Lacosamide Teva, 150 mg tablets also contain iron oxide yellow (E172), sunset yellow FCF (E110). Lacosamide Teva, 200 mg tablets also contain brilliant blue FCF (E133), cochineal red A (E124).

What Lacosamide Teva looks like and contents of the pack

Lacosamide Teva, 50 mg are pink, oval, biconvex, film-coated tablets with the number “50” embossed on one side and smooth on the other. Lacosamide Teva, 100 mg are yellow, oval, biconvex, film-coated tablets with the number “100” embossed on one side and smooth on the other. Lacosamide Teva, 150 mg are orange, oval, biconvex, film-coated tablets with the number “150” embossed on one side and smooth on the other. Lacosamide Teva, 200 mg are blue, oval, biconvex, film-coated tablets with the number “200” embossed on one side and smooth on the other. Lacosamide Teva is available in blisters of 14, 56, 98, 112, 168, 200, or 210 tablets, in single-dose blisters of 14x1, 56x1, 60x1, or 168x1 tablets, and in bottles of 60, 100, or 200 tablets. Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Teva B.V., Swensweg 5, 2031 GA Haarlem, Netherlands

Manufacturer:

TEVA Gyógyszergyár Zrt., Pallagi út 13, 4042 Debrecen, Hungary; Teva Operations Poland Sp. z o.o., ul. Mogilska 80, 31-546 Kraków; Merckle GmbH, Ludwig-Merckle-Strasse 3, 89143 Blaubeuren, Germany

For more information about this medicine and its authorized names in the European Economic Area, contact the marketing authorization holder:

Teva Pharmaceuticals Polska Sp. z o.o., ul. Emilii Plater 53, 00-113 Warsaw, tel.: (22) 345 93 00

Date of last revision of the package leaflet: October 2022