Lacosamide Zentiva

Leaflet accompanying the packaging: patient information

Lacosamide Zentiva, 50 mg, film-coated tablets

Lacosamide Zentiva, 100 mg, film-coated tablets

Lacosamide Zentiva, 150 mg, film-coated tablets

Lacosamide Zentiva, 200 mg, film-coated tablets

Lacosamide

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same as yours.
• If the patient experiences any side effects, including any possible side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Lacosamide Zentiva and what is it used for
• 2. Important information before taking Lacosamide Zentiva
• 3. How to take Lacosamide Zentiva
• 4. Possible side effects
• 5. How to store Lacosamide Zentiva
• 6. Contents of the packaging and other information

1. What is Lacosamide Zentiva and what is it used for

Lacosamide Zentiva 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.

• Lacosamide Zentiva is used: as monotherapy and in combination with other antiepileptic medicines in adults, adolescents, and children from 2 years of age for the treatment of a type of epilepsy characterized by the occurrence of partial 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 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 considered to have a genetic basis).

2. Important information before taking Lacosamide Zentiva

When not to take Lacosamide Zentiva

• if the patient is allergic to lacosamide or any of the other ingredients of this medicine (listed in section 6). If in doubt, consult your doctor;
• if the patient has a certain type of heart rhythm disorder called second- or third-degree atrioventricular block. If any of the above situations apply to the patient, they should not take Lacosamide Zentiva. If in doubt, consult your doctor or pharmacist before taking this medicine.

Warnings and precautions

Before starting treatment with Lacosamide Zentiva, the patient should discuss with their doctor if:

• the patient thinks about self-harm or suicide. Some patients treated with antiepileptic medicines, such as lacosamide, have had thoughts of self-harm or suicide. If such thoughts occur, the patient should contact their doctor immediately.
• the patient has a heart condition that affects the heart rhythm - often it is slowed, accelerated, or irregular (i.e., atrioventricular block, atrial fibrillation, or atrial flutter).
• the patient has severe heart disease, such as heart failure or has had a heart attack.
• the patient often experiences dizziness or falls. Lacosamide Zentiva may cause dizziness, which may increase the risk of accidental injury or falls. Therefore, caution should be exercised until the body gets used to the effect of the medicine.

If any of the above situations occur (or if there is doubt), the patient should consult their doctor or pharmacist before starting treatment with Lacosamide Zentiva.
If the patient is taking Lacosamide Zentiva and experiences new types of seizures or worsening of existing seizures, they should tell their doctor.
If the patient is taking Lacosamide Zentiva and experiences symptoms of abnormal heart rhythm (such as slow, fast, or irregular heartbeat, palpitations, shortness of breath, feeling of dizziness, fainting), they should seek medical attention immediately (see section 4).

Children

Lacosamide Zentiva is not recommended for children under 2 years of age with partial seizures or under 4 years of age with primary generalized tonic-clonic seizures. The efficacy of the medicine in children of this age is not yet known, and it is not known if it is safe for them.

Lacosamide Zentiva and other medicines

The patient should tell their doctor about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
In particular, the patient should tell their doctor or pharmacist if they are taking any of the following medicines, which affect the heart, as Lacosamide Zentiva also affects the heart:

• medicines used for heart conditions;
• medicines that may prolong the PR interval (visible in the heart rhythm recording, i.e., electrocardiogram - ECG), such as medicines used to treat epilepsy or pain, e.g., carbamazepine, lamotrigine, or pregabalin;
• medicines used to treat certain types of heart rhythm disorders or heart failure. If any of the above situations occur or if there is doubt, the patient should consult their doctor or pharmacist before starting treatment with Lacosamide Zentiva. The patient should also tell their doctor or pharmacist if they are taking any of the following medicines, as they may decrease or increase the effectiveness of Lacosamide Zentiva:
• medicines used to treat fungal infections, such as fluconazole, itraconazole, or ketoconazole;
• medicines used to treat HIV infection, such as ritonavir;
• medicines used to treat bacterial infections, such as clarithromycin or rifampicin;
• a herbal medicine used to treat mild anxiety and depression - St. John's Wort. If any of the above situations occur or if there is doubt, the patient should consult their doctor or pharmacist before starting treatment with Lacosamide Zentiva.

Lacosamide Zentiva with alcohol

For safety reasons, the patient should not drink alcohol while taking Lacosamide Zentiva.

Pregnancy and breastfeeding

Women of childbearing age should discuss the use of contraception with their doctor.
If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine.
Lacosamide Zentiva is not recommended during pregnancy, as its effect on pregnancy and the unborn child is not known. Breastfeeding is not recommended while taking Lacosamide Zentiva, as it passes into human milk. The patient should seek medical attention immediately if they become pregnant or plan to become pregnant. The doctor will decide together with the patient whether to take Lacosamide Zentiva.
The patient should not stop treatment without consulting their doctor, as this may cause an increase in the frequency of seizures (fits). The worsening of the mother's disease symptoms may also harm the child.

Driving and using machines

The patient should not drive a car, ride a bike, or use tools or operate machinery until they are sure how the medicine affects them. This is because Lacosamide Zentiva may cause dizziness or blurred vision.

3. How to take Lacosamide Zentiva

This medicine should always be taken exactly as prescribed by the doctor or pharmacist. If in doubt, the patient should consult their doctor or pharmacist. For children, other forms of this medicine may be more suitable; the patient should consult their doctor or pharmacist.
The patient should take Lacosamide Zentiva twice a day, approximately every 12 hours.

• Take the medicine at about the same time every day.
• Swallow the Lacosamide Zentiva tablet with a glass of water.
• Lacosamide Zentiva can be taken with or without food.

Treatment usually starts with a low daily dose of the medicine, which the doctor will gradually increase over several weeks. After reaching the dose that is effective for the patient, called the maintenance dose, the patient will continue to take it daily. Lacosamide Zentiva is used for long-term treatment. The patient should continue taking Lacosamide Zentiva until their doctor tells them to stop.
The recommended doses of Lacosamide Zentiva for patients of different age groups and body weights are shown below. The doctor may prescribe a different dose if the patient has kidney or liver problems.

Use in adults, adolescents, and children with a body weight of at least 50 kg

Monotherapy with Lacosamide Zentiva:
The typical starting dose of Lacosamide Zentiva is 50 mg twice a day.
The doctor may also start treatment with a dose of 100 mg twice a day.
The doctor may increase the dose (taken twice a day) by 50 mg every week until a maintenance dose of 100 mg to 300 mg twice a day is reached.
Adjunctive therapy with Lacosamide Zentiva:
The typical starting dose of Lacosamide Zentiva is 50 mg twice a day.
The doctor may increase the dose (taken twice a day) by 50 mg every week until a maintenance dose of 100 mg to 200 mg twice a day is reached.
If the patient weighs at least 50 kg, the doctor may decide to start Lacosamide Zentiva with a single loading dose of 200 mg. After 12 hours, the patient will start taking the maintenance dose.

Use in children and adolescents with a body weight below 50 kg

For the treatment of partial seizures: the patient should remember that Lacosamide Zentiva is not recommended for children under 2 years of age.
For the treatment of primary generalized tonic-clonic seizures: the patient should remember that Lacosamide Zentiva is not recommended for children under 4 years of age.
The dose depends on the child's body weight. Treatment usually starts with a syrup and only switches to tablets if the child can swallow them and the correct dose can be achieved using tablets of different strengths. The doctor will prescribe the medicine in the form most suitable for the child.

Taking a higher dose of Lacosamide Zentiva than recommended

If a higher dose of Lacosamide Zentiva than recommended is taken, the patient should contact their doctor immediately. The patient should not try to drive. The patient may experience:

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

Missing a dose of Lacosamide Zentiva

• If a dose is missed by less than 6 hours, the patient should take the missed dose as soon as possible.
• If a dose is missed by more than 6 hours, the patient should not take the missed dose. Instead, they should take the next dose of Lacosamide Zentiva at the usual time.
• The patient should not take a double dose to make up for a missed dose.

Stopping treatment with Lacosamide Zentiva

• The patient should not stop taking Lacosamide Zentiva without discussing it with their doctor, as the symptoms of epilepsy may return or worsen.
• If the doctor decides to stop treatment with Lacosamide Zentiva, they will inform the patient how to gradually reduce the dose.

If the patient has any doubts about taking this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Lacosamide Zentiva can cause side effects, although not everybody gets them.
Side effects on the nervous system, such as dizziness, may be stronger after taking a single loading dose.

The patient should tell their doctor or pharmacist if they experience any of the following symptoms:

Very common:may occur more often than in 1 in 10 patients

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

Common:may occur less often than in 1 in 10 patients

• brief muscle twitches or muscle groups (myoclonic seizures);
• difficulty with coordination or walking;
• balance disorders, tremors, tingling (paresthesia), or muscle cramps, frequent falls or bruising;
• memory disorders, thinking disorders, or problems finding words, confusion;
• rapid and uncontrolled eye movements (nystagmus), blurred vision;
• feeling of spinning (dizziness), feeling of being drunk;
• vomiting, dry mouth, constipation, indigestion, excess gas in the stomach or intestines (bloating), diarrhea;
• sensory disturbances (weakness), speech disturbances (speech disorders), attention disorders;
• ringing in the ears (such as buzzing, ringing, or hissing);
• irritability, difficulty sleeping, depression;
• drowsiness, fatigue, or weakness (asthenia);
• itching, rash.

Uncommon:may occur less often than in 1 in 100 patients

• slow heart rate, palpitations, irregular heartbeat, or other changes in heart activity (conduction disorders);
• excessive well-being, seeing and/or hearing non-existent things;
• allergic reaction after taking the medicine, hives;
• abnormal liver function test results (abnormal liver function, liver damage);
• thoughts of self-harm or suicide or attempted suicide: the patient should immediately inform their doctor;
• feeling angry or agitated;
• thinking disorders or loss of contact with reality;
• severe allergic reactions causing swelling of the face, throat, hands, feet, ankles, or lower legs;
• fainting;
• abnormal involuntary movements (dyskinesias). Frequency not known: cannot be estimated from the available data
• abnormal rapid heart rate (ventricular tachycardia);
• sore throat, high fever, and more frequent infections. Blood tests may show a significant decrease in the number of a certain type of white blood cell (agranulocytosis);
• severe skin reaction, which may be accompanied by high fever and flu-like symptoms, rash on the face, spreading rash, swelling of lymph nodes (enlarged lymph nodes). Blood tests may show increased liver enzyme activity and the number of one type of white blood cell (eosinophilia);
• widespread rash with blisters and peeling skin, occurring mainly in the area of the mouth, eyes, nose, and genitals (Stevens-Johnson syndrome) and a more severe form of rash causing skin peeling over 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). Feeling drowsy is a very common side effect in children and may occur in more than 1 in 10 children.

Reporting side effects

If side effects occur, including any possible side effects not listed in the leaflet, the patient should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety 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
Side effects can also be reported to the marketing authorization holder or its representative in Poland.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Lacosamide Zentiva

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after "EXP". The expiry date refers to the last day of the month.
There are no special precautions for storing the medicine.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Lacosamide Zentiva contains

• The active substance is lacosamide. One Lacosamide Zentiva tablet contains 50 mg, 100 mg, 150 mg, or 200 mg of lacosamide.
• The other ingredients are: microcrystalline cellulose, hypromellose, crospovidone, hydroxypropylcellulose, colloidal anhydrous silica, magnesium stearate. Tablet coating: hypromellose, hydroxypropylcellulose, macrogol, talc, titanium dioxide (E171), dyes. The dyes are: 100 mg tablet: yellow iron oxide (E172), brown iron oxide (E172), red iron oxide (E172). 150 mg tablet: yellow iron oxide (E172). 200 mg tablet: red iron oxide (E172).

What Lacosamide Zentiva looks like and contents of the pack

Lacosamide Zentiva 50 mg: white or almost white, elongated, film-coated tablets, approximately 10 mm x 5 mm in size.
Lacosamide Zentiva 100 mg: orange, elongated, film-coated tablets, approximately 12 mm x 6 mm in size.
Lacosamide Zentiva 150 mg: yellow, elongated, film-coated tablets, approximately 14 mm x 7 mm in size.
Lacosamide Zentiva 200 mg: pink, elongated, film-coated tablets, approximately 15 mm x 8 mm in size.
Lacosamide Zentiva is available in packs of 14, 56, or 168 tablets, packaged in PVC/PVDC/Aluminum blisters.
Not all pack sizes may be marketed.

Marketing authorization holder

Zentiva k.s., U kabelovny 130, Dolni Mĕcholupy, 102 37 Prague 10, Czech Republic

Manufacturer

Zentiva k.s., U kabelovny 130, Dolni Mĕcholupy, 102 37 Prague 10, Czech Republic

This medicinal product is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Denmark, France, Greece, Poland, Czech Republic, Sweden, United Kingdom (Northern Ireland), Italy: Lacosamide Zentiva
Austria, Germany: Lacosamid Zentiva
Spain, Portugal: Lacosamida Zentiva
Date of last revision of the leaflet:August 2022