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, you may need to read it again.
• In case of any doubts, consult a 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.
• If the patient experiences any side effects, including any possible side effects not listed in this leaflet, they should inform 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 partial-onset 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 be genetically determined).

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). In case of doubt about the existence of an allergy, consult a 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, do not take Lacosamide Zentiva. In case of doubt, consult a doctor or pharmacist before taking this medicine.

Warnings and precautions

Before starting treatment with Lacosamide Zentiva, discuss with your doctor if:

• the patient thinks about self-harm or suicide. In some patients treated with antiepileptic medicines, such as lacosamide, thoughts of self-harm or suicide have occurred. If such thoughts ever occur, contact a doctor immediately.
• the patient has a heart disease that affects the heart rhythm - often it is slowed, accelerated, or irregular (i.e., atrioventricular block, atrial flutter, or atrial fibrillation).
• 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, be cautious until the body gets used to the effect of the medicine.

If any of the above situations occur (or there are doubts about them), consult a doctor or pharmacist before starting treatment with Lacosamide Zentiva.
In case of taking Lacosamide Zentiva, report to the doctor any new type of seizures or worsening of existing seizures.
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), seek medical attention immediately (see section 4).

Children

Lacosamide Zentiva 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 of the medicine in children of this age is not yet known, and it is not known whether it is safe for them.

Lacosamide Zentiva and other medicines

Tell your doctor about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
Particularly, tell your doctor or pharmacist if you are taking any of the following medicines that affect heart function, as Lacosamide Zentiva also affects heart function:

• medicines used for heart diseases;
• medicines that may cause prolongation of 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 in the treatment of certain types of heart rhythm disorders or heart failure. If any of the above situations occur or in case of doubt, consult a doctor or pharmacist before starting treatment with Lacosamide Zentiva. 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 Zentiva:
• medicines used for fungal infections, such as fluconazole, itraconazole, or ketoconazole;
• a medicine used for HIV infection, such as ritonavir;
• medicines used for bacterial infections, such as clarithromycin or rifampicin;
• a herbal medicine used for mild anxiety and depression - St. John's Wort. If any of the above situations occur or in case of doubt, consult a doctor or pharmacist before starting treatment with Lacosamide Zentiva.

Lacosamide Zentiva with alcohol

For safety reasons, do 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 a doctor or pharmacist before taking this medicine.
Lacosamide Zentiva is not recommended during pregnancy, as the effect of this medicine on pregnancy and the unborn child is not known. Breastfeeding is not recommended while taking Lacosamide Zentiva, as it passes into human milk. Immediately consult a doctor if the patient becomes pregnant or plans to become pregnant. The doctor will decide together with the patient whether to take Lacosamide Zentiva.
Do not stop treatment without consulting a 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

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

3. How to take Lacosamide Zentiva

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, consult your doctor or pharmacist. For children, other forms of this medicine may be more suitable; consult a doctor or pharmacist.
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 then 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. Continue taking Lacosamide Zentiva until your doctor tells you to stop.
The recommended doses of Lacosamide Zentiva for patients of different age groups and body weights are shown below. Your doctor may prescribe a different dose if you have 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.
Your doctor may also start treatment with a dose of 100 mg twice a day.
Your 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.
Your 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. Then, 12 hours later, 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-onset seizures: remember that Lacosamide Zentiva is not recommended for children under 2 years of age.
For the treatment of primary generalized tonic-clonic seizures: 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

In case of taking a higher dose of Lacosamide Zentiva than recommended, immediately contact a doctor. Do not attempt 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 delayed by less than 6 hours, take the missed dose as soon as possible.
• If a dose is delayed by more than 6 hours, do not take the missed dose. Instead, take the next dose of Lacosamide Zentiva at the usual time.
• Do not take a double dose to make up for a missed dose.

Stopping treatment with Lacosamide Zentiva

• Do not stop taking Lacosamide Zentiva without discussing it with your 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.

In case of any doubts related to the use of this medicine, consult a 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 stronger after taking a single loading dose.

Tell your doctor or pharmacist if you experience any of the following symptoms:

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

• Headache;
• Dizziness or nausea (nausea);
• Double vision.

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

• Short muscle jerks 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 (sensory impairment), speech disturbances (dysarthria), attention disturbances;
• Ringing in the ears (such as buzzing, ringing, or hissing);
• Irritability, difficulty sleeping, depression;
• Sleepiness, fatigue, or weakness (asthenia);
• Itching, rash.

Uncommon:may occur less frequently 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 blood test results for liver function (abnormal liver function, liver damage);
• Thoughts of self-harm or suicide or attempted suicide: immediately inform a doctor;
• Feeling of anger or agitation;
• 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 (dyskinesia). 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 sleepy 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 any possible side effects not listed in this leaflet, tell your 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.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Lacosamide Zentiva

Keep the medicine out of the 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. Ask your pharmacist how to dispose of medicines no longer required. 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, low-substituted hydroxypropylcellulose, crospovidone, hydroxypropylcellulose, anhydrous colloidal silica, magnesium stearate. Tablet coating: hypromellose, hydroxypropylcellulose, macrogol, talc, titanium dioxide (E171), dyes. The dyes are: Tablet 100 mg: yellow iron oxide (E 172), brown iron oxide (E 172), red iron oxide (E 172). Tablet 150 mg: yellow iron oxide (E 172). Tablet 200 mg: red iron oxide (E 172).

What Lacosamide Zentiva looks like and contents of the pack

Lacosamide Zentiva 50 mg: white or almost white, elongated, film-coated tablets with approximate dimensions of 10 mm x 5 mm.
Lacosamide Zentiva 100 mg: orange, elongated, film-coated tablets with approximate dimensions of 12 mm x 6 mm.
Lacosamide Zentiva 150 mg: yellow, elongated, film-coated tablets with approximate dimensions of 14 mm x 7 mm.
Lacosamide Zentiva 200 mg: pink, elongated, film-coated tablets with approximate dimensions of 15 mm x 8 mm.
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