Zilibra

Package Leaflet: Information for the Patient

Zilibra, 50 mg, Coated Tablets

Zilibra, 100 mg, Coated Tablets

Zilibra, 150 mg, Coated Tablets

Zilibra, 200 mg, Coated Tablets

Lacosamide

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

• 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 any not listed in this leaflet, please tell your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

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

1. What is Zilibra and what is it used for

What is Zilibra

Zilibra contains lacosamide. It belongs to a group of medicines called "antiepileptic medicines", which are used to treat epilepsy.

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

What is Zilibra used for

• Zilibra is used in adults, adolescents, and children from 4 years of age.
• This medicine is used to treat a type of epilepsy called "partial seizures and partial secondary generalized 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.
• Zilibra can be used alone (as monotherapy) or with other antiepileptic medicines (as adjunctive therapy).

2. Important information before taking Zilibra

When not to take Zilibra:

• 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 second- or third-degree atrioventricular block. If any of the above applies to you, do not take Zilibra. If you are unsure, consult your doctor or pharmacist before taking this medicine.

Warnings and precautions

Before starting treatment with Zilibra, tell your doctor if:

• you are thinking 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 your heart rhythm - it is often slow, fast, or irregular (i.e., atrioventricular 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. Zilibra may cause dizziness, which may increase the risk of accidental injury or falls. Therefore, be cautious until you are used to the effect of the medicine. If any of the above applies (or if you are unsure), consult your doctor or pharmacist before taking Zilibra.

Children under 4 years

Zilibra is not recommended for children under 4 years of age, as its efficacy in this age group is not yet known and it is not known whether it is safe for children.

Zilibra with other medicines

Tell your doctor or pharmacist about all medicines you are taking now or have recently taken, and about any medicines you plan to take.

• medicines used for heart conditions;
• medicines that may prolong the PR interval (visible on an electrocardiogram), such as medicines used to treat epilepsy or pain, e.g., carbamazepine, lamotrigine, or pregabalin;
• medicines used to treat certain types of irregular heartbeat or heart failure. If any of the above applies (or if you are unsure), consult your doctor or pharmacist before taking Zilibra.

Also, tell your doctor or pharmacist if you are taking any of the following medicines, as they may decrease or increase the effectiveness of Zilibra:

• medicines used for fungal infections - fluconazole, itraconazole, or ketoconazole;
• a medicine used for HIV infection - ritonavir;
• medicines used for bacterial infections - clarithromycin or rifampicin;
• a herbal medicine used for mild anxiety and depression - St. John's Wort (Hypericum perforatum). If any of the above applies (or if you are unsure), consult your doctor or pharmacist before taking Zilibra.

Zilibra with alcohol

For safety reasons, do not drink alcohol while taking Zilibra.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before taking this medicine.

Zilibra should not be taken during pregnancy or breastfeeding, as its effect on pregnancy and the unborn child or newborn is not known. It is also not known whether Zilibra passes into breast milk. Consult your doctor urgently if you become pregnant or plan to become pregnant. Your doctor will help you decide whether to take Zilibra.

Do not stop treatment without consulting your doctor, as this may increase the frequency of seizures. The severity of the symptoms of the disease in the mother 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 Zilibra may cause dizziness or blurred vision.

Zilibra, 50 mg, Coated Tablets contain sodium

The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means it is essentially "sodium-free".

Zilibra, 200 mg, Coated Tablets contain sodium

The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means it is essentially "sodium-free".

3. How to take Zilibra

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

Taking Zilibra

• Take Zilibra twice a day - once in the morning and once in the evening.
• Take the medicine at about the same time every day.
• Swallow the Zilibra tablet with a glass of water.
• Zilibra 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 (the "maintenance dose") is reached, you will continue to take it daily. Zilibra is used for long-term treatment. Continue taking Zilibra until your doctor tells you to stop.

What dose to take

The following are the typical recommended doses of Zilibra 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:

Taking Zilibra alone (monotherapy)

The usual starting dose of Zilibra is 50 mg twice a day.

Your doctor may also recommend starting 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 the maintenance dose, which is between 100 mg and 300 mg twice a day, is reached.

Taking Zilibra with other antiepileptic medicines (adjunctive therapy)

The usual starting dose of Zilibra is 50 mg twice a day.

Your doctor may increase the dose (given twice a day) by 50 mg every week until the maintenance dose, which is between 100 mg and 200 mg twice a day, is reached.

If you weigh 50 kg or more, your doctor may decide to start Zilibra 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

The dose depends on the child's weight. Treatment usually starts with a syrup and is only switched to tablets if the child can swallow them and the correct dose can be achieved using the different tablet strengths. Your doctor will prescribe the medicine in the form that is most suitable for the child.

Taking more Zilibra than prescribed

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

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

Missing a dose of Zilibra

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

Stopping treatment with Zilibra

• Do not stop taking Zilibra without consulting your doctor, as the symptoms of epilepsy may return or worsen.
• If your doctor decides to stop treatment with Zilibra, they will inform you how to gradually reduce the dose.

If you have any questions about taking this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Zilibra 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".

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

• balance disorders, difficulty with coordination or walking, tremors, tingling, numbness (paresthesia), or muscle cramps, tendency to fall or bruise;
• memory disorders, thinking disorders, or problems finding words, confusion;
• rapid, uncontrolled eye movements (nystagmus), blurred vision;
• feeling of spinning (dizziness), feeling drunk;
• vomiting, dry mouth, constipation, indigestion, gas in the stomach or intestines (bloating), diarrhea;
• sensory disturbances (reduced sensitivity), speech disorders (articulation disorders), attention disorders;
• 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 disorders);
• excessive well-being, seeing and/or hearing things that do not exist;
• 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: contact your doctor immediately;
• 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.

Frequency not known:cannot be estimated from the available data

• sore throat, high temperature, and frequent infections. Blood tests may show a significant decrease in the number of white blood cells of a certain type (agranulocytosis);
• severe skin reaction, which may be accompanied by high temperature and flu-like symptoms, rash on the face, spreading rash, swollen lymph nodes (enlarged lymph nodes). Blood tests may show increased liver enzyme levels and an increased number of one type of white blood cell (eosinophilia);
• 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 causing skin peeling over more than 30% of the body surface (toxic epidermal necrolysis);
• seizures.

Additional side effects in children

Common:may affect up to 1 in 10 people

• decreased appetite;
• feeling sleepy or lacking energy;
• changes in behavior, the child does not behave as usual.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, please tell 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

Side effects can also be reported to the marketing authorization holder.

By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Zilibra

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

Do not use this medicine after the expiry date stated on the blister or carton after EXP. The expiry date refers to the last day of the month.

The inscription on the packaging after the abbreviation EXP indicates the expiry date, and after the abbreviation Lot/LOT, it indicates the batch number.

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 that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Zilibra contains

The active substance is lacosamide.

One Zilibra 50 mg tablet contains 50 mg of lacosamide.

One Zilibra 100 mg tablet contains 100 mg of lacosamide.

One Zilibra 150 mg tablet contains 150 mg of lacosamide.

One Zilibra 200 mg tablet contains 200 mg of lacosamide.

The other ingredients are:

Tablet core: microcrystalline cellulose (type 101), hydroxypropylcellulose, low-substituted hydroxypropylcellulose (LH 21), microcrystalline cellulose, siliconized (HD 90), crospovidone (type B), magnesium stearate.

Tablet coating: polyvinyl alcohol, macrogol, talc, titanium dioxide (E 171), dyes*.

*The dyes are:

50 mg tablet: iron oxide red (E 172), iron oxide black (E 172), indigo carmine, lake (E 132).

100 mg tablet: iron oxide yellow (E 172).

150 mg tablet: iron oxide yellow (E 172), iron oxide red (E 172), iron oxide black (E 172).

200 mg tablet: indigo carmine, lake (E 132).

What Zilibra looks like and contents of the pack

Zilibra, 50 mg: pinkish, oval, coated tablets marked "LAC" on one side and "50" on the other.

Zilibra, 100 mg: dark yellow, oval, coated tablets marked "LAC" on one side and "100" on the other.

Zilibra, 150 mg: salmon, oval, coated tablets marked "LAC" on one side and "150" on the other.

Zilibra, 200 mg: blue, oval, coated tablets marked "LAC" on one side and "200" on the other.

Zilibra is packaged in PVC/PVDC/Aluminum blisters, in a carton box. Packs of 14, 56, 84 coated tablets.

Marketing authorization holder and manufacturer

Marketing authorization holder

Pharmaceutical Works POLPHARMA S.A.

ul. Pelplińska 19, 83-200 Starogard Gdański

tel. +48 22 364 61 01

Manufacturer

Combino Pharm (Malta) Ltd.

HF60 Hal Far Industrial Estate

Hal Far BBG3000

Malta

SVUS Pharma a.s.

Smetanovo nábřeží 1238/20a

500 02 Hradec Králové

Czech Republic

Simvis Pharmaceuticals S.A.

Asklipiou 4-6, Kryoneri

Attiki, 14568, Greece

Date of last revision of the leaflet:May 2022