Breluncol

Package Leaflet: Information for the Patient

Breluncol, 10 mg, film-coated tablets

Breluncol, 25 mg, film-coated tablets

Breluncol, 50 mg, film-coated tablets

Breluncol, 75 mg, film-coated tablets

Breluncol, 100 mg, film-coated tablets

Brivaracetam

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

1. What is Breluncol and what is it used for

What is Breluncol

Breluncol contains the active substance brivaracetam. It belongs to a group of medicines called antiepileptics. These medicines are used to treat epilepsy.

What is Breluncol used for

• Breluncol is used in adults, adolescents, and children from 2 years of age.
• This medicine is used to treat epilepsy with partial seizures with or without secondary generalization.
• Partial seizures are seizures that affect only one side of the brain. Partial seizures can spread to other areas on both sides of the brain, which is called "secondary generalization".
• This medicine is used to reduce the number of seizures in the patient. Breluncol is given with other medicines used to treat epilepsy.

2. Important information before taking Breluncol

When not to take Breluncol:

• if you are allergic to brivaracetam, similar chemical compounds such as levetiracetam or piracetam, or any of the other ingredients of this medicine (listed in section 6). If you are unsure, consult your doctor or pharmacist before taking Breluncol.
• if you have ever had a severe skin rash or skin peeling, blisters, and (or) ulcers of the mouth after taking Breluncol. Serious skin reactions, including Stevens-Johnson syndrome, have been reported with Breluncol. If you notice any of the symptoms related to serious skin reactions

described in section 4, stop taking Breluncol and contact your doctor immediately.

Warnings and precautions

Before taking Breluncol, discuss with your doctor or pharmacist if:

• you have thoughts of self-harm or suicide. A small number of people taking antiepileptic medicines, such as Breluncol, have had thoughts of self-harm or suicide. If you have ever had such thoughts, contact your doctor immediately.
• you have liver problems, your doctor may decide to adjust the dose.

Children

Breluncol should not be given to children under 2 years of age.

Breluncol and other medicines

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

In particular, tell your doctor if you are taking any of the following medicines, as they may require a dose adjustment of Breluncol:

• rifampicin - a medicine used to treat bacterial infections.
• St. John's Wort (Hypericum perforatum), a herbal medicine used to treat depression, anxiety, and other disorders.

Breluncol with alcohol

• It is not recommended to take this medicine with alcohol.
• If you drink alcohol while taking Breluncol, the negative effects of alcohol may be increased.

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 child, consult your doctor or pharmacist before taking this medicine.

Breluncol should not be taken during pregnancy, as the effect of brivaracetam on pregnancy and the unborn child is not known.

Breastfeeding is not recommended during treatment with Breluncol, as brivaracetam passes into breast milk.

Do not stop treatment without consulting your doctor. Stopping treatment may lead to an increase in the number of seizures and harm the child.

Driving and using machines

• While taking Breluncol, drowsiness, dizziness, or fatigue may occur.
• These effects are more likely to occur at the start of treatment or when the dose is increased.
• Do not drive, ride a bike, or operate tools or machines until you are sure how the medicine affects you.

Breluncol contains lactose and sodium

• Lactose (a type of sugar)- If you have been diagnosed with intolerance to some sugars, contact your doctor before taking the medicine.
• Sodium- this medicine contains less than 1 mmol of sodium (23 mg) per film-coated tablet, which means it is considered "sodium-free".

3. How to take Breluncol

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

For some patients, such as children, other forms of this medicine (e.g., if the child cannot swallow the tablet whole) may be more suitable; consult your doctor or pharmacist.

Breluncol is used with other medicines to treat epilepsy.

What dose to take

Your doctor will determine the correct dose for you. The daily dose should be taken in two equal divided doses, approximately every 12 hours.

Only for the 10 mg dose: the tablet can be divided into equal doses.

Adolescents, children with a body weight of 50 kg or more, and adults

• The recommended dose is from 25 mg to 100 mg twice a day. After starting treatment, your doctor may adjust the dose to find the most suitable dose for you.

Adolescents and children with a body weight from 20 kg to less than 50 kg

• The recommended dose is from 0.5 mg to 2 mg per kilogram of body weight twice a day. After starting treatment, your doctor may adjust the dose to find the most suitable dose for you.

Children with a body weight from 10 kg to less than 20 kg

• The recommended dose is from 0.5 mg to 2.5 mg per kilogram of body weight twice a day. Your doctor may then decide to adjust the dose to find the best dose for the child.

Patients with liver function disorders

• In adolescents and children with a body weight of 50 kg or more, and adults, the maximum dose is 75 mg twice a day;
• In adolescents and children with a body weight from 20 kg to less than 50 kg, the maximum dose is 1.5 mg per kilogram of body weight twice a day.
• In children with a body weight from 10 kg to less than 20 kg, the maximum dose is 2 mg per kilogram of body weight twice a day.

How to take Breluncol tablets

• Swallow the tablets whole with a glass of liquid.
• This medicine can be taken with or without food.

How long to take Breluncol

Breluncol is intended for long-term use - it should be taken until your doctor decides to stop it.

What to do if you take more Breluncol than you should

If you take more Breluncol than you should, contact your doctor. You may experience dizziness and drowsiness. You may also experience any of the following symptoms: nausea, feeling of spinning, balance problems, anxiety, feeling of extreme fatigue, irritability, aggression, insomnia, depression, and thoughts of self-harm or suicide.

What to do if you miss a dose of Breluncol

If you miss a dose, take the missed dose as soon as possible. Take the next dose at the usual time.

• Do not take a double dose to make up for the missed dose.
• If you are unsure, consult your doctor or pharmacist.

What to do if you want to stop taking Breluncol

• Do not stop taking this medicine unless your doctor tells you to. Stopping treatment may lead to an increase in the number of seizures.
• If your doctor decides to stop treatment, the dose will be gradually reduced. This will help prevent the return or worsening of seizures.

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

4. Possible side effects

Like all medicines, Breluncol can cause side effects, although not everybody gets them.

Very common:may affect more than 1 in 10 people

• drowsiness or dizziness.

Common:may affect up to 1 in 10 people

• flu
• feeling of extreme fatigue
• seizures, feeling of spinning (dizziness)
• nausea, constipation
• depression, anxiety, insomnia, irritability
• nose and throat infections (such as a cold), cough
• decreased appetite

Uncommon:may affect up to 1 in 100 people

• allergic reactions;
• thought disorders and (or) loss of contact with reality (psychotic disorders), aggression, excitement;
• thoughts of self-harm or suicide or attempts - in such cases, inform your doctor immediately;
• decrease in white blood cell count (neutropenia) - confirmed by blood tests.

Rare:may affect up to 1 in 1,000 people

• widespread rash with blisters and skin peeling, especially around the mouth, nose, eyes, and genitals (Stevens-Johnson syndrome).

Additional side effects in children

Common:may affect up to 1 in 10 people

• restlessness and hyperactivity (excessive psychomotor activity).

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

5. How to store Breluncol

• Keep this 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 that month.
• There are no special storage instructions for this 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 pack and other information

The active substance is brivaracetam.

Breluncol, 10 mg: each film-coated tablet contains 10 mg of brivaracetam

Breluncol, 25 mg: each film-coated tablet contains 25 mg of brivaracetam

Breluncol, 50 mg: each film-coated tablet contains 50 mg of brivaracetam

Breluncol, 75 mg: each film-coated tablet contains 75 mg of brivaracetam

Breluncol, 100 mg: each film-coated tablet contains 100 mg of brivaracetam

The other ingredients are:

• Core: lactose monohydrate, microcrystalline cellulose (type 102) (E460), hypromellose 2910 (5 mPas) (E464), sodium croscarmellose, colloidal anhydrous silica (E551), magnesium stearate (E470b)
• Coating: polyvinyl alcohol (E1203), calcium carbonate (E170), macrogol 4000 (E1521), talc (E553b)

Breluncol, 25 mg, film-coated tablets also contain: iron oxide black (E172), iron oxide yellow (E172)

Breluncol, 50 mg, film-coated tablets also contain: iron oxide yellow (E172)

Breluncol, 75 mg, film-coated tablets also contain: iron oxide black (E172), iron oxide red (E172)

Breluncol, 100 mg, film-coated tablets also contain: iron oxide yellow (E172), iron oxide black (E172)

What Breluncol looks like and contents of the pack

Breluncol, 10 mg, film-coated tablets are white or almost white, round, biconvex film-coated tablets with "10" engraved on one side and a score line on the other side.

Breluncol, 25 mg, film-coated tablets are gray, oval, biconvex film-coated tablets with "25" engraved on one side and smooth on the other side.

Breluncol, 50 mg, film-coated tablets are yellow, oval, biconvex film-coated tablets with "50" engraved on one side and smooth on the other side.

Breluncol, 75 mg, film-coated tablets are purple, oval, biconvex film-coated tablets with "75" engraved on one side and smooth on the other side.

Breluncol, 100 mg, film-coated tablets are green, oval, biconvex film-coated tablets with "100" engraved on one side and smooth on the other side.

Packaging in blisters

Breluncol is available in aluminum/OPA/aluminum/PVC blisters containing 14, 56, or 100 film-coated tablets or in collective packaging containing 168 (3 packages of 56 film-coated tablets) or in single-dose perforated blisters 14 x 1, 56 x 1, or 100 x 1 film-coated tablets or in collective packaging containing 168 (3 packages of 56 x 1 film-coated tablets).

Breluncol is also available in high-density polyethylene (HDPE) bottles, closed with a polypropylene (PP) cap with a child-resistant closure, containing 60 film-coated tablets.

Not all pack sizes may be marketed.

Marketing authorization holder

Egis Pharmaceuticals PLC

Keresztúri út 30-38

1106 Budapest

Hungary

Manufacturer

PharOS MT Ltd.

HF62X, Hal Far Industrial Estate

Birzebbuga, BBG3000

Malta

Pharos Pharmaceutical Oriented Services Ltd.

Lesvou Street End, Thesi Loggos, Industrial Zone

144 52 Metamorfossi

Greece

This medicine is authorized in the Member States of the European Economic Area under the following names:

Czech Republic

Breluncol

Hungary

Breluncol 10 mg, 25 mg, 50 mg, 75 mg, 100 mg filmtabletta

Poland

Breluncol

Romania

Breluncol 10 mg, 25 mg, 50 mg, 75 mg, 100 mg comprimate filmate

Slovakia

Breluncol 10 mg, 25 mg, 50 mg, 75 mg, 100 mg

To obtain more detailed information on this medicine, please contact the local representative of the marketing authorization holder:

EGIS Polska Sp. z o.o.

ul. Komitetu Obrony Robotników 45D

02-146 Warsaw

Tel.: +48 22 417 92 00

Date of last revision of the leaflet: