Breluncol

Leaflet attached to the packaging: patient information

Breluncol, 10 mg, coated tablets

Breluncol, 25 mg, coated tablets

Breluncol, 50 mg, coated tablets

Breluncol, 75 mg, coated tablets

Breluncol, 100 mg, coated tablets

Brivaracetam

You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so you can read it again if you need to.
• If you have any doubts, you should 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 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 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 packaging 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 the patient is 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 the patient has any doubts, they should consult a doctor or pharmacist before taking Breluncol.
• if the patient has ever experienced a severe skin rash or skin peeling, blistering, and (or) ulcers of the mouth after taking Breluncol. Serious skin reactions, including Stevens-Johnson syndrome, have been reported with Breluncol. If the patient notices any of the symptoms associated with serious skin reactions

described in section 4, they should stop taking Breluncol and contact their doctor immediately.

Warnings and precautions

Before taking Breluncol, the patient should discuss it with their doctor or pharmacist if:

• the patient has 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 the patient has ever had such thoughts, they should contact their doctor immediately.
• the patient has liver problems, in which case the doctor may decide to adjust the dose.

Children

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

Breluncol and other medicines

The patient should tell their doctor or pharmacist about all medicines they are taking, have recently taken, or plan to take.

• 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 the patient drinks alcohol while taking Breluncol, the negative effects of alcohol may be enhanced.

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.

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

Breastfeeding should not be done while taking Breluncol, as brivaracetam passes into breast milk.

The patient should not stop taking the medicine without consulting their doctor. Stopping the treatment may lead to an increase in the number of epileptic seizures and harm the child.

Driving and using machines

• While taking Breluncol, the patient may experience drowsiness, dizziness, or fatigue.
• These effects are more likely to occur at the beginning of treatment or after increasing the dose.
• The patient should not drive, ride a bike, or operate tools or machines until they are sure how the medicine affects them.

Breluncol contains lactose and sodium

• - If the patient has been diagnosed with intolerance to some sugars, they should contact their doctor before taking the medicine.
• - This medicine contains less than 1 mmol of sodium (23 mg) per coated tablet, which means it is considered "sodium-free".

3. How to take Breluncol

This medicine should always be taken as directed by the doctor. If the patient has any doubts, they should consult their 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; the patient should consult their doctor or pharmacist.

Breluncol is used with other medicines to treat epilepsy.

What dose to take

The doctor will determine the appropriate dose for the patient. 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.

• For adolescents, children weighing 50 kg or more, and adults, the recommended dose is 25 mg to 100 mg twice a day. After starting treatment, the doctor may adjust the dose to determine the most suitable dose for the patient.

For adolescents and children weighing between 20 kg and less than 50 kg

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

For children weighing between 10 kg and less than 20 kg

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

For patients with liver function disorders

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

How to take Breluncol tablets

• The tablets should be swallowed 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 the doctor decides to stop it.

Taking more Breluncol than recommended

If the patient takes more Breluncol than recommended, they should consult their doctor. Dizziness and drowsiness may occur. The patient may also experience any of the following symptoms: nausea, vertigo, balance problems, anxiety, fatigue, irritability, aggression, insomnia, depression, and thoughts of self-harm or suicide.

Missing a dose of Breluncol

If the patient misses a dose, they should take the missed dose as soon as possible. The next dose should be taken at the usual time.

• The patient should not take a double dose to make up for the missed dose.
• If the patient has any doubts, they should consult their doctor or pharmacist.

Stopping Breluncol

• Unless the doctor advises otherwise, the patient should not stop taking this medicine. This is because stopping treatment may lead to an increase in the number of epileptic seizures.
• If the doctor decides to stop the treatment, the dose will be gradually reduced. This will help prevent the recurrence or worsening of seizures.

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

4. Possible side effects

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

may affect more than 1 in 10 people

• drowsiness or dizziness.

may affect up to 1 in 10 people

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

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, the doctor should be informed immediately;
• decrease in white blood cell count (neutropenia) - confirmed by a blood test.

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

may affect up to 1 in 10 people

• restlessness and hyperactivity (psychomotor hyperactivity).

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in the leaflet, they 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. By reporting side effects, more information can be gathered on the safety of the medicine.

5. How to store Breluncol

• 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 stated.
• 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

The active substance is brivaracetam.

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

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

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

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

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

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

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

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

What Breluncol looks like and contents of the pack

Breluncol, 10 mg, coated tablets are white or almost white, round, biconvex coated tablets, with the inscription "10" on one side and a dividing line on the other side.

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

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

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

Breluncol, 100 mg, coated tablets are green, oval, biconvex coated tablets, with the inscription "100" 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 coated tablets or in collective packaging containing 168 (3 packages of 56 coated tablets) or in single-dose perforated blisters 14 x 1, 56 x 1, or 100 x 1 coated tablets or in collective packaging containing 168 (3 packages of 56 x 1 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 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, the patient should 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: