Brabela

Patient Information Leaflet

Brabela, 10 mg, film-coated tablets
Brabela, 25 mg, film-coated tablets
Brabela, 50 mg, film-coated tablets
Brabela, 75 mg, film-coated tablets
Brabela, 100 mg, film-coated tablets
Brivaracetam
Please read this leaflet carefully before taking this medicine, as it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, please 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, tell your doctor or pharmacist. See section 4.

Contents of the leaflet

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

1. What Brabela is and what it is used for

What Brabela is
Brabela contains the active substance brivaracetam. It belongs to a group of medicines called antiepileptic medicines. These medicines are used in the treatment of epilepsy.

What Brabela is used for

• Brabela is used in adults, adolescents and children from 2 years of age.
• This medicine is used to treat partial-onset seizures with or without secondary generalisation.
• Partial-onset seizures are seizures affecting only one side of the brain. Partial seizures may spread to further areas on both sides of the brain, which is called "secondary generalisation".
• This medicine is used to reduce the number of seizures you experience.
• Brabela is given in addition to other medicines used to treat epilepsy.

2. Important information before taking Brabela

When not to take Brabela:

• if the patient is allergic to brivaracetam, related 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 about this, they should consult a doctor or pharmacist before starting treatment with Brabela.

• if the patient has ever experienced severe skin rash, skin peeling, blistering, and/or mouth ulcers after taking brivaracetam.

Serious skin reactions, including Stevens-Johnson syndrome, have been reported with brivaracetam treatment. If any symptoms related to serious skin reactions described in section 4 occur, treatment with Brabela must be discontinued immediately and medical advice must be sought without delay.

Warnings and precautions

Before starting treatment with Brabela, discuss with a doctor or pharmacist if:

• the patient has thoughts of self-harm or suicide. A small number of patients treated with antiepileptic medicines such as Brabela have had thoughts about self-harm or suicidal thoughts. If such thoughts occur, contact a doctor immediately.

• the patient has liver function disorders – in such cases, the doctor may decide to adjust the dose.

Children

Brabela must not be given to children under 2 years of age.

Brabela with other medicines

Inform the doctor or pharmacist about all medicines currently taken or recently taken, as well as any medicines the patient intends to take.

In particular, inform the doctor if the patient is taking any of the following medicines, as this may require adjustment of the Brabela dose:

• 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.

Brabela and alcohol

• It is not recommended to take this medicine with alcohol.
• If the patient drinks alcohol while taking Brabela, the negative effects of alcohol may be intensified.

Pregnancy and breastfeeding

Women of childbearing age should discuss contraception with their doctor.

If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult a doctor or pharmacist before using this medicine.

Brabela is not recommended during pregnancy, as the effect of Brabela on pregnancy and the unborn child is unknown.

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

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

Driving and operating machinery

• During treatment with Brabela, drowsiness, dizziness, or fatigue may occur.
• These effects are more likely at the beginning of treatment or after an increase in dose.
• Do not drive, ride a bicycle, or operate tools or machinery until the patient knows how the medicine affects them.

Brabela contains lactose and sodium

Brabela coated tablets contain:

• lactose (a type of sugar) – if the patient has previously been diagnosed with intolerance to certain sugars, they should contact their doctor before taking this medicine.
• sodium – the medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free".

3. How to take Brabela

This medicine should always be taken according to the doctor's instructions. If in doubt, consult your doctor or pharmacist. For some patients, such as children, other forms of this medicine may be more suitable (for example, if a child cannot swallow the tablet whole); please consult your doctor or pharmacist.
Brabela will be used together with other antiepileptic medicines.

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

Youth and children weighing 50 kg or more, and adults

• The recommended dose is 25 mg to 100 mg twice daily. After starting treatment, your doctor may adjust the dose to determine the most appropriate dose for the individual patient.

Youth 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 daily. After starting treatment, your doctor may adjust the dose to determine the most appropriate dose for the individual patient.

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 daily. Your doctor may then decide to adjust the dose to determine the best dose for the child.

Patients with hepatic impairment
For patients with impaired liver function:

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

How to take Brabela tablets

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

How long to take Brabela
Brabela is intended for long-term use – continue taking it until your doctor decides otherwise.

Taking more Brabela than recommended
If you take more Brabela than recommended, contact your doctor immediately. Symptoms may include dizziness and drowsiness. Other possible symptoms include nausea, vertigo, problems with balance, anxiety, extreme fatigue, irritability, aggression, insomnia, depression, and thoughts or attempts of self-harm or suicide.

If you miss a dose of Brabela

• If you miss a dose, take it as soon as possible.
• Take the next dose at the usual time.
• Do not take a double dose to make up for a missed dose.
• If in doubt, consult your doctor or pharmacist.

Stopping Brabela

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

If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.

Very common: may affect more than 1 in 10 people

• drowsiness or dizziness.

Common: may affect up to 1 in 10 people

• flu-like symptoms
• feeling very tired
• seizures, sensation of spinning (dizziness)
• nausea and vomiting, constipation
• depression, anxiety, insomnia, irritability
• infections of the nose and throat (e.g. colds), cough
• decreased appetite.

Uncommon: may affect up to 1 in 100 people

• allergic reactions
• disturbances in thinking and (or) loss of contact with reality (psychotic disorders), aggression, nervous excitement (agitation)
• thoughts of self-harm or suicide, or self-harming or suicidal attempts – in such cases, contact your doctor immediately
• reduced number of white blood cells (neutropenia) – confirmed by blood test.

Frequency unknown: frequency cannot be estimated from the available data

• widespread rash with blisters and peeling of the skin, particularly around the mouth, nose, eyes and genital organs (Stevens-Johnson syndrome).

Additional side effects in children
Common: may affect up to 1 in 10 people

• restlessness and hyperactivity (excessive psychomotor activity).

Reporting of side effects
If any side effects occur, including any side effects not listed in this leaflet, inform your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Drug Reactions 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.
Reporting side effects helps to provide more information on the safety of the medicine.

5. How to store Brabela

• Keep this medicine out of sight and reach of children.
• Do not use this medicine after the expiry date stated on the carton and blister pack following "EXP". The expiry date refers to the last day of the stated month.
• No special storage instructions apply.
• Medicines must 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 Brabela Contains
The active substance in Brabela is brivaracetam.
Each film-coated tablet contains 10 mg, 25 mg, 50 mg, 75 mg, or 100 mg of brivaracetam.
The other ingredients are:
Tablet core
Monohydrate lactose, sodium croscarmellose, lactose, magnesium stearate.
Tablet coating
Brabela 10 mg: Polyvinyl alcohol (E 1203), titanium dioxide (E 171), macrogol 4000, talc.
Brabela 25 mg: Polyvinyl alcohol (E 1203), titanium dioxide (E 171), macrogol 4000, talc,
black iron oxide (E 172), yellow iron oxide (E 172).
Brabela 50 mg: Polyvinyl alcohol (E 1203), titanium dioxide (E 171), macrogol 4000, talc,
yellow iron oxide (E 172), red iron oxide (E 172).
Brabela 75 mg: Polyvinyl alcohol (E 1203), titanium dioxide (E 171), macrogol 4000, talc,
red iron oxide (E 172), black iron oxide (E 172), yellow iron oxide (E 172).
Brabela 100 mg: Polyvinyl alcohol (E 1203), titanium dioxide (E 171), macrogol 4000, talc,
yellow iron oxide (E 172), black iron oxide (E 172).

What Brabela Looks Like and Contents of the Packaging
Brabela 10 mg tablets are white, round (5.5 mm in diameter), biconvex, film-coated tablets, embossed with the number "10" on one side and smooth on the other.
Brabela 25 mg tablets are grey, oval (8.9 mm x 5.0 mm), biconvex, film-coated tablets, embossed with the number "25" on one side and smooth on the other.
Brabela 50 mg tablets are yellow, oval (11.7 mm x 6.5 mm), biconvex, film-coated tablets, embossed with the number "50" on one side and smooth on the other.
Brabela 75 mg tablets are violet, oval (13.0 mm x 7.3 mm), biconvex, film-coated tablets, embossed with the number "75" on one side and smooth on the other.
Brabela 100 mg tablets are green-grey, oval (14.5 mm x 8.1 mm), biconvex, film-coated tablets, embossed with the number "100" on one side and smooth on the other.

Brabela 10 mg film-coated tablets are packaged in
PVC/PCTFE (Aclar) - Aluminium or PVC/PE/PVDC - Aluminium blisters, in a cardboard box containing 14 or 28 film-coated tablets.

Brabela 25 mg film-coated tablets are packaged in
PVC/PCTFE (Aclar) - Aluminium or PVC/PE/PVDC - Aluminium blisters, in a cardboard box containing 28 or 56 film-coated tablets.
HDPE bottle with PP closure and silica gel desiccant in a cardboard box containing 56 film-coated tablets.

Brabela 50 mg film-coated tablets are packaged in
PVC/PCTFE (Aclar) - Aluminium or PVC/PE/PVDC - Aluminium blisters, in a cardboard box containing 56 film-coated tablets.
HDPE bottle with PP closure and silica gel desiccant in a cardboard box containing 56 film-coated tablets, in a cardboard box.

Brabela 75 mg film-coated tablets are packaged in
PVC/PCTFE (Aclar) - Aluminium or PVC/PE/PVDC - Aluminium blisters, in a cardboard box containing 56 film-coated tablets.
HDPE bottle with PP closure and silica gel desiccant in a cardboard box containing 56 film-coated tablets, in a cardboard box.

Brabela 100 mg film-coated tablets are packaged in
PVC/PCTFE (Aclar) - Aluminium or PVC/PE/PVDC - Aluminium blisters, in a cardboard box containing 56 film-coated tablets.
HDPE bottle with PP closure and silica gel desiccant in a cardboard box containing 56 film-coated tablets, in a cardboard box.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer/Importer
Marketing Authorisation Holder
Exeltis Poland Sp. z o.o.
ul. Szamocka 8
01-748 Warsaw
e-mail: [email protected]

Manufacturer/Importer
LABORATORIOS LICONSA S.A.
Avda. Miralcampo, 7
Polígono Industrial Miralcampo
19200 Azuqueca de Henares (Guadalajara)
Spain

This medicinal product is authorised for marketing in the European Economic Area under the following names:
Finland: Brabela 10 mg kalvopäällysteiset tabletit
Brabela 25 mg kalvopäällysteiset tabletit
Brabela 50 mg kalvopäällysteiset tabletit
Brabela 75 mg kalvopäällysteiset tabletit
Brabela 100 mg kalvopäällysteiset tabletit
Poland: Brabela
Hungary: Brivelex 10 mg filmtabletta
Brivelex 25 mg filmtabletta
Brivelex 50 mg filmtabletta
Brivelex 75 mg filmtabletta
Brivelex 100 mg filmtabletta