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
Please read this leaflet carefully before using this medicine, as it contains important information for you.

• Keep this leaflet so that you can read it again if necessary.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm someone else, even if their symptoms are the same as yours.
• If you experience any adverse reactions, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet

1. What Breluncol is and what it is 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 Breluncol is and what it is used for

What Breluncol is
Breluncol 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 Breluncol is used for

• Breluncol is used in adults, adolescents, and children from 2 years of age.
• It is used in the treatment of partial-onset seizures, with or without secondary generalization.
• Partial-onset seizures are seizures that start in one part of the brain. Partial-onset seizures may spread to involve both sides of the brain, which is known as "secondary generalization".
• This medicine is used to reduce the number of seizures in patients. Breluncol is given in combination 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 about this, they should consult a doctor or pharmacist before starting treatment with Breluncol.

• if the patient has ever experienced severe skin rash, skin peeling, blistering, and/or oral mucosal ulcers after taking Breluncol. Serious skin reactions, including Stevens-Johnson syndrome, have been reported with treatment using Breluncol. If any symptoms related to serious skin reactions
  described in section 4 occur,
  treatment with Breluncol must be discontinued immediately and the patient should contact a
  doctor immediately.
  Warnings and precautions
  Before starting treatment with Breluncol, discuss with a doctor or pharmacist if:

• the patient experiences thoughts of self-harm or suicide. In a small number of people treated with antiepileptic medicines such as Breluncol, thoughts about self-harm or suicidal thoughts have occurred. If such thoughts occur at any time, the patient should contact their doctor immediately.

• the patient has liver problems, in which case the doctor may decide to adjust the dose.

Children
Breluncol must not be given to children under 2 years of age.
Breluncol and other medicines
The patient should inform their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
In particular, the patient should inform their doctor if they are taking any of the following
medicines, as this may require adjustment of the Breluncol 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.

Breluncol and alcohol

• The use of this medicine with alcohol is not recommended.
• If the patient drinks alcohol while taking Breluncol, the negative effects of alcohol may be intensified.

Pregnancy and breastfeeding
Women of childbearing age should discuss the use of 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.
The use of Breluncol during pregnancy is not recommended, as the effect of brivaracetam on pregnancy and the unborn child is unknown.
Breastfeeding is not recommended during treatment with Breluncol, as brivaracetam passes into breast milk.
Treatment must not be stopped without consulting a doctor. Stopping treatment may lead to an increase in the number of epileptic seizures and may harm the child.
Driving and operating machinery

• Drowsiness, dizziness, or fatigue may occur while taking Breluncol.
• These effects are more likely at the beginning of treatment or after an increase in dose.
• The patient must not drive, ride a bicycle, or operate tools or machinery until they are certain how the medicine affects them.

Breluncol contains lactose and sodium

• 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 – this medicine contains less than 1 mmol of sodium (23 mg) per coated tablet, meaning the medicine is considered "sodium-free".

3. How to take Breluncol

This medicine should always be taken as prescribed by your doctor. 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 a tablet whole); please consult your doctor or pharmacist.

Breluncol is used together with other medicines in the treatment of epilepsy.

What dose should be taken

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

For the 10 mg strength only: the tablet may be divided into equal doses.

Adolescents, children with body weight of 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 you.

Adolescents and children with body weight from 20 kg to 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 you.

Children with body weight from 10 kg to 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 impaired liver function

In patients with impaired liver function:

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

How to take Breluncol tablets

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

How long to take Breluncol

Breluncol is intended for long-term use – continue taking it until your doctor decides otherwise.

Taking more Breluncol than prescribed

If you take more Breluncol than prescribed, contact your doctor immediately. Dizziness and drowsiness may occur. Other possible symptoms include: nausea, vertigo, problems with balance, anxiety, extreme tiredness, irritability, aggression, insomnia, depression, and thoughts or attempts of self-harm or suicide.

If you miss a dose of Breluncol

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 Breluncol

• Do not stop taking this medicine unless your doctor advises otherwise. Stopping treatment 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 will help 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 adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody will experience them.
Very common: may occur in more than 1 out of 10 people

• drowsiness or dizziness.

Common: may occur in less than 1 out of 10 people

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

Uncommon: may occur in less than 1 out of 100 people

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

Unknown: frequency cannot be estimated from available data

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

Additional adverse reactions in children
Common: may occur in less than 1 out of 10 people

• restlessness and hyperactivity (excessive psychomotor activity).

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department for Monitoring 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
Adverse reactions can also be reported to the marketing authorization holder. Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Breluncol

• Keep the 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 conditions apply.
• 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 brywaracetam.
Breluncol 10 mg: each coated tablet contains 10 mg of brywaracetam.
Breluncol 25 mg: each coated tablet contains 25 mg of brywaracetam.
Breluncol 50 mg: each coated tablet contains 50 mg of brywaracetam.
Breluncol 75 mg: each coated tablet contains 75 mg of brywaracetam.
Breluncol 100 mg: each coated tablet contains 100 mg of brywaracetam.

The other ingredients are:

• Core: monohydrate lactose, 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: black iron oxide (E172), yellow iron oxide (E172)
Breluncol 50 mg coated tablets also contain: yellow iron oxide (E172)
Breluncol 75 mg coated tablets also contain: black iron oxide (E172), red iron oxide (E172)
Breluncol 100 mg coated tablets also contain: yellow iron oxide (E172), black iron oxide (E172)

What Breluncol looks like and contents of the pack
Breluncol 10 mg coated tablets are white or almost white, round, biconvex coated tablets, embossed with the number "10" on one side and a division line on the other side.
Breluncol 25 mg coated tablets are grey, elongated, biconvex coated tablets, embossed with the number "25" on one side and smooth on the other side.
Breluncol 50 mg coated tablets are yellow, elongated, biconvex coated tablets, embossed with the number "50" on one side and smooth on the other side.
Breluncol 75 mg coated tablets are violet, elongated, biconvex coated tablets, embossed with the number "75" on one side and smooth on the other side.
Breluncol 100 mg coated tablets are green, elongated, biconvex coated tablets, embossed with the number "100" on one side and smooth on the other side.

Blister packs
Breluncol is available in blisters made of Aluminium/OPA/Aluminium/PVC foil containing 14, 56 or 100 coated tablets, or in multipacks containing 168 tablets (3 packs of 56 coated tablets), or in single-dose perforated blister packs of 14 x 1, 56 x 1 or 100 x 1 coated tablets, or in multipacks containing 168 tablets (3 packs of 56 x 1 coated tablets).
Breluncol is also available in high-density polyethylene (HDPE) bottles closed with a polypropylene (PP) child-resistant cap, containing 60 coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation 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 medicinal product is authorised in the European Economic Area countries 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

For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
EGIS Polska Sp. z o.o.
ul. Komitetu Obrony Robotników 45D
02-146 Warsaw
Tel.: +48 22 417 92 00