Brivaracetam teva

Package leaflet: Information for the user

Brivaracetam Teva, 10 mg, film-coated tablets
Brivaracetam Teva, 25 mg, film-coated tablets
Brivaracetam Teva, 50 mg, film-coated tablets
Brivaracetam Teva, 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, ask your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm them even if their symptoms are the same.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Leaflet contents

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

1. What Brivaracetam Teva is and what it is used for

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

What Brivaracetam Teva is used for

• Brivaracetam Teva is used in adults, adolescents, and children from 2 years of age.
• This medicine is used in the treatment of partial-onset seizures with or without secondary generalisation.
• 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—this is called "secondary generalisation".
• This medicine is used to reduce the number of seizures a patient experiences.
• Brivaracetam Teva is given in combination with other medicines used to treat epilepsy.

2. Important information before taking Brivaracetam Teva

When not to take Brivaracetam Teva:

• 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 in doubt, the patient should consult a doctor or pharmacist before starting Brivaracetam Teva.
• if the patient has ever experienced severe skin rash, skin peeling, blistering, and/or oral mucosal ulcers after taking Brivaracetam Teva.

Severe skin reactions, including Stevens-Johnson syndrome, have been reported with Brivaracetam Teva treatment. If any symptoms related to severe skin reactions described in section 4 occur, Brivaracetam Teva should be discontinued immediately and the patient should contact a doctor without delay.

Warnings and precautions

Before starting Brivaracetam Teva, discuss with a doctor or pharmacist if:

• the patient has thoughts about self-harm or suicide. A small number of people treated with antiepileptic medicines such as Brivaracetam Teva have had thoughts about self-harm or suicidal thoughts. If such thoughts occur, the patient should contact a doctor immediately.
• the patient has liver problems – in this case, the doctor may decide to adjust the dose.

Children

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

Brivaracetam Teva and other medicines

Inform the doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.

Specifically, inform the doctor if the patient is taking any of the following medicines, as dose adjustment of Brivaracetam Teva may be required:

• 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.

Brivaracetam Teva and alcohol

• It is not recommended to take this medicine with alcohol.
• If the patient drinks alcohol while taking Brivaracetam Teva, 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 have a baby, she should consult a doctor or pharmacist before using this medicine.

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

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

Do not stop treatment without first 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 Brivaracetam Teva.
• 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 this medicine affects them.

Brivaracetam Teva contains lactose and sodium

Brivaracetam Teva film-coated tablets contain:

• lactose (a type of sugar) – if the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a 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 Brivaracetam Teva

This medicine should always be taken exactly as prescribed by the doctor. In case of doubt, consult
your doctor or pharmacist.
Brivaracetam Teva is used in combination with other medicines for 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 taken in two equal divided doses, approximately 12 hours apart.

Adolescents and 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 find the most suitable 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 hepatic impairment
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 Brivaracetam Teva tablets

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

How long to take Brivaracetam Teva
Brivaracetam Teva is intended for long-term use – continue taking Brivaracetam Teva until your doctor decides to stop treatment.

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

If you miss a dose of Brivaracetam Teva

• If you miss a dose, take it as soon as you remember.
• Take your 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 Brivaracetam Teva

• Do not stop taking this medicine unless your doctor tells you to do so. This is because stopping treatment suddenly could 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 adverse reactions

Like any medicine, this medicine can cause adverse reactions, although not everyone will experience them.
Very common: may occur in more than 1 in 10 people

• drowsiness or dizziness.

Common: may occur in up to 1 in 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 up to 1 in 100 people

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

Unknown: frequency cannot be determined from available data

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

Additional adverse reactions in children

Common: may occur in up to 1 in 10 people

• restlessness and hyperkinesis (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 of 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 directly to the Marketing Authorisation Holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Brivaracetam Teva

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date stated on the carton, bottle, and blister pack following “EXP”. The expiry date refers to the last day of the stated month.
• This medicine does not require any special storage conditions.
• Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. Such measures will help protect the environment.

6. Contents of the pack and other information

What Brivaracetam Teva contains
The active substance is brivaracetam.
Each coated tablet contains 10 mg of brivaracetam.
Each coated tablet contains 25 mg of brivaracetam.
Each coated tablet contains 50 mg of brivaracetam.
Each coated tablet contains 100 mg of brivaracetam.

The other ingredients are:
Core
Sodium croscarmellose, lactose, magnesium stearate.

Coating

• 10 mg coated tablets: polyvinyl alcohol (E1203), titanium dioxide (E171), macrogol 3350 (E1521), talc (E553b).
• 25 mg coated tablets: polyvinyl alcohol (E1203), titanium dioxide (E171), macrogol 3350 (E1521), talc (E553b), yellow iron oxide (E172), black iron oxide (E172).
• 50 mg coated tablets: polyvinyl alcohol (E1203), titanium dioxide (E171), macrogol 3350 (E1521), talc (E553b), yellow iron oxide (E172), red iron oxide (E172).
• 100 mg coated tablets: polyvinyl alcohol (E1203), titanium dioxide (E171), macrogol 3350 (E1521), talc (E553b), yellow iron oxide (E172), black iron oxide (E172).

What Brivaracetam Teva looks like and contents of the pack
Brivaracetam Teva 10 mg is white to almost white, round, coated tablets with a diameter of 4.9 mm, embossed with "10" on one side and "TV" on the other.
Brivaracetam Teva 25 mg is light grey to grey, oval, coated tablets measuring 8.8 mm x 4.9 mm, embossed with "25" on one side and "TV" on the other.
Brivaracetam Teva 50 mg is light yellow to yellow, oval, coated tablets measuring 11.6 mm x 6.5 mm, embossed with "50" on one side and "TV" on the other.
Brivaracetam Teva 100 mg is light greenish-grey to greenish-grey, oval, coated tablets measuring 14.4 mm x 8 mm, embossed with "100" on one side and "TV" on the other.

Brivaracetam Teva is available in cardboard boxes containing 14, 56 and 168 tablets in transparent PVC/Aclar/PVC-Aluminium blisters.
Brivaracetam Teva is available in cardboard boxes containing 14x1, 56x1 and 168x1 tablets in single-dose, transparent PVC/Aclar/PVC-Aluminium blisters.
Brivaracetam Teva is available in HDPE bottles with a moisture absorber and child-resistant PP cap, containing 100 tablets, packed in a cardboard box.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Teva B.V.
Swensweg 5
2031 GA, Haarlem
The Netherlands

Manufacturer
Actavis Ltd.
BLB015-016, Bulebel Industrial Estate
Zejtun ZTN 3000
Malta
Teva Operations Poland Sp. z o.o
ul. Mogilska 80
31-546 Kraków
For further information, contact the marketing authorisation holder:
Teva Pharmaceuticals Polska Sp. z o.o., ul. Emilii Plater 53, 00-113 Warsaw, tel. (22) 345 93 00

This medicinal product is authorised in the Member States of the European Economic Area under the following names:
Belgium Brivaracetam Teva 10 mg filmomhulde tabletten/comprimés pelliculés/Filmtabletten
Brivaracetam Teva 25 mg filmomhulde tabletten/comprimés pelliculés/Filmtabletten
Brivaracetam Teva 50 mg filmomhulde tabletten/comprimés pelliculés/Filmtabletten
Brivaracetam Teva 100 mg filmomhulde tabletten/comprimés pelliculés/Filmtabletten

Czech Republic Brivaracetam Teva

Denmark Brivaracetam Teva

Finland Brivaracetam Teva 10 mg tabletti, kalvopäällysteinen
Brivaracetam Teva 25 mg tabletti, kalvopäällysteinen
Brivaracetam Teva 50 mg tabletti, kalvopäällysteinen
Brivaracetam Teva 100 mg tabletti, kalvopäällysteinen

France BRIVARACETAM TEVA 10 mg, comprimé pelliculé
BRIVARACETAM TEVA 25 mg, comprimé pelliculé
BRIVARACETAM TEVA 50 mg, comprimé pelliculé
BRIVARACETAM TEVA 100 mg, comprimé pelliculé

Spain Brivaracetam Teva 10 mg comprimidos recubiertos con película EFG
Brivaracetam Teva 25 mg comprimidos recubiertos con película EFG
Brivaracetam Teva 50 mg comprimidos recubiertos con película EFG
Brivaracetam Teva 100 mg comprimidos recubiertos con película EFG

Netherlands Brivaracetam Teva 10 mg, filmomhulde tabletten
Brivaracetam Teva 25 mg, filmomhulde tabletten
Brivaracetam Teva 50 mg, filmomhulde tabletten
Brivaracetam Teva 100 mg, filmomhulde tabletten

Luxembourg Brivaracetam-ratiopharm 10 mg Filmtabletten
Brivaracetam-ratiopharm 25 mg Filmtabletten
Brivaracetam-ratiopharm 50 mg Filmtabletten
Brivaracetam-ratiopharm 100 mg Filmtabletten

Germany Brivaracetam-ratiopharm 10 mg Filmtabletten
Brivaracetam-ratiopharm 25 mg Filmtabletten
Brivaracetam-ratiopharm 50 mg Filmtabletten
Brivaracetam-ratiopharm 100 mg Filmtabletten

Poland Brivaracetam Teva

Romania Brivaracetam Teva 10 mg, 25 mg, 50 mg, 100 mg comprimate filmate

Slovakia Brivaracetam Teva 10 mg
Brivaracetam Teva 25 mg
Brivaracetam Teva 50 mg
Brivaracetam Teva 100 mg

Sweden Brivaracetam Teva

Hungary Brivaracetam Teva 10 mg filmtabletta
Brivaracetam Teva 25 mg filmtabletta
Brivaracetam Teva 50 mg filmtabletta
Brivaracetam Teva 100 mg filmtabletta

Italy Brivaracetam Teva