BRIVARACETAM TEVA 10 mg FILM-COATED TABLETS

2. What you need to know before you take Brivaracetam Teva

Do not take Brivaracetam Teva

• if you are allergic to brivaracetam, to other similar chemical compounds such as levetiracetam or piracetam, or to any of the other ingredients of this medicine (listed in section 6). If you are not sure, consult your doctor or pharmacist before taking brivaracetam.
• if you have ever had a severe skin rash or peeling of the skin, blisters, and/or sores in the mouth after taking brivaracetam.

Severe skin reactions, including Stevens-Johnson syndrome, have been reported with brivaracetam treatment. Do not take this medicine and seek medical attention immediately if you notice any of the symptoms related to these severe skin reactions described in section 4.

Warnings and precautions

Consult your doctor or pharmacist before starting to take brivaracetam if:

• you have had thoughts of harming yourself or committing suicide. A small number of people taking antiepileptic medicines like brivaracetam have had thoughts of harming themselves or committing suicide. If you have any of these thoughts, contact your doctor immediately.
• you have liver problems: your doctor may need to adjust your dose.

Children

Brivaracetam is not recommended for use in children under 2 years of age.

Other medicines and Brivaracetam Teva

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

In particular, tell your doctor if you are taking any of the following medicines, as your doctor may need to adjust your dose of brivaracetam:

• Rifampicin, a medicine used to treat bacterial infections.
• St. John's Wort (also known as Hypericum perforatum), a herbal medicine used to treat depression and anxiety, as well as other conditions.

Taking Brivaracetam Teva with alcohol

• It is not recommended to use this medicine with alcohol.
• If you drink alcohol while taking brivaracetam, the negative effects of alcohol may increase.

Pregnancy and breastfeeding

Women of childbearing age should discuss the use of contraceptives with their doctor.

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

It is not recommended to take brivaracetam if you are pregnant, as the effects of brivaracetam on pregnancy and the fetus are unknown.

It is not recommended to breastfeed while taking this medicine, as brivaracetam is excreted in breast milk.

Do not stop treatment without consulting your doctor first. Stopping treatment may increase the number of seizures you have and harm your baby.

Driving and using machines

• You may feel drowsy, dizzy, or tired while taking Briviact.
• These effects are more common at the start of treatment or after a dose increase.
• Do not drive, ride a bike, or use any tools or machinery until you know how this medicine affects you.

Brivaracetam Teva contains lactose and sodium

If your doctor has told you that you have an intolerance to some sugars, consult with them before taking this medicine.

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; this is essentially “sodium-free”.

3. How to take Brivaracetam Teva

Follow the instructions for administration of this medicine exactly as indicated by your doctor. If you are in doubt, consult your doctor or pharmacist again.

You will take Brivaracetam Teva together with other medicines to treat epilepsy.

Dose

Your doctor will calculate the correct daily dose for you. Take the daily dose divided into two equal doses, approximately 12 hours apart.

Adolescents and children weighing 50 kg or more, and adults

• The recommended dose ranges from 25 mg to 100 mg twice a day. Your doctor may later decide to adjust your dose to find the best dose for you.

Adolescents and children weighing between 20 kg and less than 50 kg

• The recommended dose ranges from 0.5 mg to 2 mg per kilogram of body weight, twice a day. Your doctor may later decide to adjust the dose to find the best dose for you.

Children weighing between 10 kg and less than 20 kg

• The recommended dose ranges from 0.5 mg to 2.5 mg per kilogram of body weight, twice a day. Your child's doctor may later decide to adjust the dose to find the best dose for your child.

Patient with liver problems

If you have liver problems:

• As an adolescent or child weighing 50 kg or more, or as an adult, the maximum dose you will take is 75 mg twice a day.
• As an adolescent or child weighing between 20 kg and less than 50 kg, the maximum dose you will take is 1.5 mg per kilogram of body weight twice a day.
• As a child weighing between 10 kg and less than 20 kg, the maximum dose your child will take is 2 mg per kilogram of body weight twice a day.

How to take the tablets of Brivaracetam Teva

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

Duration of treatment

Brivaracetam is a long-term treatment – continue taking this medicine until your doctor tells you to stop.

If you take more Brivaracetam Teva than you should

If you take more Brivaracetam Teva than you should, consult your doctor. You may feel dizzy and drowsy.

You may also experience any of the following symptoms: feeling unwell, feeling like you are spinning, problems keeping your balance, anxiety, feeling very tired, irritability, aggression, difficulty sleeping, depression, thoughts or attempts to harm yourself or commit suicide.

If you forget to take Brivaracetam Teva

• If you forget to take a dose, take it as soon as you remember.
• Take your next dose at the time you would normally take it.
• Do not take a double dose to make up for the forgotten dose.
• If you are not sure what to do, consult your doctor or pharmacist.

If you stop taking Brivaracetam Teva

• Do not stop treatment with this medicine unless your doctor tells you to. This is because stopping treatment may increase the number of seizures you have.
• If your doctor decides to stop your treatment, he/she will give you instructions for the gradual withdrawal of this medicine. This will help prevent your seizures from coming back or getting worse.

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

4. Possible side effects

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

Very common:may affect more than 1 in 10 people.

• feeling sleepy or dizzy

Common:may affect up to 1 in 10 people.

• flu
• feeling very tired (fatigue)
• seizure, feeling like you are spinning (vertigo)
• feeling sick and vomiting, constipation
• depression, anxiety, difficulty sleeping (insomnia), irritability
• infections of the nose and throat (such as the “common cold”), cough
• loss of appetite

Uncommon:may affect up to 1 in 100 people

• allergic reactions
• abnormal thoughts and/or loss of contact with reality (psychotic disorder), aggression, restlessness (agitation)
• thoughts or attempts to harm yourself or commit suicide: tell your doctor immediately
• a decrease in white blood cells (called ‘neutropenia’) – which appears in blood tests

Frequency not known:cannot be estimated from the available data

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

Other side effects in children

Common:may affect up to 1 in 10 people.

• restlessness and hyperactivity (psychomotor hyperactivity)

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if it is possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Medicines and Healthcare Products Agency (AEMPS) website: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Brivaracetam Teva

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton and blister after “EXP”. The expiry date refers to the last day of the month shown.

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 no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

Composition of Brivaracetam Teva

The active substance is brivaracetam.

Each film-coated tablet of Brivaracetam Teva 10 mg contains 10 mg of brivaracetam.

Each film-coated tablet of Brivaracetam Teva 25 mg contains 25 mg of brivaracetam.

Each film-coated tablet of Brivaracetam Teva 50 mg contains 50 mg of brivaracetam.

Each film-coated tablet of Brivaracetam Teva 75 mg contains 75 mg of brivaracetam.

Each film-coated tablet of Brivaracetam Teva 100 mg contains 100 mg of brivaracetam.

The other ingredients (excipients) are:

Core of the tablet:

Croscarmellose sodium, lactose, and magnesium stearate.

Coating of the tablet:

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

Appearance of the product and contents of the pack

Brivaracetam Teva 10 mg are white to off-white, round, 4.9 mm in diameter, and engraved on one side with “10” and “TV” on the other.

Brivaracetam Teva 25 mg are light grey to grey, oval, 8.8 mm x 4.9 mm, and engraved on one side with “25” and “TV” on the other.

Brivaracetam Teva 50 mg are light yellow to yellow, oval, 11.6 mm x 6.5 mm, and engraved on one side with “50” and “TV” on the other.

Brivaracetam Teva 75 mg are light purple to purple, oval, 12.9 mm x 7.2 mm, and engraved on one side with “75” and “TV” on the other.

Brivaracetam Teva 100 mg are light greenish-grey to greenish-grey, oval, 14.4 mm x 8 mm, and engraved on one side with “100” and “TV” on the other.

Brivaracetam Teva is available in packs containing 14, 56, and 168 tablets in transparent PVC/Aclar/PVC-Aluminum blisters.

Brivaracetam Teva is available in single-dose packs containing 14x1, 56x1, and 168x1 tablets in transparent PVC/Aclar/PVC-Aluminum blisters.

Brivaracetam Teva is available in HDPE bottles with a desiccant and child-resistant PP caps containing 100 tablets.

Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer

Marketing authorisation holder:

Teva B.V.

Swensweg 5,

2031GA Haarlem,

Netherlands

Manufacturer:

Actavis Ltd

BLB015-016, Bulebel Industrial Estate

Zejtun, ZTN 3000

Malta

or

Teva Operations Poland Sp. z.o.o,

ul. Mogilska 80.

31-546, Krakow

Poland

You can request more information about this medicine by contacting the local representative of the marketing authorisation holder:

Teva Pharma, S.L.U.

C/ Anabel Segura, 11 Edificio Albatros B, 1ª planta

28108 Alcobendas (Madrid)

Spain

This medicine is authorised in the Member States of the European Economic Areaunder the following names:

Date of last revision of this leaflet:March 2025

Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Healthcare Products (AEMPS) http://www.aemps.gob.es/

You can access detailed and up-to-date information about this medicine by scanning the QR code included in the packaging with your smartphone. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/XXXXX/P_XXXXX.html