BRIVARACETAM TEVA 100 mg FILM-COATED TABLETS

Introduction

Patient Information: Summary of Product Characteristics

Brivaracetam Teva 10 mg film-coated tablets EFG

Brivaracetam Teva 25 mg film-coated tablets EFG

Brivaracetam Teva 50 mg film-coated tablets EFG

Brivaracetam Teva 75 mg film-coated tablets EFG

Brivaracetam Teva 100 mg film-coated tablets EFG

Read the entire summary carefully before starting to take this medication, as it contains important information for you.

• Keep this summary, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this summary. See section 4.

Contents of the Summary

1. What is Brivaracetam Teva and what is it used for
2. What you need to know before taking Brivaracetam Teva
3. How to take Brivaracetam Teva
4. Possible side effects
5. Storage of Brivaracetam Teva
6. Package contents and additional information

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

What is Brivaracetam Teva

Brivaracetam Teva contains the active substance brivaracetam. It belongs to a group of medications called "antiepileptics". These medications are used to treat epilepsy.

What is Brivaracetam Teva used for

• Brivaracetam is used in adults, adolescents, and children from 2 years of age.
• It is used to treat a type of epilepsy that involves partial seizures with or without secondary generalization.
• Partial seizures are seizures that start by affecting only one side of the brain. These partial seizures can spread to larger areas of both sides of the brain – this is called "secondary generalization".
• Your doctor has prescribed this medication to reduce the number of seizures.
• Brivaracetam is used in combination with other medications to treat epilepsy.

2. What you need to know before taking Brivaracetam Teva

Do not take Brivaracetam Teva

• if you are allergic to brivaracetam, other similar chemical compounds such as levetiracetam or piracetam, or any of the other components of this medication (listed in section 6). If you are unsure, consult your doctor or pharmacist before taking brivaracetam.
• if you have ever had a severe skin rash, skin peeling, or 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 medication and consult your doctor immediately if you observe any 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 self-harm or suicide. A small number of people taking antiepileptic medications like brivaracetam have had thoughts of self-harm or 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 medications and Brivaracetam Teva

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

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

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

Taking Brivaracetam Teva with alcohol

• It is not recommended to use this medication 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 medication.

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 medication, as brivaracetam is excreted in breast milk.

Do not stop treatment without consulting your doctor first. Stopping treatment may increase the number of seizures 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 bicycle, or use any tools or machinery until you know how this medication affects you.

Brivaracetam Teva contains lactose and sodium

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

This medication contains less than 1 mmol of sodium (23 mg) per tablet; it is essentially "sodium-free".

3. How to take Brivaracetam Teva

Follow your doctor's instructions for taking this medication exactly. If you are unsure, consult your doctor or pharmacist again.

You will take Brivaracetam Teva in combination with other medications 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 Brivaracetam Teva tablets

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

Duration of treatment

Brivaracetam is a long-term treatment – continue taking this medication 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 some of the following symptoms: feeling unwell, feeling like you are spinning, balance problems, 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 usual time.
• Do not take a double dose to make up for the forgotten dose.
• If you are unsure what to do, consult your doctor or pharmacist.

If you stop taking Brivaracetam Teva

• Do not stop treatment with this medication 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, they will give you instructions for gradually stopping this medication. This will help prevent your seizures from coming back or getting worse.

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

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone gets them.

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

• drowsiness or dizziness

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 skin peeling, 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 (hyperkinetic disorder)

Reporting side effects

If you experience any side effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this summary. You can also report them directly through the Spanish Medication Surveillance System for Human Use: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Brivaracetam Teva

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

Do not use this medication after the expiration date stated on the packaging, blister, or bottle after "EXP". The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medications should not be disposed of via wastewater or household waste. Dispose of the packaging and any unused medication at the pharmacy's SIGRE collection point. Ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.

6. Package contents and additional information

Composition of Brivaracetam Teva

The active substance is brivaracetam.

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

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

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

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

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

The other components (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 package contents

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

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

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

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

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

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

Brivaracetam Teva is available in single-dose packages 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 package sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization 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 medication from the local representative of the marketing authorization holder:

Teva Pharma, S.L.U.

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

28108 Alcobendas (Madrid)

Spain

This medication is authorized in the Member States of the European Economic Area under the following names:

Date of last revision of this summary:March 2025

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

You can access detailed and updated information about this medication 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