BRIVARACETAM SANDOZ 25 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Brivaracetam Sandoz 25 mg film-coated tablets EFG

Brivaracetam Sandoz 50 mg film-coated tablets EFG

Brivaracetam Sandoz 75 mg film-coated tablets EFG

Brivaracetam Sandoz 100 mg film-coated tablets EFG

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

Keep this leaflet, you may need to read it again.

• 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 you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

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

What is Brivaracetam Sandoz

Brivaracetam Sandoz contains the active substance brivaracetam. It belongs to a group of medicines called “antiepileptics”. These medicines are used to treat epilepsy.

What Brivaracetam Sandoz is 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 causes 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 medicine to reduce the number of seizures you have.
• Brivaracetam is used together with other medicines to treat epilepsy.

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

Do not take Brivaracetam Sandoz:

• 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 developed a severe skin rash or peeling of the skin, blisters and/or sores in the mouth after taking brivaracetam. Serious skin reactions, including Stevens-Johnson syndrome, have been reported in relation to treatment with brivaracetam. Stop taking brivaracetam and seek medical attention immediately if you notice any of the symptoms related to these serious 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 suicide. A small number of people taking antiepileptic medicines like brivaracetam have had thoughts of harming themselves or suicide. If you have any of these thoughts, contact your doctor immediately.
• if 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 Sandoz

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 Sandoz with alcohol

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

Pregnancy and breastfeeding

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

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking 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 your baby while taking brivaracetam, as brivaracetam is excreted in breast milk.

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

Driving and using machines

• You may feel drowsy, dizzy or tired while taking brivaracetam.
• 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 Sandoz 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 Sandoz

Follow exactly the administration instructions of this medicine given by your doctor. In case of doubt, consult your doctor or pharmacist again. Other forms of this medicine may be more suitable for some patients, e.g. children (if they cannot swallow whole tablets, for example). Consult your doctor or pharmacist.

You will take brivaracetam together with other medicines to treat epilepsy.

How much to take

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 is from 25 mg to 100 mg twice a day. Afterward, your doctor may 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 is from 0.5 mg to 2 mg per kilogram of body weight, twice a day. Afterward, your doctor may 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 is from 0.5 mg to 2.5 mg per kilogram of body weight, twice a day. Afterward, your child's doctor may 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 Brivaracetam Sandoz tablets

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

Duration of treatment with Brivaracetam

Brivaracetam is a long-term treatment. Continue taking brivaracetam until your doctor tells you to stop.

If you take more Brivaracetam Sandoz than you should

If you take more brivaracetam 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 suicide.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, telephone: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Brivaracetam

• 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 forgotten doses.
• If you are not sure what to do, consult your doctor or pharmacist.

If you stop taking Brivaracetam

• Do not stop treatment with this medicine unless your doctor tells you to. This is because stopping treatment could 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 brivaracetam. This will help prevent your seizures from coming back or getting worse.

If you have any further questions on 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 suicide: inform your doctor immediately,
• a decrease in white blood cells (called ‘neutropenia’), which appears in blood tests.

Frequency not known:frequency cannot be estimated from the available data

• a widespread skin 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 or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Brivaracetam Sandoz

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

• The active substance is brivaracetam.
• Each Brivaracetam Sandoz 25 mg film-coated tablet contains 25 mg of brivaracetam.

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

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

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

The other ingredients are:

• Core of the tablet: lactose monohydrate, microcrystalline cellulose (type 102) (E460), hypromellose 2910 (5 mPa.s) (E464), croscarmellose sodium, colloidal anhydrous silica (E551) and magnesium stearate (E470b).
• Coating material: poly(vinyl alcohol) (E1203), calcium carbonate (E170), macrogol 4000 (E1521) and talc (E553b).

Brivaracetam Sandoz 25 mg tablets also contain: black iron oxide (E172) and yellow iron oxide (E172).

Brivaracetam Sandoz 50 mg tablets also contain: yellow iron oxide (E172).

Brivaracetam Sandoz 75 mg tablets also contain: black iron oxide (E172) and red iron oxide (E172).

Brivaracetam Sandoz 100 mg tablets also contain: yellow iron oxide (E172) and black iron oxide (E172).

Appearance and packaging

Brivaracetam Sandoz 25 mg tablets are film-coated, grey, oblong, biconvex and have “25” engraved on one side and are plain on the other.

Brivaracetam Sandoz 50 mg tablets are film-coated, yellow, oblong, biconvex and have “50” engraved on one side and are plain on the other.

Brivaracetam Sandoz 75 mg tablets are film-coated, purple, oblong, biconvex and have “75” engraved on one side and are plain on the other.

Brivaracetam Sandoz 100 mg tablets are film-coated, green, oblong, biconvex and have “100” engraved on one side and are plain on the other.

Brivaracetam Sandoz is marketed in packs with Aluminio-OPA/Al/PVC blisters of 14 or 56 film-coated tablets or in multiple packs containing 168 (3 packs of 56) film-coated tablets or in single-dose blisters of 14x1 or 56x1 film-coated tablets or in multiple packs containing 168 (3 packs of 56x1) film-coated tablets.

Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer

Marketing authorisation holder

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble,

C/Serrano Galvache, 56

28033 Madrid

Spain

Manufacturer

PharOS MT Ltd.

HF62X, Hal Far Industrial Estate

Birzebbugia BBG3000

Malta

Or

PharOS Pharmaceutical Oriented Services Ltd.

Lesvou Street End, Thesi Loggos Industrial Zone

Metamorfossi, 14452

Greece

Or

Lek Pharmaceuticals d.d.

Verovškova ulica 57

1526 Ljubljana

Slovenia

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

Hungary: Brivaracetam Sandoz 10mg filmtabletta

Brivaracetam Sandoz 25mg filmtabletta

Brivaracetam Sandoz 50mg filmtabletta

Brivaracetam Sandoz 75mg filmtabletta

Brivaracetam Sandoz 100mg filmtabletta

Czech Republic: Brivaracetam Sandoz

Germany: Brivaracetam - 1 A Pharma 10 mg Filmtabletten

Brivaracetam - 1 A Pharma 25 mg Filmtabletten

Brivaracetam - 1 A Pharma 50 mg Filmtabletten

Brivaracetam - 1 A Pharma 75 mg Filmtabletten

Brivaracetam - 1 A Pharma 100 mg Filmtabletten

Denmark: Brivaracetam Sandoz

Greece: Brivaracetam/Sandoz

Spain: Brivaracetam Sandoz 25 mg film-coated tablets EFG

Brivaracetam Sandoz 50 mg film-coated tablets EFG

Brivaracetam Sandoz 75 mg film-coated tablets EFG

Brivaracetam Sandoz 100 mg film-coated tablets EFG

Italy: Brivaracetam Sandoz

Netherlands: Brivaracetam Sandoz 25 mg, filmomhulde tabletten

Brivaracetam Sandoz 50 mg, filmomhulde tabletten

Brivaracetam Sandoz 75 mg, filmomhulde tabletten

Brivaracetam Sandoz 100 mg, filmomhulde tabletten

Date of last revision of this leaflet: February 2025

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