BRIVARACETAM CINFA 25 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Brivaracetam Cinfa 25 mg Film-Coated Tablets EFG

Brivaracetam Cinfa 50 mg Film-Coated Tablets EFG

Brivaracetam Cinfa 75 mg Film-Coated Tablets EFG

Brivaracetam Cinfa 100 mg Film-Coated Tablets EFG

Read the entire package leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this package 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 package leaflet. See section 4.

Contents of the package leaflet

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

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

What is Brivaracetam Cinfa

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

What Brivaracetam Cinfa 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 affect 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 Cinfa

Do not take Brivaracetam Cinfa

• 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 brivaracetam 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 Cinfa:

• If you have had thoughts of harming yourself or suicide. A small number of people taking antiepileptic medicines like Brivaracetam Cinfa 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 Cinfa

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 Cinfa 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 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.

Brivaracetam is not recommended during pregnancy, as its effects on pregnancy and the fetus are unknown.

Brivaracetam is excreted in breast milk, and it is not recommended to breastfeed while taking brivaracetam.

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 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 Cinfa contains sodium

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

3. How to take Brivaracetam Cinfa

Follow the instructions for administration of this medicine exactly as indicated by your doctor. If you are unsure, 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.

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 decide to adjust your dose later 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 decide to adjust the dose later 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 decide to adjust the dose later 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 Cinfa

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

Duration of treatment with Brivaracetam Cinfa

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

If you take more Brivaracetam Cinfa than you should

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

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.

If you forget to take Brivaracetam Cinfa

• If you forget to take a dose, take it as soon as you remember.
• Take your next dose at the time you normally would.
• 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 Cinfa

• 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 gradual withdrawal of brivaracetam. This will help prevent your seizures from coming back or getting worse.

If you have any further 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 suicide: inform 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 or pharmacist. This includes any possible side effects not listed in this package leaflet. You can also report side effects directly via 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 Cinfa

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 is 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 Cinfa

• The active substance is brivaracetam.

Brivaracetam Cinfa 25 mg film-coated tablets EFG: each tablet contains 25 mg of brivaracetam.

Brivaracetam Cinfa 50 mg film-coated tablets EFG: each tablet contains 50 mg of brivaracetam.

Brivaracetam Cinfa 75 mg film-coated tablets EFG: each tablet contains 75 mg of brivaracetam.

Brivaracetam Cinfa 100 mg film-coated tablets EFG: each tablet contains 100 mg of brivaracetam.

• The other ingredients are:

Core

Croscarmellose sodium, silicified microcrystalline cellulose (colloidal anhydrous silica and microcrystalline cellulose), cornstarch, hydroxypropylcellulose, and magnesium stearate

Coating

• Brivaracetam Cinfa 25 mg film-coated tablets EFG: Partially hydrolyzed poly(vinyl alcohol), calcium carbonate, macrogol, talc, and iron oxide black (E-172).

• Brivaracetam Cinfa 50 mg film-coated tablets EFG: Partially hydrolyzed poly(vinyl alcohol), calcium carbonate, macrogol, talc, iron oxide yellow (E-172), iron oxide red (E-172), and iron oxide black (E-172).
• Brivaracetam Cinfa 75 mg film-coated tablets EFG: Partially hydrolyzed poly(vinyl alcohol), calcium carbonate, macrogol, talc, iron oxide black (E-172), and iron oxide red (E-172).
• Brivaracetam Cinfa 100 mg film-coated tablets EFG: Partially hydrolyzed poly(vinyl alcohol), calcium carbonate, macrogol, talc, iron oxide yellow (E-172), and iron oxide black (E-172).

Appearance of the product and pack contents

Brivaracetam Cinfa 25 mg film-coated tablets EFG

Film-coated tablets are oval, gray, and marked with “B2” on one side (dimensions 8.8 x 4.7 mm).

Brivaracetam Cinfa 50 mg film-coated tablets EFG

Film-coated tablets are oval, yellow, and marked with "B5" on one side (dimensions 13 x 6 mm).

Brivaracetam Cinfa 75 mg film-coated tablets EFG

Film-coated tablets are oval, gray-violet, and marked with "B7" on one side (dimensions 15 x 7 mm).

Brivaracetam Cinfa 100 mg film-coated tablets EFG

Film-coated tablets are oval, gray-green, and marked with "B1" on one side (dimensions 16.4 x 8 mm).

Transparent PVC-PVDC/Aluminum blister pack in packs of 56 tablets.

Marketing authorization holder and manufacturer

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) – Spain

Date of last revision of this package leaflet: July 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)

Brivaracetam Cinfa 25 mg film-coated tablets EFG:

You can access detailed and updated information on this medicine by scanning the QR code included in the package leaflet and carton with your smartphone. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/90429/P_90429.html

QR code to: https://cima.aemps.es/cima/dochtml/p/90429/P_90429.html

Brivaracetam Cinfa 50 mg film-coated tablets EFG:

You can access detailed and updated information on this medicine by scanning the QR code included in the package leaflet and carton with your smartphone. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/90430/P_90430.html

QR code to: https://cima.aemps.es/cima/dochtml/p/90430/P_90430.html

Brivaracetam Cinfa 75 mg film-coated tablets EFG:

You can access detailed and updated information on this medicine by scanning the QR code included in the package leaflet and carton with your smartphone. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/90431/P_90431.html

QR code to: https://cima.aemps.es/cima/dochtml/p/90431/P_90431.html

Brivaracetam Cinfa 100 mg film-coated tablets EFG:

You can access detailed and updated information on this medicine by scanning the QR code included in the package leaflet and carton with your smartphone. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/90432/P_90432.html

QR code to: https://cima.aemps.es/cima/dochtml/p/90432/P_90432.html