BRIVARACETAM VISO FARMACEUTICA 50 mg FILM-COATED TABLETS

1. What is Brivaracetam Viso Farmacéutica and what is it used for

What is Brivaracetam Viso Farmacéutica

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

What Brivaracetam Viso Farmacéutica 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 on 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 taking Brivaracetam Viso Farmacéutica

Do not take Brivaracetam Viso Farmacéutica

• 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 skin peeling, 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 contact your doctor 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 being treated with antiepileptic medicines such as brivaracetam have had thoughts of harming themselves or committing 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 Viso Farmacéutica

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, because 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 Viso Farmacéutica 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 are planning to have a baby, consult your doctor or pharmacist 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 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 Viso Farmacéutica contains sodium

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

3. How to take Brivaracetam Viso Farmacéutica

Follow the instructions for administration of this medicine exactly as prescribed 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 is 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 is 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 is 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 Viso Farmacéutica

• Swallow the tablet whole with a glass of liquid. The tablets must be swallowed whole to ensure the correct dose is taken.
• The medicine can be taken with or without food.

Duration of treatment with Brivaracetam Viso Farmacéutica

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

If you take more Brivaracetam Viso Farmacéutica 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, problems with 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 Viso Farmacéutica

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

If you stop taking Brivaracetam Viso Farmacéutica

• 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 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
• decreased 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 (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 Vigilance System for Human Use: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Brivaracetam Viso Farmacéutica

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. Package contents and further information

Composition of Brivaracetam Viso Farmacéutica

• The active substance is brivaracetam. Each film-coated tablet contains 10 mg, 25 mg, 50 mg, 75 mg or 100 mg of brivaracetam.

• The other ingredients are:

Core: microcrystalline cellulose, pregelatinized starch (from maize), sodium croscarmellose, magnesium stearate (see section 2, “Brivaracetam Viso Farmacéutica contains sodium”).

Tablet coating:

• 10 mg film-coated tablets: poly(vinyl alcohol), calcium carbonate, macrogol (MW 3350), talc.
• 25 mg film-coated tablets: poly(vinyl alcohol), calcium carbonate, macrogol (MW 3350), talc, black iron oxide (E172), yellow iron oxide (E172).
• 50 mg film-coated tablets: poly(vinyl alcohol), calcium carbonate, macrogol (MW 3350), talc, yellow iron oxide (E172), red iron oxide (E172), black iron oxide (E172).
• 75 mg film-coated tablets: poly(vinyl alcohol), calcium carbonate, macrogol (MW 3350), talc, black iron oxide (E172), red iron oxide (E172).
• 100 mg film-coated tablets: partially hydrolyzed poly(vinyl alcohol), calcium carbonate, macrogol (MW 3350), talc, yellow iron oxide (E172), black iron oxide (E172).

Appearance of the product and package contents

Brivaracetam Viso Farmacéutica 10 mg are white or almost white, round, biconvex film-coated tablets, 6 mm in diameter, engraved with “10” on one side.

Brivaracetam Viso Farmacéutica 25 mg are grey, oval, biconvex film-coated tablets, 9 x 5 mm, engraved with “25” on one side.

Brivaracetam Viso Farmacéutica 50 mg are yellow, oval, biconvex film-coated tablets, 12 x 7 mm, engraved with “50” on one side.

Brivaracetam Viso Farmacéutica 75 mg are pink, oval, biconvex film-coated tablets, 13 x 7 mm, engraved with “75” on one side.

Brivaracetam Viso Farmacéutica 100 mg are grey-green, oval, biconvex film-coated tablets, 15 x 8 mm, engraved with “100” on one side.

Brivaracetam Viso Farmacéutica tablets are packaged in blisters included in cardboard boxes containing 14 or 56 film-coated tablets, or 100 x 1 film-coated tablets in unit dose blisters.

The 10 mg, 25 mg, 50 mg and 75 mg film-coated tablets may also be packaged in multiple packs containing 168 (2 packs of 84) film-coated tablets.

The 100 mg film-coated tablets may also be packaged in multiple packs containing 168 (3 packs of 56) film-coated tablets.

All packs are available in Aluminium/Aluminium (OPA/Aluminium/PVC) blisters.

Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer

Marketing authorisation holder

Glenmark Arzneimittel GmbH

Industriestr. 31

82194 Gröbenzell

Germany

Manufacturer

Holsten Pharma GmbH

Hahnstraße 31-35

60528 Frankfurt am Main

Germany

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

Viso Farmacéutica S.L.U.

C/ Retama 7, 7th floor

28045 Madrid

Spain

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

Germany Brivaracetam Glenmark 10 mg film-coated tablets

Brivaracetam Glenmark 25 mg film-coated tablets

Brivaracetam Glenmark 50 mg film-coated tablets

Brivaracetam Glenmark 75 mg film-coated tablets

Brivaracetam Glenmark 100 mg film-coated tablets

Denmark Brivaracetam Glenmark

Spain Brivaracetam Viso Farmacéutica 10 mg film-coated tablets EFG

Brivaracetam Viso Farmacéutica 25 mg film-coated tablets EFG

Brivaracetam Viso Farmacéutica 50 mg film-coated tablets EFG

Brivaracetam Viso Farmacéutica 75 mg film-coated tablets EFG

Brivaracetam Viso Farmacéutica 100 mg film-coated tablets EFG

Finland Brivaracetam Glenmark 10 mg film-coated tablets

Brivaracetam Glenmark 25 mg film-coated tablets

Brivaracetam Glenmark 50 mg film-coated tablets

Brivaracetam Glenmark 75 mg film-coated tablets

Brivaracetam Glenmark 100 mg film-coated tablets

Italy Brivaracetam Glenmark 10 mg film-coated tablets

Brivaracetam Glenmark 25 mg film-coated tablets

Brivaracetam Glenmark 50 mg film-coated tablets

Brivaracetam Glenmark 75 mg film-coated tablets

Brivaracetam Glenmark 100 mg film-coated tablets

Netherlands Brivaracetam Glenmark 10 mg film-coated tablets

Brivaracetam Glenmark 25 mg film-coated tablets

Brivaracetam Glenmark 50 mg film-coated tablets

Brivaracetam Glenmark 75 mg film-coated tablets

Brivaracetam Glenmark 100 mg film-coated tablets

Norway Brivaracetam Glenmark

Sweden Brivaracetam Glenmark

Slovakia Brivaracetam Glenmark 10 mg

Brivaracetam Glenmark 25 mg

Brivaracetam Glenmark 50 mg

Brivaracetam Glenmark 75 mg

Brivaracetam Glenmark 100 mg

Date of last revision of this package leaflet:March 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/).