BRIVARACETAM VISO FARMACEUTICA 100 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Brivaracetam Viso Pharmaceutical 10 mg film-coated tablets EFG

Brivaracetam Viso Pharmaceutical 25 mg film-coated tablets EFG

Brivaracetam Viso Pharmaceutical 50 mg film-coated tablets EFG

Brivaracetam Viso Pharmaceutical 75 mg film-coated tablets EFG

Brivaracetam Viso Pharmaceutical 100 mg film-coated tablets EFG

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

• Keep this package leaflet, 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 package leaflet. See section 4.

Contents of the Package Leaflet

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

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

What is Brivaracetam Viso Pharmaceutical

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

What is Brivaracetam Viso Pharmaceutical 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 Viso Pharmaceutical

Do not take Brivaracetam Viso Pharmaceutical

• 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 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, and/or mouth ulcers after taking brivaracetam.

Severe skin reactions, including Stevens-Johnson syndrome, have been reported with brivaracetam treatment. Do not take brivaracetam and consult 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 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.
• 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 medications and Brivaracetam Viso Pharmaceutical

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 Viso Pharmaceutical 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 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 bicycle, or use any tools or machinery until you know how this medication affects you.

Brivaracetam Viso Pharmaceutical contains sodium

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

3. How to take Brivaracetam Viso Pharmaceutical

Follow your doctor's instructions for taking this medication exactly. If you are unsure, consult your doctor or pharmacist again. Other forms of this medication 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 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 Brivaracetam Viso Pharmaceutical tablets

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

Duration of treatment with Brivaracetam Viso Pharmaceutical

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

If you take more Brivaracetam Viso Pharmaceutical 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 commit suicide.

If you forget to take Brivaracetam Viso Pharmaceutical

• 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 missed dose.
• If you are unsure what to do, consult your doctor or pharmacist.

If you stop taking Brivaracetam Viso Pharmaceutical

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

If you have any further 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.

• 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: 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 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 side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. You can also report side effects directly through the Spanish Medicines Monitoring System: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Brivaracetam Viso Pharmaceutical

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

Do not use this medication after the expiration date stated on the package and blister 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. Place the packaging and any unused medication in the SIGRE collection point at your pharmacy. 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 Viso Pharmaceutical

• 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 corn), sodium croscarmellose, magnesium stearate (see section 2, "Brivaracetam Viso Pharmaceutical 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 Pharmaceutical 10 mg are white or almost white, round, biconvex, 6 mm in diameter, engraved with "10" on one side.

Brivaracetam Viso Pharmaceutical 25 mg are gray, oval, biconvex, 9 x 5 mm, engraved with "25" on one side.

Brivaracetam Viso Pharmaceutical 50 mg are yellow, oval, biconvex, 12 x 7 mm, engraved with "50" on one side.

Brivaracetam Viso Pharmaceutical 75 mg are pink, oval, biconvex, 13 x 7 mm, engraved with "75" on one side.

Brivaracetam Viso Pharmaceutical 100 mg are gray-green, oval, biconvex, 15 x 8 mm, engraved with "100" on one side.

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

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

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

All packages are available in aluminum/aluminum (OPA/aluminum/PVC) blisters.

Not all package sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Glenmark Arzneimittel GmbH

Industriestr. 31

82194 Gröbenzell

Germany

Manufacturer

Holsten Pharma GmbH

Hahnstraße 31-35

60528 Frankfurt am Main

Germany

You can obtain further information on this medication by contacting the local representative of the marketing authorization holder:

Viso Farmacéutica S.L.U.

C/ Retama 7, 7th floor

28045 Madrid

Spain

This medication is authorized 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

Slovak Republic Brivaracetam Glenmark 10 mg

Brivaracetam Glenmark 25 mg

Brivaracetam Glenmark 50 mg

Brivaracetam Glenmark 75 mg

Brivaracetam Glenmark 100 mg

Date of the last revision of this package leaflet:March 2025.

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