BRIVARACETAM STADA 25 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Brivaracetam Stada 10 mg Film-Coated Tablets EFG

Brivaracetam Stada 25 mg Film-Coated Tablets EFG

Brivaracetam Stada 50 mg Film-Coated Tablets EFG

Brivaracetam Stada 75 mg Film-Coated Tablets EFG

Brivaracetam Stada 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 symptoms are the same as yours.
• If you experience 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 Stada and what is it used for
2. What you need to know before you take Brivaracetam Stada
3. How to take Brivaracetam Stada
4. Possible side effects
5. Storage of Brivaracetam Stada
6. Contents of the pack and further information

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

What is Brivaracetam Stada

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

What Brivaracetam Stada 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 Stada

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• 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. Serious 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 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 being treated with antiepileptic medicines like brivaracetam have had thoughts of harming themselves 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 medicines and Brivaracetam Stada

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 Stada 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.

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 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 Stada contains lactose and sodium

• Lactose (a type of sugar).If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.
• Sodium.This medicine contains less than 23 mg of sodium (1 mmol) per tablet; this is, essentially “sodium-free”.

3. How to take Brivaracetam Stada

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.

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.

The 10 mg tablet can be divided into equal doses.

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 Brivaracetam tablets

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

How long to take Brivaracetam Stada

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

If you take more Brivaracetam Stada 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 keeping your balance, 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, phone: 91 562 04 20, indicating the medicine and the amount ingested. It is recommended to take the package and the package leaflet of the medicine to the healthcare professional.

If you forget to take Brivaracetam Stada

• 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 Stada

• 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
• 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 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 to the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Brivaracetam Stada

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

This medicine does not require any special storage conditions.

Do not use this medicine after the expiry date which is stated on the carton, label of the bottle, and blister after “EXP”. The expiry date is the last day of the month stated.

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

6. Contents of the pack and further information

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The active substance is brivaracetam.

Brivaracetam Stada 10 mg film-coated tablets EFG contain 10 mg of brivaracetam.

Brivaracetam Stada 25 mg film-coated tablets EFG contain 25 mg of brivaracetam.

Brivaracetam Stada 50 mg film-coated tablets EFG contain 50 mg of brivaracetam.

Brivaracetam Stada 75 mg film-coated tablets EFG contain 75 mg of brivaracetam.

Brivaracetam Stada 100 mg film-coated tablets EFG contain 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), sodium croscarmellose, colloidal anhydrous silica, magnesium stearate (E470b).
• Coating of the tablet: poly(vinyl alcohol) (E1203), calcium carbonate (E170), macrogol 4000 (E1521), talc (E553b), and each dose also contains

25 mg: black iron oxide (E172), yellow iron oxide (E172)

50 mg: yellow iron oxide (E172)

75 mg: black iron oxide (E172), red iron oxide (E172)

100 mg: yellow iron oxide (E172), black iron oxide (E172)

Appearance of the product and contents of the pack

Brivaracetam Stada 10 mg are white or almost white, round, biconvex film-coated tablets with “10” engraved on one side and a score line on the other.

Brivaracetam Stada 25 mg are grey, elongated, biconvex film-coated tablets with “25” engraved on one side and smooth on the other.

Brivaracetam Stada 50 mg are yellow, elongated, biconvex film-coated tablets with “50” engraved on one side and smooth on the other.

Brivaracetam Stada 75 mg are purple, elongated, biconvex film-coated tablets with “75” engraved on one side and smooth on the other.

Brivaracetam Stada 100 mg are green, elongated, biconvex film-coated tablets with “100” engraved on one side and smooth on the other.

Brivaracetam Stada is available in aluminum-OPA/Alu/PVC blisters containing 14, 56, or 100 film-coated tablets or a multiple pack containing 168 (3 packs of 56) film-coated tablets or in unit-dose blisters containing 14x1, 56x1, or 100x1 film-coated tablets or a multiple pack containing 168 (3 packs of 56x1) film-coated tablets.

Brivaracetam Stada is also available in high-density polyethylene (HDPE) bottles closed with a white polypropylene (PP) child-resistant cap, containing 60 film-coated tablets.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

STADA Arzneimittel AG

Stadastrasse 2-18

61118 Bad Vilbel

Germany

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

Laboratorio STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

info@stada.es

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

STADA Arzneimittel AG

Stadastrasse 2- 18,

Dortelweil, Bad Vilbel, Hesse, 61118,

Germany

or

Centrafarm Services B.V.

Van de Reijtstraat 31 E,

Breda, 4814NE,

Netherlands

or

Clonmel Healthcare Ltd

Waterford Road, Gurtnafleur, Clonmel, Co.

Tipperary, E91 D768,

Ireland

or

STADA M&D SRL

Str. Trascaului nr. 10,

Municipiul Turda,

Judet Cluj 401135,

Romania

or

Laboratori Fundació Dau

c/ C 12-14,

Polígono Industrial de la Zona Franca,

08040 Barcelona

Spain

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

Germany: Brivaracetam Stada 10 mg/25 mg/50 mg/75 mg/100 mg Filmtabletten

Denmark: Brivaracetam Stada

Spain: Brivaracetam Stada 10 mg/25 mg/50 mg/75 mg/100 mg film-coated tablets EFG

Finland: Brivaracetam Stada 10 mg/25 mg/50 mg/75 mg/100 mg kalvopäällysteiset tabletit

Hungary: Brivaracetam Stada 10 mg/25 mg/50 mg/75 mg/100 mg filmtabletta

Ireland: Brivaracetam Clonmel 10 mg/25 mg/50 mg/75 mg/100 mg film-coated tablets

Iceland: Brivaracetam Stada 10 mg/25 mg/50 mg/75 mg/100 mg filmuhúðaðar töflur

Malta: Brivaracetam Clonmel 10 mg/25 mg/50 mg/75 mg/100 mg film-coated tablets

Norway: Brivaracetam Stada

Netherlands: Brivaracetam Stada 10 mg/25 mg/50 mg/75 mg/100 mg, filmomhulde tabletten

Czech Republic: Brivaracetam Stada

Sweden: Brivaracetam Stada 10 mg/25 mg/50 mg/75 mg/100 mg filmdragerade tabletter

Date of last revision of this package 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/)