BRIVARACETAM SANDOZ 50 mg FILM-COATED TABLETS

2. What you need to know before taking Brivaracetam Sandoz

Do not take Brivaracetam Sandoz:

Warnings and precautions

Consult your doctor or pharmacist before starting to take brivaracetam:

Children

Brivaracetam is not recommended for use in children under 2 years of age.

Other medications and Brivaracetam Sandoz

Tell your doctor or pharmacist if you are taking, have recently taken, or may 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 Sandoz 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 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 bicycle, or use any tools or machinery until you know how this medication affects you.

Brivaracetam Sandoz contains lactose and sodium

If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

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

3. How to take Brivaracetam Sandoz

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.

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 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 Sandoz tablets

• Swallow the tablet whole with liquid.
• The medication 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 commit 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 medication 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 normally would.
• Do not take a double dose to make up for missed doses.
• If you are unsure what to do, consult your doctor or pharmacist.

If you stop taking Brivaracetam

• Do not stop treatment with this medication 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, they will give you instructions for gradual withdrawal of brivaracetam. This will help prevent your seizures from returning or worsening.

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,
• nose and throat infections (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 commit suicide: inform your doctor immediately,
• a decrease in white blood cells (called 'neutropenia'), which appears in blood tests.

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

• a widespread skin 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 leaflet. You can also report them directly through the Spanish Medicines and Healthcare Products Agency (AEMPS) website: www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Brivaracetam Sandoz

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

Do not use this medication after the expiration date stated on the carton and blister after CAD or 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. Return the packaging and any unused medication to the pharmacy's SIGRE collection point. If you are unsure, 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

• 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 components (excipients) are:

• Core of the tablet: lactose monohydrate, microcrystalline cellulose (type 102) (E460), hypromellose 2910 (5 mPa.s) (E464), sodium croscarmellose, 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 of the product and package contents

Brivaracetam Sandoz 25 mg tablets are film-coated, gray, oblong, biconvex, and have "25" engraved on one side and are flat on the other.

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

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

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

Brivaracetam Sandoz is marketed in packs with aluminum-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 authorization holder and manufacturer

Marketing authorization 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 medication is authorized 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 the last revision of this leaflet: February 2025

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