Brivaracetam accord

Package leaflet: Information for the patient

Brivaracetam Accord, 10 mg, film-coated tablets
Brivaracetam Accord, 25 mg, film-coated tablets
Brivaracetam Accord, 50 mg, film-coated tablets
Brivaracetam Accord, 75 mg, film-coated tablets
Brivaracetam Accord, 100 mg, film-coated tablets
Brivaracetamum
Please read all of this leaflet carefully before taking this medicine, because it contains important information for you.

• Keep this 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 personally. 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, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of contents

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

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

What Brivaracetam Accord is
Brivaracetam Accord contains the active substance brivaracetam. It belongs to a group of medicines called antiepileptic drugs. These medicines are used in the treatment of epilepsy.

What Brivaracetam Accord is used for

• Brivaracetam Accord is used in adults, adolescents, and children from the age of 2 years.
• This medicine is used to treat partial-onset seizures, with or without secondary generalization.
• Partial-onset seizures are seizures affecting only one side of the brain. Partial-onset seizures may spread to involve further areas on both sides of the brain, which is called "secondary generalization".
• This medicine is used to reduce the number of seizures a patient experiences.
• Brivaracetam Accord is given together with other medicines used to treat epilepsy.

2. Important information before taking Brivaracetam Accord

When not to take Brivaracetam Accord:

• if the patient is allergic to brivaracetam, to related chemical compounds such as levetiracetam or piracetam, or to any of the other ingredients of this medicine (listed in section 6). If the patient has any doubts about this, they should consult their doctor or pharmacist before starting treatment with Brivaracetam Accord.
• if the patient has ever experienced severe skin rash or skin peeling, blistering and/or mouth ulcers after taking Brivaracetam Accord. Serious skin reactions, including Stevens-Johnson syndrome, have been reported with treatment using Brivaracetam Accord. If any symptoms related to serious skin reactions described in section 4 occur, treatment with Brivaracetam Accord must be discontinued immediately and the patient should contact their doctor without delay.

Warnings and precautions

Before starting treatment with Brivaracetam Accord, discuss with the doctor or pharmacist if:

• the patient has thoughts about self-harm or suicide. A small number of people treated with antiepileptic medicines such as Brivaracetam Accord have had thoughts about self-harm or suicidal thoughts. If such thoughts occur at any time, the patient should contact their doctor immediately.
• the patient has liver problems, in which case the doctor may decide to adjust the dose.

Children

Brivaracetam Accord must not be given to children under 2 years of age.

Brivaracetam Accord and other medicines

The patient must tell their doctor or pharmacist about all medicines they are currently taking, have recently taken, or plan to take.

In particular, the patient must inform the doctor if they are taking any of the following medicines, as this may require adjustment of the dose of Brivaracetam Accord:

• rifampicin – a medicine used to treat bacterial infections.
• St. John’s wort (Hypericum perforatum), a herbal product used in the treatment of depression, anxiety, and other disorders.

Brivaracetam Accord and alcohol

• It is not recommended to take this medicine with alcohol.
• If the patient drinks alcohol while taking Brivaracetam Accord, the negative effects of alcohol may be intensified.

Pregnancy and breastfeeding

Women of childbearing age should discuss contraception use with their doctor.

If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult her doctor or pharmacist before taking this medicine.

Use of Brivaracetam Accord during pregnancy is not recommended, as the effect of Brivaracetam Accord on pregnancy and the unborn child is unknown.

Breastfeeding is not recommended during treatment with Brivaracetam Accord, as Brivaracetam Accord passes into human milk.

Do not stop treatment without consulting your doctor. Stopping treatment may lead to an increase in the number of epileptic seizures and may harm the unborn child.

Driving and operating machinery

• Drowsiness, dizziness, or fatigue may occur while taking Brivaracetam Accord.
• These effects are more likely at the beginning of treatment or after an increase in dose.
• The patient must not drive, ride a bicycle, or operate tools or machinery until they are certain how this medicine affects them.

Brivaracetam Accord contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per tablet; therefore, this medicine is considered "sodium-free".

3. How to take Brivaracetam Accord

This medicine should always be taken exactly as prescribed by your doctor. If you have any doubts, consult your doctor or pharmacist. For some patients, such as children, other pharmaceutical forms of brivaracetam may be more appropriate (for example, if a child cannot swallow the tablet whole or if the required dose cannot be achieved using whole tablets); please consult your doctor or pharmacist.
Brivaracetam Accord is used together with other medicines in the treatment of epilepsy.

What dose should be taken

Your doctor will determine the appropriate daily dose for you. The daily dose should be divided into two equal doses taken approximately 12 hours apart.

Adolescents, children weighing 50 kg or more, and adults

• The recommended dose is 25 mg to 100 mg twice daily. After starting treatment, your doctor may adjust the dose to find the most suitable dose for you.

Adolescents and children weighing from 20 kg to less than 50 kg

• The recommended dose is 0.5 mg to 2 mg per kilogram of body weight twice daily. After starting treatment, your doctor may adjust the dose to determine the most appropriate dose for you.

Children weighing from 10 kg to less than 20 kg

• The recommended dose is 0.5 mg to 2.5 mg per kilogram of body weight twice daily. Your doctor may then decide to adjust the dose to determine the best dose for the child.

Patients with impaired liver function

In patients with impaired liver function:

• For adolescents and children weighing 50 kg or more and adults, the maximum dose is 75 mg twice daily;
• For adolescents and children weighing from 20 kg to less than 50 kg, the maximum dose is 1.5 mg per kilogram of body weight twice daily;
• For children weighing from 10 kg to less than 20 kg, the maximum dose is 2 mg per kilogram of body weight twice daily.

How to take Brivaracetam Accord tablets

• Tablets should be swallowed whole with a glass of liquid.
• Tablets must be swallowed whole to ensure the correct dose is taken. This medicine may be taken with or without food.

How long to take Brivaracetam Accord

Brivaracetam Accord is intended for long-term use – continue taking it until your doctor decides otherwise.

Taking more Brivaracetam Accord than recommended

If you take more Brivaracetam Accord than recommended, contact your doctor immediately. Symptoms may include dizziness and drowsiness. Other possible symptoms include: nausea, vertigo, problems with balance, anxiety, extreme fatigue, irritability, aggression, insomnia, depression, and thoughts or attempts of self-harm or suicide.

Missed dose of Brivaracetam Accord

If you miss a dose, take it as soon as possible. Take the next dose at your usual time.

• Do not take a double dose to make up for a missed dose.
• If in doubt, consult your doctor or pharmacist.

Stopping Brivaracetam Accord

• Do not stop taking this medicine unless your doctor tells you to. Stopping treatment suddenly may lead to an increase in the number of epileptic seizures.
• If your doctor decides to discontinue this medicine, the dose will be gradually reduced. This helps prevent recurrence or worsening of seizures.

If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Very common: may occur in more than 1 in 10 people

• drowsiness or dizziness.

Common: may occur in less than 1 in 10 people

• influenza (flu)
• feeling very tired
• seizures, sensation of spinning (dizziness)
• nausea, constipation
• depression, anxiety, insomnia, irritability
• nose and throat infections (e.g. cold), cough
• decreased appetite

Uncommon: may occur in less than 1 in 100 people

• allergic reactions;
• disturbances in thinking and/or disconnection from reality (psychotic disorders), aggression, agitation;
• thoughts of self-harm or suicide, or attempts thereof – in such cases, contact your doctor immediately;
• decrease in white blood cell count (neutropenia) – confirmed in blood tests.

Unknown: frequency cannot be estimated from available data

• widespread rash with blisters and peeling skin, especially around the mouth, nose, eyes and genital organs (Stevens-Johnson syndrome).

Additional adverse reactions in children
Common: may occur in less than 1 in 10 people

• restlessness and hyperactivity (excessive psychomotor activity).

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Brivaracetam Accord

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date stated on the carton and blister pack after "EXP". The expiry date refers to the last day of the mentioned month.
• No special storage conditions apply for this medicine.
• 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

What Brivaracetam Accord contains
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 (corn), sodium croscarmellose, magnesium stearate
(see section 2. Brivaracetam Accord contains sodium)
Coating

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

What Brivaracetam Accord looks like and contents of the pack
Brivaracetam Accord 10 mg are white or almost white, round, biconvex film-coated tablets
with a diameter of 6 mm, engraved with the number "10" on one side.
Brivaracetam Accord 25 mg are grey, oval, biconvex film-coated tablets of size
9 mm x 5 mm, engraved with the number "25" on one side.
Brivaracetam Accord 50 mg are yellow, oval, biconvex film-coated tablets of size
12 mm x 7 mm, engraved with the number "50" on one side.
Brivaracetam Accord 75 mg are pink, oval, biconvex film-coated tablets of size
13 mm x 7 mm, engraved with the number "75" on one side.
Brivaracetam Accord 100 mg are grey-green, oval, biconvex film-coated tablets
of size 15 mm x 8 mm, engraved with the number "100" on one side.
Brivaracetam Accord tablets are packed in blisters placed in cardboard boxes
containing 14 or 56 film-coated tablets or 14x1 or 100x1 film-coated tablet in perforated
unit-dose blisters made of Aluminium/Aluminium.
10 mg, 25 mg, 50 mg and 75 mg are also available in multipacks containing 168 (2 packs
of 84) film-coated tablets.
100 mg is also available in multipacks containing 168 (3 packs of 56) film-coated tablets.
All pack sizes are available in Aluminium/Aluminium (OPA/aluminium foil/PVC) blister packs.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Accord Healthcare Polska Sp. z o.o.
ul. Taśmowa 7
02-677 Warsaw
Tel: +48 22 577 28 00
Manufacturer/Importer
Holsten Pharma GmbH
Hahnstraße 31-35
60528 Frankfurt am Main
Germany
This medicinal product is authorised in the Member States of the European Economic Area under the following names: