BRIVIACT 75 mg FILM-COATED TABLETS

2. What you need to know before you take Briviact

Do not take Briviact

• 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 Briviact.

Warnings and precautions

Tell your doctor or pharmacist before you start taking Briviact:

• if you have had thoughts of harming yourself or suiciding. A small number of people taking antiepileptic medicines such as Briviact have had thoughts of harming themselves or suiciding. 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

Briviact is not recommended for use in children below 2 years of age.

Taking Briviact with other medicines

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 Briviact:

• 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 Briviact with alcohol

• It is not recommended to take this medicine with alcohol.
• If you drink alcohol while taking Briviact, the negative effects of alcohol may increase.

Pregnancy and breast-feeding

Women of childbearing potential should discuss the use of contraceptives with their doctor.

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Briviact should not be taken during pregnancy unless clearly necessary. The effects of Briviact in pregnancy and on the unborn child are not known.

Briviact should not be taken while breast-feeding. Briviact is excreted in breast milk.

Do not stop treatment without first consulting your doctor. 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 Briviact.
• 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 machines until you know how this medicine affects you.

Briviact containslactose and sodium

Briviact film-coated tablets contain:

• lactose (a type of sugar) - If your doctor has told you that you have an intolerance to some sugars, contact 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 Briviact

Take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.

You will take Briviact 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 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 Briviact tablets

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

Duration of treatment with Briviact

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

If you take more Briviact than you should

If you take more Briviact than you should, contact 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 suiciding.

If you forget to take Briviact

• If you forget to take a dose, take it as soon as you remember.
• Take your next dose at the usual time.
• 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 Briviact

• Do not stop treatment 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 tell you how to gradually reduce the dose of Briviact. 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 drowsy 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
• 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 suiciding: tell your doctor immediately
• a decrease in white blood cells (called ‘neutropenia’) – which appears in blood tests

Other side effects in children

Common:may affect up to 1 in 10 people.

• restlessness and hyperactivity (hyperkinetic disorder)

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 leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Briviact

• 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 after EXP and on the blister after EXP. The expiry date refers to the last day of that month.
• 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 to protect the environment.

6. Contents of the pack and other information

What Briviact 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

Croscarmellose sodium, lactose monohydrate, betadex, lactose anhydrous, magnesium stearate.

Tablet coating

• 10 mg film-coated tablets: polyvinyl alcohol, titanium dioxide (E171), macrogol (3350), talc.
• 25 mg film-coated tablets: polyvinyl alcohol, titanium dioxide (E171), macrogol (3350), talc, yellow iron oxide (E172), black iron oxide (E172).
• 50 mg film-coated tablets: polyvinyl alcohol, titanium dioxide (E171), macrogol (3350), talc, yellow iron oxide (E172), red iron oxide (E172).
• 75 mg film-coated tablets: polyvinyl alcohol, titanium dioxide (E171), macrogol (3350), talc, yellow iron oxide (E172), red iron oxide (E172), black iron oxide (E172).
• 100 mg film-coated tablets: polyvinyl alcohol, titanium dioxide (E171), macrogol (3350), talc, yellow iron oxide (E172), black iron oxide (E172).

Appearance and packaging

Briviact 10 mg are white to off-white, round, 6.5 mm diameter film-coated tablets engraved with “u 10” on one side.

Briviact 25 mg are grey, oval, 8.9 mm x 5.0 mm film-coated tablets engraved with “u 25” on one side.

Briviact 50 mg are yellow, oval, 11.7 mm x 6.6 mm film-coated tablets engraved with “u 50” on one side.

Briviact 75 mg are purple, oval, 13.0 mm x 7.3 mm film-coated tablets engraved with “u 75” on one side.

Briviact 100 mg are greenish-grey, oval, 14.5 mm x 8.1 mm film-coated tablets engraved with “u 100” on one side.

Briviact film-coated tablets are packaged in PVC/PCTFE-Aluminium blisters, which are included in cardboard boxes containing either 14, 56, 14 x 1 or 100 x 1 film-coated tablets, or in multiple packs containing 168 (3 packs of 56) film-coated tablets.

All pack sizes are available in PVC/PCTFE-Aluminium blisters.

Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer

Marketing authorisation holder

UCB Pharma, S.A., Allée de la Recherche 60, B-1070, Brussels, Belgium.

Manufacturer

UCB Pharma, S.A., Chemin du Foriest, B-1420 Braine-l’Alleud, Belgium.

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

Date of last revision of this leaflet:

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu