BRIVIACT 25 MG FILM-COATED TABLETS - patient leaflet, side effects, dosage

Patient leaflet - BRIVIACT 25 MG FILM-COATED TABLETS

Package leaflet: Information for the patient

Your medicine is known by the above name, but will be referred to as Briviact® throughout this leaflet.

This product is available in other strengths.

Read all of this leaflet carefully before you start 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 only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
– If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

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

1. what briviact® is and what it is used for

What Briviact® is

Briviact® contains the active substance brivaracetam. It belongs to a group of medicines called ‘anti-epileptics’. These medicines are used to treat epilepsy.

What Briviact® is used for

– Briviact® is used in adults, adolescents and children from 4 years of age.
– It is used to treat a type of epilepsy that has partial seizures with or without a secondary generalisation.
– Partial seizures are fits that start by only affecting one side of the brain. These partial seizures can spread and extend to larger areas on both sides of the brain – this is called a ‘secondary generalisation’.
– You have been given this medicine to lower the number of fits (seizures) you have.
– Briviact® is used together with other medicines for epilepsy.

2. what you need to know before you take briviact®

Do not take Briviact® if:

– you are allergic to brivaracetam, other similar chemical compounds as levetiracetam or piracetam or any of the other ingredients of this medicine (listed in section 6). If you are not sure, talk to your doctor or pharmacist before taking Briviact®.

Warnings and precautions

Talk to your doctor or pharmacist before taking Briviact® if:

– You have thoughts of harming or killing yourself. A small number of people being treated with anti-epileptic medicines such as Briviact® have had thoughts of harming or killing themselves. If you have any of these thoughts at any time, contact your doctor immediately.
– You have liver problems – your doctor may need to adjust your dose.

Children

Briviact® is not recommended for use in children under 4 years of age.

Other medicines and Briviact®

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 – this is because your doctor may need to adjust your Briviact® dose:

– 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.

Briviact® with alcohol

– Combining this medicine with alcohol is not recommended.
– If you drink alcohol while taking Briviact® the negative effects of

alcohol may be increased.

Pregnancy and breast-feeding

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

It is not recommended to take Briviact® if you are pregnant or breastfeeding, as the effects of Briviact® on pregnancy and the unborn baby or the new-born child are not known.

Do not stop treatment without talking to your doctor first. Stopping treatment could increase your seizures and harm your baby.

Driving and using machines

– You may feel sleepy, dizzy or tired while taking Briviact®.
– These effects are more likely at the start of the treatment or after a dose increase.
– Do not drive, cycle or use any tools or machines until you know how the medicine affects you.

Briviact® contains lactose and sodium

Briviact® film-coated tablets contain:

– lactose (a type of sugar). If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
– Sodium – This medicine contains less than 1 mmol sodium (23mg) per tablet, that is to say essentially ‘sodium free’.

3. how to take briviact®

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

You will take Briviact® together with other medicines for epilepsy.

How much to take

Your doctor will work out the right daily dose for you. Take the daily dose in two equal divided doses – one in the morning and one in the evening at about the same time each day.

Adults, adolescents and children weighing 50 kg or more

– The recommended dose is from 25 mg to 100 mg taken twice a day. Your doctor may then decide to adjust your dose to find the best dose for you.

Children and adolescents weighing less than 50 kg

– The recommended dose is from 0.5 mg to 2 mg for each kg of bodyweight, taken twice a day. Your doctor may then decide to adjust your dose to find the best dose for you.

People with liver problems

If you have problems with your liver:

– As an adult, adolescent or child weighing 50 kg or more, the maximum dose you will take is 75 mg twice a day.
– As a child or adolescent weighing less than 50 kg, the maximum dose you will take is 1.5 mg for each kg of bodyweight twice a day.

How to take Briviact® tablets

– Swallow the tablets whole with a glass of liquid.
– The medicine may be taken with or without food.

How long to take Briviact® for

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

If you take more Briviact® than you should

If you have taken more Briviact® than you should, talk to your doctor. You may feel dizzy and sleepy.

You may also have any of the following symptoms: feeling sick, a feeling of ‘spinning’, problems of keeping your balance, anxiety, feeling very tired, irritability, being aggressive, not being able to sleep, depression, thoughts or attempts of harming or killing yourself.

If you forget to take Briviact®

– If you miss a dose take it as soon as you remember.
– Then take your next dose at the time you would normally take it.
– Do not take a double dose to make up for a forgotten dose.
– If you are not sure what to do, ask your doctor or pharmacist.

If you stop taking Briviact®

– Do not stop taking this medicine unless your doctor tells you to. This is because stopping treatment could increase the number of fits you have. – If your doctor asks you to stop taking this medicine they will lower your dose gradually. This helps to stop your fits 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 sleepy or dizzy

Common: may affect up to 1 in 10 people

– flu
– feeling very tired (fatigue)
– convulsion, a feeling of ‘spinning’ (vertigo)
– feeling and being sick, constipation
– depression, anxiety, not being able to sleep (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 thinking and/or loss of touch with reality (psychotic disorder), being aggressive, nervous excitement (agitation)
– thoughts or attempts of harming or killing yourself: tell your doctor straight away
– a decrease in white blood cells (called ‘neutropenia’) – shown in blood tests

Additional side effects in children

Common: may affect up to 1 in 10 people

– restlessness and hyperactivity (psychomotor hyperactivity)

Reporting of side effects

If you get 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 Yellow Card Scheme at: or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

5. how to store briviact®

- Keep out of the sight and reach of children.
– Do not use this medicine after the expiry date which is stated on the label after EXP. The expiry date refers to the last day of that month.
– This medicine does not require any special storage conditions.
– If the medicine become discoloured or show any other signs of deterioration, you should seek the advice of your pharmacist who will tell you what to do.
– Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. 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 25 mg brivaracetam.

The other ingredients are:

Core

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

Coating

– 25 mg film-coated tablets: poly (vinyl alcohol), titanium dioxide (E171), macrogol (3350), talc, iron oxide yellow (E172), iron oxide black (E172).

What Briviact® looks like and contents of the pack

Briviact® 25 mg are grey, oval, film-coated tablets of 8.9 mm x 5.0 mm and debossed with ‘u25’ on one side.

Briviact® tablets are packaged in blister packs supplied in cardboard boxes containing either 14, 56, 14 × 1 or 100 × 1 film-coated tablets or in multipacks containing 168 (3 packs of 56) film-coated tablets.

All packs are available in PVC/PCTFE – Aluminium blisters.

Not all pack sizes may be marketed.

Manufacturer

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

Procured from within the EU and repackaged by the Product Licence Holder Beachcourse Ltd., Unit 2–3, Townsend Industrial Estate, Waxlow Road, London, NW10 7NU.

PLGB 16378/1072

PoM

Revision date: 14.01.2022

Briviact ® is a registered trademark of UCB Biopharma SPRL.

Blind or partially sighted?

Is this leaflet hard to see or read? Phone Beachcourse, Tel: 020 8896 9054 for help.