Patient leaflet - Brivaracetam Zydus 75 mg film-coated tablets
1. What Brivaracetam is and what it is used for What Brivaracetam is
Brivaracetam contains the active substance brivaracetam. It belongs to a group of medicines called ‘anti-epileptics’. These medicines are used to treat epilepsy.
What Brivaracetam 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
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.
Brivaracetam is used together with other
medicines for epilepsy.
2. What you need to know before you take Brivaracetam
Do not take Brivaracetam 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 Brivaracetam.
you have ever developed a severe skin
rash or skin peeling, blistering and/or mouth sores after taking Brivaracetam. Serious skin reactions including Stevens- Johnson syndrome have been reported in association with Brivaracetam treatment. Stop using Brivaracetam and seek medical attention immediately if you notice any of the symptoms related to these serious skin reactions described in section 4.
Warnings and precautions
Talk to your doctor or pharmacist before taking Brivaracetam if:
You have thoughts of harming or killing
yourself. A small number of people being treated with anti-epileptic medicines such as Brivaracetam 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
Brivaracetam is not recommended for use in children under 2 years of age.
Other medicines and Brivaracetam
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 Brivaracetam dose:
Rifampicin - a medicine used to treat
bacterial infections.
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- St John’s wort (also known as Hypericum perforatum) - a herbal medicine used to treat depression and anxiety as well as other conditions.
Brivaracetam with alcohol
- Combining this medicine with alcohol is not recommended.
If you drink alcohol while taking
Brivaracetam the negative effects of alcohol may be increased.
Pregnancy and breast-feeding
Fertile women should discuss the use of contraceptives with the doctor.
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 Brivaracetam if you are pregnant, as the effects of Brivaracetam on pregnancy and the unborn baby are not known.
It is not recommended to breast-feed your baby while taking Brivaracetam, as Brivaracetam passes into breast milk. 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 Brivaracetam.
- 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.
Brivaracetam contains lactose and sodium
Brivaracetam 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 Brivaracetam
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. Other form(s) of this medicine may be more suitable for certain patients e.g. children (if tablets can not be swallowed in whole, for example); ask your doctor or pharmacist. You will take Brivaracetam 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, approximately 12 hours apart.
Adolescents and children weighing 50 kg or more, and adults
- 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.
Adolescents and children weighing from 20 kg to 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.
Children weighing from 10 kg to less than 20 kg
- The recommended dose is from 0.5 mg to 2.5 mg for each kg of bodyweight, taken twice a day. Your child’s doctor may then decide to adjust your child’s dose to find the best dose for your child. People with liver problems
If you have problems with your liver:
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 from
20 kg to less than 50 kg, the maximum dose you will take is 1.5 mg for each kg of bodyweight twice a day.
- As a child weighing from 10 kg to less than 20 kg, the maximum dose your child will take is 2 mg for each kg of bodyweight twice a day.
How to take Brivaracetam tablets
- Swallow the tablets whole with a glass of liquid.
- The medicine may be taken with or without food
How long to take Brivaracetam for
Brivaracetam is a long term treatment – keep taking Brivaracetam until your doctor tells you to stop.
If you take more Brivaracetam than you should
If you have taken more Brivaracetam 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 Brivaracetam
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 Brivaracetam
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 Not Known: frequency cannot be estimated from available data
a widespread rash with blisters and
peeling skin, particularly around the mouth, nose, eyes and genitals (Stevens- Johnson syndrome)
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: Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard 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 Brivaracetam
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 and blister after EXP. The expiry date refers to the last day of that month.
This medicinal product does not require
any special storage conditions.
Do not throw away any medicines via
wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6. Contents of the pack and other information
What Brivaracetam contains
The active substance is brivaracetam. Each film-coated tablet contains 10 mg, 25 mg, 50 mg, 75 mg, or 100 mg brivaracetam.
The other ingredients are:
Core
Croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, hypromellose 2910 and colloidal anhydrous silica. Coating
- 10 mg film-coated tablets: poly(vinyl alcohol), calcium carbonate, macrogol and talc.
- 25 mg film-coated tablets: poly(vinyl alcohol), calcium carbonate, macrogol, talc, iron oxide yellow (E172), iron oxide black (E172).
- 50 mg film-coated tablets: poly(vinyl alcohol), calcium carbonate, macrogol, talc, iron oxide yellow (E172).
- 75 mg film-coated tablets: poly(vinyl alcohol), calcium carbonate, macrogol, talc, iron oxide red (E172), iron oxide black (E172).
- 100 mg film-coated tablets: poly(vinyl alcohol), calcium carbonate, macrogol, talc, iron oxide yellow (E172), iron oxide black (E172).
What Brivaracetam looks like and contents of the pack
Brivaracetam 10 mg film-coated tablets are white to off-white, round biconvex tablets, debossed with ‘10’ on one side and a break line on the other. The 10 mg tablet should not be divided into equal doses.
Brivaracetam 25 mg film-coated tablets are grey, oblong, biconvex tablets, debossed with ‘25’ on one side and plain on the other. Brivaracetam 50 mg film-coated tablets are yellow, oblong, biconvex tablets, debossed with ‘50’ on one side and plain on the other. Brivaracetam 75 mg film-coated tablets are purple, oblong, biconvex tablets, debossed with ‘75’ on one side and plain on the other. Brivaracetam 100 mg film-coated tablets are green, oblong, biconvex tablets, debossed with ‘100’ on one side and plain on the other.
Brivaracetam 10 mg film-coated tablets are packaged in Aluminium-OPA/Alu/PVC blister packs supplied in cardboard boxes containing either 14 film-coated tablets or in HDPE bottles with a polypropylene child-resistant closure containing 60 film-coated tablets.
Brivaracetam 25 mg, 50 mg, 75 mg and 100 mg film-coated tablets are packaged in Aluminium-OPA/Alu/PVC blister packs supplied in cardboard boxes containing either 56 film-coated tablets or in HDPE bottles with a polypropylene child-resistant closure containing 60 film-coated tablets Not all pack sizes may be marketed.
Marketing Authorisation Holder Zydus Pharmaceuticals UK Ltd
Sandretto Building
Cavalry Hill Industrial Park
Weedon
Northampton
England NN7 4PP
United Kingdom
Manufacturer:
PharOS MT Ltd
HF62X, Hal Far Industrial Estate
Birzebbugia BBG3000
Malta
Pharos Pharmaceutical Oriented Services Ltd.
Lesvou Street End
Thesi Loggos
Industrial Zone
Metamorfossi 144 52
Greece
This leaflet was last revised in Aug-2025
165 mm