Patient leaflet - Brivaracetam Celix 100 mg film-coated tablets
1. What Brivaracetam Film-coated Tablets are and what are they used for
What Brivaracetam Film-coated Tablets are
Brivaracetam Film-coated Tablets contain the active substance brivaracetam. It belongs to a group of medicines called ‘anti-epileptics’. These medicines are used to treat epilepsy.
What Brivaracetam
Film-coated Tablets are used for
Brivaracetam Film-coated
Tablets are used in adults, adolescents and children from 2 years of age.
They are 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 Film-coated Tablets are used together with
other medicines for epilepsy.
2. What you need to know before you take Brivaracetam Film-coated Tablets
Do not take Brivaracetam Film-coated Tablets 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 Film-coated Tablets.
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 Film-coated Tablets 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 Film-coated Tablets 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 Film-coated Tablets are not recommended for use in children under 2 years of age.
Other medicines and Brivaracetam Film-coated Tablets
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 Film-coated Tablets 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.
Brivaracetam Film-coated Tablets with alcohol
- Combining this medicine with alcohol is not recommended.
If you drink alcohol while taking Brivaracetam Film-coated
Tablets 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 Film-coated Tablets 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
Film-coated Tablets.
- 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 Film-coated Tablets contain 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
(23 mg) per tablet, that is to say essentially ‘sodium free’.
3. How to take Brivaracetam Film-coated Tablets
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 Film-coated Tablets 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 Film-coated Tablets
- Swallow the tablets whole with a glass of liquid.
- The medicine may be taken with or without food.
How long to take Brivaracetam Film-coated Tablets for
Brivaracetam Film-coated Tablets are a long term treatment – keep taking Brivaracetam Film-coated Tablets until your doctor tells you to stop.
If you take more Brivaracetam Film-coated Tablets than you should
If you have taken more Brivaracetam Film-coated Tablets 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 Film-coated Tablets
- 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 Film-coated Tablets
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 the Yellow Card Scheme at: 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 Film-coated Tablets
- 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 Film-coated Tablets contain
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, lactose and magnesium stearate
Coating
- 10 mg film-coated tablets: poly(vinyl alcohol), titanium dioxide (E171), macrogol (3350), talc.
- 25 mg film-coated tablets: poly(vinyl alcohol), titanium dioxide (E171), macrogol (3350), talc, iron oxide yellow (E172) and iron oxide black (E172).
- 50 mg film-coated tablets: poly(vinyl alcohol), titanium dioxide (E171), macrogol (3350), talc, iron oxide yellow (E172) and iron oxide red (E172).
- 75 mg film-coated tablets: poly(vinyl alcohol), titanium dioxide (E171), macrogol (3350), talc, iron oxide yellow (E172), iron oxide red (E172) and iron oxide black (E172).
- 100 mg film-coated tablets: poly(vinyl alcohol), titanium dioxide (E171), macrogol (3350), talc, iron oxide yellow (E172) and iron oxide black (E172).
What Brivaracetam Film-coated Tablets looks like and contents of the pack
- Brivaracetam 10 mg are white to off-white, round, film-coated tablets of approx. 5.5mm in diameter with ‘10’ debossed on one side and plain on other side.
Brivaracetam 25 mg are grey oval, film-coated tablets
(of approx. 8.9mm x 5.0mm) with ‘25’ debossed on one side and plain on the other side.
- Brivaracetam 50 mg with break line are yellow oval film-coated tablets (of approx. 11.7mm x 6.6mm) with break line on one side.
Brivaracetam 75 mg are purple oval film-coated tablets
(of approx. 13mm x 7.3mm) with ‘75’ debossed on one side and plain on the other side.
- Brivaracetam 100 mg with break line are green-grey oval film-coated tablets (of approx. 14.5mm x 8.1mm) with break line on one side.
The 50 mg and 100 mg strengths are provided as scored tablets. The break line in scored tablets is to divide the tablets into two equal doses.
Brivaracetam 10 mg Film-coated tablets are supplied as pack of 14 film-coated tablets.
Brivaracetam 25 mg, 50 mg, 75 mg and 100 mg Film-coated tablets are supplied as pack of 56 film-coated tablets. All packs are available in PVC/PCTFE//Aluminium blisters.
Marketing Authorisation
Holder
Celix Pharma Ltd.
12 Constance Street, London,
E16 2DQ, United Kingdom
Manufacturer
PharmaPath S.A.
28is Oktovriou 1
Agia Varvara, 123 51
Greece
If you are blind or partially sighted and require this leaflet in a different format, call 0800 669 6825 or contact medinfo@celixpharma.com
This leaflet was last revised in July 2025
CEL20250107P