Patient leaflet - Brivaracetam Accord 50 mg film-coated tablets
what they are used for
What Brivaracetam tablets are
Brivaracetam 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 tablets are used for
•
Brivaracetam tablets are used in adults,
adolescents and children from 2 years of age.
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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 tablets are used together with
other medicines for epilepsy.
2.
What you need to know before you
take Brivaracetam tablets
Do not take Brivaracetam 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 tablets.
•
have ever developed a severe skin rash or
skin peeling, blistering and/or mouth sores after taking Brivaracetam tablets.
Serious skin reactions including Stevens-Johnson syndrome have been reported in association with Brivaracetam tablets treatment. Stop using Brivaracetam 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 tablets if you:
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have thoughts of harming or killing yourself.
A small number of people being treated with anti-epileptic medicines such as Brivaracetam tablets have had thoughts of harming or killing themselves. If you have any of these thoughts at any time, contact your doctor immediately.
•
have liver problems - your doctor may need to
adjust your dose.
Children
Brivaracetam tablets are not recommended for use in children under 2 years of age.
Other medicines and Brivaracetam 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 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 tablets with alcohol
•
Combining this medicine with alcohol is not recommended.
•
If you drink alcohol while taking Brivaracetam 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 tablets if you are pregnant, as the effects of Brivaracetam tablets on pregnancy and the unborn baby are not known.
It is not recommended to breast-feed your baby while taking Brivaracetam tablets, as Brivaracetam tablets 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
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You may feel sleepy, dizzy or tired while taking Brivaracetam tablets.
•
These effects are more likely at the start of the treatment or after a dose increase.
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Do not drive, cycle or use any tools or machines until you know how the medicine affects you.
Brivaracetam tablets contains 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 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 brivaracetam may be more suitable for certain patients e.g. children (if tablets cannot be swallowed in whole or if the dose cannot be met with the use of whole tablets, for example); ask your doctor or pharmacist.
You will take Brivaracetam 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:
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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.
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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.
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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.
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How to take Brivaracetam tablets
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Swallow the tablets whole with a glass of
liquid. The tablets must be swallowed in whole to guarantee the intake of the correct dose. The medicine may be taken with or without food.
How long to take Brivaracetam tablets for
Brivaracetam tablets is a long-term treatment – keep taking Brivaracetam tablets until your doctor tells you to stop.
If you take more Brivaracetam tablets than you should
If you have taken more Brivaracetam 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 tablets
•
If you miss a dose take it as soon as you
remember.
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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.
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If you are not sure what to do, ask your doctor
or pharmacist.
If you stop taking Brivaracetam 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
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feeling sleepy or dizzy.
Common: may affect up to 1 in 10 people
•
flu
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feeling very tired (fatigue)
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convulsion, a feeling of ‘spinning’ (vertigo)
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feeling and being sick, constipation
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depression, anxiety, not being able to sleep
(insomnia), irritability
•
infections of the nose and throat (such as the
‘common cold’), cough
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decreased appetite.
Uncommon: may affect up to 1 in 100 people
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allergic reactions
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abnormal thinking and/or loss of touch with
reality (psychotic disorder), being aggressive, nervous excitement (agitation)
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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 the available data
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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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the 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 affects you can help provide more information on the safety of this medicine.
5. How to store Brivaracetam 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 tablets 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
Cellulose, microcrystalline, starch, pregelatinized (maize), croscarmellose sodium, magnesium stearate (see section 2, Brivaracetam tablets contains sodium).
Coating
•
10 mg film-coated tablets: poly(vinyl alcohol), calcium carbonate, macrogol (MW 3350), talc.
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25 mg film-coated tablets: poly(vinyl alcohol), calcium carbonate, macrogol (MW 3350), talc, iron oxide yellow (E172), iron oxide black (E172).
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50 mg film-coated tablets: poly(vinyl alcohol), calcium carbonate, macrogol (MW 3350), talc, iron oxide yellow (E172), iron oxide red (E172), iron oxide black (E172).
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75 mg film-coated tablets: poly(vinyl alcohol), calcium carbonate, macrogol (MW 3350), talc, iron oxide red (E172), iron oxide black (E172).
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100 mg film-coated tablets: poly(vinyl alcohol), calcium carbonate, macrogol (MW 3350), talc, iron oxide yellow (E172), iron oxide black (E172).
What Brivaracetam tablets looks like and contents of the pack
Brivaracetam tablets 10 mg are white to off-white, round, biconvex, film-coated tablets of 6 mm in diameter and debossed with “10” on one side.
Brivaracetam tablets 25 mg are grey, oval, biconvex, film-coated tablets of 9 mm x 5 mm and debossed with “25” on one side.
Brivaracetam tablets 50 mg are yellow, oval, biconvex, film-coated tablets of 12 mm x 7 mm and debossed with “50” on one side.
Brivaracetam tablets 75 mg are pink, oval, biconvex, film-coated tablets of 13 mm x 7 mm and debossed with “75” on one side.
Brivaracetam tablets 100 mg are grey-green, oval, biconvex, film-coated tablets of 15 mm x 8 mm and debossed with “100” on one side.
Brivaracetam tablets are packaged in blister packs supplied in cardboard boxes containing 14 or 56 film-coated tablets or 14x1 or 100x1 film-coated tablets in Alu/Alu perforated unit dose blister.
10 mg, 25 mg, 50 mg and 75 mg are also supplied in multipacks of 168 (2 packs of 84 film-coated tablets.
100 mg are also supplied in multipacks of 168 (3 packs of 56) film-coated tablets.
All packs are available in Aluminium/Aluminium (OPA/ aluminium foil/ PVC) blister.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
and Manufacturer
Accord-UK Ltd
Whiddon Valley
Barnstaple
Devon
EX32 8NS
Manufacturer
Holsten Pharma GmbH
Hahnstraße 31-35
60528 Frankfurt am Main
Germany
This leaflet was last revised in May 2025
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01271 385257
BBBC2295
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