Brivaracetam Rivopharm 10 mg film-coated tablets – patient leaflet, side effects, dosage

1. What Brivaracetam tablets are and what they are used for

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

• Brivaracetam tablets are 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 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.

• You 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 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 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.
• liver problems - your doctor may need to adjust your dose.

Children

Brivaracetam tablets is 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

• 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.
• Do not drive, cycle or use any tools or machines until you know how the medicine affects you.

Brivaracetam tablets contain sodium

This medicine contains less than 1 mmol sodium (23mg) 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, 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:

• 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 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.
• 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 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.

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• 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 the 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, 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 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 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 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

Cellulose, microcrystalline, starch pregelatinised (maize), Croscarmellose sodium, magnesium stearate

Coating

10 mg film-coated tablets: poly (vinyl alcohol), calcium carbonate, macrogol, 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), iron oxide red (E172), iron oxide black (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 tablets look like and contents of the pack

Brivaracetam Rivopharm 10 mg Tablets are white to off-white, round, biconvex, film-coated tablets of 6 mm in diameter and debossed with “10” on one side. Brivaracetam Rivopharm 25 mg Tablets are grey, oval, biconvex, film-coated tablets of 9 mm x 5 mm and

debossed with “25” on one side.

Brivaracetam Rivopharm 50 mg Tablets are yellow, oval, biconvex, film-coated tablets of 12 mm x 7 mm and debossed with “50” on one side.

Brivaracetam Rivopharm 75 mg Tablets are pink, oval, biconvex, film-coated tablets of 13 mm x 7 mm and debossed with “75” on one side.

Brivaracetam Rivopharm 100 mg Tablets 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 either 14, 28 or 56 film-coated tablets.

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

1. 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

Rivopharm UK Ltd

100 Bishopsgate,

London,

EC2N 4AG,

United Kingdom

This leaflet was last revised in Apr 2026.