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

1. What Brivaracetam tablets is and what it is used for What Brivaracetam tablets is

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

What Brivaracetam tablets is used for

x Brivaracetam tablets is used in adults,

adolescents and children from 2 years of age.

x It is used to treat a type of epilepsy that

has partial seizures with or without a secondary generalisation.

x 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’.

x You have been given this medicine to

lower the number of fits (seizures) you have.

x Brivaracetam tablets is 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 levitriacetam 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 as 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 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 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 are 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 on pregnancy and the unborn baby are not known.

It is not recommended to breast-feed your baby while taking Brivaracetam tablets, 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 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 contains lactose and sodium

Brivaracetam tablets 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 medicinal product.

• 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 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 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.

• 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, 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 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 medicine 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

  brivaracetam.

• Each film-coated tablet contains 25 mg

  brivaracetam.

• Each film-coated tablet contains 50 mg

  brivaracetam.

• Each film-coated tablet contains 75 mg

  brivaracetam.

• Each film-coated tablet contains 100

  mg brivaracetam.

The other ingredients are:

Core

Lactose monohydrate, croscarmellose sodium, lactose (anhydrous) and magnesium stearate.

Coating

Poly(vinyl alcohol) (E1203), titanium dioxide (E171), macrogol 4000 (E1521) and talc (E553b).

Poly(vinyl alcohol) (E1203), titanium dioxide (E171), macrogol 4000 (E1521), talc (E553b), iron oxide black (E172), iron oxide yellow (E172).

Poly(vinyl alcohol) (E1203), titanium dioxide (E171), macrogol 4000 (E1521), talc (E553b), iron oxide yellow (E172), iron oxide red (E172).

Poly(vinyl alcohol) (E1203), titanium dioxide (E171), macrogol 4000 (E1521), iron oxide red (E172), iron oxide black (E172), iron oxide yellow (E172).

Poly(vinyl alcohol) (E1203), titanium

dioxide ((E171), macrogol 4000 (E1521), talc (E553b), iron oxide yellow (E172), iron oxide black (E172).

What Brivaracetam tablets looks like and contents of the pack

Film-coated tablets are white, round (dimension 5.5 mm) biconvex film coated tablets, debossed with “10” on one side and plain on the other side.

Film-coated tablets are grey, oval (dimension 8.9 mm X 5.0 mm) biconvex film coated tablets, debossed with “25” on one side and plain on the other side.

Film-coated tablets are yellow, oval (dimension 11.7 mm X 6.5 mm) biconvex film coated tablets, debossed with “50” on one side and plain on the other side.

Film-coated tablets are purple, oval (dimension 13.0 mm X 7.3 mm) biconvex film coated tablets, debossed with “75” on one side and plain on the other side.

Film-coated tablets are green-grey, oval (dimension 14.5 mm X 8.1 mm) biconvex film coated tablets, debossed with “100” on one side and plain on the other side.

Brivaracetam Liconsa 10 mg film-coated tablets are packaged in

• Blisters composed by PVC/PCTFE(Aclar)

  Clear- Aluminium or PVC/PE/PVDC Clear

  • Aluminium containing 14, 28, 56 and 84 film-coated tablets
• HDPE bottle with silica gel desiccant contained in the polypropylene cap containing 56, 60, 100 and 168 film-coated tablets

Brivaracetam Liconsa 25 mg film-coated tablets are packaged in

• Blisters composed by PVC/PCTFE(Aclar)

  Clear- Aluminium or PVC/PE/PVDC Clear

  • Aluminium containing 14, 28, 56 and 84 film-coated tablets
• HDPE bottle with silica gel desiccant contained in the polypropylene cap containing 56, 60, 100 and 168 film-coated tablets

Brivaracetam Liconsa 50 mg film-coated tablets are packaged in

• Blisters composed by PVC/PCTFE(Aclar)

  Clear- Aluminium or PVC/PE/PVDC Clear

  • Aluminium containing 14, 28, 56 and 84 film-coated tablets
• HDPE bottle with silica gel desiccant contained in the polypropylene cap containing 56, 60, 100 and 168 film-coated tablets

Brivaracetam Liconsa 75 mg film-coated tablets are packaged in

• Blisters composed by PVC/PCTFE(Aclar)

  Clear- Aluminium or PVC/PE/PVDC Clear

  • Aluminium containing 14, 28, 56 and 84 film-coated tablets
• HDPE bottle with silica gel desiccant contained in the polypropylene cap containing 168 film-coated tablets

Brivaracetam Liconsa 100 mg film-coated tablets are packaged in

• Blisters composed by PVC/PCTFE(Aclar)

  Clear- Aluminium or PVC/PE/PVDC Clear

  • Aluminium containing 14, 28, 56 and 84 film-coated tablets
• HDPE bottle with silica gel desiccant contained in the polypropylene cap containing 56, 60, 100 and 168 film-coated tablets

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Laboratories Liconsa S.A

Dulcinea s/n,

28805 Alcala de Henares,

Madrid, Spain

Laboratorios Liconsa S.A.

Avda. Miralcampo, Nº 7

Pol. Ind. Miralcampo

19200 Azuqueca de Henares,

Guadalajara

SPAIN

Pharmadox Healthcare Ltd.

KW20A Kordin Industrial Park,

Paola PLA 3000,

Malta

This medicine is authorised in the Member States of the European Economic under the following names:

Brivaracetam Liconsa 10 mg film-coated tablets

Brivaracetam Liconsa 25 mg film-coated tablets

Brivaracetam Liconsa 50 mg film-coated tablets

Brivaracetam Liconsa 75 mg film-coated tablets

Brivaracetam Liconsa 100 mg film-coated tablets

This leaflet was last revised in June 2026

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