Brivaracetam Zentiva 25mg film-coated tablets

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

1. What Brivaracetam is and what it is used for
2. What you need to know before you take Brivaracetam
3. How to take Brivaracetam
4. Possible side effects
5. How to store Brivaracetam
6. Contents of the pack and other information

• 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 this medicine.
  Serious skin reactions including Stevens-Johnson syndrome have been reported in association with brivaracetam treatment. Stop using this medicine and seek medical attention immediately if you notice any of the symptoms related to these serious skin reactions described in section 4.

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

Brivaracetam is not recommended for use in children under 2 years of age.

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.
• St John’s wort (also known as Hypericum perforatum) - a herbal medicine used to treat depression and anxiety as well as other conditions.

• Combining this medicine with alcohol is not recommended.
• If you drink alcohol while taking Brivaracetam the negative effects of alcohol may be increased.

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.

• 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.

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium free’.

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.

• Swallow the tablets whole with a glass of liquid.
• The medicine may be taken with or without food.

Brivaracetam is a long term treatment – keep taking Brivaracetam until your doctor tells you to stop.

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 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.

• 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

Common (may affect up to 1 in 10 people):

• restlessness and hyperactivity (psychomotor hyperactivity)

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.

• 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 (E468), lactose monohydrate, lactose anhydrous, magnesium stearate (E470b)

Coating

• 10 mg film-coated tablets: polyvinyl alcohol (E1203), titanium dioxide (E171), macrogol 4000, talc (E553b).
• 25 mg film-coated tablets: polyvinyl alcohol (E1203), titanium dioxide (E171), macrogol 4000, talc (E553b), iron oxide yellow (E172), iron oxide black (E172).
• 50 mg film-coated tablets: polyvinyl alcohol (E1203), titanium dioxide (E171), macrogol 4000, talc (E553b), iron oxide yellow (E172), iron oxide red (E172).
• 75 mg film-coated tablets: polyvinyl alcohol (E1203), titanium dioxide (E171), macrogol 4000, talc (E553b), iron oxide yellow (E172), iron oxide red (E172), iron oxide black (E172).
• 100 mg film-coated tablets: polyvinyl alcohol (E1203), titanium dioxide (E171), macrogol 4000, talc (E553b), iron oxide yellow (E172), iron oxide black (E172).

Brivaracetam Zentiva 10 mg are white to off-white, round, film-coated tablets, 5.1 mm, debossed with ‘10’ on one side.

Brivaracetam Zentiva 25 mg are grey, oval, film-coated tablets, 9.1 mm x 5.1 mm, debossed with ‘25’ on one side.

Brivaracetam Zentiva 50 mg are yellow, oval, film-coated tablets, 11.8 mm x 6.7 mm, debossed with ‘50’ on one side.

Brivaracetam Zentiva 75 mg are purple, oval, film-coated tablets 13.1 mm x 7.4 mm, debossed with ‘75’ on one side.

Brivaracetam Zentiva 100 mg are greenish-grey, oval, film-coated tablets 14.7 mm x 8.3 mm, debossed with ‘100’ on one side.

Brivaracetam Zentiva 10 mg, 25 mg, 50 mg, 75 mg or 100 mg film-coated tablets are packaged in:

• White HDPE containers with PP screw caps (with liner) and silica gel desiccant cannitster.
• PVC/PCTFE - Aluminium blisters in cartons.

Pack sizes:

14, 56 film-coated tablets (blisters) or multipack of 168 (3 packs of 56) film-coated tablets or 60 film-coated tablets (bottle).

Not all pack sizes may be marketed.

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