Brivaracetam STADA 50 mg 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 STADA film-coated tablets are and what they are used for
2. What you need to know before you take Brivaracetam STADA film-coated tablets
3. How to take Brivaracetam STADA film-coated tablets
4. Possible side effects
5. How to store Brivaracetam STADA film-coated tablets
6. Contents of the pack and other information

Brivaracetam STADA 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.

• Brivaracetam is 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 is used together with other medicines for epilepsy.

• 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 STADA film-coated tablets.
• if 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 STADA 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.

Talk to your doctor or pharmacist before taking Brivaracetam STADA 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.
• if you have liver problems - your doctor may need to adjust your dose.

Brivaracetam STADA film-coated tablets are 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 are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

It is not recommended to take Brivaracetam STADA 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 STADA film-coated 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.

• You may feel sleepy, dizzy or tired while taking Brivaracetam STADA 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.

• 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 (23mg) per tablet dose, 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.

For 10mg only: The tablet can be divided into equal doses.

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 STADA film-coated tablets are a long term treatment – keep taking brivaracetam until your doctor tells you to stop.

If you have taken more of this medicine 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

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 Brivaracetam STADA 10 mg film-coated tablets contain 10 mg brivaracetam.

Each Brivaracetam STADA 25 mg film-coated tablets contain 25 mg brivaracetam.

Each Brivaracetam STADA 50 mg film-coated tablets contain 50 mg brivaracetam.

Each Brivaracetam STADA 75 mg film-coated tablets contain 75 mg brivaracetam.

Each Brivaracetam STADA 100 mg film-coated tablets contain 100 mg brivaracetam.

The other ingredients are:

• Tablet core: lactose monohydrate, cellulose, microcrystalline (type 102) (E460), hypromellose 2910 (5 mPa.s) (E464), croscarmellose sodium, silica, colloidal anhydrous (E551), magnesium stearate (E470b)
• Tablet coating: poly(vinyl alcohol) (E1203), calcium carbonate (E170), macrogol 4000 (E1521), talc (E553b)

Brivaracetam STADA 25 mg film-coated tablets also contains: Iron oxide black (E172), Iron oxide yellow (E172)

Brivaracetam STADA 50 mg film-coated tablets also contains: Iron oxide yellow (E172)

Brivaracetam STADA 75 mg film-coated tablets also contains: Iron oxide black (E172), Iron oxide red (E172)

Brivaracetam STADA 100 mg film-coated tablets also contains: Iron oxide yellow (E172), Iron oxide black (E172)

Brivaracetam STADA 10 mg film-coated tablets are white to off-white, round biconvex tablets, debossed with ‘10’ on one side and breakline on the other.

Brivaracetam STADA 25 mg film-coated tablets are grey, oblong biconvex tablets, debossed with ‘25’ on one side and plain on the other.

Brivaracetam STADA 50 mg film-coated tablets are yellow, oblong biconvex tablets, debossed with ‘50’ on one side and plain on the other.

Brivaracetam STADA 75 mg film-coated tablets are purple, oblong biconvex tablets, debossed with ‘75’ on one side and plain on the other.

Brivaracetam STADA 100 mg film-coated tablets are green, oblong biconvex tablets, debossed with ‘100’ on one side and plain on the other.

Brivaracetam STADA film-coated tablets are available in Aluminium-OPA/Alu/PVC blisters containing 14, 56 or 100 film-coated tablets or multipacks containing 168 (3 packs of 56) film-coated tablets or perforated unit-dose blisters containing 14 x 1, 56 x 1 or 100 x 1 film-coated tablets or multipacks containing 168 (3 packs of 56 x 1) film-coated tablets.

Brivaracetam STADA film-coated tablets are also available in High-Density Polyethylene (HDPE) bottles, closed with a polypropylene (PP) child resistant cap containing 60 film-coated tablets.

Not all pack sizes may be marketed.