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

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

• Brivaracetam Stirling film-coated tablets are used in adults, adolescents and children from 2 years of age.
• They are 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 Stirling film-coated tablets are used together with other medicines for epilepsy.

• 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 film-coated tablets.
• you have ever developed a severe skin rash or skin peeling, blistering and/or mouth sores after taking Brivaracetam Stirling film-coated tablets.
• Serious skin reactions including Stevens-Johnson syndrome have been reported in association with Brivaracetam Stirling film-coated tablets treatment. Stop using Brivaracetam Stirling 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 Stirling 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 Stirling film-coated tablets 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.

Brivaracetam Stirling 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 Stirling film-coated 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.

• Combining this medicine with alcohol is not recommended.
• If you drink alcohol while taking Brivaracetam Stirling film-coated tablets 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 Stirling 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 Stirling 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 Stirling 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.

Brivaracetam Stirling 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 medicine.
• sodium – this medicine contains less than 1 mmol sodium (23mg) 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 Stirling film-coated tablets are a long-term treatment – keep taking Brivaracetam Stirling film-coated tablets until your doctor tells you to stop.

If you have taken more Brivaracetam Stirling film-coated 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 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: 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.

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

Lactose monohydrate, lactose, croscarmellose sodium, magnesium stearate

Coating

• 10 mg film-coated tablets: poly(vinyl alcohol), titanium dioxide (E171), macrogol (3350), talc.
• 25 mg film-coated tablets: poly(vinyl alcohol), titanium dioxide (E171), macrogol (3350), talc, iron oxide black (E172), iron oxide yellow (E172).
• 50 mg film-coated tablets: poly(vinyl alcohol), titanium dioxide (E171), macrogol (3350), talc, iron oxide yellow (E172), iron oxide red (E172).
• 75 mg film-coated tablets: poly(vinyl alcohol), titanium dioxide (E171), macrogol (3350), talc, iron oxide black (E172), iron oxide yellow (E172), iron oxide red (E172).
• 100 mg film-coated tablets: poly(vinyl alcohol), titanium dioxide (E171), macrogol (3350), talc, iron oxide black (E172), iron oxide yellow (E172).

• Brivaracetam Stirling10 mg film-coated tablets are white to off white, round, film-coated tablets of approx. 5.5 mm diameter with '10' debossed on one side and plain on the other side.
• Brivaracetam Stirling 25 mg are grey, oval, film-coated tablets (of approx. 8.9 mm × 5.0 mm) with '25' debossed on one side and plain on the other side.
• Brivaracetam Stirling 50 mg film-coated tablets are yellow, oval, film-coated tablets (of approx. 11.7 mm × 6.6 mm) with score line on one side.
• Brivaracetam Stirling 75 mg film-coated tablets are purple, oval, film-coated tablets (of approx. 13 mm × 7.3 mm) with '75' debossed on one side and plain on the other side.
• Brivaracetam Stirling100 mg film-coated tablets are green-grey, oval, film-coated tablets (of approx. 14.5 mm× 8.1 mm) with score line on one side.

Brivaracetam Stirling film-coated tablets are packaged in blister packs supplied in cardboard boxes containing either 7, 14, 28, 56, 60, 7 × 1, 14 × 1, 28 × 1, 56 × 1 or 60 × 1 film-coated tablets or in multipacks containing either 168 (3 packs of 56) or 168 × 1 (3 packs of 56 × 1) film-coated tablets.

All packs are available in PVC/PCTFE – Aluminium blisters.

Not all pack sizes may be marketed.