BRIVIACT 10 mg/ml INJECTABLE SOLUTION AND PERFUSION SOLUTION

2. What you need to know before you use Briviact

Do not use Briviact

• if you are allergic to brivaracetam, to other similar chemical compounds such as levetiracetam or piracetam, or to any of the other ingredients of this medicine (listed in section 6). If you are not sure, consult your doctor or pharmacist before using Briviact.

Warnings and precautions

Talk to your doctor or pharmacist before starting Briviact:

• If you have had thoughts of harming yourself or committing suicide. A small number of people taking antiepileptic medicines like Briviact have had thoughts of harming themselves or committing suicide. If you have any of these thoughts, contact your doctor immediately.
• If you have liver problems, your doctor may need to adjust your dose.

Children

Do not give Briviact to children under 2 years of age.

Using Briviact with other medicines

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.

In particular, tell your doctor if you are taking any of the following medicines, as your doctor may need to adjust your dose of Briviact:

• 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.

Using Briviact with alcohol

It is not recommended to use this medicine with alcohol.

• If you drink alcohol while taking Briviact, the negative effects of alcohol may increase.

Pregnancy and breastfeeding

Women of childbearing age should discuss the use of contraceptives with their doctor.

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

It is not recommended to use Briviact if you are pregnant or breastfeeding, as the effects of Briviact on pregnancy and the fetus are unknown.

It is not recommended to breastfeed while taking Briviact, as Briviact is excreted in breast milk.

Do not stop treatment without consulting your doctor first. Stopping treatment may increase the number of seizures you have and harm your baby.

Driving and using machines

• You may feel drowsy, dizzy, or tired while using Briviact.
• These effects are more common at the start of treatment or after a dose increase.
• Do not drive, ride a bike, or use any tools or machinery until you know how this medicine affects you.

Briviact contains sodium

This medicine contains 19.1 mg of sodium (the main component of table/cooking salt) per vial. This is equivalent to 1% of the maximum recommended daily sodium intake for an adult.

3. How to use Briviact

Follow the instructions for administration of this medicine exactly as told by your doctor. If you are unsure, consult your doctor or pharmacist again.

You will use Briviact together with other medicines to treat epilepsy.

• When you start using this medicine, you will take Briviact orally (as tablets or oral solution) or it will be administered as an injection or infusion.
• Briviact solution for injection and infusion is used for a short period of time while you cannot take Briviact orally.
• You can switch from oral Briviact to the solution for injection and infusion, and vice versa.

Dose

Your doctor will calculate the correct daily dose for you. Take the daily dose in two equal doses, with an interval of approximately 12 hours.

Adolescents and children weighing 50 kg or more, and adults

• The recommended dose is between 25 mg and 100 mg twice a day. Your doctor may later decide to adjust it to find the best dose for you.

Adolescents and children weighing from 20 kg to less than 50 kg

• The recommended dose is between 0.5 mg and 2 mg per kg of body weight twice a day. Your doctor may later decide to adjust it to find the best dose for you.
• The doses given in the following table are only examples. Your doctor will calculate the correct dose for you based on your weight.

Children weighing from 10 kg to less than 20 kg

• Your child's doctor may prescribe the injection for only a few days if your child cannot take the medicine orally.
• The recommended dose is 0.5 mg to 2.5 mg per kg of body weight, twice a day. Your child's doctor may then decide to adjust the dose to find the best dose for your child.

Patient with liver problems

If you have liver problems:

• 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 per kg of body weight 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 per kg of body weight twice a day.

How to use Briviact

Briviact is administered by a doctor or nurse as an injection or infusion. This medicine is injected slowly into your vein or administered as an infusion (drip) over 15 minutes.

Duration of treatment with Briviact

• Your doctor will decide how many days you should be given the injections or infusion.
• For long-term treatment with Briviact, your doctor will ask you to take Briviact tablets or oral solution.

If you use more Briviact than you should

If you think you have been given too much Briviact, consult your doctor immediately.

If you stop treatment with Briviact

• Do not stop treatment with this medicine unless your doctor tells you to. This is because stopping treatment may increase the number of seizures you have.
• If your doctor decides to stop your treatment, he/she will give you instructions for gradual withdrawal of Briviact. This will help prevent your seizures from 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.

• drowsiness or dizziness

Common:may affect up to 1 in 10 people.

• flu
• feeling very tired (fatigue)
• seizure, feeling of spinning (vertigo)
• feeling sick and vomiting, constipation
• pain or discomfort at the injection site
• depression, anxiety, difficulty sleeping (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 thoughts and/or loss of contact with reality (psychotic disorder), aggression, restlessness (agitation)
• thoughts or attempts to harm yourself or commit suicide: tell your doctor immediately
• a decrease in white blood cells (called “neutropenia”) – which appears in blood tests

Other side effects in children

Common:may affect up to 1 in 10 people

• restlessness and hyperactivity (psychomotor hyperactivity)

Reporting of side effects

If you experience 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 national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Briviact

• 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 after CAD and on the vial after EXP. The expiry date is the last day of the month shown.
• Briviact may be diluted before injection by your doctor or nurse. In such cases, it should be used immediately after dilution.
• This medicine does not require any special storage conditions.
• Each vial of Briviact solution for injection and infusion is for single use only. The unused solution should be discarded.
• Only the clear, particle-free, and colorless solution should be used.
• Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

Composition of Briviact

The active substance is brivaracetam.

• Each ml contains 10 mg of brivaracetam.
• Each 5 ml vial contains 50 mg of brivaracetam.

The other ingredients are: sodium acetate (trihydrate), glacial acetic acid, sodium chloride, water for injections.

Appearance of the product and pack size

Briviact 10 mg/ml solution for injection and infusion is a clear, colorless, and sterile solution.

Briviact 10 mg/ml solution for injection and infusion, 5 ml vial is packaged in a cardboard box with 10 vials.

Marketing authorisation holder and manufacturer

Marketing authorisation holder

UCB Pharma, S.A., Allée de la Recherche 60, B-1070, Brussels, Belgium.

Manufacturer

UCB Pharma, S.A., Chemin du Foriest, B-1420 Braine-l’Alleud, Belgium.

You can request more information about this medicine from the local representative of the marketing authorisation holder:

Date of last revision of this leaflet:

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu

This information is intended only for healthcare professionals:

Briviact solution for injection and infusion can be administered as an intravenous bolus or as an intravenous infusion:

• Intravenous bolus: can be administered directly without dilution
• Intravenous infusion: can be administered over 15 minutes in a compatible diluent

Briviact can be diluted with the following solutions: sodium chloride 9 mg/ml (0.9%), glucose solution for injection 50 mg/ml (5%), or Ringer's lactate solution.

Each vial of Briviact solution for injection and infusion is for single use only. The unused solution should be discarded (see section 3).