Briviact 10 mg/ml solution for injection and infusion

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Briviact 10 mg/ml solution for injection and infusion

brivaracetam

Read the entire leaflet carefully before you start using this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.

• If you have any questions, consult your doctor or pharmacist.

• This medicine has been prescribed for you only, and you must not give it to other people, even if they have the same symptoms as you, because it could harm them.

  • If you experience any adverse effects, talk to your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

1. What Briviact is and what it is used for

What Briviact is

Briviact contains the active substance brivaracetam. It belongs to a group of medicines called "antiepileptics". These medicines are used for the treatment of epilepsy.

What Briviact is used for

• Briviact is used in adults, adolescents, and children over 2 years of age.
• It is used for the treatment of a type of epilepsy characterized by partial-onset seizures with or without secondary generalization.
• Partial-onset seizures are seizures that begin by affecting only one side of the brain. These partial seizures may spread to larger areas of both sides of the brain—this is called "secondary generalization".
• Your doctor has prescribed this medicine to reduce the number of seizures.
• Briviact is used in combination with other medicines for the treatment of epilepsy.

2. What you need to know before using Briviact

Do not use Briviact

• if you are allergic to brivaracetam, to other chemically related compounds such as levetiracetam or piracetam, or to any of the other ingredients of this medicine (listed in section 6). If you are unsure, consult your doctor or pharmacist before using Briviact.

Warnings and precautions

Consult your doctor or pharmacist before starting to use Briviact:

• If you have had thoughts of harming yourself or of suicide. A small number of people being treated with antiepileptic medicines such as Briviact have experienced thoughts of self-harm or suicide. If you have any such 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.

Use of Briviact with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

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

• 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.

Use of Briviact with alcohol

The use of this medicine with alcohol is not recommended.

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

Pregnancy and breastfeeding

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

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

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

Breastfeeding is not recommended while taking Briviact, as Briviact is excreted in breast milk.

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

Driving and using machines

• You may feel drowsy, dizzy, or tired while using Briviact.
• These effects are more common at the beginning of treatment or after a dose increase.
• Do not drive, ride a bicycle, or operate 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 corresponds to 1% of the maximum daily recommended sodium intake for an adult.

3. How to use Briviact

Follow exactly the administration instructions for this medicine given by your doctor. If in doubt, 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 to you as an injection or infusion.
• Briviact injectable and infusion solution is used for a short period of time while you are unable to take Briviact orally.
• You may switch from oral Briviact to injectable and infusion solution, and vice versa.

Dosage

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

Adolescents and children weighing 50 kg or more, and adults

• The recommended dose is between 25 mg and 100 mg twice daily. Your doctor may later 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 between 0.5 mg and 2 mg per kg of body weight twice daily. Your doctor may later decide to adjust your dose to find the best dose for you.
• The doses given in the table below 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 only for 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 daily. Your child's doctor may then decide to adjust the dose to find the best dose for your child.

Patients 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 daily.
• 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 daily.
• As a child weighing between 10 kg and less than 20 kg, the maximum dose your child will take is 2 mg per kg of body weight twice daily.

How to use Briviact

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

Duration of Briviact treatment

• Your doctor will decide for how many days you should receive injections or infusions.
• For long-term treatment with Briviact, your doctor will instruct 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, contact your doctor immediately.

If you interrupt Briviact treatment

• Do not interrupt treatment with this medicine unless your doctor tells you to do so. This is because stopping treatment could increase the number of seizures you have.
• If your doctor decides to discontinue your treatment, they will give you instructions for gradually withdrawing Briviact. This will help prevent your seizures from returning or worsening.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

Very common: may affect more than 1 in 10 patients.

• drowsiness or dizziness

Common: may affect up to 1 in 10 patients.

• flu
• feeling very tired (fatigue)
• seizure, sensation of spinning (vertigo)
• feeling sick and vomiting, constipation
• pain or discomfort at the injection site
• depression, anxiety, difficulty sleeping (insomnia), irritability
• nose and throat infections (such as "common cold"), cough
• decreased appetite

Uncommon: may affect up to 1 in 100 patients

• allergic reactions
• abnormal thoughts and/or loss of contact with reality (psychotic disorder), aggression, restlessness (agitation)
• thoughts or attempts of self-harm or suicide: inform your doctor immediately
• a decrease in white blood cells (called "neutropenia") – which shows up in blood tests

Other adverse effects in children

Common: may affect up to 1 in 10 patients

• restlessness and hyperactivity (psychomotor hyperactivity)

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the national reporting system included in Appendix V. By reporting adverse 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 outer carton after EXP and on the vial after EXP. The expiry date refers to the last day of the month indicated.
• Briviact may be diluted prior to injection by your doctor or nurse. In such cases, it must be used immediately after dilution.
• This medicine does not require any special storage conditions.
• Each vial of Briviact for injection and infusion solution is for single use only. Any unused solution must be discarded.
• Only use the solution if it is clear, particle-free, and without discoloration.
• Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging that you no longer need. 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 components are: sodium acetate (trihydrate), glacial acetic acid, sodium chloride, water for injections.

Appearance of the product and contents of the pack

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

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

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

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

Manufacturer

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

Further information on this medicinal product is available upon request by contacting the local representative of the Marketing Authorisation Holder:

Date of latest review of this summary:

Other sources of information

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

This information is intended for healthcare professionals only:

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

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

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

Each vial of Briviact injection solution for infusion is for single use only. Unused solution must be discarded (see section 3).