Patient Information Leaflet: Briviact 10 mg/ml Injectable and Infusion Solution

Brivaracetam

Read this 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, ask your doctor or pharmacist.

-This medicine has been prescribed for you only. Do not give it to others even if they have the same symptoms as you, as it may harm them.

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

1.What Briviact is and what it is used for

2.What you need to know before you start using Briviact

3.How to use Briviact

4.Possible side effects

5.Storage of Briviact

6.Contents of the pack and additional information

What is Briviact

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

What is Briviact used for

• Briviact is used in adults, adolescents, and children over 2 years old.
• It is used for the treatment of a type of epilepsy that involves partial seizures with or without secondary generalization.
• Partial seizures are seizures that begin 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.

Do not use Briviact

• If you are allergic to brivaracetam, other similar chemical compounds such as levetiracetam or piracetam, or any of the other components of this medication (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 committing suicide. A small number of people taking antiepileptic medications 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 administer Briviact to children under 2 years of age.

Use of Briviact with other medications

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

Particularly, inform your doctor if you are taking any of the following medications, as you will need to adjust your Briviact dose:

:

• Rifampicin, a medication used to treat bacterial infections.
• St. John's Wort (also known asHypericum perforatum), a plant-based medication used to treat depression and anxiety, as well as other conditions.

Use of Briviact with alcohol

Do not use this medication with alcohol.

• If you take 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, or think you may be pregnant, or intend to become pregnant, consult your doctor or pharmacist before using this medication.

Briviact is not recommended for use during pregnancy or breastfeeding, as the effects of Briviact on pregnancy and the fetus are unknown.

Do not breastfeed your baby 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 your seizures and harm the baby.

Driving and operating machinery

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

Briviact containssodium

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

Follow exactly the administration instructions for this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

You will use Briviact along with other medications to treat epilepsy.

• When starting to use this medication, you will take Briviact orally (as tablets or oral solution) or it will be administered as an injection or infusion.
• Briviact injectable and infusion solution is used for a short period of time while you cannot take Briviact orally.
• You can switch from Briviact oral to injectable and infusion solution, 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 then decide to adjust it to find the best dose for you.

Adolescents and children weighing between 20 kg and less than 50 kg

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

Children weighing between 10 kg and less than 20 kg

• Your child's doctor may prescribe the injection only for a few days if your child cannot take the medication orally.
• The recommended dose is 0.5 mg to 2.5 mg per kilogram 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.

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 a day.
• As an adolescent or child weighing between 20 kg and less than 50 kg, the maximum dose you will take is 1.5 mg per kilogram of body weight twice a day.
• As a child weighing between 10 kg and less than 20 kg, the maximum dose your child will take is 2 mg per kilogram of body weight twice a day.

How to use Briviact

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

Duration of Briviact treatment

• Your doctor will decide for how many days you should receive the injections or infusion.
• For long-term treatments 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 interrupt Briviact treatment

• Do not stop treatment with this medication 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, they will give you instructions for the gradual withdrawal of Briviact. This will help prevent the recurrence of seizures or make them worse.

If you have any other questions about using this medication, ask your doctor or pharmacist.

Like all medications, this medication may produce adverse effects, although not all people may experience them.

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

• drowsiness or dizziness

Frequent:may affect up to 1 in 10 patients.

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

Infrequent:May affect up to 1 in 100 patients

• allergic reactions
• abnormal thoughts and/or loss of contact with reality (psychotic disorder), aggression, nervousness (agitation)
• thoughts or attempts to harm oneself or commit suicide: report to your doctor immediately
• a decrease in white blood cells (called "neutropenia") – which appears in blood tests

Other Adverse Effects in Children

Frequent:may affect up to 1 in 10 patients

-restlessness and hyperactivity (psychomotor hyperactivity)

Reporting Adverse Effects

If you experienceany type of adverse effect, consult your doctor or pharmacist, even if it is apossibleadverse effect that does not appear in this prospectus.You can also report them directlythrough thenational notification systemincluded in theAppendix V.By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

• Keep this medication out of the sight and reach of children.
• Do not use this medication after the expiration date that appears on the carton after CAD and the vial after EXP. The expiration date is the last day of the month indicated.
• Briviact may be diluted before being injected by your doctor or nurse. In such cases, it should be used immediately after dilution.
• This medication does not require special storage conditions.
• Each vial of Briviact injectable and infusion solution must be used only once (single-use). Unused solution must be discarded.
• Only the transparent solution, free of particles and without discoloration, should be used.
• Medications should not be thrown down the drain or in the trash. Ask your pharmacist how to dispose of the containers and medications that you no longer need. This will help protect the environment.

Briviact Composition

The active ingredient is brivaracetam.

• Each milliliter 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, and water for injection preparations.

Appearance of the product and packaging contents

Briviact 10 mg/ml injectable and infusion solution is a transparent, colorless, and sterile solution.

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

Marketing authorization holder and manufacturer

Marketing authorization 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.

For more information about this medication, please contact the local representative of the marketing authorization holder:

Last revision date of this leaflet:

Other sources of information

The detailed information about this medication is available on the European Medicines Agency website:http://www.ema.europa.eu

This information is intended solely for healthcare professionals:

Briviact injectable and infusion solution can be administered as a bolus injection or as an infusion:

• Bolus intravenous injection: can be administered directly without dilution
• Infusion intravenous: 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 injection 50 mg/ml (5%), or lactated Ringer's solution.

Each vial of Briviact injectable and infusion solution should be used only once (single-use). Unused solution should be discarded (see section 3).