Briviact 100 mg comprimidos recubiertos con pelicula

Label: information for the patient

Briviact 10 mg film-coated tablets

Briviact 25 mg film-coated tablets

Briviact 50 mg film-coated tablets

Briviact 75 mg film-coated tablets

Briviact 100 mg film-coated tablets

brivaracetam

Read this label carefully before starting to take this medicine, because

it contains important information for you.

• Keep this label, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed only for you, and you should not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this label. See section 4.

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 aged 2 years and above.
• 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 take Briviact

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take Briviact:

• If you have had thoughts of harming yourself or suicide. A small number of people taking antiepileptic medicines like Briviact have had thoughts of harming themselves or 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

Briviact is not recommended for children under 2 years old.

Taking Briviact with other medicines

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

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

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

Taking Briviact with alcohol

• Do not 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 ageshould discuss the use of contraceptives with their doctor.

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

Briviact is not recommended during pregnancy, 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 your baby.

Driving and operating machinery

• You may feel drowsy, dizzy or tired while taking 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 check how this medicine affects you.

Briviact containslactose and sodium

Briviact film-coated tablets contain:

• lactose (a type of sugar) - If your doctor has told you that you have a certain sugar intolerance, consult with them before taking this medicine.
• sodium – This medicine contains less than 23 mg of sodium (1 mmol) per tablet; this is, essentially “sodium-free”.

Follow exactly the administration instructions of this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again. Other forms of this medication may be more suitable for some patients, for example, children (if they cannot swallow whole tablets, for instance). Consult your doctor or pharmacist.

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

Dosage

Your doctor will calculate the correct daily dose for you. Take the daily dose divided into two equal doses, approximately with 12 hours of difference.

Adolescents and children weighing 50 kg or more, and adults

• The recommended dose ranges from 25 mg to 100 mg twice a day. Your doctor may then decide to adjust your dose to find the best dose for you.

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

• The recommended dose ranges from 0.5 mg to 2 mg per kilogram of body weight, twice a day. Your doctor may then decide to adjust the dose to find the best dose for you.

Children weighing between 10 kg and less than 20 kg

The recommended dose ranges from 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 20 kg to 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 10 kg to less than 20 kg, the maximum dose your child will take is 2 mg per kilogram of body weight twice a day.

How to take Briviact tablets

• Swallow the tablet whole with liquid.
• The medication can be taken with or without food.

Duration of Briviact treatment

Briviact is a long-term treatment – continue taking Briviact until your doctor tells you to stop.

If you take more Briviact than you should

If you take more Briviact than you should, consult your doctor. You may feel dizzy and drowsy.

You may also experience some of the following symptoms: feeling unwell, feeling like you are spinning, difficulty maintaining balance, anxiety, feeling extremely tired, irritability, aggression, difficulty sleeping, depression, suicidal thoughts or attempts.

If you forget to take Briviact

• If you forget to take a dose, take it as soon as you remember.
• Take your next dose at the time you normally take it.
• Do not take a double dose to make up for the missed dose.
• If you are unsure of what to do, consult your doctor or pharmacist.

If you interrupt Briviact treatment

• Do not interrupt treatment with this medication unless your doctor tells you to. This is because interrupting treatment may increase the number of seizures you have.
• If your doctor decides to interrupt 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 the use of this medication, ask your doctor or pharmacist.

Like all medications, this medication may produce adverse effects, although not all people will 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
• depression, anxiety, difficulty sleeping (insomnia), irritability
• common cold and throat infections (such as "common cold"), cough
• decreased appetite

Rare: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 system included 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 blister pack after EXP. The expiration date is the last day of the month indicated.
• This medication does not require special storage conditions.
• Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the packaging and medication that you no longer need. By doing so, you will help protect the environment.

Briviact Composition

• The active ingredient is brivaracetam.
• Each film-coated tablet contains 10 mg, 25 mg, 50 mg, 75 mg or 100 mg of brivaracetam.

The other components are:

Core

Sodium croscarmellose, lactose monohydrate, beta-cyclodextrin, anhydrous lactose, magnesium stearate.

Tablet coating

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

Appearance of the product and contents of the pack

Briviact 10 mg are film-coated tablets, white to off-white, round, 6.5 mm in diameter and engraved on one side with “u 10”.

Briviact 25 mg are film-coated tablets, grey, oval, 8.9 mm x 5.0 mm and engraved on one side with “u 25”.

Briviact 50 mg are film-coated tablets, yellow, oval, 11.7 mm x 6.6 mm and engraved on one side with “u 50”.

Briviact 75 mg are film-coated tablets, purple, oval, 13.0 mm x 7.3 mm and engraved on one side with “u 75”.

Briviact 100 mg are film-coated tablets, greenish-grey, oval, 14.5 mm x 8.1 mm and engraved on one side with “u 100”.

Briviact tablets are packaged in blisters included in cartons that contain either 14, 56, 14 x 1 or 100 x 1 film-coated tablets or in multiple packs that contain 168 (3 packs of 56) film-coated tablets.

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

Not all pack sizes may be marketed.

Marketing authorisation holder and responsible person for manufacturing

Marketing authorisation holder

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

Responsible person for manufacturing

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

For further information about this medicinal product, please contact the local representative of the marketing authorisation holder:

Last update of the summary of product characteristics:

Other sources of information

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