Briviact (in Italy: Nubriveo) – patient leaflet, side effects, dosage

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 ‘anti-epileptics’. These medicines are used to treat epilepsy.

What Briviact is used for

• Briviact is used in adults, adolescents and children from 4 years of age.
• It is 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.
• Briviact is used together with other medicines for epilepsy.

2. What you need to know before you take Briviact

Do not use Briviact if:

• 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 Briviact.

Warnings and precautions

Talk to your doctor or pharmacist before using Briviact if:

• You have thoughts of harming or killing yourself. A small number of people being treated with anti-epileptic medicines such as Briviact 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.

Children

Briviact is not recommended for use in children under 4 years of age.

Other medicines and Briviact

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 Briviact 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.

Briviact with alcohol

• Combining this medicine with alcohol is not recommended.
• If you drink alcohol while taking Briviact the negative effects of alcohol may be increased.

Pregnancy and breast-feeding

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 Briviact if you are pregnant or breast-feeding, as the effects of Briviact on pregnancy and the unborn baby or the new-born child are not known.

Do not stop treatment without talking to your doctor first. Stopping treatment could increase your seizures and harm your baby.

Driving and using machines

• You may feel sleepy, dizzy or tired while using Briviact.
• 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.

Briviact contains sodium

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

3. How to use Briviact

Always use this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

You will use Briviact together with other medicines for epilepsy.

• When you start taking this medicine you will take Briviact orally (as tablets or an oral solution) or be given it as an injection or infusion.
• Briviact solution for injection/infusion is used for a short amount of time when you cannot take

Briviact orally.

• You can switch between taking Briviact orally to the solution for injection/infusion, and the other way around.

How much you will be given

Your doctor will work out the right daily dose for you.Take the daily dose in two equal divided doses -one in the morning and one in the evening at about the same time each day.

Adults, adolescents and children weighing 50 kg or more

• 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.

Children and adolescents weighing less than 50 kg

• Your doctor may prescribe the injection only for a few days if you cannot take your medicine by mouth.
• 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.

People with liver problems

If you have problems with your liver:

• As an adult, adolescent or child weighing 50 kg or more, the maximum dose you will take is 75 mg twice a day.

As a child or adolescent weighing less than 50 kg, the maximum dose you will take is 1.5 mg for each kg of bodyweight twice a day.

How Briviact is given

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

How long to use Briviact for

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

If you have more Briviact than you should

If you think you have been given too much Briviact, tell your doctor straight away.

If you stop using Briviact

• 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.

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

• feeling sleepy or dizzy

Common: may affect up to 1 in 10 people

• flu
• feeling very tired (fatigue)
• convulsion, a feeling of ‘spinning’ (vertigo)
• feeling and being sick, constipation
• pain or discomfort at the injection or infusion site
• depression, anxiety, not being able to sleep (insomnia), irritability
• infections of the nose and throat (such as the ‘common cold’), cough
• decrease appetite

Uncommon: may affect up to 1 in 100 people

• allergic reactions
• abnormal thinking and/or loss of touch with reality (psychotic disorder), being aggressive, nervous excitement (agitation)
• thoughts or attempts of harming or killing yourself: tell your doctor straight away
• a decrease in white blood cells (called ‘neutropenia’) - shown in blood tests

Additional side effects in children

Common: may affect up to 1 in 10 people

• restlessness and hyperactivity (psychomotor hyperactivity)

Reporting of side effects

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 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. How to store 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 and vial after EXP.

The expiry date refers to the last day of that month.

• Briviact may be diluted before it is injected by your doctor or nurse. In such cases, it should be used straight after dilution.
• This medicinal product does not require any special storage conditions.
• Each vial of Briviact solution for injection/infusion must be used only once (single use). Any unused solution should be discarded.
• Only clear solution free from particles and discoloration should be used.
• Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Briviact contains

The active substance is brivaracetam.

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

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

What Briviact looks like and contents of the pack

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

Briviact 10 mg/ml solution for injection/infusion 5 ml vial is packed in a carton box of 10 vials.

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.

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien

UCB Pharma SA/NV

Tél/Tel: + 32 / (0)2 559 92 00

Lietuva

UCB Pharma Oy Finland

Tel: + 358 9 2514 4221 (Suomija)

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TO CH EH Etarapua EOOfl

Tea.: + 359 (0) 2 962 30 49

Česká republika

UCB s.r.o.

Tel: + 420 221 773 411

Danmark

UCB Nordic A/S

Tlf: + 45 / 32 46 24 00

Deutschland

UCB Pharma GmbH

Tel: + 49 /(0) 2173 48 4848

Eesti

UCB Pharma Oy Finland

Tel: + 358 9 2514 4221 (Soome)

EZZáSa

UCB A.E.

Tql: + 30 /2109974000

España

UCB Pharma, S.A.

Tel: + 34 / 91 570 34 44

France

UCB Pharma S.A.

Tél: + 33 / (0)1 47 29 44 35

Hrvatska

Medis Adria d.o.o.

Tel: +385 (0) 1 230 34 46

Ireland

UCB (Pharma) Ireland Ltd.

Tel: + 353 / (0)1-46 37 395

Ísland

Vistor hf.

Simi: + 354 535 7000

Italia

UCB Pharma S.p.A.

Tel: + 39 / 02 300 791

Kúnpog

Lifepharma (Z.A.M.) Ltd

Tql: + 357 22 05 63 00

Latvija

UCB Pharma Oy Finland

Tel: + 358 9 2514 4221 (Somija)

Luxembourg/Luxemburg

UCB Pharma SA/NV

Tél/Tel: + 32 / (0)2 559 92 00

Magyarország

UCB Magyarország Kft.

Tel.: + 36-(1) 391 0060

Malta

Pharmasud Ltd.

Tel: + 356 / 21 37 64 36

Nederland

UCB Pharma B.V.

Tel.: + 31 / (0)76-573 11 40

Norge

UCB Nordic A/S

Tlf: + 45 / 32 46 24 00

Österreich

UCB Pharma GmbH

Tel: + 43-(0)1 291 80 00

Polska

UCB Pharma Sp. z o.o.

Tel: + 48 22 696 99 20

Portugal

UCB Pharma (Produtos Farmacéuticos), Lda

Tel: + 351 / 21 302 5300

Romania

UCB Pharma Romania S.R.L.

Tel: + 40 21 300 29 04

Slovenija

Medis, d.o.o.

Tel: + 386 1 589 69 00

Slovenská republika

UCB s.r.o., organizačná zložka

Tel: + 421 (0) 2 5920 2020

Suomi/Finland

UCB Pharma Oy Finland

Puh/Tel: + 358 9 2514 4221

Sverige

UCB Nordic A/S

Tel: + 46 / (0) 40 29 49 00

United Kingdom

UCB Pharma Ltd.

Tel: + 44 / (0)1753 534 655

This leaflet was last revised in {month YYYY}.

Other sources of information

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

The following information is intended for medical or healthcare professionals only

Briviact solution for injection/infusion can be administered as a bolus injection 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 %) solution for injection or lactated Ringer’s solution.

Each vial of Briviact solution for injection/infusion must be used only once (single use). Any unused solution should be discarded (see section 3).

ANNEX IV

SCIENTIFIC CONCLUSIONS AND GROUNDS FOR THE VARIATION TO THE TERMS OF THE MARKETING AUTHORISATION(S)

Scientific conclusions

Taking into account the PRAC Assessment Report on the PSUR(s) for brivaracetam, the scientific conclusions of CHMP are as follows:

In view of available post-marketing data on adverse drug reactions identified in the context of brivaracetam overdose the PRAC considers that the occurrence of adverse reactions such as nausea, vertigo, balance disorder, anxiety, fatigue, irritability, aggression, insomnia, depression, and suicidal ideation with overdose cannot be ruled out. The PRAC concluded that the product information of products containing brivaracetam should be amended accordingly.

The CHMP agrees with the scientific conclusions made by the PRAC.

Grounds for the variation to the terms of the marketing authorisation(s)

On the basis of the scientific conclusions for brivaracetam the CHMP is of the opinion that the benefit-risk balance of the medicinal product(s) containing brivaracetam is unchanged subject to the proposed changes to the product information

The CHMP recommends that the terms of the marketing authorisation(s) should be varied.

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