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

B. PACKAGE LEAFLET

Package leaflet: 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 all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• – Keep this leaflet. You may need to read it again.

• – If you have any further questions, ask your doctor or pharmacist.

• – This medicine has been prescribed for you only. Do not pass it on to others. It may harm them,

even if their signs of illness are the same as yours.

• – If you get any side effects, talk to your doctor or pharmacist. This includes any possible side

effects not listed in this leaflet. See section 4.

What is in this leaflet

• 1. What Briviact is and what it is used for

• 2. What you need to know before you take Briviact

• 3. How to take 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 ‘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 take 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 taking 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 taking 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 lactose and sodium

Briviact film-coated tablets contain:

• – lactose (a type of sugar) – If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

• – sodium – This medecine contains less than 1 mmol sodium (23mg) per tablet, that is to say essentially ‘sodium free’.

3. How to take Briviact

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

You will take Briviact together with other medicines for epilepsy.

How much to take

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

• – 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 to take Briviact tablets

• – Swallow the tablets whole with a glass of liquid.

• – The medicine may be taken with or without food.

How long to take Briviact for

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

If you take more Briviact than you should

If you have taken more Briviact than you should, talk to your doctor. You may feel dizzy and sleepy.

You may also have any of the following symptoms: feeling sick, a feeling of ‘spinning’, problems of keeping your balance, anxiety, feeling very tired, irritability, being aggressive, not being able to sleep, depression, thoughts or attempts of harming or killing yourself.

If you forget to take Briviact

• – If you miss a dose take it as soon as you remember.

• – Then take your next dose at the time you would normally take it.

• – Do not take a double dose to make up for a forgotten dose.

• – If you are not sure what to do, ask your doctor or pharmacist.

If you stop taking 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

• – depression, anxiety, not being able to sleep (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 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 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 blister after

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

• – This medicinal product does not require any special storage conditions.

• – 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 film-coated tablet contains 10 mg, 25 mg, 50mg, 75 mg, or 100 mg brivaracetam.

The other ingredients are:

Core

Croscarmellose sodium, lactose monohydrate, betadex, lactose anhydrous, magnesium stearate

Coating

• – 10 mg film-coated tablets: poly(vinyl alcohol), titanium dioxide (E171), macrogol (3350), talc.

• – 25 mg film-coated tablets: poly(vinyl alcohol), titanium dioxide (E171), macrogol (3350), talc, iron

oxide yellow (E172), iron oxide black (E172).

• – 50 mg film-coated tablets: poly(vinyl alcohol), titanium dioxide (E171), macrogol (3350), talc, iron oxide yellow (E172), iron oxide red (E172).

• – 75 mg film-coated tablets: poly(vinyl alcohol), titanium dioxide (E171), macrogol (3350), talc, iron oxide yellow (E172), iron oxide red (E172), iron oxide black (E172).

• – 100 mg film-coated tablets: poly(vinyl alcohol), titanium dioxide (E171), macrogol (3350), talc, iron

oxide yellow (E172), iron oxide black (E172).

What Briviact looks like and contents of the pack

Briviact 10 mg are white to off-white, round, film-coated tablets of 6.5 mm in diameter and debossed

with ‘u10’ on one side.

Briviact 25 mg are grey, oval, film-coated tablets of 8.9 mm x 5.0 mm and debossed with ‘u25’ on one side.

Briviact 50 mg are yellow, oval, film-coated tablets of 11.7 mm x 6.6 mm and debossed with ‘u50’ on one side.

Briviact 75 mg are purple, oval, film-coated tablets of 13.0 mm x 7.3 mm and debossed with ‘u75’ on one side.

Briviact 100 mg are green-grey, oval, film-coated tablets of 14.5 mm x 8.1 mm and debossed with ‘u100’ on one side.

Briviact tablets are packaged in blister packs supplied in cardboard boxes containing either 14, 56, 14 × 1 or 100 × 1 film-coated tablets or in multipacks containing 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

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:

Belgie/Belgiqu­e/Belgien UCB Pharma SA/NV Tél/Tel: + 32 / (0)2 559 92 00 Efc^rapufl TO CH EH E^rapua 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

Lietuva UCB Pharma Oy Finland Tel: + 358 9 2514 4221 (Suomija) 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

Ireland

UCB (Pharma) Ireland Ltd.

Tel: + 353 / (0)1–46 37 395

Latvija

UCB Pharma Oy Finland

Tel: + 358 9 2514 4221 (Somija)

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:

Package leaflet: Information for the patient

Briviact 10mg/ml oral solution brivaracetam

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• – Keep this leaflet. You may need to read it again.

• – If you have any further questions, ask your doctor or pharmacist.

• – This medicine has been prescribed for you only. Do not pass it on to others. It may harm them,

even if their signs of illness are the same as yours.

• – If you get any side effects, talk to your doctor or pharmacist. This includes any possible side

effects not listed in this leaflet. See section 4.

What is in this leaflet

• 1. What Briviact is and what it is used for

• 2. What you need to know before you take Briviact

• 3. How to take 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 ‘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 take 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 taking 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 taking 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 oral solution contains methyl parahydroxyben­zoate, sodium, sorbitol and propylene glycol

• – Methyl parahydroxybenzoate (E218): This may cause allergic reactions (possibly delayed).

• – Sodium: This medicine contains less than 1 mmol sodium (23mg) per millilitre, that is to say

essentially ‘sodium free

• – Sorbitol (E420) (a type of sugar): This medicine contains 239.8 mg sorbitol in each ml. Sorbitol

is a source of fructose. If your doctor has told you that you (or your child) have an intolerance to some sugars or if you have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disorder in which a person cannot break down fructose, talk to your doctor before you (or your child) take or receive this medicine.

• – Propylene glycol (E1520): This medicine contains maximum 5.5 mg propylene glycol in each

millilitre.

3. How to take Briviact

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

You will take Briviact together with other medicines for epilepsy.

How much to take

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

– 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.

The table below only shows examples of doses to take. Your doctor will work out the right dose for you, depending on your weight.

	Dose taken twice daily for children from 4 years of age weighing less than 50 kg.
Weight	0.5 mg/kg = 0.05 ml/kg	1 mg/kg = 0.1 ml/kg	1.5 mg/kg = 0.15 ml/kg	2 mg/kg = 0.2 ml/kg
10 kg	0.5 ml	1 ml	1.5 ml	2 ml
15 kg	0.75 ml	1.5 ml	2.25 ml	3 ml
20 kg	1 ml	2 ml	3 ml	4 ml
25 kg	1.25 ml	2.5 ml	3.75 ml	5 ml
30 kg	1.5 ml	3 ml	4.5 ml	6 ml
35 kg	1.75 ml	3.5 ml	5.25 ml	7 ml
40 kg	2 ml	4 ml	6 ml	8 ml
45 kg	2.25 ml	4.5 ml	6.75 ml	9 ml
50 kg	2.5 ml	5 ml	7.5 ml	10 ml

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 to take Briviact oral solution

• – You can take Briviact oral solution on its own, or dilute it in water or juice shortly before

swallowing.

• – The medicine may be taken with or without food.

Instructions for use for patients or carers:

Two oral syringes will be provided in the carton. Check with your doctor which one you should use.

• – If you weigh less than 20 kg, you should use the 5 ml oral syringe provided in the carton to

ensure accurate dosing.

• – If you weigh 20 kg or more, your doctor will recommend the use of the 5 ml oral syringe or the

• 10 ml oral syringe provided in the carton to ensure accurate dosing.

5 ml oral dosing syringe	10 ml oral dosing syringe
The 5 ml oral syringe has 2 overlapping graduations: in steps of 0.25 ml and in steps of 0.1 ml.	The 10 ml oral syringe has only one graduation in steps of 0.25 ml.

– Open the bottle: press the cap and turn it anti-clockwise (figure 1).

Follow these steps the first time you take Briviact:

• – Take off the adaptor from the oral syringe (figure 2).

• – Put the adaptor into the top of the bottle (figure 3). Make sure it is fixed well in place. You do not need to remove the adaptor after use.

  
  
  
  

Follow these steps each time you take Briviact:

• – Put the oral syringe into the adaptor opening (figure 4).

• – Turn the bottle upside down (figure 5).

  
  

Hold the bottle upside down in one hand and use the other hand to fill the oral syringe.

Pull the plunger down to fill the oral syringe with a small amount of solution (figure 6).

Then push the plunger up to remove any possible air bubbles (figure 7).

Pull the plunger down to the millilitre (ml) dose marker on the oral syringe prescribed by your doctor (figure 8).

Turn the bottle the right way up (figure 9).

Take the oral syringe out of the adaptor (figure 10).

There are two ways in which you can choose to drink the medicine:

• – empty the contents of the syringe into water (or juice) by pushing the plunger to the bottom of the oral syringe (figure 11) – you will then need to drink all of the water (add just enough to make it easy to drink) or

• – drink the solution directly from the oral syringe without water – drink the whole contents of the syringe (figure 12).

  
  
  
  

• – Close the bottle with the plastic screw cap (you do not need to remove the adaptor).

• – Wash the oral syringe with water only (figure 13).

• – Keep the bottle, the oral syringe, and the leaflet in the carton.

  
  

How long to take Briviact for

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

If you take more Briviact than you should

If you have taken more Briviact than you should, talk to your doctor. You may feel dizzy and sleepy.

You may also have any of the following symptoms: feeling sick, a feeling of ‘spinning’, problems of keeping your balance, anxiety, feeling very tired, irritability, being aggressive, not being able to sleep, depression, thoughts or attempts of harming or killing yourself.

If you forget to take Briviact

• – If you miss a dose take it as soon as you remember.

• – Then take your next dose at the time you would normally take it.

• – Do not take a double dose to make up for a forgotten dose.

• – If you are not sure what to do, ask your doctor or pharmacist.

If you stop taking 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

• – depression, anxiety, not being able to sleep (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 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 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 cardboard box and bottle

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

• – This medicinal product does not require any special storage conditions.

• – After first opening of the bottle, use within 5 months.

• – 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 millilitre (ml) contains 10 milligrams (mg) brivaracetam.

The other ingredients are: sodium citrate, citric acid anhydrous, methyl parahydroxybenzoate (E218), carmellose sodium, sucralose, sorbitol liquid (E420), glycerol (E422), raspberry flavour (propylene glycol (E1520) 90 % – 98 %), purified water.

What Briviact looks like and contents of the pack

Briviact 10 mg/ml oral solution is slightly viscous, clear, colourless to yellowish liquid.

The 300 ml glass bottle of Briviact is packed in a cardboard box containing a 10 ml oral syringe and a 5 ml oral syringe and an adaptor for the syringe.

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:

Belgie/Belgiqu­e/Belgien UCB Pharma SA/NV Tél/Tel: + 32 / (0)2 559 92 00 Efc^rapufl 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

Lietuva UCB Pharma Oy Finland Tel: + 358 9 2514 4221 (Suomija) Luxembourg/Lu­xemburg UCB Pharma SA/NV Tel/Tel: + 32 / (0)2 559 92 00 Magyarorszag UCB Magyarorszag 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

Detailed information on this medicine is available on the European Medicines Agency website:

Package leaflet: Information for the patient

Briviact 10mg/ml solution for injection/infusion brivaracetam

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• – Keep this leaflet. You may need to read it again.

• – If you have any further questions, ask your doctor or pharmacist.

• – This medicine has been prescribed for you only. Do not pass it on to others. It may harm them,

even if their signs of illness are the same as yours.

• – If you get any side effects, talk to your doctor or pharmacist. This includes any possible side

effects not listed in this leaflet. See section 4.

What is in this leaflet

• 1. What Briviact is and what it is used for

• 2. What you need to know before you use 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 ‘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 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:

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:

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

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.

117