Nubriveo

Package leaflet: Information for the patient

Nubriveo 10 mg film-coated tablets, 25 mg film-coated tablets, 50 mg film-coated tablets, 75 mg film-coated tablets, 100 mg film-coated tablets

brivaracetam
Please 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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as yours, because it could be harmful.
• If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Nubriveo is and what it is used for

What Nubriveo is
Nubriveo contains the active substance brivaracetam. It belongs to a group of medicines called
"antiepileptics". These medicines are used to treat epilepsy.
What Nubriveo is used for

• Nubriveo is used in adults, adolescents and children from 2 years of age.
• It is used to treat a type of epilepsy characterised by partial seizures with or without secondary generalisation.
• Partial seizures are epileptic seizures that start by affecting only one side of the brain. These partial seizures may spread and extend to wider areas on both sides of the brain – this is called "secondary generalisation".
• This medicine has been given to you to reduce the number of seizures (epileptic attacks) you have.
• Nubriveo is used together with other medicines for epilepsy.

2. What you need to know before taking Nubriveo

Do not take Nubriveo if:

• you are allergic to brivaracetam, to other chemically related compounds such as levetiracetam and piracetam, or to any of the other ingredients of this medicine (listed in section 6). If in doubt, consult your doctor or pharmacist before taking Nubriveo.
• in the past, after taking Nubriveo, you developed a severe skin rash, skin peeling, blisters and/or mouth ulcers. Serious skin reactions, including Stevens-Johnson syndrome, have been reported with Nubriveo treatment. Stop using Nubriveo and contact a doctor immediately if you notice any of the symptoms related to these serious skin reactions described in section 4.

Warnings and precautions
Talk to your doctor or pharmacist before taking Nubriveo if:

• you have thoughts of harming yourself or of suicide. A small number of people taking antiepileptic medicines, such as Nubriveo, have had thoughts of harming themselves or of suicide. If you experience any such thoughts at any time, contact your doctor immediately.
• you have liver problems; your doctor may need to adjust your dose.

Children
Nubriveo is not recommended for use in children under 2 years of age.
Other medicines and Nubriveo
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
In particular, inform your doctor if you are taking any of the following medicines – because your doctor may need to adjust your dose of Nubriveo:

• 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.

Nubriveo and alcohol

• Concomitant use of this medicine with alcohol is not recommended.
• If you drink alcohol while taking Nubriveo, the negative effects of alcohol may be increased.

Pregnancy and breastfeeding
Women of childbearing potential should discuss with their doctor the use of contraceptive measures.
If you are pregnant, think you might be pregnant, are planning to become pregnant, or are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
Taking Nubriveo during pregnancy is not recommended, as the effects of Nubriveo on pregnancy and the unborn child are unknown. Breastfeeding is not recommended while taking Nubriveo, as Nubriveo passes into breast milk.
Do not stop treatment without first talking to your doctor. Stopping treatment could lead to an increase in your epileptic seizures and may harm your baby.
Driving and using machines

• You may feel drowsy, dizzy or tired while taking Nubriveo.
• These effects are more likely at the beginning of treatment or after a dose increase.
• Do not drive, ride a bicycle, or use tools or machinery until you know how this medicine affects you.

Nubriveo contains lactose and sodium
Nubriveo film-coated tablets contain:

• lactose (a type of sugar) – If your doctor has diagnosed you with an intolerance to certain sugars, contact your doctor before taking this medicine.
• sodium – This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially ‘sodium-free’.

3. How to take Nubriveo

Take this medicine exactly as prescribed by your doctor. If you have any doubts, consult your doctor or pharmacist. Other forms of this medicine may be more suitable for certain patients, such as children (for example, if they are unable to swallow whole tablets); please consult your doctor or pharmacist.
You will take Nubriveo together with other medicines for epilepsy.

Dosage
Your doctor will determine the appropriate daily dose for you. Take the daily dose divided into 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 taken twice daily. Your doctor may later decide to adjust the dose to find the one most suitable 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 kg of body weight, taken twice daily. Your doctor may later decide to adjust the dose to find the one most suitable for you.

Children weighing between 10 kg and less than 20 kg

• The recommended dose is between 0.5 mg and 2.5 mg per kg of body weight, taken twice daily. Your doctor may later decide to adjust the dose to find the one most suitable for your child.

Patients with liver problems
If you have liver problems:

• If you are an adolescent or child weighing 50 kg or more, or an adult, the maximum dose you should take is 75 mg twice daily.
• If you are an adolescent or child weighing between 20 kg and less than 50 kg, the maximum dose you should take is 1.5 mg per kg of body weight twice daily.
• If you are a child weighing between 10 kg and less than 20 kg, the maximum dose your child should take is 2 mg per kg of body weight twice daily.

How to take Nubriveo tablets

• Swallow the tablet whole with a glass of liquid.
• This medicine can be taken with or without food.

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

If you take more Nubriveo than you should
If you have taken more Nubriveo than you should, contact your doctor. You may experience dizziness and drowsiness. You may also experience any of the following symptoms: feeling unwell, a sensation of "spinning", problems maintaining balance, anxiety, extreme tiredness, irritability, aggression, difficulty sleeping, depression, thoughts of harming yourself or suicide attempts.

If you forget to take Nubriveo

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

If you stop taking Nubriveo

• Do not stop taking this medicine unless your doctor tells you to. This is because stopping treatment may increase the number of your seizures.
• If your doctor asks you to stop taking this medicine, they will gradually reduce your dose. This helps prevent your seizures from returning or worsening.

If you have any questions about the use of this medicine, consult 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

• influenza
• feeling very tired (fatigue)
• seizures, sensation of spinning (dizziness)
• nausea and vomiting, constipation
• depression, anxiety, difficulty sleeping (insomnia), irritability
• infections of the nose and throat (such as the "common cold"), cough
• reduced appetite

Uncommon: may affect up to 1 in 100 people

• allergic reactions
• changes in thinking and/or loss of contact with reality (psychotic disorder), aggression, nervous excitement (agitation)
• thoughts or attempts of self-harm or suicide: inform your doctor immediately
• a reduction in the number of white blood cells (called 'neutropenia') – detected by blood tests

Not known: frequency cannot be estimated from the available data

• widespread rash with blisters and peeling of the skin, particularly around the mouth, nose, eyes and genitals (Stevens-Johnson syndrome)

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, including ones not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via the national reporting system listed in Annex 5.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Nubriveo

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date stated on the carton and blister after Exp. The expiry date refers to the last day of that month.
• This medicine does not require any special storage conditions.
• Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Nubriveo contains
The active substance is brivaracetam.
Each film-coated tablet contains 10 mg, 25 mg, 50 mg, 75 mg, or 100 mg of brivaracetam.
The other components are:
Tablet core
Croscarmellose sodium, monohydrate lactose, betadex, anhydrous lactose, 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, yellow iron oxide (E172), black iron oxide (E172).
• 50 mg film-coated tablets: poly(vinyl alcohol), titanium dioxide (E171), macrogol (3350), talc, yellow iron oxide (E172), red iron oxide (E172).
• 75 mg film-coated tablets: poly(vinyl alcohol), titanium dioxide (E171), macrogol (3350), talc, yellow iron oxide (E172), red iron oxide (E172), black iron oxide (E172).
• 100 mg film-coated tablets: poly(vinyl alcohol), titanium dioxide (E171), macrogol (3350), talc, yellow iron oxide (E172), black iron oxide (E172).

Description of the appearance of Nubriveo and the contents of the pack
Nubriveo 10 mg film-coated tablets are white to off-white, round, 6.5 mm in diameter, with the imprint 'u 10' on one side.
Nubriveo 25 mg film-coated tablets are grey, oval, 8.9 mm x 5.0 mm, with the imprint 'u 25' on one side.
Nubriveo 50 mg film-coated tablets are yellow, oval, 11.7 mm x 6.6 mm, with the imprint 'u 50' on one side.
Nubriveo 75 mg film-coated tablets are purple, oval, 13.0 mm x 7.3 mm, with the imprint 'u 75' on one side.
Nubriveo 100 mg film-coated tablets are grey-green, oval, 14.5 mm x 8.1 mm, with the imprint 'u 100' on one side.
Nubriveo tablets are packed in blisters supplied in cardboard boxes containing 14, 56, 14 x 1 or 100 x 1 film-coated tablets, or in multiple packs 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 Authorization Holder and Manufacturer
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 further information on this medicinal product, please contact the local representative of the Marketing Authorization Holder:
België/Belgique/Belgien Lietuva
UCB Pharma SA/NV UCB Pharma Oy Finland
Tél/Tel: + 32 / (0)2 559 92 00 Tel: + 358 9 2514 4221 (Suomija)
България Luxembourg/Luxemburg
Ю СИ БИ България ЕООД UCB Pharma SA/NV
Teл.: + 359 (0) 2 962 30 49 Tél/Tel: + 32 / (0)2 559 92 00 (Belgique/Belgien)
Česká republika Magyarország
UCB s.r.o. UCB Magyarország Kft.
Tel: + 420 221 773 411 Tel.: + 36-(1) 391 0060
Danmark Malta
UCB Nordic A/S Pharmasud Ltd.
Tlf.: + 45 / 32 46 24 00 Tel: + 356 / 21 37 64 36
Deutschland Nederland
UCB Pharma GmbH UCB Pharma B.V.
Tel: + 49 /(0) 2173 48 4848 Tel.: + 31 / (0)76-573 11 40
Eesti Norge
UCB Pharma Oy Finland UCB Nordic A/S
Tel: + 358 9 2514 4221 (Soome) Tlf: + 47 / 67 16 5880
Ελλάδα Österreich
UCB Α.Ε. UCB Pharma GmbH
Τηλ: + 30 / 2109974000 Tel: + 43-(0)1 291 80 00
España Polska
UCB Pharma, S.A. UCB Pharma Sp. z o.o. / VEDIM Sp. z o.o.
Tel: + 34 / 91 570 34 44 Tel: + 48 22 696 99 20
France Portugal
UCB Pharma S.A. UCB Pharma (Produtos Farmacêuticos), Lda
Tél: + 33 / (0)1 47 29 44 35 Tel: + 351 / 21 302 5300
Hrvatska România
Medis Adria d.o.o. UCB Pharma Romania S.R.L.
Tel: +385 (0) 1 230 34 46 Tel: + 40 21 300 29 04
Ireland Slovenija
UCB (Pharma) Ireland Ltd. Medis, d.o.o.
Tel: + 353 / (0)1-46 37 395 Tel: + 386 1 589 69 00
Ísland Slovenská republika
Vistor hf. UCB s.r.o., organizačná zložka
Simi: + 354 535 7000 Tel: + 421 (0) 2 5920 2020
Italia Suomi/Finland
UCB Pharma S.p.A. UCB Pharma Oy Finland
Tel: + 39 / 02 300 791 Puh/Tel: + 358 9 2514 4221
Κύπρος Sverige
Lifepharma (Z.A.M.) Ltd UCB Nordic A/S
Τηλ: + 357 22 05 63 00 Tel: + 46 / (0) 40 29 49 00
Latvija
UCB Pharma Oy Finland
Tel: + 358 9 2514 4221 (Somija)

Other sources of information
More detailed information on this medicinal product is available on the website of the European Medicines Agency: https://www.ema.europa.eu.

Patient information leaflet: information for the patient

Nubriveo 10 mg/mL oral solution

brivaracetam
Please read this leaflet carefully before taking this medicine because it contains
important information for you.

• Keep this leaflet. 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 other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What Nubriveo is and what it is used for
2. What you need to know before taking Nubriveo
3. How to take Nubriveo
4. Possible side effects
5. How to store Nubriveo
6. Package contents and other information

1. What Nubriveo is and what it is used for

What Nubriveo is
Nubriveo contains the active substance brivaracetam. It belongs to a group of medicines called "antiepileptics". These medicines are used to treat epilepsy.

What Nubriveo is used for

• Nubriveo is used in adults, adolescents and children from 2 years of age.
• It is used to treat a type of epilepsy characterised by partial seizures with or without secondary generalisation.
• Partial epileptic seizures are seizures that start by affecting only one side of the brain. These partial seizures may spread and extend to wider areas on both sides of the brain – this is called “secondary generalisation”.
• This medicine has been prescribed to you to reduce the number of seizures (epileptic attacks) you experience. Nubriveo is used in combination with other medicines for epilepsy.

2. What you need to know before taking Nubriveo

Do not take Nubriveo if:

• you are allergic to brivaracetam, to other chemically related compounds such as levetiracetam and 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 taking Nubriveo.
• in the past, after taking Nubriveo, you experienced severe skin rash, skin peeling, blisters and/or mouth ulcers. Serious skin reactions, including Stevens-Johnson syndrome, have been reported in association with treatment with Nubriveo. Stop using Nubriveo and contact a doctor immediately if you notice any symptoms related to these serious skin reactions described in section 4.

Warnings and precautions
Talk to your doctor or pharmacist before taking Nubriveo if:

• You have thoughts of harming yourself or committing suicide. A small number of people taking antiepileptic medicines, such as Nubriveo, have had thoughts about harming themselves or committing suicide. 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
Nubriveo is not recommended for use in children under 2 years of age.
Other medicines and Nubriveo
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
In particular, inform your doctor if you are taking any of the following medicines, as your doctor may need to adjust your dose of Nubriveo:

• 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.

Nubriveo and alcohol

• Concomitant use of this medicine with alcohol is not recommended.
• If you drink alcohol while taking Nubriveo, the negative effects of alcohol may be increased.

Pregnancy and breastfeeding
Women of childbearing potential should discuss with their doctor the use of contraceptive measures.
If you are pregnant, think you might be pregnant, are planning to become pregnant, or are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
It is not recommended to take Nubriveo during pregnancy, as the effects of Nubriveo on pregnancy and the unborn child are unknown. Breastfeeding is not recommended while taking Nubriveo, as Nubriveo passes into breast milk.
Do not stop treatment without first talking to your doctor. Stopping treatment may lead to an increase in your epileptic seizures and may harm your baby.
Driving and using machines

• You may experience drowsiness, dizziness, or fatigue while taking Nubriveo.
• These effects are more likely to occur at the beginning of treatment or after a dose increase.
• Do not drive, ride a bicycle, or use tools or machinery until you know how this medicine affects you.

Nubriveo oral solution contains methyl hydroxybenzoate, sodium, sorbitol, and propylene glycol

• Methyl parahydroxybenzoate (E218): this may cause allergic reactions (including delayed reactions).
• Sodium: this medicine contains less than 1 mmol (23 mg) of sodium per mL, i.e., essentially ‘sodium-free’.
• Sorbitol (E420) (a type of sugar): this medicine contains 168 mg of sorbitol per mL. Sorbitol is a source of fructose. If your doctor has told you that you (or your child) have an intolerance to certain sugars, or if you have been diagnosed with hereditary fructose intolerance, a rare genetic disorder in which patients cannot metabolize fructose, speak with your doctor before you (or your child) take this medicine.
• Propylene glycol (E1520): this medicine contains up to 5.5 mg of propylene glycol per mL.

3. How to take Nubriveo

Take this medicine exactly as directed by your doctor. If you have any doubts, consult your
doctor or pharmacist.
You will take Nubriveo together with other antiepileptic medicines.
How much to take
Your doctor will determine the appropriate daily dose for you. Take the daily dose divided into 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 to be taken twice daily. Your doctor may later decide to adjust the dose to find the one most suitable for you.

The table below shows only some examples of the doses to be taken and the syringe to be used. Your doctor
will determine the appropriate dose for you and which syringe to use, based on your weight.
Dose in mL to be taken twice daily and syringe to use – for adolescents and children weighing 50 kg or more, and adults:

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

• The recommended dose is between 0.5 mg and 2 mg per kg of body weight, to be taken twice daily. Your doctor may later decide to adjust the dose to find the one most suitable for you.

The following table provides only some examples of the doses to take and the syringe to use. Your doctor will determine the appropriate dose for you and which syringe to use, based on your body weight.
Dose in mL to be taken twice daily and syringe to use – for adolescents and children weighing
between 20 kg and less than 50 kg:

Children weighing between 10 kg and less than 20 kg

• The recommended dose is between 0.5 mg and 2.5 mg per kg of body weight, taken twice daily. Your doctor may later decide to adjust the dose to find the most suitable one for your child.

The following table provides only some examples of doses to take and the syringe to use. Your doctor will determine the appropriate dose for your child and which syringe to use, based on their weight.
Dose in mL to be taken twice daily and syringe to use – for children weighing between
10 kg and less than 20 kg:
Dose in mL Dose in mL Dose in mL Dose in mL Dose in mL
(corresponding to (corresponding (corresponding (corresponding (corresponding
Weight
0.5 mg/kg to 1.25 mg/kg to 1.5 mg/kg to 2 mg/kg to 2.5 mg/kg
= 0.05 mL/kg) = 0.125 mL/kg) = 0.15 mL/kg) = 0.2 mL/kg) = 0.25 mL/kg)
10 kg 0.5 mL 1.25 mL 1.5 mL 2 mL 2.5 mL
12 kg 0.6 mL 1.5 mL 1.8 mL 2.4 mL 3.0 mL
14 kg 0.7 mL 1.75 mL 2.1 mL 2.8 mL 3.5 mL
15 kg 0.75 mL 1.9 mL 2.25 mL 3 mL 3.75 mL
Use the 5 mL syringe
(blue marks)

Patients with liver problems
If you have liver problems:

• If you are an adolescent or child weighing 50 kg or more, or an adult, the maximum dose you should take is 75 mg twice daily.
• If you are an adolescent or child weighing between 20 kg and less than 50 kg, the maximum dose you should take is 1.5 mg per kg of body weight twice daily.
• If you are a child weighing between 10 kg and less than 20 kg, the maximum dose your child should take is 2 mg per kg of body weight twice daily.

How to take Nubriveo oral solution

• You may take Nubriveo oral solution alone or dilute it in water or juice shortly before swallowing.
• This medicine may be taken with or without food.

Instructions for use for patients or caregivers:
Two oral administration syringes will be provided in the cardboard box. Please check with your doctor which one you should use.

• For a volume between 0.5 mL and 5 mL, use the 5 mL oral administration syringe (blue marks) provided in the cardboard box to ensure accurate dosing.
• For a volume greater than 5 mL and up to 10 mL, use the 10 mL oral administration syringe (black marks) provided in the cardboard box to ensure accurate dosing.

Oral administration syringe Oral administration
5 mL syringe 10 mL
The 5 mL oral administration The 10 mL oral administration
syringe has double blue marks: syringe has black marks with
with increments of 0.25 mL and increments of 0.25 mL.
increments of 0.1 mL.

• Open the bottle: press down on the cap and turn it counterclockwise (Figure 1).

Follow this procedure the first time you take Nubriveo:

• Separate the adapter from the oral administration syringe (Figure 2).
• Insert the adapter into the neck of the bottle (Figure 3). Make sure it is securely attached. There is no need to remove the adapter after use.

Follow this procedure each time you take Nubriveo:

• Insert the oral administration syringe into the opening of the adapter (Figure 4).
• Turn the bottle upside down (Figure 5).

• Hold the bottle upside down with one hand and use the other hand to fill the oral administration syringe.
• Pull the plunger down to fill the oral administration 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) mark on the oral administration syringe corresponding to the dose prescribed by your doctor (Figure 8). The plunger may rise along the barrel of the syringe at the first dose. Therefore, make sure the plunger is kept in place until the oral administration syringe is disconnected from the bottle.

• Turn the bottle upright (Figure 9).
• Remove the oral administration syringe from the adapter (Figure 10).

There are two methods you can choose to take the medicine:

• empty the contents of the syringe into water (or fruit juice) by pushing the plunger fully down in the oral administration syringe (Figure 11); you should then drink all the liquid (add just enough liquid to make it easy to drink), or
• drink the solution directly from the oral administration syringe without any liquid; drink the entire contents of the syringe (Figure 12).

• Close the bottle with the plastic screw cap (there is no need to remove the adapter).
• To clean the oral administration syringe, rinse it only with cold water, moving the plunger up and down several times to draw in and expel water, without separating the two parts of the syringe (Figure 13).

• Store the bottle, the oral administration syringe, and the package leaflet in the cardboard box.

How long to take Nubriveo
Nubriveo is a long-term treatment – continue taking Nubriveo for as long as your doctor tells you to.
If you take more Nubriveo than you should
If you have taken more Nubriveo than you should, contact your doctor. You may experience dizziness and drowsiness. You may also experience any of the following symptoms: feeling unwell, a sensation of "spinning", problems maintaining balance, anxiety, extreme tiredness, irritability, aggression, difficulty sleeping, depression, thoughts of or attempts to harm yourself or commit suicide.
If you forget to take Nubriveo

• If you forget a dose, take it as soon as you remember.
• Then take the next dose at your usual time.
• Do not take a double dose to make up for a forgotten dose.
• If you have any doubts about what to do, consult your doctor or pharmacist.

If you stop taking Nubriveo

• Do not stop taking this medicine unless your doctor tells you to. This is because stopping treatment may increase the number of your seizures.
• If your doctor asks you to stop taking this medicine, they will gradually reduce your dose. This helps prevent your seizures from returning or worsening.

If you have any questions about using this medicine, consult 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

• influenza
• feeling very tired (fatigue)
• seizures, sensation of dizziness (vertigo)
• nausea and vomiting, constipation
• depression, anxiety, difficulty sleeping (insomnia), irritability
• infections of the nose and throat (such as the "common cold"), cough
• reduced appetite

Uncommon: may affect up to 1 in 100 people

• allergic reactions
• changes in thinking and/or loss of contact with reality (psychotic disorder), aggression, nervous excitement (agitation)
• thoughts or attempts of self-harm or suicide: inform your doctor immediately
• a reduction in the number of white blood cells (called 'neutropenia') – detected by blood tests

Not known: frequency cannot be estimated from the available data

• widespread skin rash with blisters and peeling of the skin, particularly around the mouth, nose, eyes, and genitals (Stevens-Johnson syndrome)

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, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via the national reporting system listed in Annex 5.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Nubriveo

• 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 on the bottle after Exp. The expiry date refers to the last day of that month.
• This medicine does not require any special storage conditions.
• After first opening the bottle, use within 8 months.
• Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package Contents and Other Information

What Nubriveo contains
The active substance is brivaracetam.
Each millilitre (mL) contains 10 milligrams (mg) of brivaracetam.
The other components are: sodium citrate, anhydrous citric acid, methyl 4-hydroxybenzoate (E218),
sodium carmellose, sucralose, liquid sorbitol (E420), glycerol (E422), raspberry flavour (propylene
glycol [E1520] 90-98%), purified water.

Description of the appearance of Nubriveo and contents of the pack
Nubriveo 10 mg/mL oral solution is a slightly viscous, clear liquid, colourless to slightly yellow.
The 300 mL glass bottle of Nubriveo is packaged in a cardboard box containing an oral dosing syringe made of polypropylene/polyethylene with 10 mL capacity (black markings), an oral dosing syringe made of polypropylene/polyethylene with 5 mL capacity (blue markings), and syringe adapters made of polyethylene.

Marketing Authorisation Holder and Manufacturer
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 further information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien Lietuva
UCB Pharma SA/NV UCB Pharma Oy Finland
Tél/Tel: + 32 / (0)2 559 92 00 Tel: + 358 9 2514 4221 (Suomija)

България Luxembourg/Luxemburg
Ю СИ БИ България ЕООД UCB Pharma SA/NV
Teл.: + 359 (0) 2 962 30 49 Tél/Tel: + 32 / (0)2 559 92 00 (Belgique/Belgien)

Česká republika Magyarország
UCB s.r.o. UCB Magyarország Kft.
Tel: + 420 221 773 411 Tel.: + 36-(1) 391 0060

Danmark Malta
UCB Nordic A/S Pharmasud Ltd.
Tlf.: + 45 / 32 46 24 00 Tel: + 356 / 21 37 64 36

Deutschland Nederland
UCB Pharma GmbH UCB Pharma B.V.
Tel: + 49 /(0) 2173 48 4848 Tel.: + 31 / (0)76-573 11 40

Eesti Norge
UCB Pharma Oy Finland UCB Nordic A/S
Tel: + 358 9 2514 4221 (Soome) Tlf: + 47 / 67 16 5880

Ελλάδα Österreich
UCB Α.Ε. UCB Pharma GmbH
Τηλ: + 30 / 2109974000 Tel: + 43-(0)1 291 80 00

España Polska
UCB Pharma, S.A. UCB Pharma Sp. z o.o. / VEDIM Sp. z o.o.
Tel: + 34 / 91 570 34 44 Tel: + 48 22 696 99 20

France Portugal
UCB Pharma S.A. UCB Pharma (Produtos Farmacêuticos), Lda
Tél: + 33 / (0)1 47 29 44 35 Tel: + 351 / 21 302 5300

Hrvatska România
Medis Adria d.o.o. UCB Pharma Romania S.R.L.
Tel: +385 (0) 1 230 34 46 Tel: + 40 21 300 29 04

Ireland Slovenija
UCB (Pharma) Ireland Ltd. Medis, d.o.o.
Tel: + 353 / (0)1-46 37 395 Tel: + 386 1 589 69 00

Ísland Slovenská republika
Vistor hf. UCB s.r.o., organizačná zložka
Simi: + 354 535 7000 Tel: + 421 (0) 2 5920 2020

Italia Suomi/Finland
UCB Pharma S.p.A. UCB Pharma Oy Finland
Tel: + 39 / 02 300 791 Puh/Tel: + 358 9 2514 4221

Κύπρος Sverige
Lifepharma (Z.A.M.) Ltd UCB Nordic A/S
Τηλ: + 357 22 05 63 00 Tel: + 46 / (0) 40 29 49 00

Latvija
UCB Pharma Oy Finland
Tel: + 358 9 2514 4221 (Somija)

Other sources of information
More detailed information on this medicine is available on the website of the European Medicines Agency: https://www.ema.europa.eu.

Patient information leaflet

Nubriveo 10 mg/mL solution for injection/infusion

brivaracetam
Please read this leaflet carefully before using this medicine because it contains important information for you.

• Keep this leaflet. 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 other people, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Nubriveo is and what it is used for

What Nubriveo is
Nubriveo contains the active substance brivaracetam. It belongs to a group of medicines called
"antiepileptics". These medicines are used to treat epilepsy.
What Nubriveo is used for

• Nubriveo is used in adults, adolescents and children from 2 years of age.
• It is used to treat a type of epilepsy characterised by partial seizures with or without secondary generalisation.
• Partial seizures are epileptic attacks that start by affecting only one side of the brain. These partial seizures may spread and extend to wider areas of both sides of the brain – this is called “secondary generalisation”.
• This medicine has been prescribed to you to reduce the number of seizures (epileptic fits) you have. Nubriveo is used in combination with other epilepsy medicines.

2. What you should know before using Nubriveo

Do not use Nubriveo if:

• you are allergic to brivaracetam, to other chemically related compounds such as levetiracetam and piracetam, or to any of the other ingredients of this medicine (listed in section 6). If in doubt, consult your doctor or pharmacist before using Nubriveo.
• in the past, after taking Nubriveo, you developed a severe skin rash, skin peeling, blisters and/or mouth ulcers. Serious skin reactions, including Stevens-Johnson syndrome, have been reported in association with Nubriveo treatment. Stop using Nubriveo and contact a doctor immediately if you notice any of the symptoms related to these serious skin reactions described in section 4.

Warnings and precautions
Talk to your doctor or pharmacist before using Nubriveo if:

• You have thoughts of harming or killing yourself. A small number of people taking antiepileptic medicines, such as Nubriveo, have had thoughts of harming or killing themselves. If you experience any such thoughts at any time, contact your doctor immediately.
• You have liver problems; your doctor may need to adjust your dose.

Children
Nubriveo is not recommended for use in children under 2 years of age.
Other medicines and Nubriveo
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
In particular, inform your doctor if you are taking any of the following medicines, as your doctor may need to adjust your dose of Nubriveo:

• 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.

Nubriveo and alcohol

• Concomitant use of this medicine with alcohol is not recommended.
• If you drink alcohol while taking Nubriveo, the negative effects of alcohol may be increased.

Pregnancy and breastfeeding
Women of childbearing potential should discuss with their doctor the use of contraceptive measures.
If you are pregnant, suspect you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Taking Nubriveo during pregnancy is not recommended, as the effects of Nubriveo on pregnancy and the unborn child are unknown. Breastfeeding is not recommended while taking Nubriveo, as Nubriveo passes into breast milk.
Do not stop treatment without first discussing it with your doctor. Stopping treatment may lead to an increase in your epileptic seizures and may harm your baby.
Driving and using machines

• You may experience drowsiness, dizziness, or fatigue while using Nubriveo.
• These effects are more likely to occur at the beginning of treatment or after a dose increase.
• Do not drive, ride a bicycle, or use tools or machinery until you know how this medicine affects you.

Nubriveo contains sodium
This medicine contains 19.1 mg of sodium (a key component of table salt) per vial. This corresponds to 1% of the maximum recommended daily dietary intake of sodium for an adult.

3. How to use Nubriveo

Use this medicine exactly as prescribed by your doctor. If you have any doubts, consult your doctor or pharmacist.
You will take Nubriveo together with other medicines for epilepsy.

• When you start taking this medicine, you will receive Nubriveo orally (as tablets or oral solution) or it will be given to you as an injection or infusion.
• Nubriveo for injectable solution/infusion is used for a short period of time when oral administration of Nubriveo is not possible.
• You may switch between taking Nubriveo orally and receiving the injectable/infusion solution, and vice versa.

Dosage
Your doctor will determine the appropriate daily dose for you. Take your daily dose divided into 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 taken twice daily. Your doctor may later decide to adjust the dose to find the most suitable one for you.

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

• Your doctor may prescribe the injection for only a few days if you are unable to take the medicine by mouth.
• The recommended dose is between 0.5 mg and 2 mg per kilogram of body weight, taken twice daily. Your doctor may later decide to adjust the dose to find the most suitable one for you.

Children weighing between 10 kg and less than 20 kg

• Your doctor may prescribe the injection for only a few days if your child is unable to take the medicine by mouth.
• The recommended dose is between 0.5 mg and 2.5 mg per kilogram of body weight, taken twice daily. Your doctor may later decide to adjust the dose to find the most suitable one for your child.

Patients with liver problems
If you have liver problems:

• If you are an adolescent or child weighing 50 kg or more, or an adult, the maximum dose you should take is 75 mg twice daily.
• If you are an adolescent or child weighing between 20 kg and less than 50 kg, the maximum dose you should take is 1.5 mg per kilogram of body weight twice daily.
• If your child weighs between 10 kg and less than 20 kg, the maximum dose your child should take is 2 mg per kilogram of body weight twice daily.

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

Duration of treatment with Nubriveo

• Your doctor will decide for how many days you will receive injections or infusions.
• For long-term treatment with Nubriveo, your doctor will ask you to take Nubriveo as tablets or oral solution.

If you use more Nubriveo than you should

• If you think you have been given too much Nubriveo, contact your doctor immediately.

If you stop treatment with Nubriveo

• Do not stop using this medicine unless your doctor tells you to do so. Stopping treatment may increase the number of your seizures.
• If your doctor asks you to stop taking this medicine, they will gradually reduce your dose. This helps prevent your seizures from returning or worsening.

If you have any questions about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences 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)
• seizures, feeling dizzy (vertigo)
• pain or discomfort at the injection or infusion site
• nausea and vomiting, constipation
• depression, anxiety, difficulty sleeping (insomnia), irritability
• nose and throat infections (such as the "common cold"), cough
• reduced appetite

Uncommon: may affect up to 1 in 100 people

• allergic reactions
• changes in thinking and/or loss of contact with reality (psychotic disorder), aggression, nervous excitement (agitation)
• thoughts or attempts of self-harm or suicide: inform your doctor immediately
• a decrease in the number of white blood cells (called 'neutropenia') – detected by blood tests

Not known: frequency cannot be estimated from the available data

• widespread skin rash with blisters and peeling of the skin, particularly around the mouth, nose, eyes, and genitals (Stevens-Johnson syndrome)

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 experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via the national reporting system listed in Annex 5.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Nubriveo

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date stated on the carton and vial after Exp. The expiry date refers to the last day of that month.
• Nubriveo may be diluted prior to injection by a 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 Nubriveo for injection/infusion is for single use only (single-dose). Any unused solution must be discarded.
• The solution should only be used if it is clear, free from particles, and has not changed in colour.
• Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Package contents and other information

What Nubriveo contains
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.

Description of the appearance of Nubriveo and contents of the pack
Nubriveo 10 mg/mL solution for injection/infusion is a sterile, clear, colourless solution.
The 5 mL vial of Nubriveo 10 mg/mL solution for injection/infusion is packaged in a cardboard box containing 10 vials.

Marketing Authorisation Holder and Manufacturer
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 further information on this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien Lietuva
UCB Pharma SA/NV UCB Pharma Oy Finland
Tél/Tel: + 32 / (0)2 559 92 00 Tel: + 358 9 2514 4221 (Suomija)

България Luxembourg/Luxemburg
Ю СИ БИ България ЕООД UCB Pharma SA/NV
Teл.: + 359 (0) 2 962 30 49 Tél/Tel: + 32 / (0)2 559 92 00 (Belgique/Belgien)

Česká republika Magyarország
UCB s.r.o. UCB Magyarország Kft.
Tel: + 420 221 773 411 Tel.: + 36-(1) 391 0060

Danmark Malta
UCB Nordic A/S Pharmasud Ltd.
Tlf.: + 45 / 32 46 24 00 Tel: + 356 / 21 37 64 36

Deutschland Nederland
UCB Pharma GmbH UCB Pharma B.V.
Tel: + 49 /(0) 2173 48 4848 Tel.: + 31 / (0)76-573 11 40

Eesti Norge
UCB Pharma Oy Finland UCB Nordic A/S
Tel: + 358 9 2514 4221 (Soome) Tlf: + 47 / 67 16 5880

Ελλάδα Österreich
UCB Α.Ε. UCB Pharma GmbH
Τηλ: + 30 / 2109974000 Tel: + 43-(0)1 291 80 00

España Polska
UCB Pharma, S.A. UCB Pharma Sp. z o.o. / VEDIM Sp. z o.o.
Tel: + 34 / 91 570 34 44 Tel: + 48 22 696 99 20

France Portugal
UCB Pharma S.A. UCB Pharma (Produtos Farmacêuticos), Lda
Tél: + 33 / (0)1 47 29 44 35 Tel: + 351 / 21 302 5300

Hrvatska România
Medis Adria d.o.o. UCB Pharma Romania S.R.L.
Tel: +385 (0) 1 230 34 46 Tel: + 40 21 300 29 04

Ireland Slovenija
UCB (Pharma) Ireland Ltd. Medis, d.o.o.
Tel: + 353 / (0)1-46 37 395 Tel: + 386 1 589 69 00

Ísland Slovenská republika
Vistor hf. UCB s.r.o., organizačná zložka
Simi: + 354 535 7000 Tel: + 421 (0) 2 5920 2020

Italia Suomi/Finland
UCB Pharma S.p.A. UCB Pharma Oy Finland
Tel: + 39 / 02 300 791 Puh/Tel: + 358 9 2514 4221

Κύπρος Sverige
Lifepharma (Z.A.M.) Ltd UCB Nordic A/S
Τηλ: + 357 22 05 63 00 Tel: + 46 / (0) 40 29 49 00

Latvija
UCB Pharma Oy Finland
Tel: + 358 9 2514 4221 (Somija)

Other sources of information
More detailed information on this medicinal product is available on the website of the European Medicines Agency: https://www.ema.europa.eu.

The following information is intended exclusively for healthcare professionals:

Nubriveo injectable solution/for infusion can be administered as a bolus or by infusion:

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

Nubriveo may be diluted with the following solutions: sodium chloride 9 mg/mL (0.9%) injection solution, glucose 50 mg/mL (5%) injection solution, or Ringer's lactate solution.
Each vial of Nubriveo injectable solution/for infusion must be used only once (single use). Any unused solution must be discarded (see section 3).

ANNEX IV
SCIENTIFIC CONCLUSIONS AND REASONS FOR THE CHANGE IN THE TERMS OF THE MARKETING AUTHORISATION

Scientific conclusions
Taking into account the assessment by the Pharmacovigilance and Risk Assessment Committee (PRAC) of the Periodic Safety Update Reports (PSURs) for brivaracetam, the PRAC's scientific conclusions are as follows:
In light of the available data on Stevens-Johnson syndrome from spontaneous reports, including four cases with a close temporal relationship and positive dechallenge, and considering a plausible mechanism of action, the PRAC considers that a causal relationship between brivaracetam and Stevens-Johnson syndrome is at least a reasonable possibility. The PRAC concluded that the product information for medicinal products containing brivaracetam should therefore be amended accordingly.

Having reviewed the PRAC recommendation, the Committee for Human Medicinal Products (CHMP) agrees with the general conclusions and the rationale of the recommendation.

Reasons for the change in the terms of the marketing authorisation
Based on the scientific conclusions for brivaracetam, the CHMP considers that the benefit-risk balance of medicinal products containing brivaracetam remains unchanged, subject to the proposed amendments to the product information.
The CHMP recommends a change to the terms of the marketing authorisation.