Brivaracetam Sandoz

Package leaflet: Information for the patient

Brivaracetam Sandoz 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

Generic medicine
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 others, even if they have the same symptoms as yours, because it could be harmful.
• If you experience any adverse reaction, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Brivaracetam Sandoz is and what it is used for

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

• Brivaracetam Sandoz is used in adults, adolescents and children from 2 years of age.
• It is used to treat a type of epilepsy characterised by partial-onset seizures with or without secondary generalisation.
• Partial-onset seizures are epileptic seizures 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) that you have.
• Brivaracetam Sandoz is used in combination with other anti-epileptic medicines.

2. What you need to know before taking Brivaracetam Sandoz

Do not take Brivaracetam Sandoz:

• 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 Brivaracetam Sandoz.
• if in the past, after taking brivaracetam, 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 brivaracetam treatment. Stop using Brivaracetam Sandoz 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 Brivaracetam Sandoz if:

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

Children
Brivaracetam Sandoz is not recommended for use in children under 2 years of age.
Other medicines and Brivaracetam Sandoz
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 Brivaracetam Sandoz:

• 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.

Brivaracetam Sandoz and alcohol

• Concomitant use of this medicine with alcohol is not recommended.
• If you drink alcohol while taking Brivaracetam Sandoz, 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, planning to become pregnant, or are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
It is not recommended to take Brivaracetam Sandoz during pregnancy, as the effects of brivaracetam on pregnancy and the unborn child are unknown.
Breastfeeding is not recommended while taking Brivaracetam Sandoz, as brivaracetam 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 Brivaracetam Sandoz.
• 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.

Brivaracetam Sandoz contains lactose and sodium

• lactose (a type of sugar) – If your doctor has diagnosed you with an intolerance to certain sugars, contact him/her 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 Brivaracetam Sandoz

Take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist. Other forms of this medicine may be more suitable for some patients, such as children (for example, if they cannot swallow whole tablets); please consult your doctor or pharmacist.
You will take Brivaracetam Sandoz together with other medicines for epilepsy.

How much to take
Your doctor will determine the daily dose suitable for you. Take the daily dose in two equal doses, approximately 12 hours apart.
For 10 mg tablets only: The tablet may be divided into equal doses.

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 most suitable dose 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 Brivaracetam Sandoz tablets

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

How long to take Brivaracetam Sandoz
Brivaracetam Sandoz is a long-term treatment – continue taking Brivaracetam Sandoz for as long as your doctor tells you to.

If you take more Brivaracetam Sandoz than you should
If you have taken more Brivaracetam Sandoz 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 dizziness, problems maintaining balance, anxiety, extreme tiredness, irritability, aggression, difficulty sleeping, depression, thoughts about or attempts to harm yourself or commit suicide.

If you forget to take Brivaracetam Sandoz

• 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 forgotten dose.
• If you are unsure what to do, consult your doctor or pharmacist.

If you stop taking Brivaracetam Sandoz

• Do not stop taking this medicine unless your doctor tells you to. 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 to prevent your seizures from returning or worsening.

If you have any questions about how to use 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

• influenza
• feeling of extreme tiredness (fatigue)
• seizure, sensation of spinning (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 of or attempts to harm or kill oneself: 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, especially 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 effect, 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 at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Brivaracetam Sandoz

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date stated on the carton, on the label of the bottle, and on the 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 Brivaracetam Sandoz contains
The active substance is brivaracetam.
Each Brivaracetam Sandoz 10 mg film-coated tablet contains 10 mg of brivaracetam.
Each Brivaracetam Sandoz 25 mg film-coated tablet contains 25 mg of brivaracetam.
Each Brivaracetam Sandoz 50 mg film-coated tablet contains 50 mg of brivaracetam.
Each Brivaracetam Sandoz 75 mg film-coated tablet contains 75 mg of brivaracetam.
Each Brivaracetam Sandoz 100 mg film-coated tablet contains 100 mg of brivaracetam.
The other components are:

• Tablet core: monohydrate lactose, microcrystalline cellulose (type 102) (E460), hypromellose 2910 (5 mPa s) (E464), sodium croscarmellose, anhydrous colloidal silica (E551), magnesium stearate (E470b).
• Tablet coating: polyvinyl alcohol (E1203), calcium carbonate (E170), macrogol 4000 (E1521), talc (E553b).
  Brivaracetam Sandoz 25 mg film-coated tablets also contain: black iron oxide (E 172) and yellow iron oxide (E 172).
  Brivaracetam Sandoz 50 mg film-coated tablets also contain: yellow iron oxide (E 172).
  Brivaracetam Sandoz 75 mg film-coated tablets also contain: black iron oxide (E 172) and red iron oxide (E 172).
  Brivaracetam Sandoz 100 mg film-coated tablets also contain: yellow iron oxide (E 172) and black iron oxide (E 172).

Description of the appearance of Brivaracetam Sandoz and contents of the pack

Brivaracetam Sandoz 10 mg film-coated tablets are white to off-white, round, biconvex tablets, with "10" engraved on one side and a break line on the other.
Brivaracetam Sandoz 25 mg film-coated tablets are grey, oblong, biconvex tablets, with "25" engraved on one side and smooth on the other.
Brivaracetam Sandoz 50 mg film-coated tablets are yellow, oblong, biconvex tablets, with "50" engraved on one side and smooth on the other.
Brivaracetam Sandoz 75 mg film-coated tablets are purple, oblong, biconvex tablets, with "75" engraved on one side and smooth on the other.
Brivaracetam Sandoz 100 mg film-coated tablets are green, oblong, biconvex tablets, with "100" engraved on one side and smooth on the other.

Brivaracetam Sandoz is available in Al-OPA/Al/PVC blisters containing 14 or 56 film-coated tablets or in multiple packs containing 168 (3 packs of 56) film-coated tablets, or in divisible unit-dose blisters containing 14 x 1 or 56 x 1 film-coated tablets, or in multiple packs containing 168 (3 packs of 56 x 1) film-coated tablets.
Brivaracetam Sandoz is also available in high-density polyethylene (HDPE) bottles with child-resistant polypropylene (PP) caps containing 60 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Sandoz S.p.A.
Viale Luigi Sturzo 43
20154 Milan
Italy

Manufacturer
PharOS MT Ltd.
HF62X, Hal Far Industrial Estate,
BBG3000 Birzebbugia
Malta
PharOS Pharmaceutical Oriented Services Ltd.
Lesvou Street End, Thesi Loggos Industrial Zone,
14452 Metamorfossi
Greece
Lek Pharmaceuticals d.d.
Verovškova ulica 57
1526 Ljubljana
Slovenia

This medicinal product is authorized in the European Economic Area Member States under the following names:
Denmark Brivaracetam Sandoz
Germany Brivaracetam - 1 A Pharma 10 mg Filmtabletten
Brivaracetam - 1 A Pharma 25 mg Filmtabletten
Brivaracetam - 1 A Pharma 50 mg Filmtabletten
Brivaracetam - 1 A Pharma 75 mg Filmtabletten
Brivaracetam - 1 A Pharma 100 mg Filmtabletten
Greece Brivaracetam/Sandoz
Italy Brivaracetam Sandoz
Netherlands Brivaracetam Sandoz 25 mg, filmomhulde tabletten
Brivaracetam Sandoz 50 mg, filmomhulde tabletten
Brivaracetam Sandoz 75 mg, filmomhulde tabletten
Brivaracetam Sandoz 100 mg, filmomhulde tabletten
Czech Republic Brivaracetam Sandoz
Spain Brivaracetam Sandoz 25 mg comprimidos recubiertos con película EFG
Brivaracetam Sandoz 50 mg comprimidos recubiertos con película EFG
Brivaracetam Sandoz 75 mg comprimidos recubiertos con película EFG
Brivaracetam Sandoz 100 mg comprimidos recubiertos con película EFG
Hungary Brivaracetam Sandoz 10 mg filmtabletta
Brivaracetam Sandoz 25 mg filmtabletta
Brivaracetam Sandoz 50 mg filmtabletta
Brivaracetam Sandoz 75 mg filmtabletta
Brivaracetam Sandoz 100 mg filmtabletta