Brivaracetam EG

Package leaflet: Information for the patient

Brivaracetam EG 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 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, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

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

• Brivaracetam EG is used in adults, adolescents, and children from 2 years of age.
• It is used to treat a type of epilepsy characterised by partial epileptic 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 of both sides of the brain – this is called "secondary generalisation".
• You have been given this medicine to reduce the number of seizures (epileptic fits) you have.
• Brivaracetam EG is used together with other medicines for epilepsy.

2. What you need to know before taking Brivaracetam EG

Do not take Brivaracetam EG 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 EG.
• in the past, after taking brivaracetam, you developed a severe skin rash, skin peeling, and/or mouth ulcers. Serious skin reactions, including Stevens-Johnson syndrome, have been reported in association with brivaracetam treatment. Stop using
  Brivaracetam EG 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 Brivaracetam EG if:

• you have thoughts of harming or killing yourself. A small number of people being treated with antiepileptic medicines, such as Brivaracetam EG, 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
Brivaracetam EG is not recommended for use in children under 2 years of age.

Other medicines and Brivaracetam EG
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 EG:

• 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 EG and alcohol

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

Pregnancy and breastfeeding
Women of childbearing age should discuss with their doctor the use of contraceptive measures.
If you are pregnant, think you might be pregnant, planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Taking Brivaracetam EG during pregnancy is not recommended, as the effects of brivaracetam on pregnancy and the unborn child are unknown. Breastfeeding is not recommended while taking Brivaracetam EG, 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 EG.
• These effects are more likely at the beginning of treatment or after a dose increase.
• Do not drive, ride a bicycle, or operate tools or machinery until you know how this medicine affects you.

Brivaracetam EG contains lactose and sodium

• lactose (a type of sugar) – If your doctor has diagnosed you with an intolerance to certain sugars, contact them 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 EG

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

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.

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 appropriate 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 your child weighs 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 EG tablets

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

How long to take Brivaracetam EG

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

If you take more Brivaracetam EG than you should

If you have taken more Brivaracetam EG 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, or thoughts or attempts of self-harm or suicide.

If you forget to take Brivaracetam EG

• If you forget a dose, take it as soon as you remember.
• Then take your 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 EG

• 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 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 of extreme tiredness (fatigue)
• seizures, feeling 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 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 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 EG

• 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. Contents of the pack and other information

What Brivaracetam EG contains
The active substance is brivaracetam.
Each film-coated tablet of Brivaracetam EG 10 mg contains 10 mg of brivaracetam.
Each film-coated tablet of Brivaracetam EG 25 mg contains 25 mg of brivaracetam.
Each film-coated tablet of Brivaracetam EG 50 mg contains 50 mg of brivaracetam.
Each film-coated tablet of Brivaracetam EG 75 mg contains 75 mg of brivaracetam.
Each film-coated tablet of Brivaracetam EG 100 mg 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 EG 25 mg film-coated tablets also contain: black iron oxide (E172), yellow iron oxide (E172).
  Brivaracetam EG 50 mg film-coated tablets also contain: yellow iron oxide (E172).
  Brivaracetam EG 75 mg film-coated tablets also contain: black iron oxide (E172), red iron oxide (E172).
  Brivaracetam EG 100 mg film-coated tablets also contain: yellow iron oxide (E172), black iron oxide (E172).

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

For Brivaracetam EG 10 mg film-coated tablets:
Brivaracetam EG is available in Al-OPA/Al/PVC blisters containing 14 or 56 film-coated tablets.
For Brivaracetam EG 25 mg, 50 mg, 75 mg and 100 mg film-coated tablets:
Brivaracetam EG is available in Al-OPA/Al/PVC blisters containing 14 or 56 film-coated tablets or
in multiple packs of 168 (3 packs of 56) film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder
EG S.p.A.
via Pavia 6,
20136 Milano
Italy

Manufacturers
Pharos MT Limited
Hf62x, Qasam Industrijali Hal Far
Hal Far, Birzebbuga
BBG 3000 Malta
PharOS Pharmaceutical Oriented Services Ltd.
Lesvou Street End, Thesi Loggos Industrial Zone,
Metamorfossi, 14452,
Greece
STADA Arzneimittel AG
Stadastrasse 2-18,
Bad Vilbel, 61118,
Germany
Stada M&D S.R.L.
Strada Trascaului Nr 10, 401135 Turda,
Cluj County,
Romania

This medicinal product is authorized in the European Economic Area countries under the following names:
DE: Brivaracetam AL 10 mg/ 25 mg/ 50 mg/ 75 mg /100 mg Filmtabletten
HU: Brivaracetam STADA Arzneimittel 10 mg/ 25 mg/ 50 mg/ 75 mg/ 100 mg filmtabletta
IT: Brivaracetam EG