Brileps

Package leaflet: Information for the patient

Brileps 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
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 could be harmful.
• If you experience any side effects, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Brileps is and what it is used for

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

• Brileps 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 reduce the number of seizures (epileptic attacks) you experience.
• Brileps is used in combination with other anti-epileptic medicines.

2. What you need to know before taking Brileps

Do not take Brileps 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 have any doubts, consult your doctor or pharmacist before taking Brileps;
• 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 Brileps 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 Brileps if:

• You have thoughts of harming yourself or of suicide. A small number of people taking antiepileptic medicines, such as Brileps, 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
Brileps is not recommended for use in children under 2 years of age.
Other medicines and Brileps
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 Brileps:

• 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.

Brileps and alcohol

• Concomitant use of this medicine with alcohol is not recommended.
• If you drink alcohol while taking Brileps, 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 may be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Taking Brileps during pregnancy is not recommended, as the effects of Brileps on pregnancy and the unborn child are unknown. Breastfeeding is not recommended while taking Brileps, 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 Brileps.
• These effects are more likely to occur at the beginning of treatment or after an increase in dose.
• Do not drive, ride a bicycle, or operate tools or machinery until you know how this medicine affects you.

Brileps contains lactose and sodium

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

Take this medicine exactly as your doctor has told you. If you are unsure, consult your doctor or pharmacist. Other formulations of this medicine may be more suitable for certain patients, such as children (for example, if they cannot swallow whole tablets); please consult your doctor or pharmacist.
You will take Brileps 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 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 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 Brileps tablets

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

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

If you take more Brileps than you should
If you have taken more Brileps 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 with balance, anxiety, extreme tiredness, irritability, aggression, difficulty sleeping, depression, or thoughts or attempts of self-harm or suicide.

If you forget to take Brileps

• If you forget a dose, take it as soon as you remember.
• Then take your next dose at the 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 Brileps

• 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 prevent your seizures from returning or worsening.

If you have any doubts 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 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)
• seizure, feeling 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 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 children

• 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 Brileps

• 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 Brileps contains
The active substance is brivaracetam.
Each Brileps 10 mg film-coated tablet contains 10 mg of brivaracetam.
Each Brileps 25 mg film-coated tablet contains 25 mg of brivaracetam.
Each Brileps 50 mg film-coated tablet contains 50 mg of brivaracetam.
Each Brileps 75 mg film-coated tablet contains 75 mg of brivaracetam.
Each Brileps 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), croscarmellose sodium, colloidal anhydrous silica (E551), magnesium stearate (E470b)
• Tablet coating: polyvinyl alcohol (E1203), calcium carbonate (E170), macrogol 4000 (E1521), talc (E553b).
  Brileps 25 mg film-coated tablets also contain: black iron oxide (E172), yellow iron oxide (E172).
  Brileps 50 mg film-coated tablets also contain: yellow iron oxide (E172).
  Brileps 75 mg film-coated tablets also contain: black iron oxide (E172), red iron oxide (E172).
  Brileps 100 mg film-coated tablets also contain: yellow iron oxide (E172), black iron oxide (E172).

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

For Brileps 10 mg film-coated tablets:
Brileps is available in Al-OPA/Al/PVC blisters containing 14 or 56 film-coated tablets.
For Brileps 25 mg, 50 mg, 75 mg, and 100 mg film-coated tablets:
Brileps is available in Al-OPA/Al/PVC blisters containing 56 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Farmitalia S.r.l.
Via Pinciana 25
00198 Rome
Italy

Manufacturers
Pharos MT Limited
Hf62x, Qasam Industrijali Hal Far
BBG 3000 Hal Far, Birzebbuga
Malta
Pharos Pharmaceutical Oriented Services Ltd.
Lesvou Street End, Thesi Loggos, Industrial Zone,
Metamorfossi, 144 52,
Greece