Brivaracetam PensA

Patient Information Leaflet: Information for the Patient

Brivaracetam Pensa 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
Equivalent medicine
Please read all of this leaflet carefully before taking this medicine, as 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, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet

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

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

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

• Brivaracetam Pensa is used in adults, adolescents, and children from 2 years of age.
• It is used to treat a type of epilepsy characterized by partial epileptic seizures with or without secondary generalization.
• 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 known as "secondary generalization".
• This medicine has been prescribed to you to reduce the number of seizures (epileptic fits) you have.
• Brivaracetam Pensa is used in combination with other medicines for epilepsy.

2. What you need to know before taking Brivaracetam Pensa

Do not take Brivaracetam Pensa 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 Pensa.
• 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 Pensa 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 Pensa if:

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

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

• 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 Pensa and alcohol

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

Driving and using machines

• You may experience drowsiness, dizziness or fatigue while taking Brivaracetam Pensa.
• 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 Pensa contains lactose and sodium
Brivaracetam Pensa 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 Brivaracetam Pensa

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 Brivaracetam Pensa together with other medicines for epilepsy.

How much to take
Your doctor will determine the appropriate daily dose for you. Take the daily dose in 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 to 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 to 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 Pensa

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

Brivaracetam Pensa 50 mg and 100 mg film-coated tablets are supplied as tablets either without or with a score line. If there is a score line, the tablet may be divided into equal doses.

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

If you take more Brivaracetam Pensa than you should
If you have taken more Brivaracetam Pensa than you should, contact your doctor. You may experience drowsiness and dizziness. 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 Pensa

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

If you stop taking Brivaracetam Pensa

• 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 everyone 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)
• seizures, feeling dizzy (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 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 Brivaracetam Pensa

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 medicines 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 Pensa 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: Monohydrate lactose, lactose, croscarmellose sodium, magnesium stearate.

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

Description of the appearance of Brivaracetam Pensa and package contents
Brivaracetam Pensa 10 mg are film-coated tablets, round, white to off-white, approximately 5.5 mm in diameter, marked with "10" on one side and smooth on the other side.
Brivaracetam Pensa 25 mg are film-coated tablets, oval, grey (approximately 8.9 mm x 5.0 mm), marked with '25' on one side and smooth on the other side.
Brivaracetam Pensa 50 mg are film-coated tablets, yellow, oval (approximately 11.7 mm x 6.6 mm):

• marked with "50" on one side and smooth on the other, or
• with a score line on one side.

Brivaracetam Pensa 75 mg are film-coated tablets, oval, purple in colour (approximately 13 mm x 7.3 mm), marked with "75" on one side and smooth on the other side.
Brivaracetam Pensa 100 mg are film-coated tablets, oval, green-grey in colour (approximately 14.5 mm x 8.1 mm):

• marked with "100" on one side and smooth on the other, or
• with a score line on one side.

Brivaracetam Pensa 10 mg tablets are packed in blisters supplied in cardboard boxes containing 14 film-coated tablets.
Brivaracetam Pensa 25 mg, 50 mg, 75 mg and 100 mg tablets are packed in blisters supplied in cardboard boxes containing 56 film-coated tablets.
All pack sizes are available in PVC/PCTFE-Aluminium blisters.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
TOWA PHARMACEUTICAL S.p.A.
Via Enrico Tazzoli, 6
20154 Milano
Italy

Manufacturer
PharmaPath S.A.
28is Oktovriou 1
Agia Varvara, 123 51
Greece

This Patient Information Leaflet was last revised on {MM/YYYY}.