Brivaracetam Doc

Package leaflet: Information for the patient

BRIVARACETAM DOC 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

Equivalent medicinal product
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, because it may be harmful.
• If you experience any adverse reactions, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What BRIVARACETAM DOC is and what it is used for

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

• BRIVARACETAM DOC is used in adults, adolescents, and children from the age of 2 years.
• 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 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.
• BRIVARACETAM DOC is used together with other medicines for epilepsy.

2. What you need to know before taking BRIVARACETAM DOC

Do not take BRIVARACETAM DOC 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 BRIVARACETAM DOC.
• in the past, after taking brivaracetam, you experienced 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 DOC 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 DOC if:

• you have thoughts of harming or killing yourself. A small number of people taking antiepileptic medicines, such as BRIVARACETAM DOC, have had thoughts about 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
BRIVARACETAM DOC is not recommended for use in children under 2 years of age.
Other medicines and BRIVARACETAM DOC
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 DOC:

• 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 DOC and alcohol

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

Pregnancy and breastfeeding
Women of childbearing age should discuss the use of contraceptive measures with their doctor.
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 brivaracetam during pregnancy is not recommended, as the effects of BRIVARACETAM DOC on pregnancy and the unborn child are unknown. Breastfeeding is not recommended while taking BRIVARACETAM DOC, 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 DOC.
• 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.

BRIVARACETAM DOC contains lactose and sodium

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

Take this medicine exactly as your doctor has told you. If you are unsure, consult your doctor or pharmacist. Other forms of this medicine may be more suitable for certain patients, such as children (for example, if they cannot swallow whole tablets); please speak to your doctor or pharmacist.
You will take BRIVARACETAM DOC together with other medicines for epilepsy.

Dosage

Your doctor will determine the appropriate daily dose 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 BRIVARACETAM DOC tablets

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

How long to take BRIVARACETAM DOC

BRIVARACETAM DOC is a long-term treatment – continue taking BRIVARACETAM DOC until your doctor tells you to stop.

If you take more BRIVARACETAM DOC than you should

If you have taken more BRIVARACETAM DOC than prescribed, contact your doctor. You may experience dizziness and drowsiness. You may also experience any of the following symptoms: feeling unwell, a sensation of "spinning" (vertigo), problems maintaining balance, anxiety, extreme fatigue, irritability, aggression, difficulty sleeping, depression, or thoughts or attempts of self-harm or suicide.

If you forget to take BRIVARACETAM DOC

• 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 DOC

• Do not stop taking this medicine unless your doctor tells you to. Stopping treatment may increase the number of your seizures.
• If your doctor decides you should 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 of extreme tiredness (fatigue)
• seizure, 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 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 DOC

• Keep this medicine out of 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 DOC contains
The active substance is brivaracetam.
Each BRIVARACETAM DOC 10 mg film-coated tablet contains 10 mg of brivaracetam.
Each BRIVARACETAM DOC 25 mg film-coated tablet contains 25 mg of brivaracetam.
Each BRIVARACETAM DOC 50 mg film-coated tablet contains 50 mg of brivaracetam.
Each BRIVARACETAM DOC 75 mg film-coated tablet contains 75 mg of brivaracetam.
Each BRIVARACETAM DOC 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: poly(vinyl) alcohol (E1203), calcium carbonate (E170), macrogol 4000 (E1521), talc (E553b).

BRIVARACETAM DOC 25 mg film-coated tablets also contain: iron oxide black (E172), iron oxide yellow (E172).
BRIVARACETAM DOC 50 mg film-coated tablets also contain: iron oxide yellow (E172).
BRIVARACETAM DOC 75 mg film-coated tablets also contain: iron oxide black (E172), iron oxide red (E172).
BRIVARACETAM DOC 100 mg film-coated tablets also contain: iron oxide yellow (E172).

Description of the appearance of BRIVARACETAM DOC and contents of the pack
BRIVARACETAM DOC 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 DOC 25 mg film-coated tablets are grey, elongated biconvex tablets, marked with "25" on one side and smooth on the other.
BRIVARACETAM DOC 50 mg film-coated tablets are yellow, elongated biconvex tablets, marked with "50" on one side and smooth on the other.
BRIVARACETAM DOC 75 mg film-coated tablets are purple, elongated biconvex tablets, marked with "75" on one side and smooth on the other.
BRIVARACETAM DOC 100 mg film-coated tablets are green, elongated biconvex tablets, marked with "100" on one side and smooth on the other.

For BRIVARACETAM DOC 10 mg film-coated tablets:
BRIVARACETAM DOC is available in Al-OPA/Al/PVC blisters containing 14 or 56 film-coated tablets.

For BRIVARACETAM DOC 25 mg, 50 mg, 75 mg and 100 mg film-coated tablets:
BRIVARACETAM DOC 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
DOC Generici S.r.l., Via Turati 40, 20121 Milan, 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, 144 52, Greece.

This medicinal product is authorized in the European Economic Area countries under the following names:
Italy: BRIVARACETAM DOC
Hungary: Brivaracetam DOC 10mg, 25mg, 50mg, 75mg, 100mg filmtabletta