BRIVARACETAM TEVA

Patient Information Leaflet

Brivaracetam Teva 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 all of 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, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet

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

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

What Brivaracetam Teva is
Brivaracetam Teva contains the active substance brivaracetam. It belongs to a group of medicines
called “antiepileptics”, used to treat epilepsy.
What Brivaracetam Teva is used for

• Brivaracetam Teva 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 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 on both sides of the brain, an effect known as “secondary generalisation”.
• This medicine has been prescribed for you to reduce the number of seizures (epileptic fits) you experience.
• Brivaracetam Teva is used together with other medicines for epilepsy.

2. What you need to know before taking Brivaracetam Teva

Do not take Brivaracetam Teva:

• if you are allergic to brivaracetam, to other chemically related compounds such as levetiracetam or 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 Teva;
• if you previously experienced a severe skin rash, skin peeling, blistering and/or mouth ulcers after taking Brivaracetam Teva.

Serious skin reactions, including Stevens-Johnson syndrome, have been reported in association with treatment with Brivaracetam Teva. If you notice any of the symptoms related to these serious skin reactions described in section 4, stop using Brivaracetam Teva and seek immediate medical advice.

Warnings and precautions
Talk to your doctor or pharmacist before taking Brivaracetam Teva:

• if you have suicidal or self-harming thoughts. A small number of people taking antiepileptic medicines such as Brivaracetam Teva have had suicidal or self-harming thoughts. If you experience such thoughts at any time, contact your doctor immediately;
• if you have liver problems; your doctor may need to adjust your dose.

Children
Brivaracetam Teva is not recommended for use in children under 2 years of age.

Other medicines and Brivaracetam Teva
Inform 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 the dose of Brivaracetam Teva:

• rifampicin, a medicine used to treat bacterial infections;
• St John’s wort (also known as Hypericum perforatum), a herbal medicine used to treat depression, anxiety, and other conditions.

Brivaracetam Teva and alcohol

• Concomitant use of this medicine with alcohol is not recommended.
• If you drink alcohol while being treated with Brivaracetam Teva, the adverse effects of alcohol may be increased.

Pregnancy and breastfeeding
Women of childbearing potential should discuss the use of contraception with their doctor.
If you are pregnant, think you might be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Taking Brivaracetam Teva during pregnancy is not recommended, as the effects of Brivaracetam Teva on pregnancy and the unborn child are unknown.
Breastfeeding is not recommended during treatment with Brivaracetam Teva, as Brivaracetam Teva 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 the baby.

Driving and using machines

• You may experience drowsiness, dizziness or fatigue during treatment with Brivaracetam Teva.
• 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 Teva contains lactose and sodium
Brivaracetam Teva film-coated tablets contain:

• 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 Teva

Take this medicine exactly as instructed by your doctor. If you have any doubts, consult your doctor or pharmacist.
You will take Brivaracetam Teva together with other antiepileptic medicines.

Dosage
Your doctor will determine the appropriate daily dose for you. Take the daily dose divided into two equal doses, approximately 12 hours apart.

Adolescents and children weighing 50 kg or more, and adults:

• The recommended dose ranges from 25 mg to 100 mg taken twice daily. Your doctor may later decide to adjust the dose to find the most suitable one for you.

Adolescents and children weighing between 20 kg and less than 50 kg:

• The recommended dose ranges from 0.5 mg to 2 mg per kg of body weight, taken twice daily. Your doctor may later decide to adjust the dose to find the most suitable one for you.

Children weighing between 10 kg and less than 20 kg:

• The recommended dose ranges from 0.5 mg to 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 one for the child.

Patients with liver problems
If you have liver problems:

• For adolescents and children weighing 50 kg or more, and for adults, the maximum dose to take is 75 mg twice daily.
• For adolescents and children 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.
• For children weighing between 10 kg and less than 20 kg, the maximum dose to take is 2 mg per kg of body weight, twice daily.

How to take Brivaracetam Teva tablets

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

How long to take Brivaracetam Teva
Brivaracetam Teva is a long-term treatment; continue taking Brivaracetam Teva until your doctor tells you to stop.

If you take more Brivaracetam Teva than you should
If you have taken more Brivaracetam Teva than you should, contact your doctor. You may experience dizziness and drowsiness. You may also develop any of the following symptoms: feeling unwell, sensation of "spinning", problems maintaining balance, anxiety, profound fatigue, irritability, aggression, difficulty sleeping, depression, or self-harming or suicidal thoughts and attempts.

If you forget to take Brivaracetam Teva

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

• Do not stop treatment with this medicine unless your doctor tells you to. Stopping treatment may increase the number of seizures you experience.
• If your doctor asks you to stop taking this medicine, they will gradually reduce your dose to help prevent 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 everyone experiences them.
Very common: may affect more than 1 in 10 people

• drowsiness or dizziness

Common: may affect up to 1 in 10 people

• influenza
• profound tiredness (fatigue)
• convulsion, sensation of "spinning" (vertigo)
• feeling unwell and vomiting, constipation
• depression, anxiety, difficulty sleeping (insomnia), irritability
• infections of the nose and throat (such as "common cold"), cough
• reduced appetite

Uncommon: may affect up to 1 in 100 people

• allergic reactions
• abnormal thoughts and/or loss of contact with reality (psychotic disorder), aggression, nervous excitement (agitation)
• self-harming thoughts or attempts or suicidal thoughts: inform your doctor immediately
• 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)

Other 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 Teva

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

The other components are:
Core
Croscarmellose sodium, lactose, magnesium stearate
Coating

• 10 mg film-coated tablets: polyvinyl alcohol (E1203), titanium dioxide (E171), macrogol 3350 (E1521), talc (E553b).
• 25 mg film-coated tablets: polyvinyl alcohol (E1203), titanium dioxide (E171), macrogol 3350 (E1521), talc (E553b), yellow iron oxide (E172), black iron oxide (E172).
• 50 mg film-coated tablets: polyvinyl alcohol (E1203), titanium dioxide (E171), macrogol 3350 (E1521), talc (E553b), yellow iron oxide (E172), red iron oxide (E172).
• 75 mg film-coated tablets: polyvinyl alcohol (E1203), titanium dioxide (E171), macrogol 3350 (E1521), talc (E553b), red iron oxide (E172), black iron oxide (E172), yellow iron oxide (E172).
• 100 mg film-coated tablets: polyvinyl alcohol (E1203), titanium dioxide (E171), macrogol 3350 (E1521), talc (E553b), yellow iron oxide (E172), black iron oxide (E172).

Description of the appearance of Brivaracetam Teva and package contents
Brivaracetam Teva 10 mg are round, film-coated tablets, white to off-white in colour, 4.9 mm in diameter, with the number “10” engraved on one side and the letters “TV” on the other.
Brivaracetam Teva 25 mg are oval, film-coated tablets, light grey to grey in colour, 8.8 mm x 4.9 mm, with the number “25” engraved on one side and the letters “TV” on the other.
Brivaracetam Teva 50 mg are oval, film-coated tablets, light yellow to yellow in colour, 11.6 mm x 6.5 mm, with the number “50” engraved on one side and the letters “TV” on the other.
Brivaracetam Teva 75 mg are oval, film-coated tablets, light purple to purple in colour, 12.9 mm x 7.2 mm, with the number “75” engraved on one side and the letters “TV” on the other.
Brivaracetam Teva 100 mg are oval, film-coated tablets, light green-grey to green-grey in colour, 14.4 mm x 8 mm, with the number “100” engraved on one side and the letters “TV” on the other.

Brivaracetam Teva is available in packs containing 14, 56 and 168 tablets in transparent PVC/Aclar/PVC-Aluminium blisters.
Brivaracetam Teva is available in packs containing 14x1, 56x1 and 168x1 tablets in transparent unit-dose divisible blisters in PVC/Aclar/PVC-Aluminium.
Brivaracetam Teva is available in HDPE bottles with desiccant and child-resistant polypropylene caps containing 100 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Teva B.V., Swensweg 5, 2031 GA Haarlem, The Netherlands

Manufacturer
Actavis Ltd., BLB015-016 Bulebel Industrial Estate, Zejtun ZTN 3000, Malta
Teva Operations Poland Sp. z.o.o, ul. Mogilska 80, 31-546 Kraków, Poland