Brivaracetam Glenmark

Patient Information Leaflet

Brivaracetam Glenmark 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 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 others, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

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

• Brivaracetam Glenmark is used in adults, adolescents and children from 2 years of age.
• It is used to treat a type of epilepsy characterised by partial-onset seizures with or without secondary generalisation.
• Partial-onset 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 you to reduce the number of seizures (epileptic fits) you have.
• Brivaracetam Glenmark is used in combination with other anti-epileptic medicines.

2. What you need to know before taking Brivaracetam Glenmark

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

• you have thoughts of harming yourself or of suicide. A small number of people taking antiepileptic medicines such as Brivaracetam Glenmark have had thoughts of harming themselves or of suicide. 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 Glenmark is not recommended for use in children under 2 years of age.

Other medicines and Brivaracetam Glenmark
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 – because your doctor may need to adjust your dose of Brivaracetam Glenmark:

• 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 Glenmark and alcohol

• Concomitant use of this medicine with alcohol is not recommended.
• If you drink alcohol while taking Brivaracetam Glenmark, 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 to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Taking Brivaracetam Glenmark during pregnancy is not recommended, as the effects of Brivaracetam Glenmark on pregnancy and the unborn child are unknown. Breastfeeding is not recommended while taking Brivaracetam Glenmark, as Brivaracetam Glenmark 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 Glenmark.
• 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 Glenmark contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially ‘sodium-free’.

3. How to take Brivaracetam Glenmark

Take this medicine exactly as instructed by your doctor. If you have any doubts, consult your doctor or pharmacist. Other forms of brivaracetam may be more suitable for certain patients, such as children (if they are unable to 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 Glenmark 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.

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 most suitable one 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 most suitable one 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 suitable one 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 Glenmark tablets

• Swallow the tablet whole with a glass of liquid. Tablets must be swallowed whole to ensure the correct dose is taken.
• This medicine can be taken with or without food.

How long to take Brivaracetam Glenmark

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

If you take more Brivaracetam Glenmark than you should

If you have taken more Brivaracetam Glenmark 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 Glenmark

• 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 Glenmark

• Do not stop taking this medicine unless your doctor tells you to. This is because 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

• flu
• feeling very tired (fatigue)
• seizures, feeling of spinning (dizziness)
• feeling unwell, 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 Glenmark

• 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 Brivaracetam Glenmark 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:
Core
Microcrystalline cellulose, starch, pregelatinized (maize), sodium croscarmellose, magnesium stearate
(see section 2, Brivaracetam Glenmark contains sodium)
Coating
10 mg film-coated tablets: poly(vinyl) alcohol, calcium carbonate, titanium dioxide (E171),
macrogol (MW 3350), talc.
25 mg film-coated tablets: poly(vinyl) alcohol, calcium carbonate, titanium dioxide (E171),
macrogol (MW 3350), talc, black iron oxide (E172), yellow iron oxide (E172).
50 mg film-coated tablets: poly(vinyl) alcohol, calcium carbonate, titanium dioxide (E171),
macrogol (MW 3350), talc, yellow iron oxide (E172), red iron oxide (E172), black iron oxide (E172).
75 mg film-coated tablets: poly(vinyl) alcohol, calcium carbonate, titanium dioxide (E171),
macrogol (MW 3350), talc, black iron oxide (E172), red iron oxide (E172).
100 mg film-coated tablets: poly(vinyl) alcohol, calcium carbonate, titanium dioxide (E171),
macrogol (MW 3350), talc, yellow iron oxide (E172), black iron oxide (E172).

Description of the appearance of Brivaracetam Glenmark and contents of the pack
Brivaracetam Glenmark 10 mg are white to off-white, round, film-coated tablets, 6 mm in diameter, with "10" engraved on one side.
Brivaracetam Glenmark 25 mg are grey, oval, biconvex, film-coated tablets, 9 x 5 mm, with "25" engraved on one side.
Brivaracetam Glenmark 50 mg are yellow, oval, biconvex, film-coated tablets, 12 x 7 mm, with "50" engraved on one side.
Brivaracetam Glenmark 75 mg are pink, oval, biconvex, film-coated tablets, 15 x 8 mm, with "75" engraved on one side.
Brivaracetam Glenmark 100 mg are grey-green, oval, biconvex, film-coated tablets, 15 x 8 mm, with "100" engraved on one side.

Brivaracetam Glenmark tablets are packed in blister packs in cardboard boxes containing 14 or 56 film-coated tablets, or 100x1 film-coated tablets in unit-dose divisible blisters.
The 10 mg, 25 mg, 50 mg and 75 mg strengths are also available in multiple packs of 168 (2 packs of 84) film-coated tablets.
The 100 mg strength is also available in multiple packs of 168 (3 packs of 56) film-coated tablets.
All packs are available in aluminium/aluminium blisters (OPA/aluminium foil/PVC).
Not all pack sizes may be marketed.

Marketing Authorization Holder
Glenmark Arzneimittel GmbH
Industriestrasse, 31
82194 Gröbenzell
Germany

Manufacturer
Holsten Pharma GmbH
Hahnstrasse, 31-35
60528 Frankfurt Am Main
Germany