Patient leaflet - Brivaracetam Glenmark 100 mg film-coated tablets
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 ‘anti-epileptics’. 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 that has partial
seizures with or without a secondary generalisation.
Partial seizures are fits that start by only affecting one
side of the brain. These partial seizures can spread and extend to larger areas on both sides of the brain – this is called a ‘secondary generalisation’.
You have been given this medicine to lower the number
of fits (seizures) you have.
Brivaracetam Glenmark is used together with other
medicines for epilepsy.
2. What you need to know before you take Brivaracetam Glenmark
Do not take Brivaracetam Glenmark if:
you are allergic to brivaracetam, other similar chemical
compounds as levetiracetam or piracetam or any of the other ingredients of this medicine (listed in section 6). If you are not sure, talk to your doctor or pharmacist before taking Brivaracetam Glenmark.
Warnings and precautions
Talk to your doctor or pharmacist before taking Brivaracetam Glenmark if:
You have thoughts of harming or killing yourself. A
small number of people being treated with anti-epileptic medicines such as Brivaracetam have had thoughts of harming or killing themselves. 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
Brivaracetam Glenmark is not recommended for use in children under 2 years of age.
Other medicines and Brivaracetam Glenmark
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
In particular, tell your doctor if you are taking any of the following medicines – this is because your doctor may need to adjust your Brivaracetam Glenmark dose:
- 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 with alcohol
Combining 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 breast-feeding
Fertile women should discuss the use of contraceptives with the doctor.
If you are pregnant or breast-feeding, think you may be pregnant or planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
It is not recommended to take Brivaracetam Glenmark if you are pregnant, as the effects of Brivaracetam Glenmark on pregnancy and the unborn baby are not known.
It is not recommended to breast-feed your baby while taking Brivaracetam Glenmark, as Brivaracetam Glenmark passes into breast milk.
Do not stop treatment without talking to your doctor first. Stopping treatment could increase your seizures and harm your baby.
Driving and using machines
You may feel sleepy, dizzy or tired while taking
Brivaracetam Glenmark.
- These effects are more likely at the start of the treatment or after a dose increase.
- Do not drive, cycle or use any tools or machines until you know how the medicine affects you.
Brivaracetam Glenmark contains sodium
This medicine contains less than 1 mmol sodium (23mg) per tablet, that is to say essentially ‘sodium free’.
3. How to take Brivaracetam Glenmark
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. Other form(s) of this medicine may be more suitable for certain patients e.g. children (if tablets cannot be swallowed in whole, for example); ask your doctor or pharmacist.
You will take Brivaracetam Glenmark together with other medicines for epilepsy.
How much to take
Your doctor will work out the right daily dose for you. Take the daily dose in two equal divided doses, approximately 12 hours apart.
Adolescents and children weighing 50 kg or more, and adults
- The recommended dose is from 25 mg to 100 mg taken twice a day. Your doctor may then decide to adjust your dose to find the best dose for you.
Adolescents and children weighing from 20 kg to less than 50 kg
- The recommended dose is from 0.5 mg to 2 mg for each kg of bodyweight, taken twice a day. Your doctor may then decide to adjust your dose to find the best dose for you.
Children weighing from 10 kg to less than 20 kg
- The recommended dose is from 0.5 mg to 2.5 mg for each kg of bodyweight, taken twice a day. Your child’s doctor may then decide to adjust your child’s dose to find the best dose for your child.
People with liver problems
If you have problems with your liver:
- As an adolescent or child weighing 50 kg or more, or as an adult, the maximum dose you will take is 75 mg twice a day.
- As an adolescent or child weighing from 20 kg to less than 50 kg, the maximum dose you will take is 1.5 mg for each kg of bodyweight twice a day.
- As a child weighing from 10 kg to less than 20 kg, the maximum dose your child will take is 2 mg for each kg of bodyweight twice a day.
How to take Brivaracetam Glenmark tablets
- Swallow the tablets whole with a glass of liquid.
- The medicine may be taken with or without food.
How long to take Brivaracetam Glenmark for
Brivaracetam Glenmark is a long-term treatment – keep 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, talk to your doctor. You may feel dizzy and sleepy. You may also have any of the following symptoms: feeling sick, a feeling of ‘spinning’, problems of keeping your balance, anxiety, feeling very tired, irritability, being aggressive, not being able to sleep, depression, thoughts or attempts of harming or killing yourself.
If you forget to take Brivaracetam Glenmark
- If you miss a dose take it as soon as you remember.
- Then take your next dose at the time you would normally take it.
- Do not take a double dose to make up for a forgotten dose.
- If you are not sure what to do, ask 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 could increase the number of fits you have.
Package leaflet: Information for the patient
Brivaracetam Glenmark 10 mg film-coated tablets Brivaracetam Glenmark 25 mg film-coated tablets Brivaracetam Glenmark 50 mg film-coated tablets Brivaracetam Glenmark75 mg film-coated tablets Brivaracetam Glenmark 100 mg film-coated tablets
brivaracetam
If your doctor asks you to stop taking this medicine they
will lower your dose gradually. This helps to stop your fits coming back or getting worse.
If you have any further questions on the use of this medicine, ask 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)
- convulsion, a feeling of ‘spinning’ (vertigo)
- feeling and being sick, constipation
depression, anxiety, not being able to sleep (insomnia),
irritability
infections of the nose and throat (such as the ‘common
cold’), cough
- decreased appetite
Uncommon: may affect up to 1 in 100 people
- allergic reactions
abnormal thinking and/or loss of touch with reality
(psychotic disorder), being aggressive, nervous excitement (agitation)
thoughts or attempts of harming or killing yourself: tell
your doctor straight away
a decrease in white blood cells (called ‘neutropenia’) -
shown in blood tests
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 get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme, Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. 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 which is
stated on the carton and blister after EXP. The expiry date refers to the last day of that month.
This medicinal product does not require any special
storage conditions.
Do not throw away any medicines via wastewater or
household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6. Contents of the pack 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 brivaracetam.
The other ingredients are:
Core
Cellulose, microcrystalline, Starch pregelatinized, Croscarmellose sodium, magnesium stearate
Coating
10 mg film-coated tablets: poly(vinyl alcohol), calcium
carbonate, macrogol (3350), talc.
25 mg film-coated tablets: poly(vinyl alcohol), calcium
carbonate, macrogol (3350), talc, iron oxide yellow (E172), iron oxide black (E172).
50 mg film-coated tablets: poly(vinyl alcohol), calcium
carbonate, macrogol (3350), talc, iron oxide yellow (E172), iron oxide red (E172), iron oxide black (E172).
75 mg film-coated tablets: poly(vinyl alcohol), calcium
carbonate, macrogol (3350), talc, iron oxide red (E172), iron oxide black (E172).
100 mg film-coated tablets: poly(vinyl alcohol), calcium
carbonate, macrogol (3350), talc, iron oxide yellow (E172), iron oxide black (E172).
What Brivaracetam Glenmark looks like and contents of the pack
Brivaracetam Glenmark 10 mg are white to off-white, round, biconvex, film-coated tablets of 5.5 mm in diameter and debossed with “10” on one side.
Brivaracetam Glenmark 25 mg are grey, oval, biconvex, film-coated tablets of 9 mm x 5.0 mm and debossed with “25” on one side.
Brivaracetam Glenmark 50 mg are yellow, oval, biconvex, film-coated tablets of 11.65 mm x 6.5 mm and debossed with “50” on one side.
Brivaracetam Glenmark 75 mg are pink, oval, biconvex, film-coated tablets of 13.0 mm x 7.25 mm and debossed with “75” on one side.
Brivaracetam Glenmark 100 mg are grey-green, oval, biconvex, film-coated tablets of 14.5 mm x 8.15 mm and debossed with “100” on one side.
Brivaracetam Glenmark tablets are packaged in blister packs supplied in cardboard boxes containing 14, 56 or 100x1 film-coated tablets or in multipacks of 168 (2packs of 84 for 10 mg,
25 mg, 50 mg and 75 mg or 3 packs of 56 for 100 mg) film-coated tablets
All packs are available in Aluminium/Aluminium (OPA/ aluminium foil/ PVC) blister.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Glenmark Pharmaceuticals Europe Limited
Laxmi House, 2-B Draycott Avenue, Kenton, Harrow, Middlesex
HA3 0BU, United Kingdom
Manufacturer
Glenmark Pharmaceuticals Europe Limited
Building 2, Croxley Green Business Park
Croxley Green, Hertfordshire
WD18 8YA, United Kingdom
For information in large print, tape, CD or Braille, telephone 0800 198 5000
Please be ready to give the following information:
Product name Reference Number
Brivaracetam Glenmark 10 mg
film-coated tablets
PL 25258/0437
Brivaracetam Glenmark 25 mg
film-coated tablets
PL 25258/0438
Brivaracetam Glenmark 50 mg
film-coated tablets
PL 25258/0439
Brivaracetam Glenmark75 mg
film-coated tablets
PL 25258/0440
Brivaracetam Glenmark 100 mg
film-coated tablets
PL 25258/0441