10 mg, 25 mg, 50 mg, 75 mg and 100 mg film-coated tablets
brivaracetam, respectively
1. What Briviact is and what it is used for
What Briviact is
Briviact contains the active substance brivaracetam. It belongs to a group of medicines called “antiepileptics”. These drugs are used to treat epilepsy.
What Briviact is used for
- Briviact is used in adults, adolescents, and children from 4 years of age
- It is used to treat a type of epilepsy that produces partial seizures with or without secondary generalization.
- Partial seizures are seizures that initially affect only one side of the brain. These partial seizures can spread and cover larger areas on both sides of the brain – this is called a “secondary generalization”.
- You have been given this medicine to reduce the number of seizures (seizures) you get. Briviact used together with other medicines to treat epilepsy.
2. What you need to know before taking Briviact
Do not take Briviact:
- if you are allergic to brivaracetam, other similar chemical compounds such 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 Briviact
Warnings and cautions
Talk to your doctor or pharmacist before taking Briviact if:
- you have thoughts of harming yourself or committing suicide. A small number of people treated with antiepileptic drugs such as Briviact have had thoughts of harming themselves or committing suicide. If you ever get any of these thoughts, contact a doctor immediately.
- you have liver problems. Your doctor may need to adjust your dose.
Children
Briviact is not recommended for children under 4 years of age.
Other medicines and Briviact
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 as your doctor may need to adjust your dose of Briviact:
- Rifampicin – a drug used to treat bacterial infection.
- St. John’s wort (also called Hypericum perforatum) – a herbal remedy used to treat depression, anxiety, and even other conditions.
Briviact with alcohol
It is not recommended to combine this drug with alcohol.
- If you drink alcohol while taking Briviact, the negative effects of alcohol may increase.
Pregnancy and breastfeeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Briviact is not recommended if you are pregnant or breast-feeding, as the effects of Briviact on your pregnancy and the unborn or newborn baby are not known.
Do not stop treatment without talking to your doctor first. Stopping taking this medicine may increase the number of seizures and harm your baby.
Driving and using machines
- You may feel drowsy, dizzy, or tired while taking Briviact.
- These effects are more likely at the beginning of treatment or after a dose increase.
- Do not drive, cycle, or use any tools or machines until you know how the medicine affects you.
Briviact contains lactose and sodium
Briviact film-coated tablets contain
- Lactose (a type of sugar – If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
- sodium – This medicine contains less than 1 mmol (23 mg) sodium per tablet, ie essentially ‘sodium-free’.
3. How to take Briviact
Always take this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.
You will be taking Briviact with other medicines for epilepsy.
How much to take
Your doctor will calculate the correct daily dose for you. Take the daily dose one divided into two equal doses – one in the morning and one in the evening at about the same time each day.
Adults, adolescents, and children weighing 50 kg or more
- The recommended dose is from 25 mg to 100 mg and is taken twice a day. Your doctor may later decide to adjust your dose to find the best dose for you.
Children and adolescents weighing less than 50 kg
- The recommended dose is from 0.5 mg to 2 mg per kilogram of body weight and is taken twice a day. Your doctor may later decide to adjust your dose to find the best dose for you.
People with liver problems
If you have liver problems:
- For adults, adolescents, and children weighing 50 kg or more, the maximum dose is 75 mg twice a day.
- For children and adolescents weighing less than 50 kg, the maximum dose is 1.5 mg for each kilogram of body weight twice a day.
How to take Briviact tablets
- Swallow the tablets whole with a glass of liquid.
- The drug can be taken with or without food.
How long to take Briviact
Briviact is a long-term treatment – keep taking Briviact until your doctor tells you to stop.
If you take more Briviact than you should
If you have taken more Briviact than you should, talk to your doctor. You may feel dizzy and sleepy.
If you forget to take Briviact
- If you miss a dose, take it as soon as you remember.
- Then take the 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 Briviact
- Do not stop taking this medicine unless your doctor has told you to. If treatment is stopped, the number of seizures you may have may increase.
- If your doctor tells you to stop taking this medicine, the dose will be reduced gradually. This helps prevent your seizures from coming back or getting worse.
If you have any further questions on the use of this product, 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 user in 10
- Feeling of drowsiness or dizziness.
Common: may affect up to 1 in 10 users
- Influenza
- Feeling very tired (fatigue)
- Cramps, a feeling of “spinning” ( vertigo )
- Nausea and vomiting, constipation
- Depression, anxiety, difficulty sleeping (insomnia), irritability
- Infection in the nose and throat (such as “common cold”), cough
- Decreased appetite
Uncommon: may affect up to 1 in 100 people
- Allergic reactions
- Abnormal thoughts and/or lost contact with reality (psychotic illness), aggressive behavior, agitation (anxiety)
- Thoughts or attempts to harm yourself or commit suicide: tell your doctor immediately
- A decrease in white blood cells (so-called “neutropenia”) – is shown in blood samples.
Additional side effects are in children
Common: may affect up to 1 in 10 users
- restlessness and overactivity ( 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 to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information.
5. How to store Briviact
- 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 expiration date is the last day of the specified month.
- No special storage instructions.
- Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. Contents of the packaging and other information
Content declaration
The active substance is brivaracetam.
Each film-coated tablet contains 10 mg, 25 mg, 50 mg, 75 mg or 100 mg of brivaracetam.
Other ingredients are:
Tablet core:
Croscarmellose sodium, lactose monohydrate, betadex, anhydrous lactose , magnesium stearate
Drag:
- 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, yellow iron oxide (E172), black 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, yellow iron oxide (E172), red iron oxide (E172), black iron oxide (E172).
- 100 mg film-coated tablets: poly (vinyl alcohol), titanium dioxide (E171), macrogol (3350), talc, yellow iron oxide (E172), black iron oxide (E172).
What the medicine looks like and the contents of the pack
Briviact 10 mg are white to off-white, round, film-coated tablets with a diameter of 6.5 mm and have “u 10” embossed on one side.
Briviact 25 mg are gray, oval, film-coated tablets measuring 8.9 mm x 5.0 mm and have “u 25” embossed on one side.
Briviact 50 mg are yellow, oval, film-coated tablets measuring 11.7 mm x 6.6 mm and have “u 50” embossed on one side.
Briviact 75 mg are purple, oval, film-coated tablets measuring 13.0 mm x 7.3 mm and have “u 75” embossed on one side.
Briviact 100 mg are green-gray, oval, film-coated tablets measuring 14.5 mm x 8.1 mm and have “u 100” embossed on one side.
Briviact tablets are packaged in blisters and are supplied in cardboard boxes containing either 14, 56, 14 x 1, or 100 x 1 film-coated tablet or in multiple packs of 168 (3 packs of 56) film-coated tablets.
All packaging is available in PVC / PCTFE – Aluminum blister.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
UCB Pharma SA, Allée de la Recherche 60, B-1070 Brussels, Belgium.
Manufacturer
UCB Pharma SA, Chemin du Foriest, B-1420 Braine-l’Alleud, Belgium.
Contact the representative of the marketing authorization holder to find out more about this medicine:
UCB Nordic A / S
Tel: + 46 / (0) 40 29 49 00