Patient leaflet - Brivaracetam Colonis 10 mg/ml oral solution
1. What Brivaracetam oral solution is and what it is used for
What Brivaracetam oral solution is
Brivaracetam oral solution contains the active substance brivaracetam. It belongs to a group of medicines called ‘anti-epileptics’. These medicines are used to treat epilepsy.
What Brivaracetam oral solution is used for
Brivaracetam oral solution 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 oral solution is used together with other medicines for epilepsy.
2. What you need to know before you take Brivaracetam oral solution
Do not take Brivaracetam oral solution 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 oral solution. ■ you have ever developed as severe skin rash or skin peeling, blistering and/or mouth sores
after taking Brivaracetam oral solution.
Serious skin reactions including Stevens-Johnson syndrome have been reported in association with Brivaracetam oral solution treatment. Stop using Brivaracetam oral solution and seek medical attention 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 oral solution if: ■ You have thoughts of harming or killing yourself. A small number of people being treated
with anti-epileptic medicines such as Brivaracetam oral solution 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 oral solution is not recommended for use in children under 2 years of age.
Other medicines and Brivaracetam oral solution
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 oral solution 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 oral solution with alcohol
- Combining this medicine with alcohol is not recommended.
If you drink alcohol while taking Brivaracetam oral solution 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 oral solution if you are pregnant, as the effects of Brivaracetam oral solution on pregnancy and the unborn baby are not known. It is not recommended to breast-feed your baby while taking Brivaracetam oral solution, as Brivaracetam oral solution 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 oral solution. ■ 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 oral solution oral solution contains methyl parahydroxybenzoate, sodium, sorbitol and propylene glycol
Methyl parahydroxybenzoate (E218): This may cause allergic reactions (possibly delayed). ■ Sodium: This medicine contains less than 1 mmol sodium (23mg) per millilitre, that is to say
essentially ‘sodium free’.
Sorbitol (E420) (a type of sugar): This medicine contains 168 mg sorbitol in each ml. Sorbitol
is a source of fructose. If your doctor has told you that you (or your child) have an intolerance to some sugars or if you have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disorder in which a person cannot break down fructose, talk to your doctor before you (or your child) take or receive this medicine. ■ Propylene glycol (E1520): This medicine contains maximum 5.5 mg propylene glycol in each
millilitre.
3. How to take Brivaracetam oral solution
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
You will take Brivaracetam oral solution 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.
The table below only shows examples of doses to take and which syringe to use. Your doctor will work out the right dose for you and which syringe to use, depending on your weight.
Dose in ml to be taken twice daily and which syringe to use - for adolescents and children weighing 50 kg or more, and adults:
Weight Dose in ml
(corresponding to 25 mg)
Dose in ml (corresponding to 50 mg)
Dose in ml
(corresponding to 75 mg)
Dose in ml (corresponding to 100 mg)
50 kg or more 2.5 ml 5 ml 7.5 ml 10 ml
Use the 5 ml syringe (black graduation marks)
Use the 10 ml syringe (black graduation marks) Package leaflet: Information for the patient
Brivaracetam Colonis 10 mg/ml oral solution brivaracetam
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. The table below only shows examples of doses to take and which syringe to use. Your doctor will work out the right dose for you and which syringe to use, depending on your weight.
Dose in ml to be taken twice daily and which syringe to use - for adolescents and children weighing from 20 kg to less than 50 kg:
Weight Dose in ml
(corresponding to 0.5 mg/kg
= 0.05 ml/kg)
Dose in ml
(corresponding to 1 mg/kg
= 0.1 ml/kg)
Dose in ml (corresponding to 1.5 mg/kg = 0.15 ml/kg)
Dose in ml (corresponding to 2 mg/kg = 0.2 ml/kg)
20 kg 1 ml 2 ml 3 ml 4 ml
25 kg 1.25 ml 2.5 ml 3.75 ml 5 ml
30 kg 1.5 ml 3 ml 4.5 ml 6 ml*
35 kg 1.75 ml 3.5 ml 5.25 ml* 7 ml*
40 kg 2 ml 4 ml 6 ml* 8 ml*
45 kg 2.25 ml 4.5 ml 6.75 ml* 9 ml*
Use the 5 ml syringe
(black graduation marks)
For volume between 0.5 ml and 5 ml, use the 5 ml oral syringe
(black graduation marks) * For volume above 5 ml and up to 10 ml, use the 10 ml oral syringe
(black graduation marks)
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.
The table below only shows examples of doses to take and which syringe to use. Your doctor will work out the right dose for you and which syringe to use, depending on your weight.
Dose in ml to be taken twice daily and which syringe to use - for children weighing from 10 kg to less than 20 kg:
Weight Dose in ml
(corresponding to 0.5 mg/kg
= 0.05 ml/kg)
Dose in ml
(corresponding to 1.25 mg/kg
= 0.125 ml/kg)
Dose in ml
(corresponding to 1.5 mg/kg
= 0.15 ml/kg)
Dose in ml (corresponding to 2 mg/kg = 0.2 ml/kg)
Dose in ml (corresponding to 2.5 mg/kg = 0.25 ml/kg)
10 kg 0.5 ml 1.25 ml 1.5 ml 2 ml 2.5 ml
12 kg 0.6 ml 1.5 ml 1.8 ml 2.4 ml 3.0 ml
14 kg 0.7 ml 1.75 ml 2.1 ml 2.8 ml 3.5 ml
15 kg 0.75 ml 1.9 ml 2.25 ml 3 ml 3.75 ml
Use the 5 ml syringe
(black graduation marks)
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 oral solution oral solution
- You can take Brivaracetam oral solution oral solution on its own, or dilute it in water or juice shortly before swallowing.
- The medicine may be taken with or without food.
Instructions for use for patients or carers:
Two oral syringes will be provided in the carton. Check with your doctor which one you should use.
- For volume between 0.5 ml and 5 ml, you should use the 5 ml oral syringe (black graduation marks) provided in the carton to ensure accurate dosing.
For volume above 5 ml and up to 10 ml, you should use the 10 ml oral syringe (black graduation marks) provided in the carton to ensure accurate dosing.
5 ml oral dosing syringe 10 ml oral dosing syringe
The 5 ml oral syringe has 2 overlapping black
graduation marks: in steps of 0.25 ml and in
steps of 0.1 ml.
The 10 ml oral syringe has black graduation marks in steps of 0.25 ml.
- Open the bottle: press the cap and turn it anti-clockwise (figure 1).
Follow these steps the first time you take Brivaracetam oral solution:
- Take off the adaptor from the oral syringe (figure 2).
- Put the adaptor into the top of the bottle (figure 3). Make sure it is fixed well in place. You do not need to remove the adaptor after use.
Follow these steps each time you take Brivaracetam oral solution:
- Put the oral syringe into the adaptor opening (figure 4).
- Turn the bottle upside down (figure 5).
10 9
11 12
13
- Hold the bottle upside down in one hand and use the other hand to fill the oral syringe.
- Pull the plunger down to fill the oral syringe with a small amount of solution (figure 6).
- Then push the plunger up to remove any possible air bubbles (figure 7).
Pull the plunger down to the millilitre (ml) dose marker on the oral syringe prescribed by
your doctor (figure 8). The plunger may rise back up the barrel on the first dosage. Therefore, ensure that the plunger is kept in position until the oral syringe is disconnected from the bottle.
- Turn the bottle the right way up (figure 9).
- Take the oral syringe out of the adaptor (figure 10).
There are two ways in which you can choose to drink the medicine:
empty the contents of the syringe into water (or juice) by pushing the plunger to the bottom
of the oral syringe (figure 11) – you will then need to drink all of the water (add just enough to make it easy to drink) or
drink the solution directly from the oral syringe without water – drink the whole contents of
the syringe (figure 12).
- Close the bottle with the plastic screw cap (you do not need to remove the adaptor).
To clean the oral syringe, rinse with cold water only, moving the plunger several times up
and down to take up and expel the water, without separating the two components of the syringe (figure 13).
- Keep the bottle, the oral syringe, and the leaflet in the carton.
How long to take Brivaracetam oral solution for
Brivaracetam oral solution is a long term treatment – keep taking Brivaracetam oral solution until your doctor tells you to stop.
If you take more Brivaracetam oral solution than you should
If you have taken more Brivaracetam oral solution 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 oral solution
- 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 oral solution
- 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.
- 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
Not known: frequency cannot be estimated from the available data
- a widespread rash with blisters and peeling 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 get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: 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 oral solution
- 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 cardboard box and bottle after EXP. The expiry date refers to the last day of that month.
- This medicinal product does not require any special storage conditions.
- After first opening of the bottle, use within 8 months.
- 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 oral solution contains
The active substance is brivaracetam.
Each millilitre (ml) contains 10 milligrams (mg) brivaracetam.
The other ingredients are: sodium citrate, citric acid anhydrous, methyl parahydroxybenzoate (E218), carmellose sodium, sucralose, sorbitol liquid (E420), glycerol (E422), raspberry flavour (propylene glycol (E1520) 90 % - 98 %), purified water.
What Brivaracetam oral solution looks like and contents of the pack
Brivaracetam oral solution 10 mg/ml oral solution is slightly viscous, clear, colourless to yellowish liquid.
The 300 ml glass bottle of Brivaracetam oral solution is packed in a cardboard box containing a 10 ml oral syringe (black graduation marks) and a 5 ml oral syringe (black graduation marks) and adaptors for the syringes.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Colonis Pharma Limited,
25 Bedford Square,
Bloomsbury,
London,
WC1B 3HH,
United Kingdom
Manufacturer
Anfarm Hellas S.A.
61st Km National Road Athens-Lamia
Schimatari Viotias, 320 09,
Greece
This leaflet was last revised in December 2025.
Product name: Brivaracetam Colonis 10 mg/ml oral solution PL/PA no: TBA
Reason for request: Amends from marked-up pdf Version no: 0.4
Date of revision: 3 February 2026
Colours: As swatch(es)
BAC ref:
Text ref: uk-pil-oral-0001-track.docx
Yellowdot job ref: 16031 (previous job number: 15971)