Brivaracetam 10 mg/ml Oral solution

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

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

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.

• 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.

• 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 a severe skin rash or skin peeling, blistering and/or mouth sores after taking brivaracetam.

Serious skin reactions including Stevens-Johnson syndrome have been reported in association with brivaracetam treatment. Stop using brivaracetam and seek medical attention immediately if you notice any of the symptoms related to these serious skin reactions described in section 4.

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 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.

Brivaracetam Oral solution is not recommended for use in children under 2 years of age.

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.

• 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.

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 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 passes into breast milk.

Do not stop treatment without talking to your doctor first. Stopping treatment could increase your seizures and harm your baby.

• 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.

• Methyl parahydroxybenzoate: May cause allergic reactions (possibly delayed).
• Sodium: This medicine contains less than 1 mmol sodium (23 mg) per millilitre, that is to say essentially ‘sodium free’.
• Sorbitol (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 0.8 mg propylene glycol in each millilitre.

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
  • 50 kg or more
• Dose in ml (corresponding to 25 mg)
  • 2.5ml
  • Use the 5ml syringe
• Dose in ml (corresponding to 50 mg)
  • 5ml
  • Use the 5ml syringe
• Dose in ml (corresponding to 75 mg)
  • 7.5ml
  • Use the 10ml syringe
• Dose in ml (corresponding to 100 mg)
  • 10ml
  • Use the 10ml syringe

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
  • 20kg
    • Dose in ml (corresponding to 0.5 mg/ kg = 0.05 ml/kg)
      • 1ml
    • Dose in ml (corresponding to 1 mg/ kg = 0.1 ml/kg)
      • 2ml
    • Dose in ml (corresponding to 1.5 mg/ kg = 0.15 ml/kg)
      • 3ml
    • Dose in ml (corresponding to 2 mg/ kg = 0.2 ml/kg)
      • 4ml
  • 25kg
    • Dose in ml (corresponding to 0.5 mg/ kg = 0.05 ml/kg)
      • 1.25ml
    • Dose in ml (corresponding to 1 mg/ kg = 0.1 ml/kg)
      • 2.5ml
    • Dose in ml (corresponding to 1.5 mg/ kg = 0.15 ml/kg)
      • 3.75ml
    • Dose in ml (corresponding to 2 mg/ kg = 0.2 ml/kg)
      • 5ml
  • 30kg
    • Dose in ml (corresponding to 0.5 mg/ kg = 0.05 ml/kg)
      • 1.5ml
    • Dose in ml (corresponding to 1 mg/ kg = 0.1 ml/kg)
      • 3ml
    • Dose in ml (corresponding to 1.5 mg/ kg = 0.15 ml/kg)
      • 4.5ml
    • Dose in ml (corresponding to 2 mg/ kg = 0.2 ml/kg)
      • 6ml*
  • 35kg
    • Dose in ml (corresponding to 0.5 mg/ kg = 0.05 ml/kg)
      • 1.75ml
    • Dose in ml (corresponding to 1 mg/ kg = 0.1 ml/kg)
      • 3.5ml
    • Dose in ml (corresponding to 1.5 mg/ kg = 0.15 ml/kg)
      • 5.25ml*
    • Dose in ml (corresponding to 2 mg/ kg = 0.2 ml/kg)
      • 7ml*
  • 40kg
    • Dose in ml (corresponding to 0.5 mg/ kg = 0.05 ml/kg)
      • 2ml
    • Dose in ml (corresponding to 1 mg/ kg = 0.1 ml/kg)
      • 4ml
    • Dose in ml (corresponding to 1.5 mg/ kg = 0.15 ml/kg)
      • 6ml*
    • Dose in ml (corresponding to 2 mg/ kg = 0.2 ml/kg)
      • 8ml*
  • 45kg
    • Dose in ml (corresponding to 0.5 mg/ kg = 0.05 ml/kg)
      • 2.25ml
    • Dose in ml (corresponding to 1 mg/ kg = 0.1 ml/kg)
      • 4.5ml
    • Dose in ml (corresponding to 1.5 mg/ kg = 0.15 ml/kg)
      • 6.75ml*
    • Dose in ml (corresponding to 2 mg/ kg = 025 ml/kg)
      • 9ml*

For volume between 0.5 ml and 5 ml, use the 5 ml oral syringe

* For volume above 5 ml and up to 10 ml, use the 10 ml oral syringe

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
  • 10kg
    • Dose in ml (corresponding to 0.5 mg/ kg = 0.05 ml/kg)
      • 0.5ml
    • Dose in ml (corresponding to 1.25 mg/ kg = 0.125 ml/kg)
      • 1.25ml
    • Dose in ml (corresponding to 1.5 mg/ kg = 0.15 ml/kg)
      • 1.5ml
    • Dose in ml (corresponding to 2 mg/ kg = 0.2 ml/kg)
      • 2ml
    • Dose in ml (corresponding to 2.5 mg/ kg = 0.25 ml/kg)
      • 2.5ml
  • 12kg
    • Dose in ml (corresponding to 0.5 mg/ kg = 0.05 ml/kg)
      • 0.6ml
    • Dose in ml (corresponding to 1.25 mg/ kg = 0.125 ml/kg)
      • 1.5ml
    • Dose in ml (corresponding to 1.5 mg/ kg = 0.15 ml/kg)
      • 1.8ml
    • Dose in ml (corresponding to 2 mg/ kg = 0.2 ml/kg)
      • 2.4ml
    • Dose in ml (corresponding to 2.5 mg/ kg = 0.25 ml/kg)
      • 3ml
  • 14kg
    • Dose in ml (corresponding to 0.5 mg/ kg = 0.05 ml/kg)
      • 0.7ml
    • Dose in ml (corresponding to 1.25 mg/ kg = 0.125 ml/kg)
      • 1.75ml
    • Dose in ml (corresponding to 1.5 mg/ kg = 0.15 ml/kg)
      • 2.1ml
    • Dose in ml (corresponding to 2 mg/ kg = 0.2 ml/kg)
      • 2.8ml
    • Dose in ml (corresponding to 2.5 mg/ kg = 0.25 ml/kg)
      • 3.5ml
  • 15kg
    • Dose in ml (corresponding to 0.5 mg/ kg = 0.05 ml/kg)
      • 0.75ml
    • Dose in ml (corresponding to 1.25 mg/ kg = 0.125 ml/kg)
      • 1.9ml
    • Dose in ml (corresponding to 1.5 mg/ kg = 0.15 ml/kg)
      • 2.25ml
    • Dose in ml (corresponding to 2 mg/ kg = 0.2 ml/kg)
      • 3ml
    • Dose in ml (corresponding to 2.5 mg/ kg = 0.25 ml/kg)
      • 3.75ml

Use the 5 ml syringe

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.

• You can take Brivaracetam Oral solution on its own, or dilute it in water or orange juice shortly before swallowing.
• The medicine may be taken with or without food.
• A nasogastric tube may be used when administering brivaracetam oral solution. The NG tubes are Polyvinylchloride (PVC), 8 French, 121 cm length, with a flush volume of 5mL.

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 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 provided in the carton to ensure accurate dosing.
• Open the bottle: press the cap and turn it anti-clockwise

Follow these steps the first time you take Brivaracetam Oral solution:

• Take off the adaptor from the oral syringe
• Put the adaptor into the top of the bottle

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.
• Turn the bottle upside down.
• 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.
• Then push the plunger up to remove any possible air bubbles.
• Pull the plunger down to the millilitre (ml) dose marker on the oral syringe prescribed by your doctor.
  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 orange 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.

Brivaracetam Oral solution is a long term treatment – keep taking Brivaracetam Oral solution until your doctor tells you to stop.

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 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.

• 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.

Common: may affect up to 1 in 10 people

• restlessness and hyperactivity (psychomotor hyperactivity)

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.

The active substance is brivaracetam.

Each millilitre (ml) contains 10 milligrams (mg) brivaracetam.

The other ingredients are sorbitol (as sorbitol liquid, non-crystallising), glycerol, carmellose sodium, methyl parahydroxybenzoate, sodium citrate, sucralose, raspberry flavour (propylene glycol (E1520) ~ 81%, triacetin (E1518) ~ 1.3%), citric acid, purified water.

Brivaracetam Oral solution is slightly viscous, clear colourless solution.

Brivaracetam Oral solution is filled in an amber glass bottle or an amber PET bottle capped with a child resistant closure (polypropylene, polyethylene) packed in a cardboard box containing a 10 ml oral syringe and a 5 ml oral syringe (polypropylene, polyethylene) and polyethylene adaptor for the syringes. Each bottle contains 300 ml of oral solution.

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