Briviact 10 mg/ml oral solution
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the patient
Briviact 10 mg/ml oral solution
brivaracetam
Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.
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Keep this leaflet, as you may need to read it again.
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If you have any questions, consult your doctor or pharmacist.
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This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, because it may harm them.
- If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.
Contents of the leaflet
- What Briviact is and what it is used for
- What you need to know before taking Briviact
- How to take Briviact
- Possible side effects
- How to store Briviact
- Contents of the pack and other information
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 "antiepileptic drugs". These medicines are used for the treatment of epilepsy.
What Briviact is used for
- Briviact is used in adults, adolescents and children over 2 years of age.
- It is used for the treatment of a type of epilepsy involving partial-onset seizures, with or without secondary generalization.
- Partial-onset seizures are seizures that start in only one side of the brain. These partial seizures may spread to larger areas on both sides of the brain – this is called "secondary generalization".
- Your doctor has prescribed this medicine to reduce the number of seizures.
- Briviact is used in combination with other anti-epileptic medicines for the treatment of epilepsy.
2. What you need to know before taking Briviact
Do not take Briviact
- if you are allergic to brivaracetam, to other chemically related compounds such as levetiracetam or piracetam, or to any of the other ingredients of this medicine (listed in section 6). If you are unsure, consult your doctor or pharmacist before taking Briviact.
Warnings and precautions
Consult your doctor or pharmacist before starting to take Briviact:
- If you have had thoughts of harming yourself or of suicide. A small number of people taking antiepileptic medicines such as Briviact have experienced thoughts of self-harm or suicide. If you have any such thoughts, contact your doctor immediately.
- If you have liver problems, your doctor may need to adjust your dose.
Children
The use of Briviact is not recommended in children under 2 years of age.
Taking Briviact with other medicines
Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
In particular, inform your doctor if you are taking any of the following medicines, as your dose of Briviact may need to be adjusted:
- 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.
Taking Briviact with alcohol
- The use of this medicine with alcohol is not recommended.
- If you drink alcohol while taking Briviact, the negative effects of alcohol may be increased.
Pregnancy and breastfeeding
Women of childbearing age should discuss the use of contraception with their doctor.
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.
Briviact is not recommended during pregnancy, as the effects of Briviact on pregnancy and the fetus are unknown.
Breastfeeding is not recommended while taking Briviact, as Briviact is excreted in breast milk.
Do not stop treatment without first consulting your doctor. Stopping treatment could increase the number of your seizures and harm your baby.
Driving and using machines
- You may feel drowsy, dizzy, or tired while taking Briviact.
- These effects are more common at the beginning of treatment or after a dose increase.
- Do not drive, ride a bicycle, or operate any tools or machinery until you know how this medicine affects you.
Briviact oral solution contains methylparaben, sodium, sorbitol, and propylene glycol
- Methylparaben (E218): may cause allergic reactions (possibly delayed).
- Sodium: this medicine contains less than 23 mg of sodium (1 mmol) per millilitre; therefore, it is essentially “sodium-free”.
- Sorbitol (E420) (a type of sugar): this medicine contains 168 mg of sorbitol per ml. Sorbitol is a source of fructose. If your doctor has advised you (or your child) that you have an intolerance to certain sugars, or if you (or your child) have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic condition in which the body cannot break down fructose, consult your doctor before taking this medicine.
- Propylene glycol (E1520): this medicine contains up to 5.5 mg of propylene glycol per millilitre.
3. How to take Briviact
Follow exactly the instructions for use of this medicine given by your doctor. If in doubt, consult your doctor or pharmacist again.
You will take Briviact together with other medicines to treat epilepsy.
Dosage
Your doctor will calculate the correct daily dose for you. Take the daily dose in two equal doses, one in the morning and one in the evening, approximately 12 hours apart.
Adolescents and children weighing 50 kg or more, and adults
- The recommended dose is between 25 mg and 100 mg twice daily. Your doctor may later decide to adjust your dose to find the best dose for you.
The following table shows only examples of doses to take and which syringe to use. Your doctor will determine the appropriate dose for you and which syringe to use, based on your weight.
Volume 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 25mg) | Dose in ml (corresponding to 50mg) | Dose in ml (corresponding to 75mg) | Dose in ml (corresponding to 100mg) |
50 kg or more | 2.5 ml | 5 ml | 7.5 ml | 10 ml |
Use the 5 ml syringe (blue graduation marks) | Use the 10 ml syringe (black graduation marks) |
Adolescents and children weighing 20 kg to less than 50 kg
- The recommended dose is between 0.5 mg and 2 mg per kg of body weight twice daily. Your doctor may later decide to adjust your dose to find the best dose for you.
The following table shows only examples of doses to take and which syringe to use. Your doctor will determine the appropriate dose for you and which syringe to use, based on your weight.
Dosage 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 | Dosage in ml (corresponding to 0.5 mg/kg = 0.05 ml/kg) | Dosage in ml (corresponding to 1 mg/kg = 0.1 ml/kg) | Dosage in ml (corresponding to 1.5 mg/kg = 0.15 ml/kg) | Dosage 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 (blue graduation marks) | For volumes between 0.5 ml and 5 ml, use the 5 ml oral syringe (blue graduation marks)
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Children weighing from 10 kg to less than 20 kg
- The recommended dose is 0.5 mg to 2.5 mg per kg of body weight, taken twice daily. Your child's doctor may decide to adjust the dose in order to find the most appropriate dose for your child.
The following table shows only examples of doses to be taken and which syringe to use. Your doctor will determine the appropriate dose and which syringe to use, based on your child's weight.
Dosage in ml to be taken twice daily and which syringe to use for children weighing from 10 kg to less than 20 kg: | |||||
Weight | Dosage in ml (corresponding to 0.5 mg/kg = 0.05 ml/kg) | Dosage in ml (corresponding to 1.25 mg/kg = 0.125 ml/kg) | Dosage in ml (corresponding to 1.5 mg/kg = 0.15 ml/kg) | Dosage in ml (corresponding to 2 mg/kg = 0.2 ml/kg) | Dosage 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 (blue graduation marks) |
Patients with liver problems
If you have liver problems:
- As an adolescent or child weighing 50 kg or more, or as an adult, the maximum dose you will take is 75 mg twice daily.
- As an adolescent or child weighing between 20 kg and less than 50 kg, the maximum dose you will take is 1.5 mg per kg of body weight twice daily.
As a child weighing between 10 kg and less than 20 kg, the maximum dose your child will take is 2 mg per kg of body weight twice daily.
How to take Briviact oral solution
- You may take Briviact oral solution alone or diluted in water or juice immediately before swallowing.
- The medicine may be taken with or without food.
Instructions for use by patients or caregivers:
The pack includes two oral syringes. Check with your doctor which one you should use.
- For a volume between 0.5 ml and 5 ml, you must use the 5 ml oral syringe (blue graduation marks) supplied in the pack to ensure accurate dosing.
- For volumes greater than 5 ml up to 10 ml, you must use the 10 ml oral syringe (black graduation marks) supplied in the pack to ensure accurate dosing.
5 ml oral syringe | 10 ml oral syringe |
The 5 ml oral syringe has two overlapping blue graduation marks: at 0.25 ml and 0.1 ml intervals. | The 10 ml oral syringe has black graduation marks at 0.25 ml intervals. |
- Open the bottle: press the cap and unscrew it counterclockwise (Figure 1).
Follow these steps the first time you take Briviact:
- Separate the adapter from the oral syringe (Figure 2).
- Insert the adapter into the neck of the bottle (Figure 3). Make sure it is securely fixed. There is no need to remove the adapter after use.
Follow these steps each time you take Briviact:
- Place the oral syringe into the opening of the adapter (Figure 4).
- Turn the bottle upside down (Figure 5).
- Hold the bottle upside down with 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 prescribed dose mark in millilitres (ml) as indicated by your doctor on the oral syringe (Figure 8).
- Turn the bottle upright (Figure 9).
- Remove the oral syringe from the adapter (Figure 10).
You may choose one of two ways to take the medicine:
- empty the contents of the syringe into water (or juice) by pushing the plunger fully down to the bottom of the oral syringe (Figure 11) – then drink all the water (add only enough to make it easy to drink) or
- drink the solution directly from the oral syringe without water – drink all the contents of the syringe (Figure 12).
- Close the bottle with the plastic screw cap (there is no need to remove the adapter).
- To clean the oral syringe, rinse it with cold water only, moving the plunger several times up and down to draw in and expel water, without separating the two parts of the syringe (Figure 13).
- Store the bottle, oral syringe, and patient leaflet in the carton.
Duration of Briviact treatment
Briviact is a long-term treatment – continue taking Briviact until your doctor tells you to stop.
If you take more Briviact than you should
If you take more Briviact than you should, consult your doctor. You may feel dizzy and drowsy.
You may also experience any of the following symptoms: feeling unwell, sensation of spinning ("vertigo"), 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 Briviact
- If you forget to take a dose, take it as soon as you remember.
- Take your next dose at the time you normally take it.
- Do not take a double dose to make up for the missed dose.
- If you are unsure what to do, consult your doctor or pharmacist.
If you interrupt Briviact treatment
- Do not interrupt treatment with this medicine unless your doctor tells you to do so. This is because stopping treatment may increase the number of seizures you have.
- If your doctor decides to discontinue your treatment, they will give you instructions for gradually withdrawing Briviact. This will help prevent your seizures from returning or worsening.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
Very common: may affect more than 1 in 10 patients.
- drowsiness or dizziness.
Common: may affect up to 1 in 10 patients.
- flu
- feeling very tired (fatigue)
- seizures, sensation of spinning (vertigo)
- feeling nauseous and vomiting, constipation
- depression, anxiety, difficulty sleeping (insomnia), irritability
- nose and throat infections (such as "common cold"), cough
- decreased appetite
Uncommon: may affect up to 1 in 100 patients.
- allergic reactions
- abnormal thoughts and/or loss of contact with reality (psychotic disorder), aggression, restlessness (agitation)
- thoughts or attempts of self-harm or suicide: inform your doctor immediately
- a decrease in white blood cells (called 'neutropenia') – detected in blood tests
Other adverse effects in children
Common: may affect up to 1 in 10 patients.
- restlessness and hyperactivity (psychomotor hyperactivity)
Reporting of adverse effects
If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the national reporting system included in Appendix V. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Briviact.
- 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 vial after EXP. The expiry date refers to the last day of the month indicated.
- This medicine does not require any special storage conditions.
- After first opening the vial, use within 8 months.
- Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.
6. Contents of the pack and other information
Composition of Briviact
- The active substance is brivaracetam.
- Each millilitre (ml) contains 10 milligrams (mg) of brivaracetam.
The other components are: sodium citrate, anhydrous citric acid, methyl 4-hydroxybenzoate (E218), sodium carmellose, sucralose, liquid sorbitol (E420), glycerol (E422), raspberry flavour (propylene glycol (E1520) 90% - 98%), purified water.
Nature of the product and contents of the container
Briviact 10 mg/ml oral solution is a slightly viscous, transparent liquid, colourless to yellowish.
The 300 ml glass bottle of Briviact is packaged in a cardboard box and supplied with a 10 ml oral syringe (black graduation marks), a 5 ml oral syringe (blue graduation marks), and syringe adapters.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
UCB Pharma, S.A., Allée de la Recherche 60, B-1070, Bruxelles, Belgium.
Manufacturer
UCB Pharma, S.A., Chemin du Foriest, B-1420 Braine-l’Alleud, Belgium.
Further information on this medicinal product is available from the local representative of the Marketing Authorisation Holder:
Belgium/Belgium/Belgium UCB Pharma SA/NV Tel/Tel: + 32 / (0)2 559 92 00 | Lithuania UCB Pharma Oy Finland Tel: + 358 9 2514 4221 (Finland) |
Bulgaria UCB Pharma Oy Finland Tel: + 359 (0) 2 962 30 49 | Luxembourg/Luxembourg UCB Pharma SA/NV Tél/Tel: + 32 / (0)2 559 92 00 (Belgium/Belgium) |
Czech Republic UCB s.r.o. Tel: + 420 221 773 411 | Hungary UCB Magyarország Kft. Tel.: + 36-(1) 391 0060 |
Denmark UCB Nordic A/S Tlf: + 45 / 32 46 24 00 | Malta Pharmasud Ltd. Tel: + 356 / 21 37 64 36 |
Germany UCB Pharma GmbH Tel: + 49 /(0) 2173 48 4848 | Netherlands UCB Pharma B.V. Tel.: + 31 / (0)76-573 11 40 |
Estonia UCB Pharma Oy Finland Tel: + 358 9 2514 4221 (Finland) | Norway UCB Nordic A/S Tlf: + 47 / 67 16 5880 |
Greece UCB Α.Ε. Tel: + 30 / 2109974000 | Austria UCB Pharma GmbH Tel: + 43-(0)1 291 80 00 |
Spain UCB Pharma, S.A. Tel: + 34 / 91 570 34 44 | Poland UCB Pharma Sp. z o.o. / VEDIM Sp. z o.o. Tel: + 48 22 696 99 20 |
France UCB Pharma S.A. Tél: + 33 / (0)1 47 29 44 35 | Portugal UCB Pharma (Pharmaceutical Products), Lda Tel: + 351 / 21 302 5300 |
Croatia Medis Adria d.o.o. Tel: +385 (0) 1 230 34 46 | Romania UCB Pharma Romania S.R.L. Tel: + 40 21 300 29 04 |
Ireland UCB (Pharma) Ireland Ltd. Tel: + 353 / (0)1-46 37 395 | Slovenia Medis, d.o.o. Tel: + 386 1 589 69 00 |
Iceland Vistor hf. Tel: + 354 535 7000 | Slovakia UCB s.r.o., organizational unit Tel: + 421 (0) 2 5920 2020 |
Italy UCB Pharma S.p.A. Tel: + 39 / 02 300 791 | Finland/Suomi UCB Pharma Oy Finland Tel/Puh: + 358 9 2514 4221 |
Cyprus Lifepharma (Z.A.M.) Ltd Tel: + 357 22 05 63 00 | Sweden UCB Nordic A/S Tel: + 46 / (0) 40 29 49 00 |
Latvia UCB Pharma Oy Finland Tel: + 358 9 2514 4221 (Finland) | United Kingdom (Northern Ireland) UCB (Pharma) Ireland Ltd. Tel: + 353 / (0)1-46 37 395 |
Date of the most recent review of this leaflet:
Other sources of information
Detailed information on this medicine is available on the website of the European Medicines Agency: http://www.ema.europa.eu