Briviact 10 mg/ml solucion oral
Introduction
Patient Information Leaflet
Briviact 10 mg/ml Oral Solution
brivaracetam
Read this leaflet carefully before you start taking this medicine, because
it contains important information for you.
- Keep this leaflet, as you may need to read it again.
- If you have any questions, ask your doctor or pharmacist.
-This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
- If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.
1.What Briviact is and what it is used for
2.What you need to know before you start taking Briviact
3.How to take Briviact
4.Possible side effects
5.Storage of Briviact
6.Contents of the pack and additional information
1. What is Briviact and what is it used for
What is Briviact
Briviact contains the active ingredient brivaracetam. It belongs to a group of medicines called “antiepileptics”. These medicines are used for the treatment of epilepsy.
What is Briviact used for
-Briviact is used in adults, adolescents, and children over 2 years old.
-It is used for the treatment of a type of epilepsy that involves partial seizures with or without secondary generalization.
-Partial seizures are seizures that begin affecting only one side of the brain. These partial seizures may spread to larger areas of 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 medicines for the treatment of epilepsy.
2. What you need to know before starting 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 components of this medication (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 committing suicide. A small number of people taking antiepileptic medications like Briviact have had thoughts of harming themselves or committing suicide. If you have any of these thoughts, contact your doctor immediately.
- If you have liver problems, your doctor may need to adjust your dose.
Children
Briviact is not recommended for use in children under 2 years of age.
Taking Briviact with other medications
Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.
Particularly, inform your doctor if you are taking any of the following medications, as you will need to adjust your Briviact dose:
- Rifampicin, a medication used to treat bacterial infections.
- St. John's Wort (also known asHypericum perforatum) a plant-based medication used to treat depression and anxiety, as well as other conditions.
Taking Briviact with alcohol
- Do not use this medication with alcohol.
- If you take alcohol while taking Briviact, the negative effects of alcohol may increase.
Pregnancy and breastfeeding
Women of childbearing age should discuss the use of contraceptives with their doctor.
If you are pregnant or breastfeeding, think you may be pregnant, or intend to become pregnant, consult your doctor or pharmacist before using this medication.
Do not take Briviact if you are pregnant, as the effects of Briviact on pregnancy and the fetus are unknown.
Do not breastfeed your baby while taking Briviact, as Briviact is excreted in breast milk.
Do not stop treatment without consulting your doctor first. Stopping treatment may increase the number of seizures and harm your baby.
Driving and operating machinery
- 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 bike, or use any tools or machinery until you find out how this medication affects you.
Briviact oral solution containsparahydroxybenzoic acid, sodium, sorbitol, and propylene glycol
- Parahydroxybenzoic acid (E218): may cause allergic reactions (possibly delayed).
- Sodium: this medication contains less than 23mg of sodium (1mmol) per milliliter; it is essentially “sodium-free”.
- Sorbitol (E420) (a type of sugar): this medication contains 168mg of sorbitol in each milliliter. Sorbitol is a source of fructose. If your doctor has indicated that you (or your child) have a condition where you are intolerant to certain sugars, or have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disorder in which the patient cannot break down fructose, consult your doctor (or your child) before taking this medication.
- Propylene glycol (E1520): this medication contains a maximum of 5.5mg of propylene glycol in each milliliter.
3. How to Take Briviact
Follow exactly the administration instructions of this medication as indicated by your doctor. If in doubt, consult your doctor or pharmacist again.
You will take Briviact along with other medications to treat epilepsy.
Dose
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 afternoon, 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 a day. Your doctor may then decide to adjust it to find the best dose for you.
Only the following examples of doses to be taken and what syringe to use are shown in the following table. Your doctor will determine the appropriate dose for you and which syringe to use, based on your weight.
Dose in ml to be taken twice a day and what 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 (blue graduation marks) | Use the 10 ml syringe (black graduation marks) |
Adolescents and children weighing between 20 kg and less than 50 kg
- The recommended dose is between 0.5 mg and 2 mg per kilogram of body weight twice a day. Your doctor may then decide to adjust it to find the best dose for you.
Only the following examples of doses to be taken and what syringe to use are shown in the following table. Your doctor will determine the appropriate dose for you and which syringe to use, based on your weight.
Dose in ml to be taken twice a day and what syringe to use: for adolescents and children weighing between 20 kg and 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 (blue graduation marks) | For volumes between 0.5 ml and 5 ml, use the 5 ml oral syringe (blue graduation marks) * For volumes above 5 ml and up to 10 ml, use the 10 ml oral syringe (black graduation marks) |
Children weighing between 10 kg and less than 20 kg
- The recommended dose is between 0.5 mg and 2.5 mg per kilogram of body weight, twice a day. Your child's doctor may then decide to adjust the dose to find the best dose for your child.
Only the following examples of doses to be taken and what syringe to use are shown in the following table. Your doctor will determine the appropriate dose for you and which syringe to use, based on your weight.
Dose in ml to be taken twice a day and what syringe to use for children weighing between 10 kg and 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 (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 a day.
- 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 kilogram of body weight twice a day.
As a child weighing between 10 kg and less than 20 kg, the maximum dose your child will take is 2 mg per kilogram of body weight twice a day.
How to take Briviact oral solution
- You can take Briviact oral solution alone or diluted in water or juice immediately before swallowing.
- The medication can be taken with or without food.
Instructions for use by patients or caregivers:
The package includes two oral syringes. Check with your doctor which one to use.
- For a volume between 0.5 ml and 5 ml, you must use the 5 ml oral syringe (blue graduation marks) provided in the package to ensure precise dosing.
- For volumes above 5 ml and up to 10 ml, you must use the 10 ml oral syringe (black graduation marks) provided in the package to ensure precise dosing
5 ml oral syringe | 10 ml oral syringe |
The 5 ml oral syringe has two superimposed blue graduation marks at intervals of 0.25 ml and 0.1 ml. | The 10 ml oral syringe has black graduation marks at intervals of 0.25 ml. |
- Open the bottle: press the cap and unscrew it in the opposite direction to the clock hands (figure 1).
Follow these steps the first time you take Briviact:
- Separate the syringe adapter from the oral syringe (figure 2).
- Insert the adapter into the bottle neck (figure 3). Make sure it is securely attached. You do not need to remove the adapter after use.
Follow these steps each time you take Briviact:
- Place the oral syringe in the adapter opening (figure 4).
- Place the bottle upside down (figure 5).
- Hold the bottle upside down with one hand and use the other hand to fill the oral syringe.
- Lower the plunger to fill the oral syringe with a small amount of solution (figure 6).
- Then, raise the plunger to remove any possible bubbles (figure 7).
- Lower the plunger to the dose mark in milliliters (ml) on the oral syringe prescribed by your doctor (figure 8).
- Place the bottle right side up (figure 9).
- Remove the oral syringe from the adapter (figure 10).
You can choose between two ways to take the medication:
- Empty the contents of the oral syringe into water (or juice) by pushing the plunger to the bottom of the oral syringe (figure 11) – then you will have to 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 oral syringe (figure 12).
- Close the bottle with the plastic screw cap (you do not need to remove the adapter).
- To clean the oral syringe, rinse it only with cold water, moving the plunger several times up and down to collect and expel the water, without separating the two components of the syringe (figure 13).
- Store the bottle, oral syringe, and package insert in the box.
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 some of the following symptoms: feeling unwell, feeling like you're spinning, difficulty maintaining balance, anxiety, feeling extremely tired, irritability, aggression, difficulty sleeping, depression, suicidal thoughts or attempts, or thoughts of self-harm.
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 of what to do, consult your doctor or pharmacist.
If you interrupt Briviact treatment
- Do not interrupt treatment with this medication unless your doctor tells you to. This is because interrupting treatment may increase the number of seizures you have.
- If your doctor decides to interrupt your treatment, they will give you instructions for the gradual withdrawal of Briviact. This will help prevent the recurrence of seizures or make them worse.
If you have any other questions about the use of this medication, ask your doctor or pharmacist.
4. Possible Adverse Effects
Like all medications, this medication may produce adverse effects, although not all people may experience them.
Very Frequent:may affect more than 1 in 10 patients.
- drowsiness or dizziness.
Frequent:may affect up to 1 in 10 patients.
- flu
- feeling extremely tired (fatigue)
- seizure, sensation of rotation (vertigo)
- sensation of nausea and vomiting, constipation
- depression, anxiety, difficulty sleeping (insomnia), irritability
- common cold and throat infections (such as "common cold"), cough
- decreased appetite
Rare:May affect up to 1 in 100 patients
- allergic reactions
- abnormal thoughts and/or loss of contact with reality (psychotic disorder), aggression, nervousness (agitation)
- thoughts or attempts to harm oneself or commit suicide: report to your doctor immediately
- a decrease in white blood cells (called 'neutropenia') – which appears in blood tests
Other Adverse Effects in Children
Frequent:may affect up to 1 in 10 patients.
-restlessness and hyperactivity (psychomotor hyperactivity)
Reporting Adverse Effects
If you experienceany type of adverse effect, consult your doctor or pharmacist, even if it is apossibleadverse effect that does not appear in this prospectus.You can also report them directlythrough thenational notification system included in theAppendix V.By reporting adverse effects, you can contribute to providing more information about the safety of this medication.
5. Conservation of Briviact.
- Keep this medication out of the sight and reach of children.
- Do not use this medication after the expiration date that appears on the carton and the bottle after CAD. The expiration date is the last day of the month indicated.
- This medication does not require special storage conditions.
- Use after the first opening of the bottle within 8 months.
- Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the containers and medications that you no longer need. This will help protect the environment.
6. Contents of the packaging and additional information
Briviact Composition
- The active ingredient is brivaracetam.
- Each milliliter (ml) contains 10 milligrams (mg) of brivaracetam.
The other components are: sodium citrate, anhydrous citric acid, methyl parahydroxybenzoate (E218), sodium caramel, sucralose, sorbitol liquid (E420), glycerol (E422), raspberry flavor (propylene glycol (E1520) 90% - 98%), purified water.
Appearance of the product and contents of the package
Briviact 10 mg/ml oral solution is a slightly viscous, transparent, colorless to yellowish liquid.
The 300 ml glass bottle of Briviact is packaged in a cardboard box accompanied by an oral syringe of 10 ml (black graduation marks), an oral syringe of 5 ml (blue graduation marks), and syringe adapters.
Marketing authorization holder and responsible manufacturer
Marketing authorization holder
UCB Pharma, S.A., Allée de la Recherche 60, B-1070, Brussels, Belgium.
Responsible manufacturer
UCB Pharma, S.A., Chemin du Foriest, B-1420 Braine-l’Alleud, Belgium.
For more information about this medication, please contact the local representative of the marketing authorization holder:
België/Belgique/Belgien UCB Pharma SA/NV Tel/Tel: + 32 / (0)2 559 92 00 | Lietuva UCB Pharma Oy Finland Tel: + 358 9 2514 4221 (Suomija) | |
?????? ? ?? ?????????? ???? Te?.: + 359 (0) 2 962 30 49 | Luxembourg/Luxemburg UCB Pharma SA/NV Tél/Tel: + 32 / (0)2 559 92 00(Belgique/Belgien) | |
Ceská republika UCB s.r.o. Tel:+ 420221 773 411 | Magyarország UCB Magyarország Kft. Tel.: + 36-(1) 391 0060 | |
Danmark UCB Nordic A/S Tlf: + 45 / 32 46 24 00 | Malta Pharmasud Ltd. Tel: + 356 / 21 37 64 36 | |
Deutschland UCB Pharma GmbH Tel: + 49 /(0) 2173 48 4848 | Nederland UCB Pharma B.V. Tel.: + 31 / (0)76-573 11 40 | |
Eesti UCB Pharma Oy Finland Tel: + 358 9 2514 4221 (Soome) | Norge UCB Nordic A/S Tlf: +47/67 16 5880 | |
Ελλ?δα UCBΑ.Ε. Τηλ: + 30 / 2109974000 | Österreich UCB Pharma GmbH Tel: + 43-(0)1 291 80 00 | |
España UCB Pharma, S.A. Tel: + 34 / 91 570 34 44 | Polska 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)147 29 44 35 | Portugal UCB Pharma (Produtos Farmacêuticos), Lda Tel: + 351 / 21 302 5300 | |
Hrvatska Medis Adria d.o.o. Tel: +385 (0) 1 230 34 46 | România UCB Pharma Romania S.R.L. Tel: + 40 21 300 29 04 | |
Ireland UCB (Pharma) Ireland Ltd. Tel: + 353 / (0)1-46 37 395 | Slovenija Medis, d.o.o. Tel: + 386 1 589 69 00 | |
Ísland Vistor hf. Simi: + 354 535 7000 | Slovenská republika UCB s.r.o.,organizacná zložka Tel: + 421 (0) 2 5920 2020 | |
Italia UCB Pharma S.p.A. Tel: + 39 / 02 300 791 | Suomi/Finland UCB Pharma Oy Finland Puh/Tel: + 358 9 2514 4221 | |
Κ?προς Lifepharma (Z.A.M.) Ltd Τηλ: + 357 22 05 63 00 | Sverige UCB Nordic A/S Tel: + 46 / (0) 40 29 49 00 | |
Latvija UCB Pharma Oy Finland Tel: + 358 9 2514 4221 (Somija) | United Kingdom(Northern Ireland) UCB (Pharma)IrelandLtd. Tel:+353 / (0)1-46 37 395 |
Last review date of this leaflet:
Other sources of information
Detailed information about this medication is available on the European Medicines Agency website:http://www.ema.europa.eu
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