Abavalex

Package leaflet: Information for the patient

Abavalex, 10 mg, coated tablets
Abavalex, 25 mg, coated tablets
Abavalex, 50 mg, coated tablets
Abavalex, 75 mg, coated tablets
Abavalex, 100 mg, coated tablets
Brivaracetam
Please read carefully the entire leaflet before using the medicine, as it contains important information for the patient.

• Keep this leaflet, so that you can read it again if necessary.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm other people, even if their symptoms are the same.
• If you experience any adverse effects, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of the leaflet

1. What Abavalex is and what it is used for
2. Important information before taking Abavalex
3. How to take Abavalex
4. Possible side effects
5. How to store Abavalex
6. Contents of the pack and other information

1. What Abavalex is and what it is used for

What Abavalex is
Abavalex contains the active substance brivaracetam. It belongs to a group of medicines called antiepileptic drugs. These medicines are used in the treatment of epilepsy.

What Abavalex is used for

• Abavalex is used in adults, adolescents, and children from the age of 2 years.
• This medicine is used in the treatment of partial-onset seizures, with or without secondary generalization.
• Partial-onset seizures are seizures affecting only one side of the brain. These seizures may spread to both sides of the brain, which is known as "secondary generalization".
• This medicine is used to reduce the number of seizures the patient experiences.
• Abavalex is given together with other medicines used to treat epilepsy.

2. Important information before using Abavalex

When not to take Abavalex:

• if the patient is allergic to brivaracetam, related chemical compounds such as levetiracetam or piracetam, or any of the other ingredients of this medicine (listed in section 6). If there is any doubt, the patient should consult a doctor or pharmacist before starting treatment with Abavalex.
• if the patient has ever experienced a severe skin rash or skin peeling, blistering, and/or mouth ulcers after taking Abavalex. Serious skin reactions, including Stevens-Johnson syndrome, have been reported with Abavalex treatment. If any symptoms related to serious skin reactions described in section 4 occur, Abavalex should be discontinued immediately and the patient should contact a doctor without delay.

Warnings and precautions

Before starting treatment with Abavalex, discuss with a doctor or pharmacist if:

• the patient has thoughts about self-harm or suicide. In a small number of patients treated with antiepileptic medicines such as Abavalex, thoughts about self-harm or suicidal thoughts have occurred. If such thoughts occur at any time, the patient should contact a doctor immediately.
• the patient has liver problems; in this case, the doctor may decide to adjust the dose.

Children

Abavalex must not be given to children under 2 years of age.

Abavalex and other medicines

Inform the doctor or pharmacist about all medicines currently taken or recently taken, as well as any medicines the patient plans to take.
In particular, inform the doctor if the patient is taking any of the following medicines, as this may require adjustment of the Abavalex dose:

• rifampicin – a medicine used to treat bacterial infections.
• St John’s wort (Hypericum perforatum), a herbal remedy used to treat depression, anxiety, and other disorders.

Abavalex and alcohol

The use of this medicine with alcohol is not recommended. If the patient drinks alcohol while taking Abavalex, the negative effects of alcohol may be intensified.

Pregnancy and breastfeeding

Women of childbearing age should discuss contraception with their doctor.
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans to become pregnant, she should consult a doctor or pharmacist before using this medicine.
The use of Abavalex during pregnancy is not recommended, as the effect of Abavalex on pregnancy and the unborn child is unknown.
Breastfeeding is not recommended during treatment with Abavalex, as Abavalex passes into human milk.

Do not stop treatment without consulting a doctor. Stopping treatment may lead to an increase in the number of epileptic seizures and harm the child.

Driving and operating machinery

During treatment with Abavalex, drowsiness, dizziness, or fatigue may occur. These effects are more likely at the beginning of treatment or after an increase in dose. Do not drive, ride a bicycle, or operate tools or machinery until it is clear how the medicine affects the patient.

Abavalex contains lactose and sodium

Abavalex coated tablets contain:

• lactose (a type of sugar) – If the doctor has informed the patient that he or she cannot tolerate certain sugars, the patient should consult the doctor before taking this medicine.
• sodium – The medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free".

3. How to take Abavalex

This medicine should always be taken as directed by your doctor. If you have any doubts, you should
consult your doctor or pharmacist. For some patients, such as children, other forms of this medicine
may be more appropriate (for example, if they are unable to swallow the tablet whole, or if an
appropriate dose cannot be achieved using whole tablets); you should consult your doctor or
pharmacist.
Abavalex is used in combination with other medicines for the treatment of epilepsy.

What dose should be taken
Your doctor will determine the appropriate daily dose for you. The daily dose should be taken in two
equal divided doses, at intervals of at least 12 hours.

Adolescents, children with body weight of 50 kg or more, and adults
The recommended dose is 25 mg to 100 mg twice daily. After starting treatment, your doctor may
adjust the dose to determine the most appropriate dose for the individual patient.

Adolescents and children with body weight from 20 kg to below 50 kg
The recommended dose is 0.5 mg to 2 mg per kilogram of body weight twice daily. After starting
treatment, your doctor may adjust the dose to determine the most appropriate dose for the individual
patient.

Children with body weight from 10 kg to below 20 kg
The recommended dose is 0.5 mg to 2.5 mg per kilogram of body weight twice daily. Your doctor may
then decide to adjust the dose to determine the best dose for the child.

Patients with impaired liver function
For patients with impaired liver function:

• For adolescents and children with body weight of 50 kg or more, and adults, the maximum dose is 75 mg twice daily.
• For adolescents and children with body weight from 20 kg to below 50 kg, the maximum dose is 1.5 mg per kilogram of body weight twice daily.
• For children with body weight from 10 kg to below 20 kg, the maximum dose is 2 mg per kilogram of body weight twice daily.

How to take Abavalex tablets
The tablets should be swallowed with an adequate amount of liquid. It is recommended to swallow the
tablets whole, as the active substance has a bitter taste. This medicine may be taken with or without
food.

How long should Abavalex be taken
Abavalex is intended for long-term use – you should continue taking it until your doctor decides
otherwise.

Taking more Abavalex than recommended
If you take more Abavalex than recommended, you should consult your doctor. Dizziness and
drowsiness may occur. Any of the following symptoms may also occur: nausea, vertigo, problems with
balance, anxiety, feeling of extreme fatigue, irritability, aggression, insomnia, depression, and
thoughts or attempts of self-harm or suicide.

Missed dose of Abavalex
If you miss a dose, take it as soon as possible. Take the next dose at the usual time. Do not take a
double dose to make up for a missed dose. If you have any doubts, consult your doctor or pharmacist.

Stopping Abavalex treatment
Do not stop taking this medicine unless your doctor advises otherwise. This is because stopping
treatment could lead to an increase in the number of epileptic seizures. If your doctor decides to
discontinue this medicine, the dose will be gradually reduced. This will help prevent recurrence or
worsening of seizures.

If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine may cause side effects, although not everyone gets them.

Very common: may affect more than 1 in 10 people

• drowsiness or dizziness

Common: may affect up to 1 in 10 people

• flu-like symptoms
• feeling very tired
• seizures, sensation of spinning (dizziness)
• nausea, constipation
• depression, anxiety, insomnia, irritability
• infections of the nose and throat (e.g. colds), cough
• decreased appetite

Uncommon: may affect up to 1 in 100 people

• allergic reactions
• disturbances in thinking and/or disconnection from reality (psychotic disorders), aggression, agitation
• thoughts of self-harm or suicide, or attempts thereof – in such cases, contact your doctor immediately
• decrease in white blood cell count (neutropenia) – confirmed in blood tests

Frequency not known: frequency cannot be estimated from the available data

• widespread rash with blisters and peeling of the skin, particularly around the mouth, nose, eyes and genital organs (Stevens-Johnson syndrome)

Additional side effects in children
Common: may affect up to 1 in 10 children

• restlessness and hyperactivity (excessive psychomotor activity)

Reporting of side effects
If you experience any adverse effects, including any not listed in this leaflet, tell your doctor, pharmacist or nurse. Side effects can also be reported directly to the Department of Monitoring of Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C,
02-222 Warsaw
tel.: +48 22 49 21 301
fax: +48 22 49 21 309
website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects helps to provide more information on the safety of this medicine.

5. How to store Abavalex

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the blister pack and the cardboard
container after: "EXP". The expiry date refers to the last day of the stated month.
This medicine does not require any special storage conditions.
Medicines must not be disposed of via wastewater or household waste. You should ask your
pharmacist how to dispose of medicines no longer in use. This will help protect
the environment.

6. Contents of the pack and other information

What Abavalex contains
The active substance is brivaracetam. Each coated tablet contains 10 mg, 25 mg, 50 mg,
75 mg or 100 mg of brivaracetam.
The other ingredients are:
Core
Monohydrate lactose, sodium croscarmellose (E 468), lactose (see section 2 "Abavalex contains
lactose and sodium"), magnesium stearate (E 470b).
Coating

• 10 mg coated tablets: polyvinyl alcohol (E 1203), titanium dioxide (E171), macrogol 3350 (E 1521), talc (E 553b).
• 25 mg coated tablets: polyvinyl alcohol (E 1203), titanium dioxide (E171), macrogol 3350 (E 1521), talc (E 553b), black iron oxide (E172), yellow iron oxide (E172).
• 50 mg coated tablets: polyvinyl alcohol (E 1203), titanium dioxide (E171), macrogol 3350 (E 1521), talc (E 553b), yellow iron oxide (E172), red iron oxide (E172).
• 75 mg coated tablets: polyvinyl alcohol (E 1203), titanium dioxide (E171), macrogol 3350 (E 1521), talc (E 553b), red iron oxide (E172), black iron oxide (E172), yellow iron oxide (E172).
• 100 mg coated tablets: polyvinyl alcohol (E 1203), titanium dioxide (E171), macrogol 3350 (E 1521), talc (E 553b), black iron oxide (E172), yellow iron oxide (E172),

What Abavalex looks like and contents of the pack
Abavalex 10 mg are white to off-white, round, biconvex coated tablets with a diameter of 5.1 mm.
Abavalex 25 mg are grey, oval, biconvex coated tablets with a length of 9.0 mm.
Abavalex 50 mg are yellow, oval, biconvex coated tablets with a length of 11.8 mm.
Abavalex 75 mg are light pink, oval, biconvex coated tablets with a length of 13.1 mm.
Abavalex 100 mg are beige, oval, biconvex coated tablets with a length of 14.6 mm.
Abavalex tablets are packed in opaque blisters in a cardboard box.
Pack sizes contain: 14, 20, 56, 60, 70 and 168 coated tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
G.L. Pharma GmbH
Schlossplatz 1
8502 Lannach
Austria
Manufacturer
G.L. Pharma GmbH
Industriestrasse 1
8502 Lannach
Austria
This medicinal product is authorised in the Member States of the European Economic Area
under the following names:
Sweden: Abavalex
Czech Republic: Abavalex
Germany: Abavalex
Denmark: Abavalex
Hungary: Abavalex
Slovakia: Abavalex
Austria: Abavalex
Bulgaria: Абавалекс филмирани таблетки
Romania: Abavalex comprimate filmate
Poland: Abavalex
For further information about this medicinal product, contact the local representative of the
Marketing Authorisation Holder:
G.L. PHARMA POLAND Sp. z o.o.
ul. Sienna 75; 00-833 Warsaw, Poland
Tel: 022/ 636 52 23; 636 53 02
[email protected]