Gemgerta

Package leaflet: Information for the patient

Gemgerta, 50 mg, film-coated tablets
Brivaracetam
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for a specific individual only. 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, tell your doctor or pharmacist. See section 4.

Contents of the leaflet

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

1. What Gemgerta is and what it is used for

What Gemgerta is
Gemgerta 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 Gemgerta is used for

• Gemgerta is used in adults, adolescents, and children aged 2 years and older.
• This medicine is used in the treatment of partial-onset seizures, with or without secondary generalization.
• Partial-onset seizures are seizures that start in one part of the brain. These seizures may spread to involve both sides of the brain, which is known as "secondary generalization".
• This medicine is used to reduce the number of seizures experienced by the patient.
• Gemgerta is given in combination with other medicines used to treat epilepsy.

2. Important information before taking Gemgerta

When not to take Gemgerta

• if the patient is allergic to brivaracetam, similar chemical compounds such as levetiracetam or piracetam, or any of the other ingredients of this medicine (listed in section 6). If in doubt, the patient should consult a doctor or pharmacist before starting treatment with Gemgerta.
• if the patient has ever experienced severe skin rash, skin peeling, blistering, and/or oral mucosal ulcers after taking this medicine.

Serious skin reactions, including Stevens-Johnson syndrome, have been reported with brivaracetam treatment. If any symptoms of serious skin reactions described in section 4 occur, treatment must be discontinued immediately and the patient should contact a doctor without delay.

Warnings and precautions

Before starting Gemgerta, discuss with a doctor or pharmacist if:

• the patient has thoughts of self-harm or suicide. A small number of people taking antiepileptic medicines such as Gemgerta have had thoughts of self-harm or suicidal thoughts. If such thoughts occur, contact a doctor immediately.
• the patient has liver problems, in which case the doctor may decide to adjust the dose.

Children

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

Gemgerta 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 dose adjustment of Gemgerta may be required:

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

Taking Gemgerta with alcohol

• Concomitant use of this medicine with alcohol is not recommended.
• If the patient drinks alcohol while taking Gemgerta, the adverse 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 is planning to become pregnant, she should consult a doctor or pharmacist before using this medicine.

Gemgerta is not recommended during pregnancy, as the effect of Gemgerta on pregnancy and the unborn child is unknown.

Breastfeeding is not recommended during treatment with Gemgerta, as brivaracetam passes into human milk.

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

Driving and operating machinery

• Drowsiness, dizziness, or fatigue may occur during treatment with Gemgerta.
• 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 known how the medicine affects the patient.

Gemgerta contains lactose and sodium

Gemgerta film-coated tablets contain:

• lactose (a type of sugar) – If the doctor has informed the patient that he or she has an intolerance to certain sugars, the patient should consult a doctor before taking this medicine.
• sodium – This medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free".

3. How to take Gemgerta

This medicine should always be taken as directed by the doctor. If in doubt, consult
your doctor or pharmacist. For some patients, such as children, other pharmaceutical forms of brivaracetam may be more suitable (for example, if a child cannot swallow
a tablet whole); consult your doctor or pharmacist.
If the required dose cannot be achieved with this product, your doctor will check
the availability of other medicinal products containing brivaracetam.
Gemgerta 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 total daily dose should be divided into two equal doses taken approximately 12 hours apart.

Adolescents and children weighing 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 weighing from 20 kg to less than 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 weighing from 10 kg to less than 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 weighing 50 kg or more, and adults, the maximum dose is 75 mg twice daily;
• For adolescents and children weighing from 20 kg to less than 50 kg, the maximum dose is 1.5 mg per kilogram of body weight twice daily;
• For children weighing from 10 kg to less than 20 kg, the maximum dose is 2 mg per kilogram of body weight twice daily;

How to take Gemgerta tablets

• Swallow the tablets whole with a glass of liquid.
• This medicine may be taken with food or independently of meals.

How long to take Gemgerta
Gemgerta is intended for long-term use – continue taking Gemgerta until your doctor decides otherwise.

Taking more than the recommended dose of Gemgerta
If more than the recommended dose of Gemgerta is taken, consult your doctor immediately. Symptoms may include dizziness and drowsiness. Other possible symptoms include:
nausea, vertigo, problems with balance, anxiety, extreme fatigue, irritability, aggression, insomnia, depression, and thoughts or attempts of self-harm or suicide.

Missing a dose of Gemgerta

• If a dose is missed, 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 in doubt, consult your doctor or pharmacist.

Stopping Gemgerta

• Do not stop taking this medicine unless otherwise instructed by your doctor. Stopping treatment may 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 can cause side effects, although not everybody gets them.
Very common: may affect more than 1 in 10 people

• drowsiness or dizziness

Common: may affect less than 1 in 10 people

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

Uncommon: may affect less than 1 in 100 people

• allergic reactions
• disturbances in thinking and/or loss of contact with reality (psychotic disturbances), aggression, agitation
• thoughts about self-harm or suicide, or attempts thereof – in such cases, contact a doctor immediately
• decrease in white blood cells (neutropenia) – confirmed in blood tests

Unknown: frequency cannot be estimated from the available data

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

Additional side effects in children
Common: may affect less than 1 in 10 people

• restlessness and hyperactivity (excessive psychomotor activity)

Reporting of side effects
If any side effects occur, including any side effects not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department for Monitoring Adverse Drug Reactions of 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 Authorisation Holder or its representative in Poland.
Reporting side effects helps provide more information on the safety of this medicine.

5. How to store Gemgerta

• 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 blister after: EXP. The expiry date refers to the last day of the stated month.
• No special storage conditions are required for this medicine.
• Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Gemgerta contains
The active substance is brivaracetam.
Each coated tablet contains 50 mg of brivaracetam.
The other ingredients are:
Core:
sodium croscarmellose, lactose monohydrate, anhydrous lactose, magnesium stearate
Coating:
polyvinyl alcohol, titanium dioxide (E171), macrogol (3350), talc, yellow iron oxide (E 172),
red iron oxide (E 172).
What Gemgerta looks like and contents of the pack
Gemgerta 50 mg is a yellow, oval, film-coated tablet measuring 11.8 mm x 6.7 mm,
with the engraved mark “50” on one side.
Pack sizes: 14, 56 film-coated tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Zentiva, k.s.
U kabelovny 130
Dolní Měcholupy
102 37 Prague 10
Czech Republic
Importer
Misom Labs Limited
Malta Life Sciences Park
LS2.01.06 Industrial Estate
San Gwann, SGN 3000, Malta
Adalvo Limited
Malta Life Sciences Park Building 1 Level 4
Sir Temi Zammit Buildings, San Gwann
San Gwann, SGN 3000, Malta
For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
Zentiva Polska Sp. z o.o.
ul. Bonifraterska 17
00-203 Warsaw
Tel. +48 22 375 92
This medicinal product is authorised for marketing in the Member States of the European Economic Area under the following names:
Czech Republic, Iceland, Poland: Gemgerta
Croatia: Gemgerta 50 mg filmom obložene tablete