Brivaracetam +pharma

Package leaflet: Information for the patient

Brivaracetam +pharma, 10 mg, film-coated tablets
Brivaracetam +pharma, 25 mg, film-coated tablets
Brivaracetam +pharma, 50 mg, film-coated tablets
Brivaracetam +pharma, 75 mg, film-coated tablets
Brivaracetam +pharma, 100 mg, film-coated tablets
Brivaracetam
Please read this leaflet carefully before taking this medicine because it contains important information for you.

• 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 a specific individual. Do not pass it on to others. It may harm them even if their symptoms are the same.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of the leaflet

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

1. What Brivaracetam +pharma is and what it is used for

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

What Brivaracetam +pharma is used for

• Brivaracetam +pharma is used in adults, adolescents, and children from 2 years of age.
• This medicine is used to treat partial-onset seizures, with or without secondary generalization.
• Partial-onset seizures are seizures affecting only one side of the brain. Partial-onset 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 in the patient. Brivaracetam +pharma is given in combination with other medicines used to treat epilepsy.

2. Important information before taking Brivaracetam +pharma

When not to take Brivaracetam +pharma:

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

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

Warnings and precautions

Before starting treatment with Brivaracetam +pharma, the patient should discuss the following with their doctor or pharmacist:

• if the patient experiences thoughts about self-harm or suicide. A small number of people treated with antiepileptic medicines, such as Brivaracetam +pharma, have had thoughts about self-harm or suicidal thoughts. If such thoughts occur, the patient should contact their doctor immediately.
• if the patient has liver problems, in which case the doctor may decide to adjust the dose.

Children

Brivaracetam +pharma should not be given to children under 2 years of age.

Brivaracetam +pharma and other medicines

The patient should inform their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.

In particular, the patient should inform their doctor if they are taking any of the following medicines, as this may require adjustment of the Brivaracetam +pharma dose:

• 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.

Brivaracetam +pharma and alcohol

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

Pregnancy and breastfeeding

Women of childbearing potential should discuss the use of contraception with their doctor.

If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before using this medicine.

The use of Brivaracetam +pharma during pregnancy is not recommended, as the effect of brivaracetam on pregnancy and the unborn child is unknown.

Breastfeeding is not recommended during treatment with Brivaracetam +pharma, as brivaracetam passes into breast milk.

Do not stop treatment without consulting a doctor. Stopping 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 Brivaracetam +pharma.
• These effects are more likely at the beginning of treatment or after an increase in dose.
• The patient must not drive, ride a bicycle, or operate tools or machinery until they are certain how the medicine affects them.

Brivaracetam +pharma contains lactose and sodium

Brivaracetam +pharma, coated tablets contain:

• lactose (a type of sugar) – If the patient has previously been diagnosed with intolerance to certain sugars, they should contact their doctor before taking this medicine.
• sodium – This medicine contains less than 1 mmol of sodium (23 mg) per coated tablet, meaning the medicine is considered "sodium-free".

3. How to take Brivaracetam +pharma

This medicine should always be taken exactly as directed by the doctor. If in doubt, consult the
doctor or pharmacist. For some patients, such as children, other formulations of this medicine may be more suitable (for example, if a child cannot swallow the tablet whole); please consult the
doctor or pharmacist.
Brivaracetam +pharma is used in combination with other medicines for the treatment of epilepsy.
What dose should be taken
The doctor will determine the appropriate daily dose for the patient. The daily dose should be taken in two equal divided doses, approximately 12 hours apart.
Adolescents, children weighing 50 kg or more, and adults

• The recommended dose is 25 mg to 100 mg twice daily. After starting treatment, the doctor may adjust the dose to determine the most appropriate dose for the individual patient.

Adolescents and children weighing between 20 kg and less than 50 kg

• The recommended dose is 0.5 mg to 2 mg per kilogram of body weight twice daily. After starting treatment, the doctor may adjust the dose to determine the most appropriate dose for the individual patient.

Children weighing between 10 kg and less than 20 kg

• The recommended dose is 0.5 mg to 2.5 mg per kilogram of body weight twice daily. The doctor may then decide to adjust the dose to determine the best dose for the child.

Patients with hepatic impairment
In patients with impaired liver function

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

How to take Brivaracetam +pharma tablets
Brivaracetam +pharma 10 mg, 25 mg, 75 mg, film-coated tablets
The tablets should be swallowed whole with a glass of liquid.
Brivaracetam +pharma 50 mg, 100 mg, film-coated tablets
The tablets may be divided into equal doses.
The tablets should be swallowed with a glass of liquid.
This medicine may be taken with or without food.
How long to take Brivaracetam +pharma
Brivaracetam +pharma is intended for long-term use – continue taking it until the doctor decides to discontinue treatment.
Taking more Brivaracetam +pharma than prescribed
If more Brivaracetam +pharma than prescribed has been taken, consult a doctor immediately. Dizziness and drowsiness may occur. The following symptoms may also occur: nausea, vertigo, problems with maintaining balance, anxiety, extreme fatigue, irritability, aggression, insomnia, depression, and thoughts or attempts of self-harm or suicide.
Missed dose of Brivaracetam +pharma

• If a dose is missed, take the missed dose 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 the doctor or pharmacist.

Stopping Brivaracetam +pharma

• Do not stop taking this medicine unless otherwise instructed by the doctor. This is because stopping treatment could lead to an increase in the number of epileptic seizures.
• If the 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 adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody will get them.
Very common: may occur in more than 1 in 10 people

• drowsiness or dizziness.

Common: may occur in less than 1 in 10 people

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

Uncommon: may occur in less than 1 in 100 people

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

Unknown: frequency cannot be estimated from available data

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

Additional adverse reactions in children
Common: may occur in less than 1 in 10 people

• restlessness and hyperactivity (excessive psychomotor activity).

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of 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 4921301, Fax: +48 22 4921309, website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorisation holder or the representative of the marketing authorisation holder in Poland.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Brivaracetam +pharma

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 pack following "EXP".
The expiry date refers to the last day of the stated month.
No special storage instructions apply 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. Such measures help protect the environment.

6. Contents of the pack and other information

The active substance is brivaracetam.
Brivaracetam +pharma, 10 mg: each coated tablet contains 10 mg of brivaracetam.
Brivaracetam +pharma, 25 mg: each coated tablet contains 25 mg of brivaracetam.
Brivaracetam +pharma, 50 mg: each coated tablet contains 50 mg of brivaracetam.
Brivaracetam +pharma, 75 mg: each coated tablet contains 75 mg of brivaracetam.
Brivaracetam +pharma, 100 mg: each coated tablet contains 100 mg of brivaracetam.

The other ingredients are:
Core:
monohydrate lactose, lactose, sodium croscarmellose, magnesium stearate.

Coating:
Brivaracetam +pharma, 10 mg, coated tablets: polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, talc.
Brivaracetam +pharma, 25 mg, coated tablets: polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, talc, black iron oxide (E172), yellow iron oxide (E172).
Brivaracetam +pharma, 50 mg, coated tablets: polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, talc, yellow iron oxide (E172), red iron oxide (E172).
Brivaracetam +pharma, 75 mg, coated tablets: polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, talc, black iron oxide (E172), yellow iron oxide (E172), red iron oxide (E172).
Brivaracetam +pharma, 100 mg, coated tablets: polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, talc, black iron oxide (E172), yellow iron oxide (E172).

What Brivaracetam +pharma looks like and contents of the pack
Brivaracetam +pharma, 10 mg, coated tablets are white or almost white, round coated tablets with a diameter of approximately 5.5 mm, embossed with the number "10" on one side and smooth on the other side.
Brivaracetam +pharma, 25 mg, coated tablets are grey, oval coated tablets (measuring approximately 8.8 mm x 5.0 mm), embossed with the number "25" on one side and smooth on the other side.
Brivaracetam +pharma, 50 mg, coated tablets are yellow, oval coated tablets (measuring approximately 11.7 mm x 6.6 mm) with a score line on one side.
Brivaracetam +pharma, 75 mg, coated tablets are violet, oval coated tablets (measuring approximately 13 mm x 7.3 mm), embossed with the number "75" on one side and smooth on the other side.
Brivaracetam +pharma, 100 mg, coated tablets are green-grey, oval coated tablets (measuring approximately 14.5 mm x 8.1 mm) with a score line on one side.

Brivaracetam +pharma is available in PVC/PCTFE/Aluminium foil blisters packed in cardboard boxes containing 14, 20, 56 or 60 coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
+pharma arzneimittel gmbh
Hafnerstrasse 211
8054 Graz
Austria

Manufacturer
PharmaPath S.A.
28is Oktovriou 1
123 51 Agia Varvara
Greece
Genericon Pharma Ges.m.b.H.
Hafnerstrasse 211
8054 Graz
Austria

This medicinal product is authorised in the European Economic Area countries under the following names:
Hungary Litrunga, 10 mg, 25 mg, 50 mg, 75 mg, 100 mg, filmtabletta
Austria Brivaracetam Genericon 10 mg, 25 mg, 50 mg, 75 mg, 100 mg, Filmtabletten
Czech Republic Brivaracetam +pharma
Poland Brivaracetam +pharma

For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
+pharma Polska sp. z o.o.
ul. Podgórska 34
31-536 Kraków
Poland
tel: +48 12 262 32 36
e-mail: [email protected]