Package leaflet: Information for the user

Gamibetal 500 mg tablets

Buxamina
Please read all of this leaflet carefully before you start taking this medicine, as it contains important information for you.

Keep this leaflet. 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. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

What Gamibetal is and what it is used for
What you need to know before taking Gamibetal
How to take Gamibetal
Possible side effects
How to store Gamibetal
Contents of the pack and other information

1. What Gamibetal is and what it is used for

Gamibetal contains the active substance buxamina. This belongs to a group of medicines known as "antiepileptics" or "anticonvulsants". This medicine is used for the treatment of:

epilepsy;
febrile convulsions in children.

Talk to your doctor if you do not feel better or if you feel worse.

2. What you need to know before using Gamibetal

Do not use Gamibetal
if you are allergic to buxamine or to any of the other ingredients of this medicine (listed in
section 6).
Warnings and precautions
Talk to your doctor or pharmacist before using this medicine.
In some cases, patients treated with antiepileptic medicines may experience suicidal thoughts. If such
thoughts occur, contact your doctor immediately.
Other medicines and Gamibetal
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other
medicines.
If you are being treated with other antiepileptic medicines, your doctor will advise you on how to
gradually reduce their dosage, while simultaneously increasing the initial dose of Gamibetal.
Pregnancy, breastfeeding and fertility
If you are pregnant, think you might be pregnant, planning a pregnancy, or breastfeeding, ask your
doctor or pharmacist for advice before using this medicine.
If you are planning a pregnancy, it is important that you discuss with your doctor whether you need to
continue antiepileptic therapy.
Take this medicine during pregnancy only if prescribed by your doctor and under medical supervision, as
it may increase the risk of birth defects in your baby (cleft lip, heart and blood vessel malformations,
nervous system development problems).
The risk of birth defects is higher if you are taking more than one antiepileptic medicine at the same time.
Do not stop taking this medicine suddenly, as this may cause sudden seizures, which could have serious consequences for you and your baby.
Driving and using machines
This medicine may cause drowsiness. Keep this in mind if you drive or operate machinery.

3. How to use Gamibetal

Use this medicine exactly as prescribed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
The recommended dose is 2-6 tablets per day, according to medical prescription.
Elderly patients
If you are elderly, your doctor will prescribe the most appropriate dose for you.
If you stop treatment with Gamibetal
Do not stop treatment with this medicine without first talking to your doctor, as this
may cause sudden onset of epileptic seizures.
If you have any doubts about how to use this medicine, consult your doctor.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
In some cases, temporary loss of appetite (transient anorexia) and drowsiness may occur.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via the national reporting system at www.agenziafarmaco.gov.it/it/responsabili.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Gamibetal

Keep this medicine out of the sight and reach of children.
This medicine does not require any special storage conditions.
Do not use this medicine after the expiry date stated on the carton after “Expiry”.
The expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Gamibetal contains

The active substance is buxamina. Each tablet contains 500 mg of buxamina (gamma-amino-beta-hydroxybutyric acid).
The other ingredients are maize starch, gelatin and magnesium stearate.

Description of the appearance of Gamibetal and contents of the pack
Pack containing 20 tablets in 2 PVC-aluminium blisters, 10 tablets each.
Marketing Authorization Holder and Manufacturer
Laboratorio Farmaceutico SIT Specialità Igienico Terapeutiche S.r.l. – Via Cavour, 70 – 27035 Mede (PV)