GAMIBETAL 500 mg Coated Tablet

Зміст інструкції

1. Gamibetal 500 mg tablets
   1. What Gamibetal is and what it is used for
   2. What you need to know before you use Gamibetal
   3. How to use Gamibetal
   4. Possible side effects
   5. How to store Gamibetal
   6. Contents of the pack and other information

Gamibetal 500 mg tablets

Buxamina

Read this leaflet carefully before using 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 pass it on to others, even if their symptoms are the same as yours, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Gamibetal is and what it is used for

Gamibetal contains the active ingredient buxamina. This belongs to a group of medicines called
“antiepileptics” or “anticonvulsants”. This medicine is used in the treatment of:

• epilepsy;
• convulsions in children. If you do not feel better or if you feel worse, please contact your doctor.

2. What you need to know before you use Gamibetal

Do not use Gamibetal
if you are allergic to buxamina 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 the medicine.
In some cases, patients treated with antiepileptic medicines may experience thoughts of
suicide. If you have these thoughts, contact your doctor immediately.

Other medicines and Gamibetal
Tell 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 and, at the same time, how to gradually increase the initial dose of
Gamibetal.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant, or are planning to become pregnant, or if you are
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 to continue
antiepileptic therapy.
Take this medicine during pregnancy only if your doctor prescribes it and under their supervision,
as it may increase the risk of birth defects in your baby (cleft lip, heart and blood vessel defects, problems
with the development of the nervous system).
The risk of birth defects is higher if you are taking multiple antiepileptic medicines together.
Do not suddenly stop taking this medicine, as this may cause the sudden onset of epileptic seizures,
which can have serious consequences for you and your baby.

Driving and using machines
This medicine can cause drowsiness. Keep this in mind if you drive vehicles or use machines.

3. How to use Gamibetal

Use this medicine following the instructions of your doctor or pharmacist exactly. If you have
any doubts, consult your doctor or pharmacist.
The recommended dose is 2-6 tablets per day, as prescribed by your doctor.

Elderly
If you are elderly, your doctor will prescribe the most appropriate dose for you.

If you stop taking Gamibetal
Do not stop treatmentwith this medicine without first talking to your doctor, as this
may cause the sudden onset of epileptic seizures.
If you have any questions about the use of this medicine, ask 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 effects, including those not listed in this leaflet, please inform your
doctor or pharmacist.
You can also report side effects directly through 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 that is stated on the pack after “Expiry”. The
expiry date refers to the last day of that month.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Gamibetal contains

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

Description of the appearance of Gamibetal and contents of the pack
Pack of 20 tablets in 2 PVC-aluminium blisters of 10 tablets each.

Marketing authorisation holder and manufacturer
Laboratorio Farmaceutico SIT Specialità Igienico Terapeutiche S.r.l. – Via Cavour, 70 – 27035 Mede
(PV)