Package leaflet: Information for the patient

Gamibetal Plus 250 mg + 10 mg tablets, 5 mg tablets

buxamina + diazepam
Please read this leaflet carefully before using this medicine because it contains important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, consult your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Gamibetal Plus is and what it is used for

Gamibetal Plus contains the active substances buxamina and diazepam.
Buxamina belongs to a group of medicines called "antiepileptics" or "anticonvulsants".
Diazepam belongs to a group of medicines called "benzodiazepines" and acts on seizures.
This medicine is used to treat:

epileptic seizures, in combination with other medicines;
convulsions in children;
behavioural disturbances.

Contact your doctor if you do not feel better or if you feel worse.

2. What you need to know before using Gamibetal Plus

Do not use Gamibetal Plus

if you are allergic to the active substances or to any of the other ingredients of this medicine (listed in section 6);
in infants;
if you suffer from eye problems (closed-angle glaucoma).

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.
Be especially careful if you have a predisposition to dependence. This medicine contains diazepam, which, if used for a prolonged period at high doses, may lead to dependence. Dependence manifests as a withdrawal syndrome when treatment is stopped.
If you have been taking this medicine for a long time, your doctor may want to prescribe blood tests or monitor the health of your liver.

Other medicines and Gamibetal Plus
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Avoid concomitant use of this medicine with other medicines acting on the brain, such as neuroleptics (used to treat schizophrenia), tranquillizers (used to treat anxiety), antidepressants (used to treat depression), hypnotics (used to treat insomnia), analgesics (used for pain), anesthetics (used for anesthesia), and antihistamines (used to treat allergies), because the diazepam contained in this medicine may alter their effects.
The concomitant use of Gamibetal Plus and opioids (strong painkillers, medicines for opioid addiction replacement therapy, and some cough medicines) increases the risk of drowsiness, breathing difficulties (respiratory depression), and coma, and may be life-threatening. For this reason, concomitant use should only be considered when no other alternative treatments are possible.
However, if your doctor has prescribed Gamibetal Plus together with opioids, the dose and duration of concomitant treatment must be limited by the doctor. Please inform your doctor about all opioid medicines you are taking and carefully follow the dose recommended by your doctor. It may be helpful to inform your friends or relatives about the signs and symptoms listed above. Contact your doctor if these symptoms occur.

Gamibetal Plus and alcohol
This medicine interacts with alcohol. As a precautionary safety measure, do not take Gamibetal Plus with alcohol.

Pregnancy, breastfeeding, and fertility
If you are pregnant, think you might be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before using this medicine.

Pregnancy
If you are planning a pregnancy, it is important that you discuss with your doctor how to continue your antiepileptic treatment.
Do not use this medicine during the first trimester of pregnancy.
During the second and third trimesters of pregnancy, this medicine should not be used unless strictly necessary and under medical supervision. Take this medicine during the second and third trimesters of pregnancy only if instructed by your doctor, as it may increase the risk of birth defects in your baby (cleft lip, heart and blood vessel malformations, nervous system development problems).
Do not stop taking this medicine suddenly, as this may cause sudden onset of epileptic seizures, which could have serious consequences for you and your baby.

Breastfeeding
Stop breastfeeding if your doctor has told you that you need to take this medicine regularly.
The diazepam contained in this medicine passes into breast milk.

Driving and using machines
This medicine may affect your ability to drive or operate machinery. Do not drive or operate machinery until you know how this medicine affects you.

3. How to use Gamibetal Plus

Use this medicine exactly as directed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
Adults
The recommended dose is 2 – 4 tablets of Gamibetal Plus 250 mg + 10 mg tablets per day,
according to medical prescription.
Use in children and adolescents
The recommended dose is 1 – 4 tablets of Gamibetal Plus 250 mg + 5 mg tablets per day,
according to medical prescription. The dose chosen by the doctor will depend on age and condition.
Elderly
If you are elderly, your doctor will prescribe the most appropriate dose for you.
If you take more Gamibetal Plus than you should
If you take too much of this medicine, contact your doctor immediately or
go to the nearest hospital.
Symptoms of overdose may include drowsiness, movement difficulties (ataxia), and speech difficulties (dysarthria).
If you stop treatment with Gamibetal Plus
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 everyone gets them.
If the dose is incorrect, excessive sedation and excessive muscle relaxation may occur, manifesting as the following side effects:

drowsiness;
feeling of fatigue;
dizziness;
muscle weakness.

Very rare side effects, usually due to an excessively high dose of the medicine, which tend to disappear after a few days or with an appropriate dose adjustment, are:

movement difficulties (ataxia), confusion, depression, double vision (diplopia), difficulty speaking (dysarthria), changes in sexual desire (libido), anxiety, excitement, tremors;
constipation, nausea;
liver problems causing yellowing of the skin and whites of the eyes (jaundice);
low blood pressure (hypotension);
urinary incontinence or difficulty urinating (urinary retention);
skin rashes.

In elderly patients and in patients with liver, kidney or heart problems, reduced excretion of water and minerals (hydrosaline retention) and decreased potassium levels in the blood (potassium depletion) 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 website:
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Gamibetal Plus

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 Plus contains
Gamibetal Plus 250 mg + 5 mg tablets:

The active substances are buxamine and diazepam. One tablet contains 250 mg of buxamine and 5 mg of diazepam.
The other components are maize starch, gelatin and magnesium stearate.

Gamibetal Plus 250 mg + 10 mg tablets:

The active substances are buxamine and diazepam. One tablet contains 250 mg of buxamine and 10 mg of diazepam.
The other components are maize starch, gelatin and magnesium stearate.

Description of the appearance of Gamibetal Plus and package contents
Gamibetal Plus 250 mg + 10 mg tablets are supplied in a box containing 30 tablets in blister packs.
Gamibetal Plus 250 mg + 5 mg tablets are supplied in a box containing 30 tablets in blister packs.
Marketing Authorization Holder and Manufacturer
Laboratorio Farmaceutico SIT S.r.l. - Via Cavour, 70 - 27035 Mede (PV)