GAMIBETAL 50 mg/850 mg Tabletki Powlekane
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Treść ulotki
Gamibetal Plus 250 mg + 10 mg tablets, 5 mg tablets
buxamina + diazepam
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 could 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 Plus is and what it is used for
- 2. What you need to know before you use Gamibetal Plus
- 3. How to use Gamibetal Plus
- 4. Possible side effects
- 5. How to store Gamibetal Plus
- 6. Contents of the pack and other information
1. What is Gamibetal Plus and what is it used for
Gamibetal Plus contains the active ingredients 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
convulsions.
This medicine is used in the treatment:
- of epileptic seizures, together with other medicines;
- of convulsions in children;
- of behavioral disturbances. Consult 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 ingredients 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
Consult your doctor or pharmacist before using the medicine.
In some cases, patients treated with antiepileptic drugs may experience thoughts of
suicide. If these thoughts occur, contact your doctor immediately.
Pay particular attention ifyou have a predisposition to addiction. This medicine contains
diazepam which, in case of prolonged treatment with high doses, can cause addiction. Addiction
manifests as a withdrawal syndrome when treatment is stopped.
If you have been treated with this medicine for a long time, your doctor may want to prescribe blood
tests or assess your liver health.
Other medicines and Gamibetal Plus
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
Avoid the simultaneous useof this medicine with other medicines that act on the brain such as
neuroleptics (used to treat schizophrenia), sedatives (used to treat anxiety), antidepressants
(used to treat depression), hypnotics (used to treat insomnia), analgesics (used against
pain), anesthetics (used for anesthesia) and antihistamines (used to treat allergies), because the
diazepam contained in this medicine may alter their activity.
The concomitant use of Gamibetal Plus and opioids (strong painkillers, medicines for substitution therapy
for detoxification in subjects with opioid dependence and some cough medicines)
increases the risk of drowsiness, respiratory distress (respiratory depression) and coma and can be
life-threatening. For this reason, concomitant use should only be considered when other alternative
treatments are not possible.
However, if your doctor has prescribed Gamibetal Plus together with opioids, the dose and duration of
concomitant therapy must be limited by your doctor. Please inform your doctor of all opioid medicines
you are taking and carefully follow the dose recommended by your doctor. It may be
helpful to inform friends or family about the signs and symptoms indicated above. Contact your doctor when
these symptoms occur.
Gamibetal Plus with alcohol
This medicine interacts with alcohol. As a safety precaution, do not take
Gamibetal Plus with alcohol.
Pregnancy, breastfeeding and fertility
If you are pregnant, suspect or are planning a pregnancy, or if you are breastfeeding with breast
milk, ask your doctor or pharmacist for advice before using this medicine.
Pregnancy
If you are planning a pregnancy it is important that you discuss with your doctor first how
to continue antiepileptic therapy.
Do not usethis medicine during the first trimester of pregnancy.
During the second and third trimester of pregnancy this medicine should not be used unless
strictly necessary and under the control of your doctor. Take this medicine during the second and
third trimester of pregnancy only if your doctor tells you to, as it may increase the risk of
birth defects in your baby (cleft lip, heart and blood vessel malformations, problems of
nervous system development).
Do not suddenly stop taking this medicinebecause this can cause
the sudden onset of epileptic seizures which can have serious consequences for you and for the
baby.
Breastfeeding
Stop breastfeedingif your doctor has told you that you must take this medicine regularly.
The diazepam contained in this medicine passes into breast milk.
Driving and using machines
This medicine can affect your ability to drive vehicles or use machines. Do not drive
vehicles and do not use machines until you know how the medicine affects you.
3. How to use Gamibetal Plus
Use this medicine following exactly the instructions of 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,
as prescribed by your doctor.
Use in children and adolescents
The recommended dose is 1 – 4 tablets of Gamibetal Plus 250 mg + 5 mg tablets per day,
as prescribed by your doctor. The dose chosen by the doctor will depend on age and the disease.
Elderly
If you are elderly, your doctor will prescribe the most appropriate dose for you.
If you use more Gamibetal Plus than you should
In case of taking an excessive amount of the medicine immediately inform your doctoror
go to the nearest hospital.
Symptoms of overdose may include drowsiness, difficulty in movements (ataxia) and difficulty
speaking (dysarthria).
If you stop taking Gamibetal Plus
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 doubts 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.
If the dose is not correct, an excessive state of “calm” (sedation) and excessive
muscle relaxation can be obtained, which manifest with the following side effects:
- drowsiness;
- feeling of fatigue;
- dizziness;
- muscle weakness.
Very rare side effects, usually due to a dose that is too high of the medicine, which tend to
disappear after a few days or with appropriate dose adjustment are:
- difficulty with movements (ataxia), confusion, depression, double vision (diplopia), difficulty speaking (dysarthria), alteration of sexual desire (libido), anxiety, excitement, tremors;
- constipation, nausea;
- liver problems causing yellowing of the skin and the white of the eye (jaundice);
- low blood pressure (hypotension);
- loss of urine (incontinence) or problems with urination (urinary retention);
- skin rashes.
In the elderly and in patients with liver, kidney or heart problems, there may be a decreased
elimination of water and mineral salts (hydrosaline retention) and a reduction in blood potassium
levels (potassium depletion).
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 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 particular storage conditions.
Do not use this medicine after the expiry date that is reported 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 Plus contains
Gamibetal Plus 250 mg + 5 mg tablets:
- The active ingredients are buxamine and diazepam. One tablet contains 250 mg of buxamine and 5 mg of diazepam.
- The other ingredients are corn starch, gelatin and magnesium stearate.
Gamibetal Plus 250 mg + 10 mg tablets:
- The active ingredients are buxamine and diazepam. One tablet contains 250 mg of buxamine and 10 mg of diazepam.
- The other ingredients are corn starch, gelatin and magnesium stearate.
Description of the appearance of Gamibetal Plus and contents of the pack
Gamibetal Plus 250 mg + 10 mg tablets are presented in a carton containing 30 tablets in
blisters.
Gamibetal Plus 250 mg + 5 mg tablets are presented in a carton containing 30 tablets in
blisters.
Marketing Authorisation Holder and Manufacturer
Laboratorio Farmaceutico SIT S.r.l. - Via Cavour, 70 - 27035 Mede (PV)
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- Zamienniki GAMIBETAL PLUSPostać farmaceutyczna: Extended-release tablet, 300 MGSubstancja czynna: valproic acidProducent: EG S.P.A.Wymaga receptyPostać farmaceutyczna: Extended-release tablet, 300 MGSubstancja czynna: valproic acidProducent: RATIOPHARM GMBHWymaga receptyPostać farmaceutyczna: Extended-release tablet, 300 MGSubstancja czynna: valproic acidProducent: SANDOZ S.P.A.Wymaga recepty
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GAMIBETAL PLUS jest produkowany przez LABORATORIO FARMACEUTICO SIT SPECIALITA IGIENICO TERAPEUTICHE S.R.L.. Nazwy handlowe i opakowania mogą się różnić w zależności od dystrybutora.
Lekarze, tacy jak Lekarze rodzinni, Psychiatrzy, Dermatolodzy, Kardiolodzy, Endokrynolodzy, Gastroenterolodzy, Pulmonolodzy, Nefrolodzy, Reumatolodzy, Hematolodzy, Zakaźnicy, Alergolodzy, Geriatrzy, Pediatrzy, Onkolodzy, mogą ocenić, czy stosowanie GAMIBETAL PLUS jest odpowiednie w Twoim przypadku, w zależności od sytuacji klinicznej i lokalnych przepisów. Możesz umówić konsultację online, aby omówić objawy i możliwe dalsze kroki.
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Inne leki zawierające tę samą substancję czynną () to m.in. AKIDO VALPROIKO E SODIO VALPROATO EG, AKIDO VALPROIKO E SODIO VALPROATO RATIOPARM, AKIDO VALPROIKO SANDOTS. Mogą one różnić się nazwą handlową lub postacią, ale zawierają ten sam składnik terapeutyczny. Przed zmianą lub rozpoczęciem nowego leku skonsultuj się z lekarzem.
