GAMIBETAL 250 mg Coated Tablet

Зміст інструкції

1. Gamibetal Complex tablets
   1. Cos’è Gamibetal Complex e a cosa serve
   2. Cosa deve sapere prima di usare Gamibetal Complex
   3. How to use Gamibetal Complex
   4. Possible side effects
   5. How to store Gamibetal Complex
   6. Contents of the pack and other information

Gamibetal Complex tablets

buxamina + phenobarbital + sodium phenytoin

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

1. Cos’è Gamibetal Complex e a cosa serve

Gamibetal Complex contains buxamine and phenytoin, which belong to a group of
medicines called “antiepileptics” or “anticonvulsants” and phenobarbital, which belongs to
a group of medicines called “barbiturates”.
This medicine is used in the treatment:

• of epilepsy;
• of convulsions in children. See your doctor if you do not feel better or if you feel worse.

2. Cosa deve sapere prima di usare Gamibetal Complex

Do not use Gamibetal Complex

• if you are allergic to the active ingredients or to any of the other ingredients of this medicine (listed in section 6);
• if you have a blood disease called porphyria;
• if you have liver problems (hepatic insufficiency);
• if you have kidney problems (renal insufficiency);
• if you have problems with your bronchi or lungs (respiratory insufficiency).

Warnings and precautions
Talk to your doctor or pharmacist before using Gamibetal Complex.
In some cases, patients treated with antiepileptic medicines may experience
thoughts of suicide. If you should have these thoughts, contact your doctor immediately.
Do not suddenly stop treatment with this medicine without first talking to
your doctor, as this may cause the sudden onset of seizures.
Take particular care if:

• you have a predisposition to barbiturate dependence. This medicine contains phenobarbital, a barbiturate, which can be addictive;
• you are taking medicines for pain (analgesics);
• you are debilitated;
• you have a lung disease;
• you need to undergo the metopirone test or the protein-bound iodine test, inform your doctor who prescribed it to you that you are taking Gamibetal Complex. The phenytoin contained in this medicine may alter the results of some tests;
• you notice swelling in your neck (enlargement of the lymph nodes) or the appearance of a skin rash accompanied by redness, scaling or blisters on the skin, consult your doctor immediately fordiscontinuation of this medicine. If the rash is mild (similar to a scarlet fever or measles rash) and disappears completely when the medicine is stopped, resume therapy regularly. If the rash reappears when therapy is resumed, do not take thismedicine again.

Potentially life-threatening skin rashes (Stevens-Johnson syndrome, toxic epidermal
necrolysis) have been reported with the use of Gamibetal Complex. These initially appear
as red, round spots or circular patches often accompanied by blisters
in the central part of the trunk. Further signs to note include ulcers in the mouth,
throat, nose, genitals and conjunctivitis (red and swollen eyes).
These potentially life-threatening skin rashes are often accompanied by
flu-like symptoms. The rash may progress with the development of widespread blisters or
exfoliation of the skin. The highest risk of developing severe skin reactions occurs
within the first weeks of treatment.
If you have developed Stevens-Johnson syndrome or toxic epidermal necrolysis with
the use of Gamibetal Complex, Gamibetal Complex should no longer be reused.
If you develop a skin rash or these skin symptoms, urgently consult a doctor
and tell them that you are taking this medicine.
The risk of developing Stevens-Johnson syndrome during treatment with Gamibetal
Complex may be associated with a variant in the genes in subjects of Chinese or Thai origin.
If you belong to one of these ethnicities and have previously been informed that you are
a carrier of this genetic variant (HLA-B*1502), consult your doctor before
taking Gamibetal Complex.
If you are of Taiwanese, Japanese, Malaysian or Thai origin and tests have shown
that you are a carrier of the CYP2C9*3 genetic variant.
If Gamibetal Complex is used during pregnancy, there is a risk of harm to the
unborn child. Women of childbearing potential must use effective contraceptive measures during
treatment with Gamibetal Complex (see “Pregnancy and breastfeeding”).

Children
In early infancy, this medicine should not be used unless strictly
necessary and under the control of a doctor.

Other medicines and Gamibetal Complex
Tell your doctor or pharmacist if you are taking, have recently taken or might
take any other medicines.
During therapy with other antiepileptic drugs, the initial dose of the medicine must be
gradually increased and, at the same time, your doctor will tell you how to gradually reduce
the dose of the drugs used previously.
There are medicines that can alter the effect of Gamibetal Complex or whose effect
may be altered by the medicine, in particular:

• Some oral anticoagulant medicines, e.g. rivaroxaban, dabigatran, apixaban, edoxaban;
• Medicines used against alcoholism (e.g. disulfiram), anti-inflammatory drugs (e.g. phenylbutazone), antibacterial drugs (e.g. sulfafenazole and isoniazid) and barbiturates, may interact with the phenytoin contained in this medicine;
• Taking medicines used against depression (tricyclic antidepressants) in high doses may promote the onset of seizures;
• Taking Hypericum perforatum (St. John's wort) medicines at the same time may reduce the effectiveness of this medicine;
• Valproic acid (used for convulsions). See your doctor if you experience nausea, vomiting, agitation, confusion, seizures, drowsiness, muscle coordination disorders (symptoms of hyperammonemia);
• Lacosamide;
• Ticagrelor.

Gamibetal Complex with food, beverages and alcohol
This medicine can enhance the effects of alcohol. As a precautionary measure
do not take the medicine with alcohol.

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.
Due to the presence of phenytoin
Gamibetal Complex can cause serious birth defects. If you take Gamibetal Complex
during pregnancy, the risk of your baby developing a birth defect is
up to 3 times higher than in women who do not take antiepileptic drugs. Serious birth defects have been observed, including growth abnormalities, skull, face,
nails, fingers and heart. Some of these may occur together as
part of the fetal hydantoin syndrome.
Neurological development problems (brain development) have been observed in children born to mothers who took phenytoin during pregnancy. Some studies
have shown that phenytoin negatively affects the neurological development of
children exposed to phenytoin in the womb, while other studies have not found such
effect. The possibility of an effect on neurological development cannot be excluded.
If you are a woman of childbearing potential and are not planning a pregnancy, you must use an effective method of contraception during
treatment with Gamibetal Complex. Gamibetal Complex
can affect the way hormonal contraceptives work, such as the birth control pill,
making them less effective in preventing pregnancy. Talk to your doctor, who will advise you on the most suitable type of contraception to
use while taking Gamibetal Complex.
If you are a woman of childbearing potential and are planning a pregnancy, before stopping
contraception and before starting a pregnancy, consult your doctor to assess
switching to other appropriate treatments, in order to avoid exposing the fetus to phenytoin.
If you are pregnant, or think you may be, you should tell your doctor immediately. Do not
stop taking the medicine until you have spoken to your doctor.
Stopping treatment without consulting your doctor may cause seizures
which could be dangerous for you and the fetus. Your doctor may decide to
change the treatment.
Due to the presence of phenobarbital
If taken during pregnancy, phenobarbital can cause serious birth defects and can
affect the way the baby develops during growth. Birth defects that
have been reported in studies include cleft lip (split in the upper lip) and
cleft palate (split in the palate) and heart abnormalities. Other
birth defects have also been reported, such as penile malformation (hypospadias), head size smaller
than normal, facial abnormalities, nail and finger abnormalities.
If you take phenobarbital during pregnancy, you are at a higher risk than other women
of having a child with birth defects that require medical care. In the general population,
the baseline risk of major malformations is 2-3%. This risk is increased
by about 3 times in women taking phenobarbital.
Babies born to mothers who use phenobarbital during pregnancy may also be
at greater risk of being smaller than expected.
Neurological development disorders (delays in development due to brain development disorders) have been reported in children exposed to phenobarbital during pregnancy. Studies on the risk of neurological development disorders remain contradictory.
Phenobarbital should not be used during pregnancy unless an equally effective alternative therapy is available.
Immediately inform your doctor if you are pregnant. The doctor should discuss the possible effects
of phenobarbital on the unborn child and carefully consider the risks and benefits of treatment.
Do not stop taking phenobarbital until you have discussed it with your doctor,
as sudden discontinuation of the drug may increase the risk of developing
seizures, which may have harmful effects on you and the unborn child.
If you have taken phenobarbital during the last trimester of pregnancy, appropriate monitoring should be performed to detect potential disorders in the newborn, such as seizures,
excessive crying, muscle weakness, sucking disorders.
Woman of childbearing age / Contraception
If you are a woman of childbearing age, you should use an effective method of contraception during
treatment with phenobarbital and for two months after treatment. Phenobarbital may
affect the functioning of hormonal contraceptives, such as the birth control pill, and
make them less effective in preventing pregnancy. Talk to your doctor, who will discuss with you
the most suitable type of contraception to use while taking phenobarbital.
If you are a woman of childbearing potential and are planning a pregnancy, before stopping
contraception and before starting a pregnancy, consult your doctor about switching to
other appropriate treatments to avoid exposing the fetus to phenobarbital.

Driving and using machines
This medicine can cause drowsiness and difficulty walking. Do not drive vehicles or use
machinery until you know how the medicine affects you.

3. How to use Gamibetal Complex

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 in adults is: 2 – 4 tablets per day, as prescribed by your doctor.

Use in children and adolescents
The recommended dose is:

• up to 5 years of age: from half a tablet to 1 tablet per day, as prescribed by your doctor;
• from 5 years to 10 years of age: from 1 to 2 tablets per day, as prescribed by your doctor;
• from 10 years of age and above: from 2 to 4 tablets per day, as prescribed by your doctor. In early infancy, this medicine should not be used unless strictly necessary and under the control of a doctor. The tablet can be divided into equal parts.

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

If you use more Gamibetal Complex than you should
In case of taking an excessive amount of the medicine immediately inform your
doctoror go to the nearest hospital.
If you have taken more medicine than prescribed, you may experience: difficulty or inability to
breathe (respiratory depression), difficulty with movements (depression of superficial and deep
reflexes), constricted pupils (miosis), reduced urine production (reduced diuresis),
lowering of body temperature (hypothermia) and loss of consciousness up to
coma.

If you stop taking Gamibetal Complex
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 or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects may be very serious. If any of these happen to you seek urgent medical adviceand tell the doctor that you are taking this
medicine or go to the hospital immediately:
Appearance of red, round spots or circular patches that are often accompanied by
blisters on the central part of the trunk; ulcers in the mouth, throat, nose, genitals and
conjunctivitis (red and swollen eyes) accompanied by flu-like symptoms.
These could be signs of potentially life-threatening skin reactions (Stevens Johnson syndrome, toxic epidermal necrolysis) which have been reported very rarely with
the use of this medicine (see section 2 “Warnings and precautions”).
Rarely reported side effects are:

• skin problems such as skin rashes (erythema multiforme), rashes similar to measles or scarlet fever and, even more rarely, rashes with blister development, skin peeling or redness;
• liver problems (hepatitis and toxic hepatitis);
• blood problems (leukopenia, agranulocytosis, thrombocytopenia and purpura);
• red blood cell problems and anemias (macrocytosis or megaloblastic anemia);
• excitement, agitation and delirium;
• dizziness, rapid and involuntary eye movements (nystagmus), impaired coordination of movements (ataxia), speech disorders, mental confusion, muscle contractions and headache; These effects subside spontaneously by reducing the dose;
• mild drowsiness, dizziness and skin rashes may appear at low doses of this medicine. Drowsiness and difficulty walking (gait disturbances) may appear at high doses of this medicine. These effects are due to the phenobarbital contained in the medicine;
• nausea, vomiting, heartburn, constipation. You can avoid these effects by taking this medicine with a full stomach;
• redness and swelling of the gums (gingival hyperplasia). This phenomenon is due to the phenytoin contained in this medicine. You can avoid or minimize it with thorough and repeated cleaning of the mouth and teeth, combined with gentle massage and a balanced diet with sufficient calorie and vitamin intake;
• bone problems (osteopenia), thinning of the bones (osteoporosis) and fractures. If you have been on an antiepileptic medicine for a long time, if you have or have had osteoporosis or if you are being treated with steroids (medicines used for inflammation or allergies), tell your doctor or pharmacist.

Side effects with unknown frequency:

• a reduction in the number of a type of red blood cells (specific red series aplasia).

Additional side effects in children
In children and adolescents, manifestations of hyperactivity may occur.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet,
tell your doctor or pharmacist.
You can also report side effects directly through the national reporting system at 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 Complex

This medicine does not require any particular storage conditions.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which 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 Complex contains

• The active ingredients are buxamine, phenobarbital and sodium phenytoin. One tablet contains 250 mg of buxamine, 50 mg of phenobarbital, 50 mg of sodium phenytoin.
• The other ingredients are corn starch, gelatin, hydrated colloidal silica, magnesium stearate and talc.

Description of the appearance of Gamibetal Complex and contents of the pack
Gamibetal Complex is presented in a box containing 30 tablets in blisters.

Marketing Authorisation Holder and Manufacturer
Laboratorio Farmaceutico S.I.T. S.r.l. - Via Cavour, 70 - 27035 Mede (PV)