Colour : White
Shape : Oblong, Flat and Scored
EACH TABLET CONTAINS
Glibenclamide ................................ 5 mg
Glibenclamide is a hypoglycaemic agent which is effective when given by
mouth. It acts by stimulating the release of insulin from the beta cells of
the pancreatic islets. It is not a substitute for insulin as it is effective
only in the presence of functioning islet tissue.
About 45% of a 5 mg dose is absorbed after oral administration. After an
oral dose of 5 mg, peak serum concentrations of about 0.04 mcg/ml are
attained in 2 to 4 hours. Plasma half-life is 3 to 7 hours; half-life
determined from urinary excretion data is about 10 hours. It is widely
distributed throughout the body and does not appear to accumulate. About 98%
is bound to plasma proteins. It is metabolised by hydroxylation of the
cyclohexyl ring at positions 3 and 4; in the rat, rabbit and dog, the
3-cis-hydroxy metabolite is additionally produced; hydroxylated metabolites
may be conjugated. In 5 days, 95% of a dose is excreted in the urine and
faeces with about 54% excreted as unchanged drug; of the 95% excreted about
75% is found in the faeces and 20% in the urine; excretion of an intravenous
dose is more rapid than that from either oral or intramuscular doses.
Non-insulin-dependent diabetes mellitus (type II, maturity-onset diabetes)
whenever dietary treatment alone proves inadequate.
Stabilisation should be instituted by a doctor only.
The tablets are to be swallowed whole with some liquid.
Treatment is started with a daily dose of half a tablet (2.5 mg), taken
immediately before breakfast. If necessary, raise the dose in increments of
2.5 mg until the blood glucose levels have been normalised. As a rule, the
maximum effect is obtained with 3 tablets daily, in exceptional cases 4
tablets daily. A maximum single dose of 2 tablets (10 mg) should not be
exceeded. It is to be taken before breakfast, any remaining portion before
the evening meal.
Insulin-dependent diabetes mellitus (type I, growth-onset diabetes),
diabetic coma, diabetic metabolic decompensation (e.g. ketoacidosis), severe
renal impairment, hypersensitivity to Glibenclamide, pregnancy. If children
are wanted, the matter should be discussed with the doctor.
WARNING AND PRECAUTIONS
Compliance to diet and regular tablet intake are of utmost importance for
successful treatment and will prevent undesirable changes in blood sugar
levels. Hypoglycaemic reactions may result from overdose of Glibenclamide,
from interactions with certain drugs, or from dietary errors (e.g. omission
of meals). Warning signs are headache, irritability, restlessness, profuse
sweating, insomnia, tremor, impairment of performance and alertness. Such
hypoglycaemic episodes are nearly always promptly relieved by the intake of
Their occurrence must be reported to the doctor without delay. The treatment
of diabetes requires regular check-up. Until optimal control is achieved, or
when changing the antidiabetic preparation, or when the tablets are not
taken regularly, the patient's alertness and reactivity may be impaired to
such an extent as to make him unable to cope with road traffic or operate
machinery. When situations of unusual stress arise (e.g. emergency surgery,
febrile infections), a temporary change to insulin may become necessary.
If Glibenclamide is taken at the same time as certain other drugs, also
alcohol, there may be an undesirable potentiation or attenuation of the
blood-sugar-lowering action of Glibenclamide. Therefore, other drugs should
be taken only with the doctor's approval or on his prescription.
Hypoglycaemic reactions as a manifestation of potentiation of the
hypoglycaemic effect may occur when Glibenclamide is taken at the same time
as: Beta-receptor blockers, bezafibrate, biguanides, chloramphenicol,
clofibrate, coumarin derivatives, fenfluramin, MAOI, miconazole,
pentoxifyline in high parenteral dosage, phenylbutazone, phenyramidol,
phosphamides, salicylates, sulphinpyrazone, sulphonamides, tetracyclines.
An attenuation of the hypoglycaemic action of Glibenclamide and aggravation
of the metabolic state may be caused by: Laxative (chronic abuse),
corticosteroids, nicotinic acid and its derivatives in high dosage,
oestrogens, gestagens, phenothiazine derivatives, saluretics,
sympathomimetic agents, thyroid hormones. Alcohol may increase the
hypoglycaemic effect of Glibenclamide. The amount permitted should be
discussed with the doctor. Chronic alcoholism may result in a deterioration
of metabolic control.
PREGNANCY AND LACTATION
Pregnancy: There is no information on the use of Euglucon in
human pregnancy but is has been in wide, general use for many years without
apparent ill consequence. Animal studies have shown no hazard.
Nursing mothers: It has not been established whether
Glibenclamide is excreted in human milk. Other sulphonylureas have been
found in milk. There is no evidence that Glibenclamide differs from the
group in this respect.
SIDE EFFECTS/ADVERSE REACTIONS
Hypoglycaemia, leukopaenia, thrombocytopaenia, pancytopaenia,
agranulocytosis, aplastic anaemia, haemolytic anaemia, thrombocytopaenic
purpura, paresthesia, joint pain, nocturia. Nausea and sensations of gastric
fullness are very rare. The same is true for hypersensitivity reactions of
the skin and changes of the haemopoietic system (e.g. decrease in the number
of platelets, white and red blood cells). Cholestasis and hepatitis may
occur in isolated cases. If these side effects are experienced, the doctor
will decide whether Glibenclamide treatment should be continued or not. A
cross allergy with sulphonamides and sulphonamide derivatives is possible.
SYMPTOMS AND TREATMENT OF OVERDOSE
Overdose causes hypoglycaemia. Symptoms of hypoglycaemia are intense
hunger, sweating, tremor, restlessness, irritability, depressive mood,
headaches and sleep disturbances. Hypoglycaemia is nearly always promptly
relieved by the intake of carbohydrates (sugar, e.g. in the form of sugar
lumps, sugared fruit juices, sugared tea). Synthetic sweeteners are not
suitable. The hypoglycaemia episode must be reported to the doctor as soon
as possible. He will decide whether the dosage of Glibenclamide needs
adjusting. If the hypoglycaemia cannot be corrected immediately, a doctor
must be called urgently.
If another illness occurs during treatment with Glibenclamide, the doctor
must be consulted immediately. If the diabetic sees a different doctor (e.g.
if admitted to hospital or if taken ill on holiday) he must tell him that he
suffers from diabetes. The treatment of diabetes requires regular checks.
Until optimal control is achieved, or when changing the antidiabetic
preparation, or when the tablets are not taken regularly, the patients
alertness and reactivity may be impaired to such an extent as to make him
unable to cope with road traffic or operate machinery. For successful
treatment, it is essential that the patient take the prescribed dose at the
times stipulated by the doctor. Doses he has missed must therefore not be
taken at a later time.
Plastic container of 1000's (For EXPORT/TENDER Only).
Blister packs of
10 x 10's and 100 x 10's.
4 years from the date of manufacture.
KEEP OUT OF REACH OF CHILDREN
Keep Container Tightly Closed
Store In A Dry Place Below 25°C
Protect From Light