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Glibenclamide

 

DESCRIPTION
White, oblong tablets with characteristic markings on both sides.


COMPOSITION
Each tablet contains Glibenclamide 5mg


INDICATIONS
Non-insulin-dependent diabetes mellitus (type II, maturity-onset diabetes), whenever dietary treatment alone proves inadequate.


CONTRAINDICATIONS
Insulin-dependent diabetes mellitus (type I, growth-onset diabetes), diabetic coma, diabetic metabolic decompensation (e.g. ketoacidosis), severe renal impairment, hypersensitivity to glibenaclamide, pregnancy.

ADVERSE REACTIONS
Nausea and sensations of gastric fullness are very rare. The same is true for hypersensitivity reactions of the skin. Changes of the haemopoietic system (e.g. decrease in the number of platelets, white and red blood cells) are rare.

 

INTERACTIONS
If glibenclamide is taken at the same time as certain other drugs including 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 prescription.

Drugs that may potentiate the hypoglycaemic action of glibenclamide are :

Beta-receptor blockers Pentoxifylline in high parenteral dosage
Bezafibrate Phenylbutazone
Biguanides Phenyramidol
Chloramphenicol Phosphamides
Clofibrate Salicylates
Coumarin derivatives Sulphinpyrazone
Fenfluramin Sulphonamides
MAO-inhibitors Tetracyclines

An attenuation of the hypoglycaemic action of glibenclamide may be caused by :

Abuse of laxatives

Phenotiazine derivatives

Corticosteroids

Saluretics

Nicotinic acid in high doses

Sympathomimetic agents

Oestrogens, gestagens

Thyroid hormones

 

SPECIAL NOTES

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 overdosage 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 an alertness.

Such hypoglycaemic episodes are nearly always promptly relieved by the intake of sugar. Their occurrence must be reported to the doctor without delay. the treatment of diabetes requires regular checks. Until optimal control is achieved, or when changing the anti-diabetic preparation, or when the tablets are not taken regularly, the patient's alertness and reactivity maybe 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.

DOSAGE AND ADMINISTRATION

Stabilisation on glibenclamide may 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 (2.5mg) taken immediately before breakfast. If necessary, raise the dose in increments of 2.5mg until the blood glucose levels have 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 (10mg) should not be exceeded. It is to be taken before breakfast, any remaining portion before the evening meal.

STORAGE CONDITIONS

Store below 25C.

Keep container tightly closed.

Protect from light.

 

SHELF LIFE

Product should not be used beyond the expiry date imprinted on the product packaging.

 

PRESENTATION

Bottles of 1000 tablets.

Cartons of 10, 20, 30, 50, 100, 250 and 500 tablets in blisters of 10 tablets.

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