MEDOCLAZIDE Tablet Ref.[28196] Active ingredients: Gliclazide

Posology

Adults

The total daily dose may vary from 40 to 320 mg taken orally. The dose should be adjusted according to the individual patient’s response, commencing with 40-80 mg daily (½ - 1 tablet) and increasing until adequate control is achieved. A single dose should not exceed 160 mg (2 tablets). When higher doses are required, Medoclazide should be taken twice daily and according to the main meals of the day.

In obese patients or those not showing adequate response to Medoclazide alone, additional therapy may be required.

Elderly

Plasma clearance of gliclazide is not altered in the elderly and steady state plasma levels can therefore be expected to be similar to those in adults under 65 years. Clinical experience in the elderly to date shows that Medoclazide is effective and well tolerated. Care should be exercised, however, when prescribing sulphonylureas in the elderly due to a possible age-related increased risk of hypoglycaemia.

Paediatric population

Medoclazide as with other sulphonylureas, is not indicated for the treatment of juvenile onset diabetes mellitus.

Method of administration

Medoclazide is for oral use.

An overdose of sulphonylureas may cause hypoglycaemia.

Moderate symptoms of hypoglycaemia, without any loss of consciousness or neurological signs, must be corrected by carbohydrate intake, dose adjustment and/or change of diet. Strict monitoring should be continued until the doctor is sure that the patient is out of danger.

Severe hypoglycaemic reactions, with coma, convulsions or other neurological disorders are possible and must be treated as a medical emergency, requiring immediate hospitalisation.

If hypoglycaemic coma is diagnosed or suspected, the patient should be given a rapid I.V. injection of 50 mL of concentrated glucose solution (20 to 30 ). This should be followed by continuous infusion of a more dilute glucose solution (10) at a rate that will maintain blood glucose levels above 1 g/L. Patients should be monitored closely and, depending on the patient’s condition after this time, the doctor will decide if further monitoring is necessary.

Dialysis is of no benefit to patients due to the strong binding of gliclazide to proteins.

5 years.

No special precautions for storage needed.

Blisters of aluminium foil and polyvinylchloride film containing ten tablets. Blisters are supplied, with a patient information leaflet, in cartons of 20, 60 and 100 tablets. Dispensing packs of 500 and 1000 tablets are also available, either packed in blisters in a carton or in polyvinylchloride securitainers. Note that not all packaging presentations may be available in the market.

None.