DIABREZIDE Tablet Ref.[50283] Active ingredients: Gliclazide

Tablets for oral use.

The desired blood glucose levels and the Diabrezide dosage must be determined individually in relation to the degree of diabetes.

ADULTS: The usual initial dose is 40-80 mg/day (half to one tablet) before breakfast. If necessary, the dosage may be increased by 40-80 mg every 7-14 days, until a satisfactory metabolic control is achieved. The maximum dose is 320 mg/day. The usual maintenance dose is 80-160 mg in two daily administrations (before breakfast and before dinner); higher doses (up to 320 mg/day) may be used, although it has not been demonstrated that the increase of doses over 160 mg/day necessarily leads to an improvement of glycaemic control.

ELDERLY: The usual initial dose is 40 mg (half tablet) before breakfast, increasing the dose of 40 mg every 7-14 days if necessary. Caution should be used when prescribing doses over 160 mg/day, particularly if renal function is impaired.

CHILDREN: Diabrezide is contraindicated in children (see section 4.3)

Gliclazide is not indicated in the treatment of type 1 diabetes mellitus.

Diabrezide tablets must be swallowed without chewing preferably 30 minutes before the meal.

Accidental or deliberate overdose of sulphonylureas, including gliclazide, can produce hypoglycaemia (for symptoms see 4.8).

Treatment

Mild hypoglycaemia symptoms, without loss of consciousness or neurological finding, should be treated aggressively with oral glucose and adjustments in drug dosage and/or meal patterns. Close monitoring should continue until the physician is assured that the patient is out of danger. Severe hypoglycaemic reactions with coma, seizure, or other neurological impairment occur infrequently, but constitute medical emergencies requiring immediate hospitalisation. If hypoglycaemic coma is diagnosed or suspected, the patient should be given a rapid intravenous injection of concentrated (50%) glucose solution. This should be followed by a continuous infusion of a more diluted (10%) glucose solution at a rate which will maintain the blood glucose at a level above 100 mg/dl. Patients should be closely monitored for a minimum of 48 h, and, depending on the status of the patient at this time, the physician should decide whether further monitoring is required.

3 years.

Do not store above 25°C.

AI/PVC+PE+PVDC strip (aluminium foil: thickness 20 ± 1.6 μm; plastic sheet: PVC, thickness 200 ± 10 μm – PE, thickness 30 ± 3 μm; spreading of PVDC: 90 g/m²± 5%).

Pack sizes:

• Carton box with 28 tablets (2 × 14).
• Carton box with 30 tablets (2 × 15).
• Carton box with 60 tablets (3 × 20).
• Carton box with 100 tablets (5 × 20).
• Carton box with 120 tablets (6 × 20).
• Carton box with 180 tablets (9 × 20).

Not all pack sizes may be marketed.

No special requirements.