The main component of this product is gliclazide.

Chemical Name: 1-(3-Azabicyclo[3,3,0]oct-3-yl)-3-p-toluenesulfonylurea.

Structural Formula:

Molecular formula: C₁₅H₂₁N₃O₃S

Molecular weight:  323.41

The product is white film-coated tablet, and it is white to off-white after removal of the film coating

Non insulin-dependent diabetes (type 2) in adults when dietary measures, physical exercise and weight loss alone are not sufficient to control blood glucose. 

Orally. For adults only. The daily dose may vary from 1 to 4 tablets per day, from 30 to 120 mg. It is recommended to take it at breakfast time.

If a dose is forgotten, there must be no increase in the dose taken the next day. As with any hypoglycemic agent, the dose should be adjusted according to the individual patient's metabolic response (blood glucose, HbAlc).

* Initial dose: The recommended starting dose is 30 mg daily (1 tablet).

If blood glucose is effectively controlled, this dose may be used for maintenance treatment.

If blood glucose is not adequately controlled, the dose may be increased to 60, 90 or 120 mg daily, in successive steps. The interval between each dose increment should be at least 1 month except in patients whose blood glucose has not reduced after two weeks of treatment. In such cases, the dose may be increased at the end of the second week of treatment. The maximum recommended daily dose is 120 mg (4 tablets).

* Switching from gliclazide 80 mg tablets to Gliclazide Modified-release Tablets:

1 tablet of gliclazide 80 mg is comparable to 1 tablet of Gliclazide Modified-release Tablets. Consequently, the switch can be performed provided careful blood monitoring is undertaken.

* Switching from another oral anti-diabetic agent to Gliclazide Modified-release Tablets: Gliclazide Modified-release Tablets can be used to replace other oral anti-diabetic agents. The dosage and the half-life of the previous anti-diabetic agent should be taken into account. When switching to Gliclazide Modified-release Tablets.

A transitional period is not generally necessary. A starting dose of 30 mg should be used and this should be adjusted to suit the patient's blood glucose response, as described above.

When switching from a hypoglycaemic sulphonylurea with a prolonged half-life, a treatment free period of a few days may be necessary to avoid an additive effect of the two products, which might cause hypoglycaemia.  

The procedure described for initiating treatment should also be used when switching to treatment with Gliclazide Modified-release Tablets, a starting dose of 30 mg/day, followed by a stepwise increase in dose, depending on the metabolic response.

* Combination treatment with other anti-diabetic agents: Gliclazide Modified-release Tablets can be given in combination with biguanides, alpha glucosidase inhibitors or insulin.

In patients not adequately controlled with Gliclazide Modified-release Tablets, concomitant insulin therapy can be used in early treatment under close medical supervision.  

* Patients with mild to moderate renal insufficiency: The same dosing regimen can be used as in patients with normal renal function with careful patient monitoring.

These data have been confirmed in clinical trials.

* Patients at risk of hypoglycaemia:

·Undernourished or malnourished patients;

·Patients with severe or poorly compensated endocrine disorders (hypopituitarism, hypothyroidism, adrenocorticotrophic insufficiency);

·Following withdrawal of prolonged and/or high dose corticosteroid therapy;

·Patients with severe vascular disease (severe coronary heart disease, severe carotid impairment or diffuse vascular disease), it is recommended that the minimum daily starting dose of 30 mg is used or follow the doctor's advice