GLYCINORM-MR TABLETS 60 MG [SIN17073P]

Product Info

GLYCINORM-MR TABLETS 60 MG

[SIN17073P]

INDICATIONS
Gliclazide prolonged release tablets are indicated in Type 2 diabetes mellitus in adults when dietary measures, physical exercise and weight loss alone are not sufficient to control blood glucose.

DOSAGE AND ADMINISTRATION
Oral use – For adult use only
The daily dose may vary from 30 to 120mg taken orally in a single intake at breakfast time. It is recommended that the tablets be swallowed whole.
If a dose is forgotten, there must be no increase in the dose taken the next day.
As with any hypoglycaemic agent, the dose should be adjusted according to the individual patient's metabolic response (blood glucose, HbA_1C).
Initial dose
The recommended starting dose is 30mg daily.
If blood glucose is effectively controlled, this dose maybe used for maintenance treatment.
If blood glucose is not adequately controlled, the dose may be increased to 60, 90 or 120mg 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 120mg.
Switching from another oral antidiabetic agent to gliclazide prolonged release tablets
The dosage and the half-life of the previous antidiabetic agent should be taken into account when switching to gliclazide prolonged 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.
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 prolonged release gliclazide, i.e. a starting dose of 30 mg/day, followed by a stepwise increase in dose, depending on the metabolic response.
Combination treatment with other antidiabetic agents
Gliclazide prolonged release tablets can be given in combination with biguanides, alpha glucosidase inhibitors or insulin.
In patients not adequately controlled with gliclazide prolonged release tablets, concomitant insulin therapy can be initiated under close medical supervision.

Elderly
Gliclazide prolonged release tablets should be prescribed using the same dosing regimen recommended for patients under 65 years of age.

Patients with renal impairment
In 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.

Patients at risk of hypoglycaemia

• undernourished or malnourished,

• severe or poorly compensated endocrine disorders (hypopituitarism, hypothyroidism, adrenocorticotrophic insufficiency),

• withdrawal of prolonged and/or high dose corticosteroid therapy,

• severe vascular disease (severe coronary heart disease, severe carotid impairment, diffuse vascular disease);

It is recommended that the minimum daily starting dose of 30mg is used.

CONTRAINDICATIONS
Gliclazide prolonged release tablets are contraindicated in patients with:

• hypersensitivity to gliclazide, other sulfonylureas, sulphonamides, or to any of the excipients;

• type 1 diabetes;

• diabetic pre-coma and coma; diabetic keto-acidosis;

• severe renal or hepatic insufficiency: in these cases, the use of insulin is recommended;

• treatment with miconazole (refer to Drug interactions – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information);

• pregnancy and lactation (refer to Usage in pregnancy and lactation – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).