GLILUPI MR TABLET 60MG

5.1 Therapeutic indications

Gliclazide modified release tablets are indicated for the treatment of type II diabetes in association with dietary measures and with, physical exercise when these measures alone are inadequate to control blood glucose.

During controlled clinical trials in patients with type II diabetes, a modified release formulation of gliclazide (30mg – 120mg), taken as a single daily dose, was shown to be effective long term in controlling blood glucose levels, based on monitoring of HbA1c.

5.3 Contraindications

This medicine is contra-indicated in case of:

• Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.
• Hypersensitivity to sulphonylurea or sulphonamides,
  • Type 1 diabetes,
    • diabetic pre-coma and coma, diabetic ketoacidosis,
• Severe renal or hepatic insufficiency: in these cases, the use of insulin is recommended
• Treatment with miconazole,
• Pregnancy and Lactation

5.2 Posology and method of administration

Posology

The daily dose of Gliclazide 60 mg MR Tablets may vary from one half to 2 tablets per day, i.e., from 30 to 120 mg taken orally in a single intake at breakfast time.

It is recommended to swallow the dose without crushing or chewing.

If a dose is forgotten, there must be no increase in the dose taken the next day.

These products should be taken with food because there is an increased risk of hypoglycemia if a meal is taken late, if an inadequate amount of food is consumed or if the food is low in carbohydrate. It is recommended that the medication be taken at breakfast time.

As with any hypoglycaemic 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 (half a tablet of Gliclazide 60 mg MR Tablets).

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.

Switching from another oral antidiabetic agent to Gliclazide 60 mg MR Tablets:

Gliclazide 60 mg MR Tablets can be used to replace other oral antidiabetic agents.

The dosage and the half-life of the previous antidiabetic agent should be taken into account when switching to Gliclazide 60 mg MR 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.

If a patient is switched from a hypoglycaemic sulfonylurea with a prolonged half-life, he/she should be carefully monitored (for one to two weeks) in order to avoid hypoglycaemia due to possible residual effects of the previous therapy.

Combination treatment with other antidiabetic agents:

Gliclazide 60 mg MR Tablets can be given in combination with biguanides, alpha glucosidase inhibitors or insulin.

In patients not adequately controlled with gliclazide, concomitant insulin therapy can be initiated under close medical supervision.

Special Populations

Older people (over 65 years of age)

The efficacy and tolerance of the modified release formulation of gliclazide (30mg – 120mg) has been confirmed in clinical trials in subjects over 65 years who were given the same dosage regimen as the general population. The dosage is therefore identical to that recommended for adults under the age of 65 years.

Patients with renal impairment

The efficacy and tolerance of the modified release formulation of gliclazide (30mg – 120mg) has been confirmed in clinical trials of subjects with mild to moderate renal failure (creatinine clearance of between 15 and 80mL/min) who were given the same dosage regimen as the general population. No dosage adjustment is therefore required in subjects with impaired renal function.

Patients at risk of hypoglycaemia

There is an increased risk of hypoglycaemia in the following circumstances:

• undernourished or malnourished patients,
• patients with severe or poorly compensated endocrine disorders (hypopituitarism, hypothyroidism, adrenal insufficiency),
• withdrawal of prolonged and/or high dose corticosteroid therapy,
• patients with severe vascular disease (severe coronary heart disease, severe carotid impairment, diffuse vascular disease)

It is recommended that treatment be systematically initiated with a minimal dose of 30mg / day.

Pediatric population

As per the information reported in literature, the safety and efficacy of gliclazide in children and adolescents have not been established. There are no data or clinical studies in children.

Method of Administration

Oral use.