DIAMICRON MR Modified release tablet Ref.[50875] Active ingredients: Gliclazide

Posology

The daily dose may vary from 1 to 4 tablets per day, i.e. from 30 to 120 mg taken orally in a single intake at breakfast time.

It is recommended that the tablet(s) 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, HbAlc)

Initial dose:

The recommended starting dose is 30 mg daily.

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 Diamicron 80 mg tablets to DIAMICRON MR 30 mg modified release tablets:

1 tablet of Diamicron 80 mg is comparable to1 tablet of DIAMICRON MR 30 mg. Consequently the switch can be performed with careful blood monitoring.

Switching from another oral antidiabetic agent to DIAMICRON MR 30 mg:

DIAMICRON MR 30 mg 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 DIAMICRON MR 30 mg.

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 sulfonylurea 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 DIAMICRON MR 30 mg, i.e. a starting dose of 30 mg/day, followed by a stepwise increase in dose, depending on the metabolicresponse.

Combination treatment with other antidiabetic agents:

DIAMICRON MR 30 mg can be given in combination with biguanides, alpha glucosidase inhibitors or insulin. In patients not adequately controlled with DIAMICRON MR 30 mg, concomitant insulin therapy can be initiated under close medical supervision.

Special Populations

Elderly

DIAMICRON MR 30 mg should be prescribed using the same dosing regimen recommended for patients under 65 years of age.

Renal impairment

In patients with mild to moderate renal insufficiency the same dosing regimen canbe 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,
• 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 30 mg is used.

Paediatric population

The safety and efficacy of DIAMICRON MR 30 mg in children and adolescents have not been established. No data are available in children.

An overdose of sulfonylureas 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 mustbe 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.

3 years.

This medicinal product does not require any special storage conditions.

7, 10, 14, 20, 28, 30, 56, 60, 84, 90, 100, 112, 120, 180 and 500 tablets in Aluminium/Poly(vinylchloride) blister, packed in cardboard boxes.

Not all pack sizes may be marketed.

No special requirements.