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Diamicron MR

 

1. NAME OF THE MEDICINAL PRODUCT

DIAMICRON MR 60 mg, modified release tablet.

2. QUALITATIVE AND QUANTITATIVE COMPOSITION
One modified release tablet contains gliclazide 60 mg Excipient with known effect: lactose monohydrate For the full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM
Modified release tablet.
White, oblong, tablet, scored and engraved, with 'DIA 60' on both faces The tablet can be divided into equal doses.

CLINICAL PARTICULARS
4.1 Therapeutic indications

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

4.2 Posology and method of administration
Oral use.
The daily dose of DIAMICRON MR 60 mg 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.

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 DIAMICRON MR 60 mg). 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.

One DIAMICRON MR 60 mg modified release tablet is equivalent to two DIAMICRON 30 mg modified release tablets. The breakability of me DIAMICRON MR 60 mg modified release tablet enables flexibility of dosing to be achieved.

- Switching from DIAMICRON 80 me tablets to DIAMICRON MR 60 mg modified release tablets: One tablet of DIAMICRON 80 mg is comparable to 30 mg of the modified release formulation (i.e. half a tablet of DIAMICRON MR 60 mg.) Consequently the switch can be performed with careful blood monitoring.

- Switching from another oral antidiabetic agent to DIAMICRON MR 60 mg:

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

In patients not adequately controlled with DIAMICRON MR 60 mg, concomitant insulin therapy can be initiated under close medical supervision.

Special Populations
Elderly
DIAMICRON MR 60 mg 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. 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.

Pediatric population
The safety and efficacy of DIAMICRON MR 60 mg in children and adolescents have not been established. No data are available.

4.3 Contraindications
- Hypersensitivity to gliclazide or to any of the excipients listed in section 6.1, other sulfonylurea, sulphonamides,
- 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 (see section 4.5),

- lactation (see section 4.6).

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