1. NAME OF THE MEDICINAL
DIAMICRON MR 60 mg, modified
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
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.
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
4.2 Posology and method of administration
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
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
- 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
- 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
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
- 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.
The safety and efficacy of DIAMICRON MR 60 mg in children and adolescents
have not been established. No data are available.
- Hypersensitivity to gliclazide or to any of the excipients listed in
section 6.1, other sulfonylurea, sulphonamides,
- type 1 diabetes,
pre-coma and coma, diabetic keto-acidosis,
- severe renal or hepatic insufficiency: in these cases the use of insulin
- treatment with miconazole (see section 4.5),
- lactation (see section 4.6).