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 30 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 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.

• In the elderly (over 65), Diamicron MR 30 mg should be prescribed using the same dosing regimen recommended for patients under 65 years of age. 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.

• In 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.

• There are no data and clinical studies available in children.

4.3 Contraindications

 • known hypersensitivity to gliclazide or to any of the excipients, other sulphonylureas, 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 "Interactions with other medicinal products and other forms of interaction"),

• lactation (see Section "Pregnancy and Lactation").

4.4 Special warnings and precautions for use

 HYPOGLYCAEMIA:

This treatment should be prescribed only if the patient is likely to have a regular food intake (including breakfast). It is important to have a regular carbohydrate intake due to the increased risk of hypoglycaemia if a meal is taken late, if an inadequate amount of food is consumed or if the food is low in carbohydrate. Hypoglycaemia is more likely to occur during low-calorie diets, following prolonged or strenuous exercise, alcohol intake or if a combination of hypoglycaemic agents is being used.

Hypoglycaemia may occur following administration of sulphonylureas (see 4.8. Undesirable effects). Some cases may be severe and prolonged. Hospitalisation may be necessary and glucose administration may need to be continued for several days.

Careful selection of patients, of the dose used, and clear patient directions are necessary to reduce the risk of hypoglycaemic episodes.

Factors which increase the risk of hypoglycaemia:

• patient ref