DIAMICRON TABLET 80 MG [SIN04316P]

Product Info

DIAMICRON TABLET 80 MG

[SIN04316P]

Indications

Non-insulin-dependent diabetes, in association with an adapted diet, in cases where dietary measures alone provide inadequate control of blood glucose levels.

Dosage and method of administration

For adults only.

As with all hypoglycaemic agents, the dosage must be adapted to suit each individual case.

In the case of transient disturbance of glucose control, administration of the product for a short period of time may be sufficient in a patient in whom the glucose balance is normally well maintained by dietary measures.

*Subjects under the age of 65 years

Initial dose

The recommended initial dose is 1 tablet per day.

Dosage increments

The dosage is usually adjusted in increments of 1 tablet depending on the glycemic response. Each dosage increment should be separated by at least 14 days.

Maintenance treatment

The dosage varies from 1 to 3 tablets per day, 4 in exceptional cases.

The standard dosage is 2 tablets per day, taken as 2 daily doses.

*High-risk subjects

Subjects over the age of 65 years

• Begin the treatment with ½ tablet taken once a day.

• This dosage may be progressively increased until satisfactory glucose control is obtained in the patient, provided that an interval of at least 14 days is maintained after each dosage increase and blood sugar levels are monitored closely.

In other high-risk patients

In patients who are undernourished or with a marked change in their general state or whose calorie intake is irregular, and in patients with renal or hepatic insufficiency, treatment must be initiated at the lowest dose and the guidelines for dosage increases scrupulously respected, so as to avoid any hypoglycaemic reactions (cf. Warnings and special precautions for use – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Patients receiving other oral hypoglycaemic agents

As with all hypoglycaemic sulphonylureas, this drug may replace other anti-diabetic treatments without any transition period. On changing from a hypoglycaemic sulphonylurea with a longer half-life (e.g. chlorpropamide) to this drug, patients should be closely monitored (over several weeks) to avoid the occurrence of hypoglycaemia, due to the possibility of an overlap of the therapeutic effects.

Contra-indications

The use of this medicine is contra-indicated in the following cases:

• hypersensitivity to gliclazide or other sulphonylureas or sulphonamides, or to any of the excipients used;

• Type I diabetes, insulin-dependent diabetes, particularly juvenile diabetes;

• diabetic precoma and coma; diabetic ketoacidosis;

• severe hepatic or renal insufficiency: in these cases, the use of insulin is recommended;

• treatment with miconazole (see Drug interactions – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information);

• pregnancy and lactation (see Pregnancy and Lactation – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

In general, it is not advisable to combine this drug with phenylbutazone, danazol (see Drug interactions – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information) or alcohol.