Hypoglycaemia: This medication should be prescribed only to patients who are able to feed themselves regularly (including having breakfast).
It is important to consume carbohydrates regularly, in view of the increased risk of hypoglycaemia if meals are taken late, if food intake is inadequate or if there is an imbalance in carbohydrates.
Hypoglycaemia is all the more likely to occur when the patient's diet is low in calories, following major or prolonged exercise, following ingestion of alcohol or when a combination of hypoglycaemic agents is being administered.
Hypoglycaemia can occur following administration of sulfonylureas (see Adverse Reactions). Some episodes can be severe and prolonged. Admission to hospital may then be necessary, and glucose administration may need to be carried out for several days.
To reduce the risk of hypoglycaemia, the patient must be carefully selected, the posology must be carefully matched to the patient, and the patient must be given appropriate information.
Factors which increase the risk of hypoglycaemia: patient refuses or is unable to co-operate (particularly in elderly subjects), malnutrition, irregular mealtimes, skipping meals, periods of fasting or dietary changes, imbalance between physical exercise and carbohydrate intake, renal insufficiency, severe hepatic insufficiency, overdose of Diamicron, certain endocrine disorders: thyroid disorders, hypopituitarism and adrenal insufficiency, concomitant administration of certain other medicines (see Interactions).
Renal and hepatic insufficiency: The pharmacokinetics and/or pharmacodynamics of gliclazide may be altered in patients with hepatic insufficiency or severe renal failure. If hypoglycaemia occurs in such patients, it can be prolonged, so appropriate management should be initiated.
Information for the patient: The risks of hypoglycaemia, together with its symptoms (see Adverse Reactions), treatment, and conditions that predispose to its development, should be explained to patients and to family members.
They must be informed of the importance of keeping to an appropriate diet, undertaking regular physical exercise, and of regular monitoring of blood glucose levels.
Blood sugar imbalance: Blood glucose control in a patient receiving oral antidiabetic treatment may be affected by any of the following: St. John's Wort (Hypericum perforatum) preparations (see Interactions), fever, injury, infection or surgery.
In some cases, it may be necessary to administer insulin.
The hypoglycaemic efficacy of any oral antidiabetic agent, including gliclazide, is attenuated over time in many patients: this may be due to progression in the severity of the diabetes or to a reduced response to treatment. This phenomenon is known as secondary failure which is distinct from primary failure, when an active substance is ineffective as first-line treatment. Adequate dose adjustment and dietary compliance should be considered before classifying the patient as secondary failure.
Dysglycaemia: Disturbances in blood glucose, including hypoglycaemia and hyperglycaemia have been reported in diabetic patients receiving concomitant treatment with fluoroquinolones, especially in elderly patients. Indeed, careful monitoring of blood glucose is recommended in all patients receiving at the same time Diamicron 80 mg and a fluoroquinolone.
Laboratory tests: Measurement of glycated haemoglobin levels (or fasting venous plasma glucose) is recommended in assessing blood glucose control. Blood glucose self-monitoring may also be useful.
Treatment of patients with G6PD-deficiency (glucose-6-phosphate dehydrogenase deficiency) with sulfonylurea agents can lead to haemolytic anaemia. Since gliclazide belongs to the chemical class of sulfonylurea drugs, caution should be used in patients with G6PD-deficiency and a non-sulfonylurea alternative should be considered.
Porphyric patients: Cases of acute porphyria have been described with some other sulfonylurea drugs, in patients who have porphyria.
Excipients: This medicinal product contains lactose. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Effect on ability to drive and use machines: Diamicron 80 mg has no or negligible influence on the ability to drive and use machines. However, patients should be made aware of the symptoms of hypoglycaemia and should be careful if driving or operating machinery, especially at the beginning of treatment.