Hypoglycaemia: Diamicron MR 60 mg should only be prescribed 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 sulfonylurea (see Adverse Reactions). 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 Increases the Risk of Hypoglycaemia: Patient refuses or (particularly in elderly subjects) is unable to cooperate; malnutrition, irregular meal times, skipping meals, fasting periods or dietary changes; imbalance between physical exercise and carbohydrate intake; renal and severe hepatic insufficiency; overdose of Diamicron MR 60 mg; certain endocrine disorders: Thyroid disorders, hypopituitarism and adrenal insufficiency; concomitant administration of certain other medicinal products (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. A hypoglycaemic episode occurring in these patients may be prolonged, so appropriate management should be initiated.
Patient Information: The risks of hypoglycaemia, together with its symptoms, treatment and conditions that predispose to its development, should be explained to the patient and to family members.
The patient should be informed of the importance of following dietary advice, of taking regular exercise and of regular monitoring of blood glucose levels.
Poor Blood Glucose Control: Blood glucose control in a patient receiving antidiabetic treatment may be affected by any of the following: Fever, trauma, infection or surgical intervention. 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 1st-line treatment. Adequate dose adjustment and dietary compliance should be considered before classifying the patient as secondary failure.
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 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 nonsulfonylurea alternative should be considered.
Excipients: Diamicron MR 60 mg should not be administered to patients with rare hereditary problems of galactose intolerance, the Lapp-lactase deficiency or glucose-galactose malabsorption.
Effects on the Ability to Drive or Operate Machinery: Patients should be made aware of the symptoms of hypoglycaemia and should be careful in driving or operating machinery, especially at the beginning of treatment.
Use in pregnancy: There is no experience with the use of gliclazide during pregnancy in humans, even though there are few data with other sulfonylurea.
In animal studies, gliclazide is not teratogenic.
Control of diabetes should be obtained before the time of conception to reduce the risk of congenital abnormalities linked to uncontrolled diabetes.
Oral hypoglycaemic agents are not suitable, insulin is the drug of 1st choice for treatment of diabetes during pregnancy. It is recommended that oral hypoglycaemic therapy is changed to insulin before a pregnancy is attempted, or as soon as pregnancy is discovered.
Use in children: There are no data and clinical studies available in children.