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Hypoglycaemia: Diamicron/Diamicron MR is susceptible to cause episodes of hypoglycaemia. In the case of sweating, intense hunger, trembling, pallor, visual disturbances, feeling of malaise and abnormal behaviour, immediately eat sugar or something containing sugar and inform the doctor.
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 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, dose used and clear patient directions are necessary to reduce the risk of hypoglycaemic episodes.
In consequence, treatment with a hypoglycaemic sulfonylurea requires: Regular Diet: It is important to eat regular meals, including breakfast, never to miss a meal, due to an increase in the risk of the onset of hypoglycaemia caused by an inadequate diet or a sugar imbalance.
Precise Regularity in the Administration of Treatment: It is important to take treatment regularly, once a day, preferably at breakfast (see Dosage & Administration).
Every administration of Diamicron MR must be followed by a meal.
Glycaemic Imbalance: In the case of surgery, trauma, fever or infection, the doctor may discontinue treatment with Diamicron/Diamicron MR and prescribe insulin.
Factors which Increase the Risk of Hypoglycaemia: Patient refuses or (particularly in elderly subjects) is unable to cooperate; 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 MR 60 mg scored tablet; 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 scored tablet should not be administered to patients with rare hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption.
If the treatment is discontinued, there is a risk of an imbalance in diabetes (hyperglycaemia).
In all cases, strictly comply with the doctor's prescription.
Follow as closely as possible the diet prescribed by the doctor.
Regularly carry out the laboratory tests as prescribed or recommended by the doctor.
Inform the doctor in the following cases: Surgery, trauma, fever or infection, difficulty in eating; planned pregnancy; administration of other drugs, in particular, anti-inflammatory agents, β-blockers, corticoids.
Also inform the dentist of treatment.
Avoid alcohol and alcoholic drinks.
Effects on the Ability to Drive or Operate Machinery: Patients should be made aware of the symptoms of hypoglycaemia and should be careful when 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.
