Special Warning : אזהרת שימוש

4.4 Special warnings and precautions for use
Glucose-6-phosphate dehydrogenase deficiency
Since glipizide belongs to the class of sulfonylurea agents, caution should be used in patients with G6PD-deficiency. Treatment of patients with G6PD-deficiency with sulfonylurea agents can lead to haemolytic anaemia and a non-sulfonylurea alternative should be considered.
Hypoglycaemia
All sulphonylurea agents are capable of producing severe hypoglycaemia. Renal or hepatic insufficiency may cause elevated blood levels of glipizide and the latter may also diminish gluconeogenic capacity, both of which increase the risk of serious hypoglycaemic reactions. Elderly, debilitated or malnourished patients and those with adrenal or pituitary insufficiency are particularly susceptible to the hypoglycaemic action of glucose-lowering drugs.
Hypoglycaemia may be difficult to recognise in the elderly, and in people who are taking beta-adrenergic blocking drugs (see section 4.5.). Hypoglycaemia is more likely to occur when caloric- intake is deficient, after severe or prolonged exercise, when alcohol is ingested, or when more than one glucose-lowering drug is used.
Loss of control of blood glucose
When a patient stabilised on a diabetic regimen is exposed to stress such as fever, trauma, infection, or surgery, a loss of control may occur. At such times, it may be necessary to discontinue glipizide and administer insulin.
The effectiveness of any oral hypoglycaemic drug, including glipizide, in lowering blood glucose to a desired level decreases in many patients over a period of time, which may be due to progression of the severity of diabetes or due to diminished responsiveness to the drug. This phenomenon is known as secondary failure, to distinguish it from primary failure in which the drug is ineffective in an individual patient when first given. Adequate adjustment of dose and adherence to diet should be assessed before classifying a patient as a secondary failure.
Renal and Hepatic Disease
The pharmacokinetics and/or pharmacodynamics of glipizide may be affected in patients with impaired renal or hepatic function. If hypoglycaemia should occur in such patients, it may be prolonged and appropriate management should be instituted.
Information for Patients
Patients should be informed of the potential risks and advantages of glipizide and of alternative modes of therapy. They should also be informed about the importance of adherence to dietary instructions, of a regular exercise program, and of regular testing of urine and/or blood glucose.
The risks of hypoglycaemia, its symptoms and treatment, and conditions that predispose to its development should be explained to patients and responsible family members. Primary and secondary failure should also be explained.
Laboratory Tests
Blood and urine glucose should be monitored periodically. Measurement of glycosylated haemoglobin may be useful.

This product contains lactose. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency, glucose-galactose malabsorption should not take this medicine.

Effects on Driving

4.7 Effects on ability to drive and use machines
The effect of glipizide on the ability to drive or operate machines has not been studied. However, there is no evidence to suggest that glipizide may affect these abilities. Patients should be aware of the symptoms of hypoglycaemia and be careful about driving and the use ofmachines, especially when optimum stabilisation has not been achieved, for example during the change-over from other medications or during irregular use.