There may be increased cardiovascular mortality as compared to treatment with diet alone or diet plus insulin.
In the initial weeks of treatment, the risk of hypoglycemia may be increased and necessitates careful monitoring. Glucose levels in blood and urine must be checked regularly, as should, additionally the proportion of glycated haemoglobin.
Information for Patients: Patients should be informed of the potential risks and advantages of Perglim and about other modes of therapy. They should be also informed about the importance of adherence to dietary instructions, of a regular exercise program and of regular testing of blood glucose.
The risks of hypoglycemia, its symptoms and treatment, and conditions that predispose to its development should be explained to patients and responsible family members. The potential for primary and secondary failure should also be explained.
Effects on the Ability to Drive or Operate Machinery: Alertness and reactions may be impaired due to hypo- or hyperglycemia. This may affect the ability to operate a vehicle or heavy machinery.
Use in pregnancy & lactation: As there are no adequate and well-controlled studies in pregnant women and lactating mothers with glimepiride, Perglim should not be used during pregnancy unless clearly needed. Recent studies indicate that abnormal blood glucose levels during pregnancy may lead to congenital abnormalities.
Similarly, caution should be exercised while administering Perglim to lactating mothers. A decision whether to discontinue nursing or the drug should be taken depending on the importance of the drug to the mother.
Use in children: Not recommended.