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Pancreatitis: If pancreatitis is suspected, sitagliptin phosphate monohydrate and other potentially suspect medicinal products should be discontinued.
Lactic Acidosis: Reported cases of lactic acidosis in patients on metformin have occurred primarily in diabetic patients with significant renal failure.
Renal Function: Metformin and sitagliptin are known to be substantially excreted by the kidney. Metformin-related lactic acidosis increases with the degree of impairment of renal function, therefore, serum creatinine concentrations should be determined regularly.
Hypoglycemia: Patients receiving Ziglip M, in combination with a sulphonylurea or with insulin may be at risk for hypoglycemia. Therefore, a reduction in the dose of the sulphonylurea or insulin may be necessary.
Use in pregnancy: Studies in animals have shown reproductive toxicity at high doses. The potential risk for humans is unknown. Due to lack of human data, Ziglip-M should not be used during pregnancy.
