Pregnancy: There is no experience with the use of gliclazide during pregnancy in humans, even though there are few data with other sulphonylureas. The sulfonylureas may enter the fetal circulation and cause neonatal hypoglycaemia.
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 first 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.
Breast-feeding: It is not known whether gliclazide or its metabolites is excreted into breast milk. Given the risk of neonatal hypoglycaemia the product is contraindicated in breast-feeding mother.