Pregnancy: There is no or limited amount of data (less than 300 pregnancy outcomes) from the use of gliclazide in pregnant women, even though there are few data with other sulphonylureas. As a precautionary measure, it is preferable to avoid the use of Gliclazide during pregnancy.
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 first choice for the treatment of diabetes during pregnancy. It is recommended that oral hypoglycaemic therapy is changed to insulin before pregnancy is attempted or as soon as pregnancy is discovered.
Lactation: It is not known whether gliclazide or its metabolites are excreted in breast milk. Given the risk of neonatal hypoglycaemia, the product is contraindicated in breastfeeding mothers A risk to newborns/infants cannot be excluded.