Pregnancy: There is no or limited amount of data (less than 300 pregnancy outcomes) from the use of gliclazide during in pregnant women, even though there are few data with other sulfonylurea.
In animal studies, gliclazide is not teratogenic (see Pharmacology: Toxicology: Preclinical safety data under Actions).
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 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 unknown whether gliclazide or its metabolites are excreted in human milk. Given the risk of neonatal hypoglycaemia, the product is therefore contra-indicated in breast-feeding mother. A risk to the newborns/infants cannot be excluded.
Fertility: No effect on fertility or reproductive performance was noted in male and female rats (see Pharmacology: Toxicology: Preclinical safety data under Actions).