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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 sulfonylureas.
Studies in animals have shown reproductive toxicity (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/metabolites are excreted in human milk. Given the risk of neonatal hypoglycaemia, the product is therefore contraindicated in breast-feeding mothers. A risk to the newborn infant/children 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).
