Natrilix SR Use In Pregnancy & Lactation

Pregnancy: There are no or limited amount of data (less than 300 pregnancy outcomes) from the use of indapamide in pregnant women. Prolonged exposure to thiazide during the third trimester of pregnancy can reduce maternal plasma volume as well as uteroplacental blood flow, which may cause a feto-placental ischaemia and growth retardation.
Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see "Pharmacology: Toxicology: Preclinical safety data under Actions").
As a precautionary measure, it is preferable to avoid the use of Indapamide during pregnancy.
Breast-feeding: Natrilix SR is excreted into human milk in small amounts, and when given at high doses during breast-feeding is not recommended, because it can inhibit the milk production. Using Natrilix SR in breast-feeding women should be kept as low as possible.
There is insufficient information on the excretion of indapamide/metabolites in human milk. Hypersensitivity to sulphonamide-derived medicines and hypokalaemia might occur. A risk to the newborns/infants cannot be excluded.
Indapamide is closely related to thiazide diuretics which have been associated, during breast-feeding, with decrease or even suppression of milk lactation.
Indapamide is not recommended during breast-feeding.
Fertility: Reproductive toxicity studies showed no effect on fertility in female and male rats (see "Pharmacology: Toxicology: Preclinical safety data under Actions"). No effects on human fertility are anticipated.