Natrixam Use In Pregnancy & Lactation

Given the effects of the individual components in this combination product on pregnancy and lactation: Natrixam is not recommended during pregnancy.
Natrixam is contra-indicated during lactation.
Pregnancy: Linked to indapamide: 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 foeto-placental ischaemia and growth retardation. Moreover, rare cases of hypoglycemia and thrombocytopenia in neonates have been reported following exposure near term.
Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see Pharmacology: Toxicology: Preclinical safety data under Actions).
Linked to amlodipine: The safety of amlodipine in human pregnancy has not been established.
In animal studies, reproductive toxicity was observed at high doses (see Pharmacology: Toxicology: Preclinical safety data under Actions).
Breastfeeding: Linked to indapamide: There is insufficient information on the excretion of indapamide/metabolites in human milk. Indapamide is closely related to thiazide diuretics which have been associated, during breast-feeding, with decrease or even suppression of milk lactation. Hypersensitivity to sulphonamide-derived medicines and hypokalaemia might occur.
A risk to the newborns/infants cannot be excluded.
Linked to amlodipine: It is not known whether amlodipine is excreted in breast milk.
Fertility: Linked to indapamide: 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.
Linked to amlodipine: Reversible biochemical changes in the head of spermatozoa have been reported in some patients treated by calcium channel blockers. Clinical data are insufficient regarding the potential effect of amlodipine on fertility. In one rat study, adverse reactions were found on male fertility (see Pharmacology: Toxicology: Preclinical safety data under Actions).