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Women of childbearing potential and contraception in males and females: Due to lack of data on effects of Revatio in pregnant women, Revatio is not recommended for women of childbearing potential unless also using appropriate contraceptive measures.
Pregnancy: There are no data from the use of sildenafil in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, and embryonal/foetal development. Studies in animals have shown toxicity with respect to postnatal development (see Pharmacology: Toxicology: Preclinical safety data under Actions).
Due to lack of data, Revatio should not be used in pregnant women unless strictly necessary.
Breast Feeding: It is not known whether sildenafil enters the breast milk. Since many drugs are excreted in human milk, caution should be exercise when Revatio is administered to breast-feeding mothers.
Fertility: Non-clinical data revealed no special hazard for humans based on conventional studies of fertility (see Pharmacology: Toxicology: Preclinical safety data under Actions).
