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Women of childbearing potential: Safinamide should not be given to women of childbearing potential unless adequate contraception is practiced.
Pregnancy: There are no or limited amount of data from the use of safinamide in pregnant women. Studies in animals have shown reproductive toxicity (see PHARMACOLOGY: Toxicology: Preclinical safety data under Actions). Equfina is not recommended during pregnancy and in women of childbearing potential not using contraception.
Breast-feeding: Available pharmacodynamic/toxicological data in animals have shown excretion of safinamide in milk (for details see PHARMACOLOGY: Toxicology: Preclinical safety data under Actions).
A risk for the breast-fed child cannot be excluded. Equfina should not be used during breast-feeding.
Fertility: Animal studies indicate that safinamide treatment is associated with adverse reactions on female rat reproductive performance and sperm quality. Male rat fertility is not affected (see PHARMACOLOGY: Toxicology: Preclinical safety data under Actions).
