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Pregnancy: No clinical data are available from women who became pregnant while taking solifenacin. Animal studies do not indicate direct harmful effects on fertility, embryonal/foetal development or parturition (see Pharmacology: Toxicology: Preclinical safety data under Actions). The potential risk for humans is unknown. Caution should be exercised when prescribing to pregnant women.
Breast-feeding: No data on the excretion of solifenacin in human milk are available. In mice, solifenacin and/or its metabolites was excreted in milk, and caused a dose dependent failure to thrive in neonatal mice (see Pharmacology: Toxicology: Preclinical safety data under Actions). The use of solifenacin succinate should therefore be avoided during breast-feeding.
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