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AVORNA-DUO is contraindicated in women.
No studies have been conducted with AVORNA-DUO to investigate the effect on pregnancy and lactation. The following statements reflect the information available on the individual components.
Pregnancy: 5α-reductase inhibitors can inhibit the development of the external genitalia of male foetuses.
As dutasteride is absorbed through the skin, contact (especially with leaking capsules) should be avoided during pregnancy.
It is not known whether a male foetus may be adversely affected if his mother is exposed to the semen of a patient being treated with dutasteride.
Breast-feeding: It is not known whether dutasteride or tamsulosin hydrochloride are excreted in human breast milk.
Fertility: Dutasteride has been reported to affect semen characteristics (reduction in sperm count, semen volume, and sperm motility) in healthy men. The possibility of reduced male fertility cannot be excluded.
Effects of Tamsulosin hydrochloride on sperm counts or sperm function have not been evaluated.
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