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Long-term data on fertility in humans are lackingand specific studies in subfertile men have not been conductedThe male patients who were planning to father a child were initially excluded from clinical trialsAlthoughanimal studies did not show relevant negative effects on fertilityspontaneous reports of infertility andor poor seminal quality were received post-marketingIn some of these reportspatients had other risk factors that might have contributed to infertilityNormalisation or improvement of seminal quality has been reported after discontinuation of finasteride.

Long-term data on fertility in humans are lackingand specific studies in subfertile men have not been conductedThe male patients who were planning to father a child were initially excluded from clinical trialsAlthoughanimal studies did not show relevant negative effects on fertilityspontaneous reports of infertility andor poor seminal quality were received post-marketingIn some of these reportspatients had other risk factors that might have contributed to infertilityNormalisation or improvement of seminal quality has been reported after discontinuation of finasteride.

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‘Propeciashould not be used in childrenThere are no data demonstrating efficacy or safety of finasteride in children under the age of 18.

Finasteride for male pattern hair loss has been evaluated for safety in clinical studies involving more than 3,200 menIn three 12-monthplacebo-controlleddouble-blindmulticentre studies of comparable designthe overall safety profiles ofPropeciaand placebo were similarDiscontinuation of therapy due to any clinical adverse experience occurred in 1.7of 945 men treated withPropeciaand 2.1of 934 men treated with placebo.

In three controlled clinical trials for PROPECIA of 12-month duration1.4of patients taking PROPECIAn=945were discontinued due to adverse experiences that were considered to be possiblyprobably or definitely drug-related1.6for placebon=934

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if a woman who is pregnant with a male baby absorbs the active ingredient in propecia, either by swallowing or through the skin, it may cause abnormalities of a male baby s sex organs.
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