Pregnancy: The administration of Norcolut during pregnancy is not indicated.
Since reproduction toxicity studies showed the risk of masculinisation in female foetuses when administered at high doses of norethisterone at the time of the development of the external genitalia, it must be stated that Norcolut may provoke signs of virilisation in female foetuses if administered during the hormone-sensitive stage of somatic sexual differentiation. Apart from this, no indications of teratogenic effects were obtained from the studies.
Breastfeeding: No case reports or epidemiological studies on norethisterone are available for use in breastfeeding. Norethisterone should be avoided in breastfeeding.