Resolor Use In Pregnancy & Lactation

Women of childbearing potential: Women of childbearing potential have to use effective contraception during treatment with prucalopride.
Pregnancy: There is a limited amount of data from the use of prucalopride in pregnant women. Cases of spontaneous abortion have been observed during clinical studies, although, in the presence of other risk factors, the relationship to prucalopride is unknown. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity (including pregnancy, embryonal/foetal development, parturition or postnatal development) (see Pharmacology: Toxicology: Preclinical safety data under Actions).
Resolor is not recommended during pregnancy and in women of childbearing potential not using contraception.
Breast-feeding: A human study has shown that prucalopride is excreted in breast milk. At therapeutic doses of Resolor, no effects on breast-fed newborns/infants are anticipated. In the absence of human data in women who actively breast fed while taking Resolor, a decision should be made whether to discontinue breast feeding or to discontinue Resolor therapy taking into account the benefit of breast feeding for the child and the benefit of therapy for the woman.
Fertility: Animal studies indicate that there is no effect on male or female fertility.