Rupafin Use In Pregnancy & Lactation

Pregnancy: Data on a limited number (2) of exposed pregnancies indicate no adverse effects of rupatadine on pregnancy or on the health of the foetus/newborn child. To date, no other relevant epidemiological data are available. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition or postnatal development (see Pharmacology: Toxicology: Preclinical safety data under Actions). As a precautionary measure, it is preferable to avoid the use of rupatadine during pregnancy.
Breastfeeding: Tablet: Rupatadine is excreted in animal milk. It is unknown whether rupatadine is excreted into breastmilk. Due to the lack of human data, caution should be exercised when prescribing rupatadine to lactating women.
Oral solution: Rupatadine is excreted in animal milk. It is unknown whether rupatadine is excreted into breast milk. A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from rupatadine therapy taking into account the benefit of breast feeding for the child and the benefit of therapy for the woman.
Fertility: There are no clinical data on fertility. Studies in animals have shown a significant reduction of fertility at exposure levels higher than those observed in humans at the maximum therapeutic dose (see Pharmacology: Toxicology: Preclinical safety data under Actions).