Use in Pregnancy: Clinical data of TIRONEM on pregnancy are very limited. Animal studies are insufficient to draw conclusion for pregnancy, embryonal/foetal development, parturition or postnatal development. The potential risk for human is unknown. TIRONEM should not be used during pregnancy unless clearly necessary.
Use in Lactation: It is not known whether TIRONEM is excreted in human breast milk. A study in rats has shown that TIRONEM and its metabolite are transferred to milk. A decision on whether to continue/discontinue breast-feeding or to continue/discontinue therapy with TIRONEM should be made taking into account the benefit of breastfeeding to the child and the benefit of TIRONEM therapy to the woman.