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Pregnancy: Data on a very limited number of exposed pregnancies have not indicated any adverse effects of Febuxostat on pregnancy or on the health of the fetus/new born child. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/fetal development or parturition. The potential risk for human is unknown. Febuxostat Tablets should not be used during pregnancy.
Breast-feeding: It is unknown whether Febuxostat is excreted in human breast milk. Animal studies have shown excretion of this active substance in breast milk and an impaired development of suckling pups. A risk to a suckling infant cannot be excluded. Febuxostat Tablets should not be used while breast-feeding.
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