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Pregnancy: There are no data from the use of this medicinal product or empagliflozin in pregnant women. Animal studies show that empagliflozin crosses the placenta during late gestation to a very limited extent but do not indicate direct or indirect harmful effects with respect to early embryonic development. However, animal studies have shown adverse effects on postnatal development. A limited amount of data suggests that the use of metformin in pregnant women is not associated with an increased risk of congenital malformations. Animal studies with the combination of empagliflozin and metformin or with metformin alone have shown reproductive toxicity at higher doses of metformin only. When the patient plans to become pregnant, and during pregnancy, it is recommended that diabetes is not treated with this medicinal product.
Lactation: Metformin is excreted into human breast milk. No adverse effects were observed in breastfed newborns/infants. It is unknown whether empagliflozin is excreted in human milk.
Available nonclinical data in animals have shown excretion of empagliflozin in milk. A risk to human newborns/infants cannot be excluded. It is recommended to discontinue breast feeding during treatment with Jardiance Duo.
Fertility: No studies on the effect on human fertility have been conducted with Jardiance Duo or its individual components.
Non-clinical studies in animals with the individual components do not indicate direct or indirect harmful effects with respect to fertility.
