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Pregnancy: There is a limited amount of data from the use of empagliflozin and linagliptin in pregnant women. Nonclinical studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity. As a precautionary measure it is recommended to avoid the use of GLYXAMBI during pregnancy unless clearly needed.
Lactation: No data in humans are available on excretion of empagliflozin and linagliptin into milk.
Available nonclinical data in animals have shown excretion of empagliflozin and linagliptin in milk. A risk to human newborns/infants cannot be excluded. It is recommended to discontinue breast feeding during treatment with GLYXAMBI.
Fertility: No studies on the effect on human fertility have been conducted for GLYXAMBI or with the individual components.
Nonclinical studies of empagliflozin alone and of linagliptin alone do not indicate direct or indirect harmful effects with respect to fertility.
