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Fertility: No animal studies have been conducted with the combined products in sitagliptin and metformin hydrochloride to evaluate effects on reproduction.
Pregnancy: There are no adequate and well-controlled studies in pregnant women with sitagliptin and metformin hydrochloride or its individual components; therefore, the safety of in pregnant women is not known. XIGLIP M is not recommended for use in pregnancy.
Lactation: No studies in lactating animals have been conducted with combined components of sitagliptin and metformin hydrochloride. In studies performed with the individual active substances, both sitagliptin and metformin are excreted in the milk of lactating rats.
Metformin is excreted in human milk in small amounts. It is not known whether sitagliptin is excreted in human milk. XIGLIP M must not be used in women who are breastfeeding.
