Pregnancy: There are no adequate data from the use of Galvus Met in pregnant women. For vildagliptin studies in animals have shown reproductive toxicity at high doses. For metformin, studies in animals have not shown reproductive toxicity. Studies in animals performed with vildagliptin and metformin have not shown evidence of teratogenicity, but foetotoxic effects at maternotoxic doses (see Pharmacology: Toxicology: PRECLINICAL SAFETY DATA under Actions). The potential risk for humans is unknown. Galvus Met should not be used during pregnancy.
Breast-feeding: Studies in animals have shown excretion of both metformin and vildagliptin in milk. It is unknown whether vildagliptin is excreted in human milk, but metformin is excreted in human milk in low amounts. Due to both the potential risk of neonate hypoglycaemia related to metformin and the lack of human data with vildagliptin, Galvus Met should not be used during breast-feeding (see CONTRAINDICATIONS).
Fertility: No studies on the effect on human fertility have been conducted for Galvus Met. (see Pharmacology: Toxicology: PRECLINICAL SAFETY DATA under Actions).