Glucophage/Glucophage Forte/Glucophage XR: Pregnancy: Uncontrolled diabetes during pregnancy (gestational or permanent) is associated with increased congenital abnormalities and perinatal mortality.
A limited amount of data from the use of metformin in pregnant women does not indicate an increased risk of congenital abnormalities. Animal studies do not indicate harmful effects with respect to pregnancy, embryonic or fetal development, parturition or postnatal development.
However, when the patient plans to become pregnant and during pregnancy, it is recommended that prediabetes and diabetes are not treated with metformin. In diabetes, insulin should be used to maintain blood glucose levels as close to normal as possible.
Lactation: Metformin is excreted into human breast milk in very small amounts. No adverse effects were observed in breastfed newborns/infants. However, as only limited data are available, breastfeeding is not recommended during metformin treatment.
A decision on whether to discontinue breastfeeding or to discontinue metformin needs to take into account the benefit of breastfeeding, the importance of the medicinal product to the mother, and the potential risk of adverse effects in the infant.