Zemimet SR Use In Pregnancy & Lactation

Pregnancy: No studies have been conducted with the combined active substances of Zemimet SR. There are no adequate and well-controlled studies in pregnant women with gemigliptin. Animal studies have shown reproductive toxicity at high doses of gemigliptin. Because of the high safety margin, no relevant risk is suggested for pregnant women.
To date, no relevant epidemiological data are available with regard to the use of metformin. Animal studies with metformin do not indicate harmful effects with respect to pregnancy, embryonic or foetal development, parturition, or postnatal development.
Zemimet SR should not be used during pregnancy. If a patient wishes to become pregnant or if a pregnancy occurs, treatment with Zemimet SR should be discontinued and switched to insulin treatment as soon as possible.
Lactation: No studies have been conducted with the combined active substances of Zemimet SR There is no information on excretion of gemigliptin or metformin into human milk. In animal studies performed with the individual active substances, both gemigliptin and metformin are excreted in the milk of lactating rats.
Zemimet SR must therefore not be used in women who are breastfeeding.
Fertility: No studies have been conducted with the combined active substances of Zemimet SR.
No studies on the effect on human fertility have been conducted for gemigliptin.
Animal studies with gemigliptin or metformin do not indicate harmful effects to fertility in male and female rats.