Zemimet SR Use In Pregnancy & Lactation

Pregnancy: No studies have been conducted with the combined active substances of Zemimet SR 50/1000 mg.
There are no adequate and well-controlled studies in pregnant women with gemigliptin. Animal studies have shown reproductive toxicity at high doses of gemigliptin (see PHARMACOLOGY: Toxicology: Preclinical safety data under Actions). 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 (see also PHARMACOLOGY: Toxicology: Preclinical safety data under Actions).
Zemimet SR 50/1000 mg should not be used during pregnancy. If a patient wishes to become pregnant or if a pregnancy occurs, treatment with Zemimet SR 50/1000 mg should be discontinued and switched to insulin treatment as soon as possible (see Precautions).
Lactation: No studies have been conducted with the combined active substances of Zemimet SR 50/1000 mg.
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 50/1000 mg must therefore not be used in women who are breastfeeding (see Precautions).
Fertility: No studies have been conducted with the combined active substances of Zemimet SR 50/1000 mg.
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 rat.