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Ezetimibe Sandoz co-administered with a statin is contraindicated during pregnancy and lactation (see Contraindications), please refer to the SmPC for that particular statin.
Use in Pregnancy: Ezetimibe Sandoz should be given to pregnant women only if clearly necessary. No clinical data are available on the use of Ezetimibe Sandoz during pregnancy. Animal studies on the use of ezetimibe in monotherapy have shown no evidence of direct or indirect harmful effects on pregnancy, embryofoetal development, birth or postnatal development (see Pharmacology: Toxicology: Preclinical Safety Data under Actions).
Use in Lactation: Ezetimibe Sandoz should not be used during lactation. Studies on rats have shown that ezetimibe is secreted into breast milk. It is not known if ezetimibe is secreted into human breast milk.
Fertility: No clinical trial data are available on the effects of Ezetimibe Sandoz on human fertility. Ezetimibe had no effect on the fertility of male or female rats (see Pharmacology: Toxicology: Preclinical Safety Data under Actions).
