Belara Use In Pregnancy & Lactation

Pregnancy: Belara is not recommended during pregnancy. Prior to starting to use the medicine pregnancy must be ruled out. If pregnancy occurs during Belara treatment, the medicinal product is to be discontinued immediately. Thus far, most of the epidemiological studies have shown no clinical evidence of teratogenic or foetotoxic effects when estrogens were accidentally taken during pregnancy in combination with other progestogens in doses similar to those in Belara. Although animal experiments have shown evidence of reproductive toxicity, clinical data of more than 330 exposed human pregnancies did not show any embryotoxic effects of chlormadinone acetate.
The increased risk of VTE during the postpartum period should be considered when re-starting Belara (see Dosage & Administration and Precautions).
Breast-feeding: Lactation may be affected by estrogens as they may affect the quantity and composition of the breastmilk.
Small quantities of contraceptive steroids and/or their metabolites may be excreted in the breastmilk and may thus affect the child. Therefore Belara should not be used during lactation.