Volina Use In Pregnancy & Lactation

Pregnancy: Volina is not indicated during pregnancy.
If pregnancy occurs during use of Volina, the preparation should be withdrawn immediately. Neither an increased risk of birth defects in children born to women who used COCs prior to pregnancy, nor a teratogenic effect when COCs were taken inadvertently during pregnancy have been revealed.
Animal data have shown undesirable effects during pregnancy and lactation. Based on these animal data, undesirable effects due to hormonal action of the active compounds cannot be excluded. However, general experience with COCs during pregnancy did not provide evidence for an actual undesirable effect in humans.
The available data regarding the use of drospirenone/ethinylestradiol during pregnancy are too limited to permit conclusions concerning negative effects of drospirenone/ethinylestradiol on pregnancy, health of the foetus or neonate. To date, no relevant epidemiological data are available.
The increased risk of VTE during the postpartum period should be considered when re-starting Volina (see Dosage & Administration and Precautions).
Breast-feeding: Lactation may be influenced by COCs as they may reduce the quantity and change the composition of breast milk. Therefore, the use of COCs should generally not be recommended until the breast-feeding mother has completely weaned her child. Small amounts of the contraceptive steroids and/or their metabolites may be excreted with the milk during COC use. These amounts may affect the child.