Drospirenone

Drospirenone is not indicated during pregnancy.

If pregnancy occurs during use of drospirenone, the preparation should be withdrawn immediately. Extensive epidemiological studies have revealed neither an increased risk of birth defects in children born to women who used OCs prior to pregnancy, nor a teratogenic effect when OCs were taken inadvertently during pregnancy.

Animal studies 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 OCs during pregnancy did not provide evidence for an actual undesirable effect in humans.

The available data regarding the use of drospirenone during pregnancy are too limited to permit conclusions concerning negative effects of drospirenone 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 drospirenone.

Lactation may be influenced by OCs as they may reduce the quantity and change the composition of breast milk. Therefore, the use of OCs 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.

No studies on the effects on the ability to drive and use machines have been performed. No effects on ability to drive and use machines have been observed in users of OCs.