Gveza Use In Pregnancy & Lactation

Pregnancy: Gveza film-coated tablet is not indicated during pregnancy.
If pregnancy occurs during use of Gveza film-coated tablets, the preparation should be withdrawn immediately.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 COCs prior to pregnancy, nor a teratogenic effect when COCs were taken inadvertently during pregnancy.
Animal studies have shown undesirable effects during pregnancy and lactation (see Pharmacology: Toxicology: Preclinical safety data under Actions). 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 Gveza film-coated tablets during pregnancy are too limited to permit conclusions concerning negative effects of Gveza film-coated tablets 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 Gveza (see Dosage & Administration and Precautions).
Breastfeeding: 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.