Pregnancy: Ella is not intended for use during pregnancy and should not be taken by any woman suspected or known to be pregnant (see Dosage & Administration).
Ella does not interrupt an existing pregnancy.
Pregnancy may occasionally occur after Ella intake. Although no teratogenic potential has been observed, animal data are insufficient with regard to reproduction toxicity (see Pharmacology: Toxicology: Preclinical safety data under Actions). Limited human data regarding pregnancy exposure to Ella do not suggest any safety concern. Nevertheless it is important that any pregnancy in a woman who has taken Ella be reported to Product Registration Holder. The purpose is to collect safety information from women who have taken Ella during pregnancy or who become pregnant after Ella intake. All patient data collected will remain anonymous.
Breastfeeding: Ulipristal acetate is excreted in breast milk (see Pharmacology: Pharmacokinetics under Actions). The effect on newborn/infants has not been studied. A risk to the breastfed child cannot be excluded. After intake of Ella breastfeeding is not recommended for one week. During this time it is recommended to express and discard the breast milk in order to stimulate lactation.
Fertility: A rapid return of fertility is likely following treatment with Ella for emergency contraception. Women should be advised to use a reliable barrier method for all subsequent acts of intercourse until the next menstrual period.