EllaOne

Warnings

ellaOne is for occasional use only. It should in no instance replace a regular contraceptive method. In any case, women should be advised to adopt a regular method of contraception.

ellaOne is not intended for use during pregnancy and should not be taken by any woman suspected or known to be pregnant. However, ellaOne does not interrupt an existing pregnancy.

ellaOne does not prevent pregnancy in every case.

In case the next menstrual period is more than 7 days late, if the menstrual period is abnormal in character or if there are symptoms suggestive of pregnancy or in case of doubt, a pregnancy test should be performed. As with any pregnancy, the possibility of an ectopic pregnancy should be considered. It is important to know that the occurrence of uterine bleeding does not rule out ectopic pregnancy. Women who become pregnant after taking ellaOne should contact their doctor.

ellaOne inhibits or postpones ovulation. If ovulation has already occurred, ellaOne is no longer effective. The timing of ovulation cannot be predicted and therefore ellaOne should be taken as soon as possible after unprotected intercourse.

Limited and inconclusive data suggest that there may be reduced efficacy of ellaOne with increasing body weight or body mass index (BMI). In all women, emergency contraception should be taken as soon as possible after unprotected intercourse, regardless of the woman’s body weight or BMI.

After ellaOne intake menstrual periods can sometimes occur a few days earlier or later than expected. In approximately 7% of the women, menstrual periods occurred more than 7 days earlier than expected. In 18.5% of the women a delay of more than 7 days occurred, and in 4% the delay was greater than 20 days.

Concomitant use of ulipristal acetate and emergency contraception containing levonorgestrel is not recommended.

See patient information leaflet for more information.