Precautions for use

  • Potential pregnancy

If there is any reason to believe that the woman may already have an established pregnancy, she should be referred to a doctor1

ellaOne® is not intended for use during pregnancy and should not be taken by any woman suspected or known to be pregnant.1

However, ellaOne® does not interrupt an existing pregnancy

Women may believe they are pregnant from the moment of unprotected sex, so asking “Could you be pregnant?” is unhelpful.
More specific questions e.g. “Is your menstrual period due or late?” will be more helpful. If the woman’s period is late, or in case of symptoms of pregnancy, she should do a pregnancy test or be referred to a doctor before taking ellaOne.

  • ellaOne® does not prevent pregnancy in every case.

If the woman’s next menstrual period is more than 7 days late, or abnormal in
character, or if there are symptoms suggestive of pregnancy, or in case of
doubt, a pregnancy test should be performed. It is important that any pregnancy
in a woman who has taken ellaOne® be reported to www.hra-pregnancy-registry.com. The purpose of this web-based registry is to collect safety information from women who have taken ellaOne® during pregnancy or who become pregnant after ellaOne® intake. All patient data collected will remain anonymous.

Pregnancy registry

  • 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.

  • After using ellaOne®, women should be advised to use a reliable barrier method until their next menstrual period.

If a woman wishes to initiate or continue using hormonal contraception, she can do so after using ellaOne®, however she should be advised to use a reliable barrier method until her next menstrual period.

 

 

References

1.ellaOne ® European Union Summary of Product Characteristics