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ELLA- ulipristal acetate tablet

Patient Information

[See FDA-Approved Patient Labeling]

Information for Patients

  • Instruct patients to takeellaas soon as possible and not more than 120 hours after unprotected intercourse or a known or suspected contraceptive failure.
  • Advise patients that they should not takeellaif they know or suspect they are pregnant and thatellais not indicated for termination of an existing pregnancy.
  • Advise patients to contact their healthcare provider immediately in case of vomiting within 3 hours of taking the tablet, to discuss whether to take another tablet.
  • Advise patients to seek medical attention if they experience severe lower abdominal pain 3 to 5 weeks after takingella, in order to be evaluated for an ectopic pregnancy.
  • Advise patients to contact their healthcare provider and consider the possibility of pregnancy if their period is delayed after takingellaby more than 1 week beyond the date it was expected.
  • A web-based study has been established to collect information on the pregnancy outcomes of women who inadvertently receive ella during the cycle in which pregnancy started or at any time during pregnancy. Notify patients that they can enroll by completing the forms available at where voluntary reports from health care providers or consumers are received.
  • Advise patients not to useellaas routine contraception, or to use it repeatedly in the same menstrual cycle.
  • Advise patients that using ella and hormonal contraceptives together can affect the effectiveness of each. Advise patients to use a reliable barrier method for all subsequent acts of intercourse until the next menstrual period. If a woman wishes to use hormonal contraception, she should do so no sooner than 5 days after intake ofella, and she should use a reliable barrier method until the next menstrual period.
  • Advise patients not to use ella if they are taking a CYP3A4 inducer.
  • Inform patients thatelladoes not protect against HIV infection (AIDS) and other sexually transmitted diseases/infections.
  • Advise patients that they should not useellaif they are breastfeeding because ella enters the breast milk.

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