Emergency contraception, For pre-operative treatment of moderate to severe symptoms of uterine fibroids in adult women of reproductive age

May be taken with or without food.

Oral Emergency Contraception: One tablet taken orally as soon as possible within 120 hours (5 days) after unprotected intercourse or a known or suspected contraceptive failure. If vomiting occurs within 3 hours of Ulipristal Acetate intake, consideration should be given to repeating the dose. Uterine Fibroids: The treatment consists of 1 tablet of 5 mg to be taken orally once daily for up to 3 months. This 3-month treatment course can be repeated once. Re-treatment should start at the earliest during the second menstruation following the 1st treatment course completion. Treatments should always be started during the 1st week of menstruation. If a patient misses a dose, the patient should take ulipristal acetate as soon as possible. If the dose was missed by >12 hrs, the patient should not take the missed dose and simply resume the usual dosing schedule.

Ulipristal Acetate is contraindicated for use in the case of known or suspected pregnancy. Hypersensitivity to ulipristal acetate or to any of the excipients. Genital bleedng or unknown aetiology or for reasons other than uterine fibroids. Uterine, cervical, ovarian or breast cancer. Breastfeeding.

Selective progesterone receptor modulator with antagonistic and partial agonistic effects. When taken immediately before ovulation, postpones follicular rupture. It is thought that the primary mechanism of action for emergency contraception is inhibition or delay of ovulation; however, alterations to the endometrium that may affect implantation may also occur.

Existing Pregnancy Not indicated for termination of an existing pregnancy. Pregnancy should be excluded before prescribing Ulipristal Acetate. Ectopic Pregnancy A history of ectopic pregnancy is not a contraindication to use of this emergency contraceptive method. Repeated Use Ulipristal Acetate is for occasional use as an emergency contraceptive. It should not replace a regular method of contraception. Repeated use of Ulipristal Acetate within the same menstrual cycle is not recommended, as safety and efficacy of repeat use within the same cycle has not been evaluated. Fertility Following Use A rapid return of fertility is likely following treatment with Ulipristal Acetate for emergency contraception; therefore, routine contraception should be continued or initiated as soon as possible following use of Ulipristal Acetate to ensure ongoing prevention of pregnancy. Effect on Menstrual Cycle After Ulipristal Acetate intake, menses sometimes occur earlier or later than expected by a few days. Contraception Concomitant use of progestagen only pills, a progestagen releasing intrauterine device or combined oral contraceptive pills is not recommended (see Interactions). Although a majority of women taking a therapeutic dose of ulipristal acetate have anovulation, a non hormonal contraceptive method is recommended during treatment. Sexually Transmitted Infections/HIV This does not protect against HIV infection (AIDS) or other sexually transmitted infections (STIs). Endometrial Changes Changes in the histology of the endometrium may be observed in patients treated with ulipristal acetate. These changes are reversible after treatment cessation. These histological changes should not be mistaken for endometrial hyperplasia .

Mood disorders; headache, dizziness; nausea, abdominal pain/discomfort, vomiting; myalgia, back pain; dysmenorrhea, pelvic pain, breast tenderness; fatigue.

Concomitant administration of medicinal products containing progestagen is not recommended. Also concomitant use of ulipristal acetate and potent CYP3A4 inducers (eg, rifampicin, rifabutin, carbamazepine, oxcarbazepine, phenytoin, fosphenytoin, phenobarbital, primidone, St John´s wort, efzvirenz, nevirapine, long term use of ritonavir) is not recommended.