Ulipristal Acetate is indicated for the preoperative treatment of moderate to severe symptoms associated with uterine fibroids, which are benign tumors of the uterus. It is used in adult women who have not yet reached menopause.

Ulipristal Acetate is a selective progesterone receptor modulator that works by blocking progesterone receptors. Progesterone is a hormone involved in regulating the growth of the uterine lining and may contribute to the growth of fibroids in some women. By inhibiting progesterone activity, Ulipristal Acetate prevents fibroid cells from dividing, leading to cell death, reduction in fibroid size, and improvement of symptoms such as heavy bleeding, anemia, and abdominal pain.

Ulipristal acetate is taken by mouth and the recommended dose is one tablet (5 mg) a day for up to three months. The three month treatment can be repeated but only once. Treatment should always be started during the first week of the menstrual cycle (period bleeding).

Ulipristal Acetate is contraindicated in patients with

• hypersensitivity to the active substance or any of its excipients.
• It should not be used during pregnancy or breastfeeding.
• It is also contraindicated in patients with genital bleeding of unknown origin or bleeding unrelated to uterine fibroids.
• Patients with uterine, cervical, ovarian, or breast cancer should not use this medication.

Common side effects of Ulipristal Acetate include endometrial thickening, hot flush, headache, and uterine hemorrhage.

Pregnancy Category X. Ulipristal Acetate is contraindicated during pregnancy. The drug is excreted into human breast milk and is not recommended during breastfeeding.

Ulipristal Acetate should only be prescribed after proper diagnosis, and pregnancy must be excluded before treatment.

• Contraception: Concurrent use of progestagen-only pills, progestagen-releasing intrauterine devices, or combined oral contraceptives is not recommended. Although many women may not ovulate during treatment, a non-hormonal contraceptive method is advised.
• Endometrial Changes: Ulipristal Acetate may cause endometrial thickening or Progesterone Receptor Modulator Associated Endometrial Changes (PAEC). Endometrial thickness usually returns to normal after treatment ends. Persistent thickening beyond 3 months should be clinically evaluated.
• Bleeding Pattern: Treatment often reduces menstrual bleeding or may cause temporary absence of menstruation within the first 10 days. Persistent excessive bleeding should be reported to a physician.
• Asthma Patients: Use is not recommended in women with severe asthma that is not adequately controlled with oral glucocorticoids.

Hepatic Impairment: Ulipristal Acetate is not recommended in severe hepatic impairment unless closely monitored.

Renal Impairment: Dose elimination is not expected to be significantly affected in renal impairment, but use is not recommended in moderate to severe renal impairment without close monitoring.

Experience with overdose is limited. Single doses up to 200 mg and repeated doses of 50 mg daily for 10 days have been administered without serious adverse reactions.

Drugs acting on the Uterus

Store below 25°C, protected from light and moisture. Keep out of the reach of children.