PRODUCT DESCRIPTION:

Ulipristal Acetate Tablets are a selective progesterone receptor modulator (SPRM) designed for dual clinical applications: as a highly effective emergency contraceptive and as a fibroid management therapy in women of reproductive age.

The 30 MG strength is used as a single-dose oral emergency contraceptive to prevent pregnancy within 120 hours (5 days) of unprotected intercourse or contraceptive failure.

The 5 MG strength is used in the intermittent or continuous treatment of uterine fibroids, helping to reduce their size and control related symptoms such as heavy menstrual bleeding.

Formulation & Presentation:

• Dosage Form: Tablets
• Presentation: Blister Pack Strips
• Available Strengths
  • Ulipristal Acetate 5 MG Tablets
  • Ulipristal Acetate 30 MG Tablets
• Route of Administration: Oral (As per physician’s discretion or therapeutic indication)

Therapeutic Indications:

• 30 MG Tablet: Emergency contraception within 120 hours (5 days) of unprotected intercourse
• 5 MG Tablet: Preoperative or intermittent treatment of moderate to severe symptoms of uterine fibroids in adult women of reproductive age

Side Effects:

• COMMON Headache, Nausea, Abdominal pain, Menstrual irregularities, Fatigue, Breast tenderness
• SERIOUS (RARE): Liver enzyme elevation, Endometrial changes (benign and reversible), Hypersensitivity reactions, Risk of liver injury requiring monitoring during long-term use (primarily with 5 MG)
• PRECAUTIONS: Not intended for ongoing contraceptive use
  • Contraindicated in known or suspected pregnancy
  • Caution in patients with hepatic impairment; regular liver function monitoring advised (especially for 5 MG)
  • Not recommended in women with unexplained vaginal bleeding
  • Should not be used with hormonal contraceptives, which may reduce its effectiveness