Fibropress

Generic Name: Ulipristal Acetate
Dosage Form: Tablet
TG Name: Hormones & Steroid

1. What Fibropress^® is and what it is used for?
Uterine fibroids are a major cause of morbidity in women of a reproductive age. The management of symptomatic fibroids has traditionally been surgical. However, USFDA recently approved ulipristal acetate, an oral selective progesterone-receptor modulator, for the same indication. Ulipristal acetate is a new, effective, and well-tolerated option for the preoperative treatment of moderate and severe symptoms of uterine fibroids in women of reproductive age. Clinical data shows ulipristal acetate has several advantages: it acts faster in reducing the fibroid-associated bleeding, it significantly improves hemoglobin and hematocrit levels in anemic patients, and it grants a significant reduction in the size of fibroids.

Uses:
Ulipristal acetate is indicated for pre-operative treatment of moderate to severe symptoms of uterine fibroids in adult women of reproductive age.

2. How to take this medicine?
The treatment consists of one tablet of 5 mg to be taken once daily for treatment courses of up to 3 months each. Tablets may be taken with or without food

3. Who should NOT take this medication?
Fibropress is contraindicated in:
Contact your doctor if you experience these side effects and they are severe or bothersome.

1. Hypersensitivity to the drug or to any of its components.
2. Pregnancy and breastfeeding.
3. Genital bleeding of unknown aetiology or for reasons other than uterine fibroids.
4. Uterine, cervical, ovarian or breast cancer.

4. What special precautions for use?
Ulipristal acetate should only be prescribed after careful diagnosis. Pregnancy should be precluded prior to treatment. If pregnancy is suspected prior to initiation of a new treatment course, a pregnancy test should be performed. Other precautions include;

• Patients with severe renal or moderate to severe hepatic impairment.
• Women with Endometrial changes, reduction in menstrual blood loss or amenorrhea.
• Not recommended w/ concomitant use of progestagen-only pills, a progestagen-releasing IUD or combined OC pills.

5. What side effects are possible with this medication?
Amenorrhea, hot flush, endometrial thickening. Headache; vertigo; abdominal pain, nausea; acne, hyperhidrosis; musculoskeletal pain; uterine hemorrhage, pelvic pain, ovarian cyst, breast tenderness/pain; edema, fatigue; increased blood cholesterol.

6. How supplied and storage condition of Fibropress^® Tablet?

• Fibropress^® Tablet: Box containing 10 tablets in 1X10’s blister strip. Each tablet contains Ulipristal acetate INN 5 mg.
• Fibropress^®must be kept out of the reach and sight of children. Protect from light and store below 30°C.