Brand Name: Norpregna 5mg Tablet.
Composition:
Each Norpregna Tablet 5 mg contains: Ulipristal acetate ................................................... 5 mg
Therapeutic Indications:
- Norpregna is a medicine for treating moderate to severe symptoms of uterine fibroids. Uterine fibroids arevnon-cancerous (benign) tumors of the womb (uterus).
- Norpregna 5mg is for use only in women who have not yet reached the menopause and in whom fibroid embolisation (a non-surgical procedure to block off the arteries that feed the fibroids) or surgery is not suitable or has not worked.
Dosage and Administration:
- 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.
- Treatments should only be initiated when menstruation has occurred:
- The first treatment course should start during the first week of menstruation.
- Re-treatment courses should start at the earliest during the first week of the second menstruation following the previous treatment course completion.
- Repeated intermittent treatment has been studied up to 4 intermittent courses.
- If a patient misses a dose, the patient should take ulipristal acetate as soon as possible. If the dose was missed by more than 12 hours, the patient should not take the missed dose and simply resume the usual dosing schedule
Contraindications:
- Hypersensitivity to the active substance or to any of the excipients listed in section
- Pregnancy and breastfeeding.
- Genital bleeding of unknown etiology or for reasons other than uterine fibroids.
- Uterine, cervical, ovarian or breast cancer.
- Underlying hepatic disorder
Warnings and precautions:
- Contraception
- Endometrial changes
- Bleeding pattern
- Renal impairment
- Hepatic injury
- Asthma patients
- Co-administration of moderate (e.g. erythromycin, grapefruit juice, verapamil) or potent (e.g. ketoconazole, ritonavir, nefazodone, itraconazole, telithromycin, clarithromycin) CYP3A4 inhibitors and ulipristal acetate is not recommended
Undesirable Effects:
- Amenorrhea Endometrial thickening
- Headache
- Vertigo
- Abdominal pain Nausea
- Hot flush* Pelvic pain Ovarian cyst* Breast tenderness/pain
- Weight increased
- Musculoskeletal pain
Pharmacological Properties:
Norpregna is an orally-active synthetic selective progesterone receptor modulator characterized
by a tissue-specific partial progesterone antagonist effect. Mechanism of action
Ulipristal acetate exerts a direct effect on the endometrium. Ulipristal acetate exerts a direct action on fibroids reducing their size through inhibition of cell proliferation and induction of apoptosis
Packaging:
Norpregna Tablet 5 mg: Box containing 1 blister of 10 tablets.
