Norpregna-5 (1)
Norpregna-5 (1)

Norpregna 5mg

Pharmaceutical

Product Details:

Brand Name: Norpregna 5mg Tablet

Composition

Each Norpregna Tablet 5 mg contains: 

Ulipristal acetate ........................................................ 5 mg                                                           

Therapeutic Indications                 

  • a 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 are not suitable or have 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 blisters of 10 tablets