Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2021 Publisher: Gedeon Richter Plc., Gyรถmrลi รบt 19-21., 1103 Budapest, Hungary
Ulipristal acetate is indicated for intermittent treatment of moderate to severe symptoms of uterine fibroids in adult women who have not reached menopause when uterine fibroid embolisation and/or surgical treatment options are not suitable or have failed.
Esmya treatment is to be initiated and supervised by physicians experienced in the diagnosis and treatment of uterine fibroids.
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 treating physician should explain to the patient the requirement for treatment free intervals.
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.
No dose adjustment is recommended in patients with mild or moderate renal impairment. In the absence of specific studies, ulipristal acetate is not recommended in patients with severe renal impairment unless the patient is closely monitored (see sections 4.4 and 5.2).
There is no relevant use of ulipristal acetate in the paediatric population. The safety and efficacy of ulipristal acetate was only established in women of 18 years and older.
Oral use. Tablets should be swallowed with water.
Experience with ulipristal acetate overdose is limited.
Single doses up to 200 mg and daily doses of 50 mg for 10 consecutive days were administered to a limited number of subjects, and no severe or serious adverse reactions were reported.
3 years.
Keep the blisters in the outer carton in order to protect from light.
Alu/PVC/PE/PVDC or Alu/PVC/PVDC blister.
Pack of 28, 30 and 84 tablets.
Not all pack sizes may be marketed.
No special requirements.
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