Nazione: Unione Europea
Lingua: inglese
Fonte: EMA (European Medicines Agency)
ulipristal acetate
Gedeon Richter Plc.
G03XB02
ulipristal acetate
Sex hormones and modulators of the genital system,
Leiomyoma
Ulipristal acetate is indicated for one treatment course of pre-operative treatment of moderate to severe symptoms of uterine fibroids in adult women of reproductive age.Ulipristal acetate is indicated for intermittent treatment of moderate to severe symptoms of uterine fibroids in adult women of reproductive age who are not eligible for surgery.
Revision: 1
Withdrawn
2018-08-27
26 B. PACKAGE LEAFLET Medicinal product no longer authorised 27 PACKAGE LEAFLET: INFORMATION FOR THE USER _ _ ULIPRISTAL ACETATE GEDEON RICHTER 5 MG TABLETS Ulipristal acetate READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor or pharmacist. - This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. - If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Ulipristal Acetate Gedeon Richter is and what it is used for 2. What you need to know before you take Ulipristal Acetate Gedeon Richter 3. How to take Ulipristal Acetate Gedeon Richter 4. Possible side effects 5. How to store Ulipristal Acetate Gedeon Richter 6. Contents of the pack and other information 1. WHAT ULIPRISTAL ACETATE GEDEON RICHTER IS AND WHAT IT IS USED FOR Ulipristal Acetate Gedeon Richter contains the active substance ulipristal acetate. It is used to treat moderate to severe symptoms of uterine fibroids (commonly known as myomas), which are non-cancerous tumours of the uterus (womb). Ulipristal Acetate Gedeon Richter is used in adult women (over 18 years of age) before they reach the menopause. In some women, uterine fibroids may cause heavy menstrual bleeding (your ‘period’), pelvic pain (discomfort in the belly) and create pressure on other organs. This medicine acts by modifying the activity of progesterone, a naturally occuring hormone in the body. It is used for long term treatment of your fibroids to reduce their size, to stop or reduce bleeding and to increase your red blood cell count. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ULIPRISTAL ACETATE GEDEON RICHTER _ _ You should know that most women have no menstrual bleeding (period) during the treat Leggi il documento completo
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS Medicinal product no longer authorised 2 1. NAME OF THE MEDICINAL PRODUCT Ulipristal Acetate Gedeon Richter 5 mg tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 5 mg of ulipristal acetate. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Tablet. White to off-white, round biconvex tablet of 7 mm engraved with “ES5” on one face. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS 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. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Ulipristal Acetate Gedeon Richter treatment is to be initiated and supervised by physicians experienced in the diagnosis and treatment of uterine fibroids. Posology 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. 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. _Special population_ _Renal impairment _ 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 impair Leggi il documento completo