Pays: Nouvelle-Zélande
Langue: anglais
Source: Medsafe (Medicines Safety Authority)
Ulipristal acetate 5mg
Pharmacy Retailing (NZ) Ltd t/a Healthcare Logistics
Ulipristal acetate 5 mg
5 mg
Tablet
Active: Ulipristal acetate 5mg Excipient: Croscarmellose sodium Magnesium stearate Mannitol Microcrystalline cellulose Purified talc
Prescription
Crystal Pharma SA
Ulipristal acetate is indicated for intermittent treatment of moderate to severe symptoms of uterine fibroids in adult women of reproductive age.
Package - Contents - Shelf Life: Blister pack, PVC/PE/PVDC, PVC/PVDC blister packs, Al foil closure - 28 tablets - 36 months from date of manufacture stored at or below 30°C protect from light - Blister pack, PVC/PE/PVDC, PVC/PVDC blister packs, Al foil closure - 84 tablets - 36 months from date of manufacture stored at or below 30°C protect from light
2017-03-27
Esmya ® _Version 3.0 - January 2019_ Page 1 of 3 ESMYA ® ULIPRISTAL ACETATE 5 MG TABLET CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET _ _ This leaflet answers some common questions about Esmya ® . It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you being given Esmya ® against the expected benefits it will have for you. IF YOU HAVE ANY CONCERNS ABOUT BEING GIVEN THIS MEDICINE, ASK YOUR DOCTOR. KEEP THIS LEAFLET. You may need to read it again. WHAT ESMYA ® IS USED FOR Esmya ® 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). Esmya ® is used in adult women (over 18 years of age) before they reach 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 occurring hormone in the body. It is used either before an operation on your fibroids or for long term treatment of your fibroids to reduce their size, to stop or reduce bleeding and to increase your red blood cell count. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY THIS MEDICINE HAS BEEN PRESCRIBED FOR YOU. BEFORE YOU TAKE ESMYA ® You should know that most women have no menstrual bleeding (period) during the treatment and for a few weeks afterwards. _WHEN YOU MUST NOT TAKE IT _ - if you are allergic to ulipristal acetate or any of the ingredients listed at the end of this leaflet. - if you have an underlying hepatic disorder. if you are pregnant or if you are breastfeeding. - if you have vaginal bleeding not caused by uterine fibroids. - if you have cancer of the uterus (womb), cervix (the neck of the womb), ovary or breast. You should not use this medicine after th Lire le document complet
NEW ZEALAND DATA SHEET_ - ESMYA_ ® _ _ V2.0 January 2019 Page 1 of 21 NEW ZEALAND DATA SHEET 1 PRODUCT NAME Esmya ® 5 mg ulipristal acetate tablet 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 of reproductive age who are not eligible for surgery. 4.2 DOSE AND METHOD OF ADMINISTRATION Esmya treatment is to be initiated and supervised by physicians experienced in the diagnosis and treatment of uterine fibroids. DOSE 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. NEW ZEALAND DATA SHEET_ - ESMYA_ ® _ _ V2.0 January 2019 Page 2 of 21 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 POPULATIONS _ _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 impairment unless the patient is closely monitored. _Paediatric pop Lire le document complet