País: Irlanda
Idioma: inglés
Fuente: HPRA (Health Products Regulatory Authority)
ESTRADIOL ESTRADIOL MEDROXYPROGESTERONE ACETATE
Resource Medical (UK) Limited
Film Coated Tablet
2008-03-07
PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Estopause Film-coated Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each white tablet contains 2 mg of Oestradiol. Each pale blue tablet contains 2 mg of Oestradiol and 5 mg of Medroxyprogesterone Acetate. _For excipients see 6.1._ 3 PHARMACEUTICAL FORM Film-coated tablet. Calendar pack consisting of 16 round, white, biconvex tablets and 12 round, pale-blue, biconvex tablets. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Hormone replacement therapy (HRT) for estrogen deficiency symptoms. In post menopausal women with an intact uterus. Second line therapy for prevention of osteoporosis in postmenopausal women at high risk of future fractures who are intolerant of, or contraindicated for , other medicinal products approved for the prevention of osteoporosis. The experience of treating women older than 65 years is limited. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Adults and elderly Estopause is a continuous sequential combined HRT regimen (Oestrogen and Medroxyprogesterone). The oestrogen phase (2mg oestrogen [17 oestradol] is given for the first 16 days. This is followed by a combined oestrogen and progesterone acetate for 12 days. The regimen is based on a 28 day cycle which one tablet is taken daily without interruption. One tablet of oestrogen 2mg is taken daily for the first 16 days. This is followed by one tablet daily for the following 12 days of combined tablet contains (oestrogen 2mg and medroxyprogesterone 5mg). In menstruating women or women already on HRT, the first tablet should be taken in the fifth day of menstrual bleeding. If menstruating has stopped or is infrequent or sporadic, the first tablet can be taken at any time. Tablets should be taken approximately at the same Leer el documento completo