Country: Irlanda
Lingwa: Ingliż
Sors: HPRA (Health Products Regulatory Authority)
ESTRADIOL DROSPIRENONE
Bayer Limited
ESTRADIOL DROSPIRENONE
1, 2 Milligram
Film Coated Tablet
Product subject to prescription which may not be renewed (A)
Withdrawn
2010-10-15
PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Allurene 1 mg/2 mg film-coated tablets. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains: 1 mg estradiol (as estradiol hemihydrate) and 2 mg drospirenone. Excipient: 46 mg lactose. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet Medium red, round tablet with convex faces, one side embossed with the letters DL in a regular hexagon. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Hormone replacement therapy for oestrogen deficiency symptoms in postmenopausal women more than 1 year post menopause. 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. _(See also Section 4.4)_ The experience treating women older than 65 years is limited. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Women who do not take hormone replacement therapy (HRT) or women who change from another continuous combined product may start treatment at any time. Women changing from a cyclic, sequential combined HRT regimen, treatment should begin the day following completion of the prior regimen. _Dosage_ One tablet is taken daily. Each blister is for 28 days of treatment. _Administration_ The tablets are to be swallowed whole with some liquid irrespective of food intake. Treatment is continuous, which means that the next pack follows immediately without a break. The tablets should preferably be taken at the same time every day. If a tablet is forgotten it should be taken as soon as possible. If more than 24 hours have elapsed no extra tablet needs to be taken. If several tablets are forgotten, vaginal bleeding may occur. F Aqra d-dokument sħiħ