Држава: Ирска
Језик: Енглески
Извор: HPRA (Health Products Regulatory Authority)
ETHINYLESTRADIOL GESTODENE
Clonmel Healthcare Ltd
ETHINYLESTRADIOL GESTODENE
20/75 Microgram
Coated Tablets
Product subject to prescription which may be renewed (B)
Withdrawn
2013-03-20
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Estelle 20 micrograms/75 micrograms Coated Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 20 micrograms ethinylestradiol and 75 micrograms gestodene. Excipients: contains 38 mg lactose monohydrate and 20 mg sucrose. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Coated tablet. White, round, biconvex sugar coated tablets, both sides are without imprinting. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Oral contraception. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION _How to take Estelle:_ The tablets should be taken in the order indicated on the package, every day at approximately the same time. One tablet per day should be taken for 21 days. Each subsequent pack should be started after a 7-day tablet-free interval during which time a withdrawal bleeding will occur. This bleeding usually starts on the 2 nd or 3 rd day after taking the last tablet, and may not stop until the next pack is started. _How to start taking Estelle:_ _If no preceding hormonal contraceptive use in the past month:_ Taking of the tablets should begin on the first day of the woman’s natural cycle (i.e. on the first day of the woman’s menstrual bleeding). One may begin taking the pills on day 2 – 5, but in these cases, it is recommended that a barrier method also be used for the first 7 days on which pills are taken during the first cycle. _When replacing another contraceptive pill of the combination type:_ The woman should start taking Estelle on the next day after taking the last active tablet in her previous package of contraceptive pills – but no later than the day after the usual tablet-free or placebo-tablet period of her previous contraceptive pill. _When changin Прочитајте комплетан документ