Country: Irlanda
Lingwa: Ingliż
Sors: HPRA (Health Products Regulatory Authority)
NORGESTIMATE ETHINYLESTRADIOL
PCO Manufacturing
250/35 Microgram
Tablets
2009-07-03
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Cilest 250/35 microgram Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 250 micrograms norgestimate and 35 micrograms ethinylestradiol. Excipient: contains lactose anhydrous For a full list of excipients see section 6.1. 3 PHARMACEUTICAL FORM Tablet _Product imported from the UK:_ A dark blue, flat, bevel-edged tablet engraved “C” over “250” on both faces. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Hormonal contraception. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION For oral administration. Adults: When used perfectly, without missing any pills, the chance of becoming pregnant is less than 1% (i.e. <1 pregnancy per 100 women in their first year of use). Typical failure rates are actually 5% in the first year. The chance of becoming pregnant increases with each missed pill during a menstrual cycle. Before starting Cilest, a thorough general medical and gynaecological examination (including the breasts and a cytological smear of the cervix) if appropriate should be carried out and the family medical history carefully noted. Disturbances of the clotting mechanisms should be ruled out if any members of the family have suffered from thrombo- embolic diseases (eg deep vein thrombosis, stroke, myocardial infarction) at a young age. Pregnancy must be excluded ideally by a pregnancy test. As a precaution, thorough medical examinations should be conducted at approximately six month intervals during use of the tablets. Children: Safety and efficacy of Cilest Tablets have only been established in women of reproductive age. Elderly: Not indicated in post menopausal women. IRISH MEDICINES BOARD _____________________________________________________________________________________________________________________ Aqra d-dokument sħiħ