Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
ETHINYLESTRADIOL LEVONORGESTREL ETHINYLESTRADIOL LEVONORGESTREL ETHINYLESTRADIOL LEVONORGESTREL
Medimpex France SA
Coated Tablets
2005-02-11
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Triregol coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 6 pink tablets: each tablet contains 50 microgram levonorgestrel and 30 microgram ethinylestradiol 5 white tablets: each tablet contains 75 microgram levonorgestrel and 40 microgram ethinylestradiol 10 ochre tablets: each tablet contains 125 microgram levonorgestrel and 30 microgram ethinylestradiol Each tablet contains 33 mg of lactose monohydrate and 22 mg of sucrose. For full list of excipients, _see section 6.1._ 3 PHARMACEUTICAL FORM Coated tablet. Pink, bright, biconvex, circular tablets White, bright, biconvex, circular tablets Ochre, bright, biconvex, circular tablets 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Oral contraception 4.2 POSOLOGY AND METHOD OF ADMINISTRATION How is triregol taken? The tablets must be taken in the order directed on the pack every day at approximately the same time of the day. One tablet daily is taken for 21 consecutive days. Each subsequent pack is started after a 7-day tablet-free interval ; during which time a withdrawal bleed usually occurs. This bleeding will usually begin on the 2nd or 3rd day after ingestion of the last tablet and it may not have ceased, before the next pack is started. How to start triregol _No preceding intake of hormonal contraceptives (within the last month)_ The tablet intake should start on day 1 in the woman's normal cycle (i.e. On the first day on which the woman has a menstrual bleeding). Starting intake on day 2-5 is allowed, but during the first cycle the concurrent use of barrier method during the first 7 days of tablet intake is advisable. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________ Read the complete document