国家: 爱尔兰
语言: 英文
来源: HPRA (Health Products Regulatory Authority)
Drospirenone; Ethinylestradiol
Laboratorios Leon Farma, S.A.
G03AA; G03AA12
Drospirenone; Ethinylestradiol
0.03 / 3 milligram(s)
Film-coated tablet
Product subject to prescription which may be renewed (B)
Progestogens and estrogens, fixed combinations; drospirenone and ethinylestradiol
Not marketed
2009-10-09
LF-DRSP-EE-CC-IE.H.0763.001.IA.011-D0 1 PACKAGE LEAFLET: INFORMATION FOR THE USER0.02 MG/3 MG FILM-COATED TABLETS ETHINYLESTRADIOL/DROSPIRENONE) READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU • Keep this leaflet. You may need to read it again. • If you have any further questions, ask your doctor, pharmacist or nurse. • This medicine has been prescribed for you only, do not pass it on to others. It may harm them, even if their symptoms are the same as yours. • If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. IMPORTANT THINGS TO KNOW ABOUT COMBINED HORMONAL CONTRACEPTIVES (CHCS): • They are one of the most reliable reversible methods of contraception if used correctly • They slightly increase the risk of having a blood clot in the veins and arteries, especially in the first year or when restarting a combined hormonal contraceptive following a break of 4 or more weeks • Please be alert and see your doctor if you think you may have symptoms of a blood clot (see section 2 “Blood clots”) WHAT IS IN THIS LEAFLET : 1. What 阅读完整的文件is and what it is used for 2. What you need to know before you take 3. How to take 4. Possible side effects 5. How to store 6. Contents of the pack and other information LF-DRSP-EE-CC-IE.H.0763.001.IA.011-D0 2 1. WHAT IS AND WHAT IT IS USED FOR • is a contraceptive pill and is used to prevent pregnancy. • Each film-coated tablet contains a small amount of two different female hormones, namely drospirenone and ethinylestradiol. • Contraceptive pills that contain two hormones are called “combination” pills. 2. WHAT YOU NEED TO KNOW BEFORE TO TAKE GENERAL NOTES Before you start using you should read the information on blood clots in section 2. It is particul
Health Products Regulatory Authority 09 November 2022 CRN00D6FY Page 1 of 17 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Ethinylestradiol / Drospirenone Leon Farma 0.03mg/3 mg Film-coated Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 0.03 mg of ethinylestradiol and 3 mg of drospirenone Excipient with known effect: each tablet contains 62 mg lactose monohydrate For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablets Yellow, round film-coated tablets with a diameter of 5.7mm approx. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Oral contraception The decision to prescribe Ethinylestradiol/Drospirenone Leon Farma should take into consideration the individual woman’s current risk factors, particularly those for venous thromboembolism (VTE), and how the risk of VTE with Ethinylestradiol/Drospirenone Leon Farma compares with other combined hormonal contraceptives (CHCs) (see sections 4.3 and 4.4). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION _METHOD OF ADMINISTRATION_ Oral use. Posology HOW TO TAKE ETHINYLESTRADIOL/DROSPIRENONE LEON FARMA 0.03MG/3 MG FILM-COATED TABLETS The tablets must be taken every day at about the same time, if necessary with a little liquid, in the order shown on the blister pack. One tablet is to be taken daily 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 usually starts on day 2-3 after the last tablet and may not have finished before the next pack is started. HOW TO START ETHINYLESTRADIOL/DROSPIRENONE LEON FARMA 0.02 MG/ 3 MG FILM COATEDTABLETS No preceding hormonal contraceptive use (in the past month) Tablet-taking has to start on day 1 of the woman's natural cycle (i.e. the first day of her menstrual bleeding). Changing from a combined hormonal contraceptive (combined oral contraceptive (COC), vaginal ring, or transdermal patch) Health Products Regulatory Authority 09 November 2022 阅读完整的文件