Država: Irska
Jezik: angleščina
Source: HPRA (Health Products Regulatory Authority)
Drospirenone; Ethinylestradiol
Laboratorios Leon Farma, S.A.
G03AA; G03AA12
Drospirenone; Ethinylestradiol
0.03 mg/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-DRSPEE-IE-IE.H.0764.002.IA.013_Day 0 1 PACKAGE LEAFLET: INFORMATION FOR THE USER ETHINYLESTRADIOL/DROSPIRENONE LEON FARMA 0.03 MG/3 MG 28 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 or pharmacist. • This medicine has been prescribed for you only. Do no pass it on to others. It may harm them. • If you get any side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. 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 Ethinylestradiol/Drospirenone Leon Farma is and what it is used for 2. What you need to know before you take Ethinylestradiol/Drospirenone Leon Farma 3. How to take Ethinylestradiol/Drospirenone Leon Farma 4. Possible side effects 5. How to store Ethinylestradiol/Drospirenone Leon Farma 6. Contents of the pack and other information 1. WHAT ETHINYLESTRADIOL/DROSPIRENONE LEON FARMA IS AND WHAT IT IS USED FOR • Ethinylestradiol/Drospirenone Leon Farma is a contraceptive pill and is used to prevent pregnancy. • Each of the 21yellow tablet contains a small amount of two different female hormones, namely drospirenone and ethinylestradiol. • The 7 white tablets contain no active substances and are also called placebo tablets. • Contraceptive pills that contain two hormones are called “combination” pills. 2. WHAT YOU NEE Preberite celoten dokument
Health Products Regulatory Authority 27 October 2022 CRN00D6Z2 Page 1 of 17 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Ethinylestradiol / Drospirenone Leon Farma & Placebo 0.03 mg/ 3 mg Film-coated Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION YELLOW TABLETS (ACTIVE TABLETS): Each film-coated tablet contains 0.03 mg of ethinylestradiol and 3 mg of drospirenone Excipient with known effect: Each film-coated tablet contains 62 mg lactose monohydrate WHITE TABLETS (PLACEBO TABLETS): The tablet does not contain active substances Excipient with known effect: Each film-coated tablet contains 89.5 mg lactose anhydrous For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet. Active tablets: Yellow, round film-coated tablets with a diameter of 5.7 mm approx. Placebo tablets: White, round film-coated tablets with a diameter of 5.7 mm approx. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Oral contraception 4.2 POSOLOGY AND METHOD OF ADMINISTRATION _METHOD OF ADMINISTRATION_ Oral use. Posology HOW TO TAKE ETHINYLESTRADIOL/DROSPIRENONE LEON 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. Tablet taking is continuous. One tablet is to be taken daily for 28 consecutive days. Each subsequent pack is started the day after the last tablet of the previous pack. Withdrawal bleeding usually starts on day 2-3 after starting the placebo tablets (last row) and may not have finished before the next pack is started. HOW TO START ETHINYLESTRADIOL/DROSPIRENONE LEON 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) The woman should start with Ethinylestradiol/Drospirenone Leonpreferably on the day after the last active tablet (the last tablet con Preberite celoten dokument