Country: Írland
Tungumál: enska
Heimild: HPRA (Health Products Regulatory Authority)
Ethinyloestradiol; Desogestrel
Gedeon Richter Plc
G03AA; G03AA09
Ethinyloestradiol; Desogestrel
20mcg/150 microgram(s)
Film-coated tablet
Product subject to prescription which may be renewed (B)
Progestogens and estrogens, fixed combinations; desogestrel and ethinylestradiol
Not marketed
2009-01-23
1 PACKAGE LEAFLET: INFORMATION FOR THE USER GEDAREL 20/150 MICROGRAMS FILM-COATED TABLETS ethinylestradiol and desogestrel 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”). 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 not pass it on to others. It may harm them. - If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Gedarel is and what it is used for 2. What you need to know before you take Gedarel 3. How to take Gedarel 4. Possible side effects 5. How to store Gedarel 6. Contents of the pack and other information 1. WHAT GEDAREL IS AND WHAT IT IS USED FOR Gedarel is a COC, also called the pill. It contains two types of female hormones: a progestogen, desogestrel, and an oestrogen, ethinylestradiol in a low dose. These help to stop you from getting pregnant, just as your natural hormones would stop you conceiving again when you are already pregnant. The COC pill protects you against getting pregnant in three ways. These hormones 1. stop the ovary from releasing an egg each month (ovulation). 2. also thicken the fluid (at the neck of the womb making it more difficult for the sperm to reach the egg. 3. alter the lining of the womb to make it less likely to accept a fertilised egg. GENERAL INFORMATION If tak Lestu allt skjalið
Health Products Regulatory Authority 15 February 2023 CRN00CX32 Page 1 of 16 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Gedarel 20/150 microgram film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 20 micrograms ethinylestradiol 150 micrograms desogestrel Excipient with known effect: 64.3 mg lactose (as lactose monohydrate). For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet Slightly yellow, round shaped, biconvex film-coated tablets of about 6 mm diameter, with P9 sign on one side and RG sign on other side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Oral contraception The decision to prescribe Gedarel should take into consideration the individual woman's current risk factors, particularly those for venous thromboembolism (VTE), and how the risk of VTE with Gedarel compares with other combined hormonal contraceptives (CHCs) (see sections 4.3 and 4.4). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology HOW TO TAKE GEDAREL Tablets must be taken in the order directed on the package every day at about the same time. One tablet is 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 GEDAREL _No preceding hormonal contraceptive use [in the past month]_ The tablet intake must be started on day 1 of the normal menstrual cycle (i.e. on the first day on which the woman has a menstrual bleeding). Tablet intake is also allowed to start on day 2-5, but during the first cycle concurrent use of a barrier method for the first 7 days of tablet intake is advisable. _Changing from a combined hormonal contraceptive (combined oral contraceptive (COC), combined contraceptive vaginal ring or _ _transdermal patch)_ The woman should start taking Gedarel on the day after the last active tablet (th Lestu allt skjalið