Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Drospirenone; Ethinylestradiol
McDermott Laboratories Ltd t/a Gerard Laboratories
G03AA12
Drospirenone; Ethinylestradiol
0.02mg/3 milligram(s)
Tablet
drospirenone and ethinylestradiol
Not marketed
2019-03-22
1 PACKAGE LEAFLET: INFORMATION FOR THE USER MYELLE 0.02 MG / 3 MG TABLETS (ethinylestradiol/drospirenone) 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 Myelle is and what it is used for 2. What you need to know before you take Myelle 3. How to take Myelle 4. Possible side effects 5. How to store Myelle 6. Contents of the pack and other information 1. WHAT MYELLE IS AND WHAT IT IS USED FOR • Myelle is a contraceptive pill and is used to prevent pregnancy. • Each 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 YOU TAKE MYELLE GENERAL NOTES Before you start using Myelle you should read the information on blood clots in section 2. It is particularly important to read the symptoms of a blood clot – see Section 2 “Blood clots”. Before you start taking Myelle, your doctor will ask you about your personal health history and the health history of your close relatives. The doctor will also m Read the complete document
Health Products Regulatory Authority 23 May 2019 CRN0091SC Page 1 of 15 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Myelle 0.02 mg/3 mg tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 0.02 mg of ethinylestradiol and 3 mg of drospirenone. Excipients with known effect: Each tablet contains 72 mg of lactose monohydrate, 0.03 mg of Tartrazine (E102) and 0.008 mg of Sunset Yellow (E110). For the full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Tablet. Round, light yellow, uncoated biconvex tablets 6 mm in diameter, thickness 2.70mm, with '144' debossed on one side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Oral contraception. The decision to prescribe Myelle should take into consideration the individual woman's current risk factors, particularly those for venous thromboembolism (VTE), and how the risk of VTE with Myelle 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 MYELLE 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 MYELLE _No preceding hormonal contraceptive use (in the previous month)._ Start taking Myelle on the first day 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 Myelle preferably on the day after the last active tablet (the last tablet containing the active substances) of her previous COC, but at the latest on the day following the usual tablet-free or placebo tablet inte Read the complete document