Krajina: Malta
Jazyk: angličtina
Zdroj: Medicines Authority
ETHINYLESTRADIOL, DROSPIRENONE
Mithra Pharmaceuticals S.A Rue Saint-Georges 5, 4000, Liege, Belgium
G03AA12
ETHINYLESTRADIOL 0.03 mg DROSPIRENONE 3 mg
FILM-COATED TABLET
ETHINYLESTRADIOL 0.03 mg DROSPIRENONE 3 mg
POM
SEX HORMONES AND MODULATORS OF THE GENITAL SYSTEM
Withdrawn
2017-06-20
Page 1 of 17 PACKAGE LEAFLET: INFORMATION FOR THE USER JULIA 28 0.03 MG/3 MG FILM-COATED TABLETS Ethinylestradiol and 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, even if their signs of illness are the same as yours. - If you get any side effect, 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 Julia 28 is and what it is used for 2. What you need to know before you use Julia 28 3. How to take Julia 28 4. Possible side effects 5. How to store Julia 28 6. Contents of the pack and other information 1. WHAT JULIA 28 IS AND WHAT IT IS USED FOR - Julia 28 is a contraceptive pill and is used to prevent pregnancy. - Each of the 21 yellow tablets 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 NEED TO KNOW BEFORE YOU USE JULIA 28 GENERAL NOTES Before you start using Julia 28 you should read the information on blood clots in section 2. It is particularly important to read the symptoms of a blood clot – Prečítajte si celý dokument
Page 1 of 21 1. NAME OF THE MEDICINAL PRODUCT Julia 28 0.03 mg /3 mg film-coated tablets. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 21 YELLOW FILM-COATED TABLETS (ACTIVE TABLETS): Each film-coated tablet contains 0.03 mg ethinylestradiol and 3 mg drospirenone. Excipients with known effect: each film-coated tablet contains 49.77 mg of lactose monohydrate. 7 WHITE PLACEBO (INACTIVE) FILM-COATED TABLETS: The tablets do not contain any active substances. Excipients with known effect: each film-coated tablet contains 39.80 mg of lactose monohydrate. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet. Active tablet: Yellow, round, biconvex film-coated tablet with “30” on one side. The other side is without engraving. Placebo tablets: White, round, biconvex film-coated tablet with (PL” on one side. The other side is without engraving. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Oral contraception. The decision to prescribe Julia 28 should take into consideration the individual woman’s current risk factors, particularly those for venous thromboembolism (VTE), and how the risk of VTE with Julia 28 compares with other combined hormonal contraceptives (CHCs) (see sections 4.3 and 4.4). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Page 2 of 21 Posology Route of administration: oral use HOW TO TAKE JULIA 28 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 JULIA 28 - 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 another Prečítajte si celý dokument