País: Malta
Idioma: inglés
Fuente: Medicines Authority
DESOGESTREL, ETHINYLESTRADIOL
Merck Sharp & Dohme B.V. Waarderweg 39, Haarlem Noord-Holland, 2031 BN, Netherlands
G03AA09
DESOGESTREL, ETHINYLESTRADIOL
TABLET
DESOGESTREL 150 microgram(s) ; ETHINYLESTRADIOL 20 microgram(s)
POM
SEX HORMONES AND MODULATORS OF THE GENITAL SYSTEM
Authorised
2005-10-28
1 Package leaflet: Information for the user MERCILON® TABLETS 150mcg/20 microgram Tablets DESOGESTREL ETHINYLESTRADIOL 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 USING THIS MEDICINE. • Keep this leaflet. You may need to read it again. • If you have further questions, please ask your doctor, or your pharmacist. • This medicine has been prescribed for you. Do not pass it on to others. It may harm them even if their symptoms are the same as yours. • If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. IN THIS LEAFLET: 1. What is Mercilon and what is it used for? 1.1 Composition and type of Pill 1.2 Why use Mercilon 2. What you need to know before you use Mercilon 2.1 When you should not use Mercilon 2.2 When to take special care with Mercilon 2.3 When should you contact your doctor 3. How to use Mercilon 3.1 When and how to take the tablets 3.2 Starting your first pack of Mercilon 3.3 If too many Mercilon tablets are taken (overdose) 3.4 What to do if 3.5 If you want to stop taking Mercilon 4. Possible side effects 5. How to store Mercilon 6. Further information 6.1 What Mercilon contains 6.2 What Mercilon looks like and content of the pack 6.3 Marketing Authorisation Holder and Manufacturer 6.4 Last revision of this package leaflet. 1. WHAT IS MERCILON AND WHAT IS IT USED FOR? 1.1 COMPOSITION AND TYPE OF PILL 2 MERCILON is a combined oral contraceptive (‘the combined Pill’). Each tablet contains a small amount of two d Leer el documento completo
1. NAME OF THE MEDICINAL PRODUCT Mercilon 150/20 microgram Tablets. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains: Desogestrel 150 micrograms Ethinylestradiol 20 micrograms Also contains approximately 68mg Lactose Monohydrate per tablet. For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Tablet. The tablets are white, round, biconvex and 6mm in diameter. They are coded on one side ‘Organon’ and an asterix ‘*’ and on the reverse side ‘TR’ above ‘4’. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATION Contraception. The decision to prescribe Mercilon should take into consideration the individual woman’s current risk factors, particularly those for venous thromboembolism (VTE), and how the risk of VTE with Mercilon compares with other CHCs (see sections 4.3 and 4.4). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION PAEDIATRIC POPULATION The safety and efficacy of Mercilon in adolescents under the age of 18 years have not been studied. Method of administration: oral use. Before starting Mercilon, a thorough general medical and gynaecological examination (including breasts and a cytological smear of the cervix) should be carried out and the family medical history carefully noted. Disturbances of the clotting mechanisms should be ruled out if any members of the family have suffered from thromboembolic diseases (e.g. deep vein thrombosis, stroke, myocardial infarction) at a young age. Pregnancy must be excluded ideally by a pregnancy test. As a precaution, thorough examinations should be conducted at approximately six month intervals during the use of the tablets. Page 1 of 18 HOW TO TAKE MERCILON Tablets must be taken in the order directed on the package every day at about the same time with some liquid as needed. 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 befo Leer el documento completo