البلد: مالطا
اللغة: الإنجليزية
المصدر: Medicines Authority
DROSPIRENONE, ETHINYLESTRADIOL
Bayer Public Limited Company 400 South Oak Way, Reading Berkshire RG2 6AD, United Kingdom
G03AA12
DROSPIRENONE 3 mg ETHINYLESTRADIOL 0.02 mg
FILM-COATED TABLET
DROSPIRENONE 3 mg ETHINYLESTRADIOL 0.02 mg
POM
SEX HORMONES AND MODULATORS OF THE GENITAL SYSTEM
Withdrawn
2013-01-29
Flexyess PIL Page: 1 of 19 v006_0 Page 1 of 19 PACKAGE LEAFLET: INFORMATION FOR THE USER Flexyess 0.02 mg / 3 mg 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 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. _ 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 6T [/PIL_MA513_04401.html#2] 1. [/PIL_MA513_04401.html#2] [/PIL_MA513_04401.html#2] What Flexyess is and what it is used for ................................................................................... 2 [/PIL_MA513_04401.html#2] [/PIL_MA513_04401.html#2] 2. [/PIL_MA513_04401.html#2] [/PIL_MA513_04401.html#2] What you need to know before you take Flexyess ................................................................... 2 [/PIL_MA513_04401.html#2] [/PIL_MA513_04401.html#2] General notes .............................................................. اقرأ الوثيقة كاملة
Page 1 of 1 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT 0T Flexyess 0.02 mg / 3 mg film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 0.020 mg ethinylestradiol (as betadex clathrate) and 3 mg drospirenone. Excipient with known effect: lactose 46 mg For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablets The tablets are light pink, round with convex faces, one side embossed with the letters "DS" in a regular hexagon. The tablets have a diameter of 6 mm and a thickness of 3 mm. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Oral contraception. The decision to prescribe Flexyess should take into consideration the individual woman’s current risk factors, particularly those for venous thromboembolism (VTE), and how the risk of VTE with Flexyess compares with other Combined Hormonal Contraceptives (CHCs) (see sections 4.3 and 4.4). Page 2 of 2 4.2 POSOLOGY AND METHOD OF ADMINISTRATION _METHOD OF ADMINISTRATION_: oral use _POSOLOGY_ HOW TO TAKE FLEXYESS Flexyess can only be used in combination with the Clyk tablet dispenser. The tablet dispenser will guide the user through the regimen. The Instructions for Use for the Clyk tablet dispenser should be read carefully before use and kept for future reference. For instructions on how to prepare the Clyk tablet dispenser for use and how to dispense a tablet, see section 6.6. One tablet must be taken every day at about the same time, if necessary with a little liquid. Tablets must always be taken continuously for a minimum of 24 days. Flexyess tablets can be taken continuously for up to 120 days, after which a 4-day tablet free اقرأ الوثيقة كاملة