Šalis: Nyderlandai
kalba: olandų
Šaltinis: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
DROSPIRENON 3 mg/stuk ; ETHINYLESTRADIOL 0,02 mg/stuk
Laboratorios Liconsa S.A. C/ Dulcinea S/N 28805 MADRID (SPANJE)
G03AA12
DROSPIRENON 3 mg/stuk ; ETHINYLESTRADIOL 0,02 mg/stuk
Filmomhulde tablet
CROSCARMELLOSE NATRIUM (E 468) ; IJZEROXIDE GEEL (E 172) ; IJZEROXIDE ROOD (E 172) ; IJZEROXIDE ZWART (E 172) ; LACTOSE 1-WATER ; MACROGOL 3350 ; MAGNESIUMSTEARAAT (E 470b) ; MAÏSZETMEEL, GEPREGELATINEERD ; POLYSORBAAT 80 (E 433) ; POLYVINYLALCOHOL, GEDEELTELIJK GEHYDROLYSEERD (E1203) ; POVIDON K 30 (E 1201) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171), CROSCARMELLOSE NATRIUM (E 468) ; IJZEROXIDE GEEL (E 172) ; IJZEROXIDE ROOD (E 172) ; IJZEROXIDE ZWART (E 172) ; LACTOSE 1-WATER ; MACROGOL 3350 ; MAGNESIUMSTEARAAT (E 470b) ; MAÏSZETMEEL, GEPREGELATINEERD ; POLYSORBAAT 80 (E 433) ; POLYVINYLALCOHOL, GEDEELTELIJK GEHYDROLYSEERD (E1203) ; POVIDON K 30 (E 1201) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171),
Oraal gebruik
Drospirenone And Ethinylestradiol
Hulpstoffen: CROSCARMELLOSE NATRIUM (E 468); IJZEROXIDE GEEL (E 172); IJZEROXIDE ROOD (E 172); IJZEROXIDE ZWART (E 172); LACTOSE 1-WATER; MACROGOL 3350; MAGNESIUMSTEARAAT (E 470b); MAÏSZETMEEL, GEPREGELATINEERD; POLYSORBAAT 80 (E 433); POLYVINYLALCOHOL, GEDEELTELIJK GEHYDROLYSEERD (E1203); POVIDON K 30 (E 1201); TALK (E 553 B); TITAANDIOXIDE (E 171);
1900-01-01
LF-DRSP/EE-NL-NL/H/2888/001/IB/028/G 1 PACKAGE LEAFLET: INFORMATION FOR THE USER MODOLEW 0.02 MG/3 MG FILMOMHULDE TABLETTEN 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. Do no pass it on to others. It may harm them even if their signs of illness 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. 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”) IN THIS LEAFLET : 1. WHAT MODOLEW IS AND WHAT IT IS USED FOR 2. BEFORE YOU TAKE MODOLEW 3. HOW TO TAKE MODOLEW 4. POSSIBLE SIDE EFFECTS 5. HOW TO STORE MODOLEW 6. CONTENTS OF THE PACK AND OTHER INFORMATION LF-DRSP/EE-NL-NL/H/2888/001/IB/028/G 2 1. WHAT MODOLEW IS AND WHAT IT IS USED FOR • Modolew is a contraceptive pill and is used to prevent pregnancy. • Each film-coated 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. BEFORE YOU TAKE MODOLEW GENERAL NOTES Before you start using Modolew 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 can begin taking Modolew, y Perskaitykite visą dokumentą
SPC-DRSP/EE-NL-NL/H/2888/001/IA/027-D0 1/21 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Modolew 0.02 mg/3 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 0.02 mg of ethinylestradiol and 3 mg of drospirenone Excipients with known effect: Lactose monohydrate 44 mg For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet. Pink, round film-coated tablets of 5.7 mm diameter. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Oral contraception The decision to prescribe Modolew should take into consideration the individual woman’s current risk factors, particularly those for venous thromboembolism (VTE), and how the risk of VTE with Modolew compares with other CHCs (see sections 4.3 and 4.4). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION METHOD OF ADMINISTRATION: oral use. POSOLOGY HOW TO TAKE MODOLEW 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 MODOLEW • 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). SPC-DRSP/EE-NL-NL/H/2888/001/IA/027-D0 2/21 • Changing from a combined hormonal contraceptive (combined oral contraceptive (COC), vaginal ring, or transdermal patch) The woman should start with Modolew 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 interval of her previous COC. In case a vaginal ring or transdermal patch has been used the woman sh Perskaitykite visą dokumentą