Country: Netherlands
Language: Dutch
Source: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
DROSPIRENON ; ETHINYLESTRADIOL
Laboratorios Leon Farma, S.A.
G03AA12
DROSPIRENON ; ETHINYLESTRADIOL
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),
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);
2011-09-07
LF-DRSPEE-NL-NO.H.0193.001.IA.017-D0 1 PACKAGE LEAFLET LF-DRSPEE-NL-NO.H.0193.001.IA.017-D0 2 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT VALLCLARA 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, pharmacist or nurse. 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 effects, talk to your doctor, pharmacist or nurse. 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 1. What Vallclara is and what it is used for 2. What you need to know before you take Vallclara 3. How to take Vallclara 4. Possible side effects 5. How to store Vallclara 6. Contents of the pack and other information 1. 1. WHAT VALLCLARA IS AND WHAT IT IS USED FOR Vallclara 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 VALLCLARA GENERAL NOTES LF-DRSPEE-NL-NO.H.0193.001.IA.017-D0 3 Before you start using Vallclara you should read the information on blood clots in section 2. It is particularly impo Read the complete document
SPC-DRSPEE-NL-NO.H.0193.001.IA.017-D0 SUMMARY OF PRODUCT CHARACTERISTICS SPC-DRSPEE-NL-NO.H.0193.001.IA.017-D0 1. NAME OF THE MEDICINAL PRODUCT Vallclara 0,02 mg/3 mg filmomhulde tabletten 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 0,02 mg of ethinylestradiol and 3 mg of drospirenone Excipient with known effect: Each tablet contains 44 mg lactose monohydrate For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet. Pink, round film-coated tablets 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Oral contraception The decision to prescribe Vallclara should take into consideration the individual woman’s current risk factors, particularly those for venous thromboembolism (VTE), and how the risk of VTE with Vallclara 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 VALLCLARA 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 VALLCLARA 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 a combined hormonal contraceptive (combined oral contraceptive (COC), vaginal ring, or transdermal patch) SPC-DRSPEE-NL-NO.H.0193.001.IA.017-D0 The woman should start with Vallclara 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 trans Read the complete document