Nazione: Paesi Bassi
Lingua: olandese
Fonte: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
DESOGESTREL 0,15 mg/stuk ; ETHINYLESTRADIOL 0,02 mg/stuk
Exeltis Healthcare S.L Avenue Miralcampo 7, Poligono Ind. Miralcampo 19200 AZUQUECA DE HENARES (SPANJE)
G03AA09
DESOGESTREL 0,15 mg/stuk ; ETHINYLESTRADIOL 0,02 mg/stuk
Filmomhulde tablet
GLYCEROLTRIACETAAT (E 1518) ; HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464) ; IJZEROXIDE GEEL (E 172) ; INDIGOKARMIJN ALUMINIUMLAK (E 132) ; LACTOSE 1-WATER ; MAGNESIUMSTEARAAT (E 470b) ; MAÏSZETMEEL ; POLYETHYLEENGLYCOL (E 1521) ; POLYSORBAAT 80 (E 433) ; POVIDON K 30 (E 1201) ; SILICIUMDIOXIDE (E 551) ; SILICIUMDIOXIDE, GEHYDRATEERD (E 551) ; STEARINEZUUR (E 570) ; TITAANDIOXIDE (E 171) ; TOCOFEROL, D-ALFA (E 307)
Oraal gebruik
Desogestrel And Ethinylestradiol
2018-09-04
1 PACKAGE LEAFLET: INFORMATION FOR THE USER LUMIVELA 0,150/0,02 MG FILMOMHULDE TABLETTEN 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 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. WHAT IS IN THIS LEAFLET : 1. What Lumivela is and what it is used for 2. What you need to know before you take Lumivela 3. How to take Lumivela 4. Possible side effects 5. How to store Lumivela 6. Contents of the pack and other information 1. WHAT LUMIVELA IS AND WHAT IS USED FOR Lumivela are a combined oral contraceptive, also called the pill. • Each of the 21 white tablets contains a small amount of two types of female hormones, namely, a progestogen, desogestrel and an oestrogen, ethinylestradiol. • The 7 green tablets contain no active substances and are also called placebo tablets. These help to stop you from getting pregnant, just as your natural hormones would stop you conceiving again when you are already pregnant. _ _ 2 _ _ The combined contraceptive pill protects you against getting pregnant in three ways. These hormones 1. stop the ovary from releasing an egg each month (ovulation). 2. also thicken the fluid (at the neck o Leggi il documento completo
1 SUMMARY OF THE PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Lumivela 0,150/0,02 mg filmomhulde tabletten 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 21 WHITE FILM-COATED TABLETS (ACTIVE TABLETS): Each film-coated tablet contains 150 micrograms of desogestrel and 20 micrograms of ethinylestradiol Excipients with known effect: Lactose monohydrate 55 mg, soybean oil (maximum 0.026 mg). 7 GREEN PLACEBO (INACTIVE) FILM-COATED TABLETS: The tablet does not contain active substances Excipient with known effect: Lactose monohydrate 55 mg For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet. Active tablets: White, round film-coated tablets of 5.00 mm diameter. They are coded on one side “C” and on the reverse side “5”. Placebo tablets: Green, round film-coated tablets of 5.00 mm diameter. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Oral contraception The decision to prescribe Lumivela should take into consideration the individual woman’s current risk factors, particularly those for venous thromboembolism (VTE), and how the risk of VTE with Lumivela compares with other CHCs (see sections 4.3 and 4.4). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Route of administration: oral use HOW TO TAKE LUMIVELA 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. 2 Withdrawal bleeding usually starts on day 2-3 after starting the placebo tablets (last row) and may not have finished before the next strip is started. _Paedriatic population _ The safety and efficacy of desogestrel and ethinylestradiol in adolescents below 18 years has not yet been established. No data are available. HOW TO START LUMIVELA • No preceding hormonal contraceptive use (in the past month) Tablet-taking has to start on day 1 of the woman’s natural Leggi il documento completo