Země: Nizozemsko
Jazyk: nizozemština
Zdroj: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
ETHINYLESTRADIOL 0,015 mg/stuk ; GESTODEEN 0,06 mg/stuk
Egis Pharmaceuticals Plc Kereszturi ut 30-38 1106 BOEDAPEST (HONGARIJE)
G03AA10
ETHINYLESTRADIOL 0,015 mg/stuk ; GESTODEEN 0,06 mg/stuk
Filmomhulde tablet
ALUMINIUMOXIDE 0-WATER ; CELLULOSE, MICROKRISTALLIJN (E 460(i)) ; IJZEROXIDE GEEL (E 172) ; LACTOSE 1-WATER ; LECITHINE, SOYA (E 322) ; MAGNESIUMSTEARAAT (E 470b) ; NATRIUMZETMEELGLYCOLAAT ; POLACRILINE KALIUM ; POLYVINYLALCOHOL, GEDEELTELIJK GEHYDROLYSEERD (E1203) ; POVIDON K 25 (E 1201) ; SILICIUMDIOXIDE (E 551) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171) ; XANTHAANGOM (E 415), ALUMINIUMOXIDE 0-WATER ; CELLULOSE, MICROKRISTALLIJN (E 460) ; IJZEROXIDE GEEL (E 172) ; LACTOSE 1-WATER ; LECITHINE, SOYA (E 322) ; MAGNESIUMSTEARAAT (E 470b) ; NATRIUMZETMEELGLYCOLAAT ; POLACRILINE KALIUM ; POLYVINYLALCOHOL, GEDEELTELIJK GEHYDROLYSEERD (E1203) ; POVIDON K 25 (E 1201) ; SILICIUMDIOXIDE (E 551) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171) ; XANTHAANGOM (E 415), ALUMINIUMOXIDE 0-WATER ; CELLULOSE, MICROKRISTALLIJN (E 460) ; IJZEROXIDE GEEL (E 172) ; LACTOSE 1-WATER ; LECITHINE, SOYA (E 322) ; MAGNESIUMSTEARAAT (E 470b) ; NATRIUMZETMEELGLYCOLAAT (E468) ; POLACRILINE KALIUM ; POLYVINYLALCOHOL, GEDEELTELIJK GEHYDROLYSEERD (E1203) ; POVIDON K 25 (E 1201) ; SILICIUMDIOXIDE (E 551) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171) ; XANTHAANGOM (E 415),
Oraal gebruik
Gestodene And Ethinylestradiol
Hulpstoffen: ALUMINIUMOXIDE 0-WATER; CELLULOSE, MICROKRISTALLIJN (E 460); IJZEROXIDE GEEL (E 172); LACTOSE 1-WATER; LECITHINE, SOYA (E 322); MAGNESIUMSTEARAAT (E 470b); NATRIUMZETMEELGLYCOLAAT (E468); POLACRILINE KALIUM; POLYVINYLALCOHOL, GEDEELTELIJK GEHYDROLYSEERD (E1203); POVIDON K 25 (E 1201); SILICIUMDIOXIDE (E 551); TALK (E 553 B); TITAANDIOXIDE (E 171); XANTHAANGOM (E 415);
1900-01-01
1/15 PACKAGE LEAFLET: INFORMATION FOR THE USER DITINELL 0,060 MG/ 0,015 MG FILMOMHULDE TABLETTEN Gestodene / 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. See section 4. WHAT IS IN THIS LEAFLET 1. Whatis and what it is used for 2. What you need to know before you take Přečtěte si celý dokument3. How to take 4. Possible side effects 5. How to store 6. Contents of the pack and other information 1. WHAT IS AND WHAT IT IS USED FOR is a combined oral contraceptive tablet. You take it to stop you getting pregnant. The yellow tablets contain a small amount of two different female hormones, 0.060 mg of gestodene, and 0.015 mg of ethinylestradiol. Contraceptive tablets that contain two hormones are called ‘combination tablets.’ Due to the small amount of hormones, is a so-called light tablet. The white tablets do not contain active substances (only inactive ingredients or excipients) and are known as placebo tablets. Because both hormones in all tablets in the strip are combined in the same amount, i
1/19 SUMMARY OF THE PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Ditinell 0,060 mg/ 0,015 mg filmomhulde tabletten 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each yellow active tablet contains 0.060 mg of gestodene and 0.015 mg of ethinylestradiol. The white placebo tablet does not contain active ingredients. _ _ Excipients with known effect The yellow active tablet contains 57.61 mg of lactose monohydrate and 0,042 mg of lecithin (soya). The white tablet contains 70.897 mg of lactose monohydrate. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet.yellow tablet is round, plain, and film-coated tablet of 5.5 mm diameter. The white tablet (placebo) is round and biconvex tablet of 5.5 mm diameter. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Oral contraception The decision to prescribe Přečtěte si celý dokumentshould take into consideration the individual woman’s current risk factors, particularly those for venous thromboembolism (VTE), and how the risk of VTE with compares with other CHCs (see sections 4.3 and 4.4). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology 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. Withdrawal bleeding usually starts on day 2-3 after starting the placebo tablets (last row) and may not have finished before the next pack is started. HOW TO START 2/19 • No preceding hormonal contraceptive use in the past month Tablet-taking has to start on day 1 of the women’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) The woman should start with preferably on the day after the last active ta