Valsts: Nīderlande
Valoda: holandiešu
Klimata pārmaiņas: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
ETHINYLESTRADIOL ; LEVONORGESTREL
Laboratoires Chemical Farma
G03AA07
ETHINYL ESTRADIOL ; LEVONORGESTREL
Filmomhulde tablet
CROSPOVIDON (E 1202) ; IJZEROXIDE GEEL (E 172) ; LACTOSE 1-WATER ; MACROGOL 3350 ; MAGNESIUMSTEARAAT (E 470b) ; POLYVINYLALCOHOL, GEDEELTELIJK GEHYDROLYSEERD (E1203) ; POVIDON K 30 (E 1201) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171),
Oraal gebruik
Levonorgestrel And Ethinylestradiol
Hulpstoffen: CROSPOVIDON (E 1202); IJZEROXIDE GEEL (E 172); LACTOSE 1-WATER; MACROGOL 3350; MAGNESIUMSTEARAAT (E 470b); POLYVINYLALCOHOL, GEDEELTELIJK GEHYDROLYSEERD (E1203); POVIDON K 30 (E 1201); TALK (E 553 B); TITAANDIOXIDE (E 171);
2013-10-24
1 PACKAGE LEAFLET: INFORMATION FOR THE USER LEVONORGESTREL/ETHINYLESTRADIOL CHEMICAL FARMA 150/30 MICROGRAM, FILMOMHULDE TABLETTEN Levonorgestrel / 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”) WHAT IS IN THIS LEAFLET 1. What Levonorgestrel/Ethinylestradiol Chemical Farma 150/30 microgram, filmomhulde tabletten is and what it is used for 2. What you need to know before you take Levonorgestrel/Ethinylestradiol Chemical Farma 150/30 microgram, filmomhulde tabletten 3. How to take Levonorgestrel/Ethinylestradiol Chemical Farma 150/30 microgram, filmomhulde tabletten 4. Possible side effects 5. How to store Levonorgestrel/Ethinylestradiol Chemical Farma 150/30 microgram, filmomhulde tabletten 6. Contents of the pack and other information 1. WHAT LEVONORGESTREL/ETHINYLESTRADIOL CHEMICAL FARMA 150/30 MICROGRAM, FILMOMHULDE TABLETTEN IS AND WHAT IT IS USED FOR Levonorgestrel/Ethinylestradiol Chemical Farma 150/30 microgram, filmomhulde tabletten is a contraceptive pill and it is used to prevent pregnancy. • Each of the 21 yellow tablets contains a small amount of two different female hormones, namely levonorgestrel and ethinylestradiol. • The 7 white tablets contain no active substances and are also called placebo tablets. Contraceptive pills that contain two hormones are called “combination” pills. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE LEVONORGESTREL/ETHINYLESTRADIOL CHEMICAL FARMA 150/30 MICROGRAM, FILMOMHULDE TABLETTEN READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. Izlasiet visu dokumentu
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Levonorgestrel/Ethinylestradiol Chemical Farma 150/30 microgram, filmomhulde tabletten 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 21 YELLOW FILM-COATED TABLETS (ACTIVE TABLETS): 0.15 mg levonorgestrel and 0.03 mg ethinylestradiol Excipients with known effect:Each tablet contains 84.32 mg of lactose monohydrate 7 WHITE PLACEBO (INACTIVE) FILM-COATED TABLETS: The tablet do not contain active substances Excipients with known effect: Each tablet contains 89.50 mg of lactose anhydrous For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet. Active tablet: Yellow, round, with a diameter of 6 mm and thickness less than 4 mm approximately. Placebo tablet: White, round, with a diameter of 6 mm and thickness of 3 - 4 mm approximately. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Oral Contraception. The decision to prescribe Levonorgestrel/Ethinylestradiol Chemical Farma 150/30 microgram should take into consideration the individual woman's current risk factors, particularly those for venous thromboembolism (VTE), and how the risk of VTE with Levonorgestrel/Ethinylestradiol Chemical Farma 150/30 microgram compares with other combined hormonal contraceptives (CHCs) (see sections 4.3 and 4.4). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION _Method of administration_ Oral use _Posology_ How to take Levonorgestrel/Ethinylestradiol Chemical Farma 150/30 microgram The tablets must be taken every day at about the same time, if necessary with a little in the order shown on the blister pack. One tablet is to be taken daily for 28 consecutive days. Each subsequent pack is started after a 7-day placebo-tablet-intake interval, during which time a withdrawal bleed usually occurs. This usually starts on day 2-3 after the last active tablet and may not have finished before the next pack is started. How to start Levonorgestrel/Ethinylestradiol Chemical Farma 150/30 microgram No preceding hormonal contraceptive use [in the past mon Izlasiet visu dokumentu