국가: 네덜란드
언어: 네덜란드어
출처: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
DROSPIRENON 3 mg/stuk ; ETHINYLESTRADIOL 0,02 mg/stuk
Exeltis Healthcare S.L Avenue Miralcampo 7, Poligono Ind. Miralcampo 19200 AZUQUECA DE HENARES (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
Talia Package Leaflet 1 PACKAGE LEAFLET: INFORMATION FOR THE USER TALIA 0.02 MG/3 MG FILM-COATED TABLETS Ethinylestradiol/Drospirenone 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 Talia is and what it is used for 2. What you need to know before you take Talia 3. How to take Talia 4. Possible side effects 5. How to store Talia 6. Contents of the pack and other information 1. WHAT TALIAIS AND WHAT IT IS USED FOR • Talia is a contraceptive pill and is used to prevent pregnancy. • Each of the 24 tablets 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 TAKETALIA READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE 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, even if their signs of illness are the same as yours. • 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. BEFORE YOU START USING TALIA FOR THE FIRST TIME YOU SHOULD DISCUSS WITH YOUR DOCTOR HOW TO USE THIS PRODUCT. Before you start using Talia you should read the information on blood clots in section 2. It is particularly important to read the symptoms of a blood clot – see se 전체 문서 읽기
Talia SmPC 1 SUMMARY OF PRODUCT CHARACTERISTICS TALIA 0.02 MG/3 MG FILM COATED TABLETS 1. NAME OF THE MEDICINAL PRODUCT Talia 0.02 mg/3 mg film coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 0.02 mg ethinylestradiol and 3 mg drospirenone. Excipient with known effect: lactose 44 mg. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet The tablet is a pink and round film-coated of 5.7 mm diameter. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Oral contraception. The decision to prescribe [invented name] should take into consideration the individual woman’s current risk factors, particularly those for venous thromboembolism (VTE), and how the risk of VTE with [invented name] compares with other CHCs (see sections 4.3 and 4.4). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION METHOD OF ADMINISTRATION: oral use POSOLOGY The tablets must be taken every day at about the same time, if necessary with a small amount of liquid. Tablets must always be taken without interruption for a minimum of 24 days.Talia can be taken without interruption for up to 120 days, after which a 4-day tablet-free interval must be started. THE TABLET TAKING CONSIST OF TWO PHASES: 1. Mandatory phase (day 1-24) When starting Talia tablets must be taken without interruption for a minimum of 24 days, after which the woman can either: - take a 4-day tablet-free interval - or continue to take the tablets for up to 120 days (see flexible phase below). 2. Flexible phase (day 25-120) During the days 25-120, the tablets can be taken without interruption up to a maximum of 120 days. During this period, the woman may decide herself to take the 4-day tablet-free interval (to induce withdrawal bleeding). This 4-day free-tablet-interval should only be started if tablet taking has been uninterrupted for a period of 24 days. Talia SmPC 2 Talia SmPC 3 In the event of continued bleeding (three consecutive days) during the flexible phase (days 25-120), it is advisable to take the 4- 전체 문서 읽기