Χώρα: Ολλανδία
Γλώσσα: Ολλανδικά
Πηγή: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
ETHINYLESTRADIOL 0,03 mg/stuk ; GESTODEEN 0,075 mg/stuk
Egis Pharmaceuticals Plc Kereszturi ut 30-38 1106 BOEDAPEST (HONGARIJE)
G03AA10
ETHINYLESTRADIOL 0,03 mg/stuk ; GESTODEEN 0,075 mg/stuk
Tablet
CELLULOSE, MICROKRISTALLIJN (E 460(i)) ; LACTOSE 1-WATER ; MAGNESIUMSTEARAAT (E 470b) ; POLACRILINE KALIUM ; POVIDON K 30 (E 1201), CELLULOSE, MICROKRISTALLIJN (E 460) ; LACTOSE 1-WATER ; MAGNESIUMSTEARAAT (E 470b) ; POLACRILINE KALIUM ; POVIDON K 30 (E 1201),
Oraal gebruik
Gestodene And Ethinylestradiol
Hulpstoffen: CELLULOSE, MICROKRISTALLIJN (E 460); LACTOSE 1-WATER; MAGNESIUMSTEARAAT (E 470b); POLACRILINE KALIUM; POVIDON K 30 (E 1201);
1900-01-01
2 PACKAGE LEAFLET: INFORMATION FOR THE USER NOBABELLE 0.075 MG / 0.030 MG 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 or need more advice, ask your doctor, family planning nurse, 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 Διαβάστε το πλήρες έγγραφο3. 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 contraceptive tablet and is used to prevent pregnancy. Each tablet contains a small amount of two different female hormones, namely ethinylestradiol and gestodene. Contraceptive tablets as that contain two hormones are called “combination” contraceptives. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE GENERAL NOTES Before you start using you should read the information on blood clots in section 2. It is particularly important to read the symptoms of a blood clot – see Section 2 “Blood clots”. Before you can b
2 1. NAME OF THE MEDICINAL PRODUCT Nobabelle 0.075 mg / 0.030 mg tabletten 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each white tablet contains 0.075 mg gestodene and 0.030 mg ethinylestradiol. Excipient with known effect Each tablet contains 59.12 mg lactose monohydrate. For the full list of excipients, see section 6.1 3. PHARMACEUTICAL FORM Tablet Round, white tablets, with a diameter of 5.7 mm approximately. The white tablet is debossed with a ‘ _C’_ on one side and ‘ _33’_ on the other side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Oral contraception. The decision to prescribeshould take into consideration the individual woman’s current risk factors, particularly those for venous thromboembolism (VTE), and how the risk of VTE with Διαβάστε το πλήρες έγγραφοcompares with other CHCs (see sections 4.3 and 4.4). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _How to take _ The tablets must be taken every day at approximately the same time, if necessary with a little liquid, in the order indicated on the blister pack. One tablet per day should be taken for 21 days. Each subsequent pack should be started after a 7-day tablet-free interval during which time a withdrawal bleeding will occur. This bleeding usually starts on the 2 nd or 3 rd day after taking the last tablet, and may not stop until the next pack is started. _How to start taking _ _If no preceding hormonal contraceptive use in the past month _ Taking of the tablets should begin on the first day of the woman’s natural cycle (i.e. on the first day of the woman’s menstrual bleeding). One may begin taking the pills on day 2-5, but in these cases, it is recommended that a barrier method also be used for the first 7 days on which pills are taken during the first cycle. _Changing from a combined hormonal contraceptive (combined oral contraceptive (COC), vaginal ring, or _ _transdermal patch _ The woman should start taking on the next day after taking the last active tablet in