Country: Հարավաֆրիկյան Հանրապետություն
language: անգլերեն
source: South African Health Products Regulatory Authority (SAHPRA)
Bayer (Pty) Ltd û Isando
See ingredients
TABLET
EACH TABLET CONTAINS ETHINYLESTRADIOL 0,030 mg GESTODENE 0,75 mg
Registered
1990-03-09
APPLICANT/PHRC: Bayer (Pty) Ltd DOSAGE FORM: C oated tablet PRODUCT PROPRIETARY NAME: FEMODENE ED CCPI14/09.2016/SA3/02.2022 Page 1 of 12 PATIENT INFORMATION LEAFLET SCHEDULING STATUS: S3 FEMODENE ® ED 0,03 MG/0,075 MG COATED TABLETS ETHINYLESTRADIOL/GESTODENE CONTAINS SUGAR (LACTOSE AND SUCROSE) READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING FEMODENE ED • Keep this leaflet. You may need to read it again. • If you have further questions, ask your doctor or pharmacist. • FEMODENE ED has been prescribed for you personally and you should not share you r medicine with other people. It may harm them, even if their symptoms are the same as yours. WHAT IS IN THIS LEAFLET 1. What FEMODENE ED is and what it is used for 2. What you need to know before you take FEMODENE ED 3. How to take FEMODENE ED 4. Possible side effects 5. How to store FEMODENE ED 6. Contents of the pack and other information 1. WHAT FEMODENE ED IS AND WHAT IT IS USED FOR FEMODENE ED is a combined oral contraceptive pill and is used to prevent pregnancy. Each of the 21 smaller white coated tablets contains a small amount of the female hormones ethinylestradiol and gestodene. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE FEMODENE ED GENERAL NOTES Before you can begin taking FEMODENE ED, your doctor will ask you some questions about your personal health history and that of your close relatives. The doctor will also measure your blood pressure and, depending upon your personal situation, may also carry out some other tests. In this leaflet, several situations are described where you should stop using FEMODENE ED, or where the reliability of FEMODENE ED may be decreased. In such situations you should either not have sex or you should take extra non-hormonal contraceptive precautions, e.g. use a condom or another barrier method. Do not use rhythm or temperature methods. These methods can be unreliable because FEMODENE ED alters the monthly changes of body temperature and cervical mucus. FEMODENE ED, LIKE OTHER HORMONAL CONTRACEPTIVES, DOES NOT read_full_document
APPLICANT/PHRC: Bayer (Pty) Ltd DOSAGE FORM: Coated tablet PRODUCT PROPRIETARY NAME: FEMODENE ED CCDS14/09.2016/SA3/05.2022 Page 1 of 12 SCHEDULING STATUS S3 1. NAME OF THE MEDICINE FEMODENE ® ED 0,03 mg/0,075 mg coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION The 28-day pack (Every-Day pack) contains: 21 hormone-containing small white tablets: Each coated tablet contains ethinylestradiol 0,03 mg and gestodene 0,075 mg. Contains sugar (lactose – 36 mg and sucrose – 20 mg) 7 hormone-free large white coated tablets. Contains sugar (lactose –46 mg and sucrose – 34 mg) For full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Coated tablets. The hormone-containing tablets are small, white, round with convex faces. The hormone-free tablets are larger, white, round with convex faces. 4. CLINICAL PARTICULARS 4.1. THERAPEUTIC INDICATIONS Oral contraception. 4.2. POSOLOGY AND METHOD OF ADMINISTRATION POSOLOGY _How to take FEMODENE ED _ The first course of FEMODENE ED is started on the first day of the menstrual period (day 1 of the cycle) from the silver section of the pack by selecting the appropriate tablet for that day of the week (e.g. "MO" for Monday). The tablet is swallowed whole with some liquid. Thereafter one tablet must be taken daily for 28 days following the direction shown by the arrows. It does not matter at what time of the day the tablet is taken, but once the patient has selected a particular time, the tablet should be taken as near as possible at the same time each day. Withdrawal bleeding usually starts on day 2 to 3 after starting the hormone-free larger white tablets and may not have finished before the next pack is started. Each subsequent pack is started the day after the last tablet of the current pack. If a patient starts FEMODENE ED during the latter part of the week, the very first cycle may be slightly shortened. _How to start FEMODENE ED _ • No preceding hormonal contraceptive use (in the past month) Tablet-taking has to start on day 1 of the woman’s natural read_full_document