Country: Նոր Զելանդիա
language: անգլերեն
source: Medsafe (Medicines Safety Authority)
Desogestrel 0.075mg;
Organon (New Zealand) Limited
Desogestrel 0.075 mg
0.07 mg
Film coated tablet
Active: Desogestrel 0.075mg Excipient: Colloidal silicon dioxide dl-Alpha tocopherol Hypromellose Lactose monohydrate Macrogol 400 Maize starch Povidone Purified talc Stearic acid Titanium dioxide
Calendar pack, 1 strip of 28 tabs, 28 tablets
Prescription
Prescription
Aspen Oss B.V
Package - Contents - Shelf Life: Calendar pack, 1 strip of 28 tabs - 28 tablets - 36 months from date of manufacture stored at or below 30°C - Calendar pack, 3 strips of 28 tabs - 84 tablets - 36 months from date of manufacture stored at or below 30°C - Calendar pack, 6 strips of 28 tabs - 168 tablets - 36 months from date of manufacture stored at or below 30°C
1997-05-13
CERAZETTE ® Tablets for oral use CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET • Keep this leaflet. You may need to read it again. • This leaflet will provide information about the benefits and risks of Cerazette ® . It will also advise you about how to take Cerazette ® properly and when to tell your doctor about health-related conditions. If you have any further questions, ask your doctor or your pharmacist. • This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. • If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or your pharmacist. WHAT IS CERAZETTE ® AND WHAT IS IT USED FOR? _HOW DOES CERAZETTE_ _®_ _ _ _WORK? _ Cerazette ® contains a small amount of one type of female sex hormone, the progestagen desogestrel. For this reason Cerazette ® is called a progestagen-only-pill (POP), or a mini-pill. Contrary to combined pills, mini-pills do not contain an oestrogen hormone next to the progestagen. Most mini-pills work primarily by preventing the sperm cells from entering the womb but, unlike combined pills, they do not always prevent an egg cell from ripening. Cerazette ® is distinct from other mini-pills because, like combined pills, in most cases it does prevent the egg cells from ripening. As a result, Cerazette ® provides high contraceptive efficacy. In contrast to the combined pill, Cerazette ® can be used by women who do not tolerate oestrogens and by women who are breast feeding. A disadvantage is that vaginal bleeding may occur at irregular intervals during the use of Cerazette ® . You also may not have any bleeding at all. _WHY IS CERAZETTE_ _®_ _ USED? _ To prevent pregnancy. When Cerazette ® is taken correctly (without missing tablets), the chance of becoming pregnant is very low. BEFORE YOU START TO TAKE CERAZETTE ® Cerazette ® , like all hormonal contraceptives, does not protect against HIV infection (AIDS) or any o read_full_document
Page 1 of 9 NEW ZEALAND DATA SHEET 1 CERAZETTE 75 MICROGRAM FILM-COATED TABLET 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 75 microgram desogestrel. Excipient with known effect: - lactose monohydrate For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS. 3 PHARMACEUTICAL FORM Film coated tablet. The tablet is white, round, biconvex and 5 mm in diameter. On one side it is coded KV above 2 and on the reverse side ORGANON. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Oral contraception. 4.2 DOSE AND METHOD OF ADMINISTRATION HOW TO TAKE CERAZETTE Tablets must be taken in the order directed on the package, every day at about the same time, with some liquid as needed. One tablet is to be taken daily for 28 consecutive days. Each subsequent pack is started immediately after finishing the previous pack. HOW TO START CERAZETTE No preceding hormonal contraceptive use (in the past month) Tablet-taking has to start on day 1 of the woman’s natural cycle (day 1 is the first day of her menstrual bleeding). Starting on days 2-5 is allowed, but during the first cycle a barrier method is recommended in addition for the first 7 days of tablet-taking. Changing from a combined hormonal contraceptive (combined oral contraceptive (COC), vaginal ring, or transdermal patch) The woman should start with CERAZETTE preferably on the day after the last active tablet (the last tablet containing the active substances), or on the day of removal of her vaginal ring or patch. In these cases, the use of an additional contraceptive is not necessary. The women may also start at the latest on the day following the usual tablet-free, patch-free, ring-free, or placebo tablet interval of her previous combined hormonal contraceptive, but during the first 7 days of tablet-taking an additional barrier method is recommended. Changing from a progestogen-only-method (minipill, injection, implant or from a progestogen- releasing intrauterine system [IUS]) The woman may switch any day from the minipill, (from an implant read_full_document