Land: Israel
Sprog: engelsk
Kilde: Ministry of Health
DESOGESTREL
ORGANON PHARMA ISRAEL LTD., ISRAEL
G03AC09
FILM COATED TABLETS
DESOGESTREL 0.075 MG
PER OS
Required
ORGANON LLC, USA
DESOGESTREL
DESOGESTREL
Contraceptive.
2014-06-30
[Organon] Proprietary PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS REGULATIONS (PREPARATIONS) 1986 This medicine can be sold under doctor's prescription only CERAZETTE ® Film coated Tablets Each film coated tablet contains: Desogestrel 0.075 mg For a list of inactive ingredients see section 6.1 "What CERAZETTE contains". See also section 2.8 “IMPORTANT INFORMATION ABOUT SOME OF THE INGREDIENTS OF CERAZETTE”. READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE. • This leaflet contains concise information about CERAZETTE. If you have any further questions, ask your doctor or pharmacist. • This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their medical condition seems similar to yours. 1. WHAT CERAZETTE IS AND WHAT IT IS USED FOR? CERAZETTE is used to prevent pregnancy. THERAPEUTIC GROUP: Progestogens, hormonal contraceptives. • There are 2 main kinds of hormone contraceptive. − The combined pill, "THE PILL", which contains 2 types of female sex hormone an oestrogen and a progestogen, − The progestogen-only pill, POP, which doesn't contain an oestrogen. • CERAZETTE is a progestogen-only-pill (POP or a mini-pil). • CERAZETTE contains a small amount of one type of female sex hormone, the progestogen DESOGESTREL. • Most POPs work primarily by preventing the sperm cells from entering the womb but they do not always prevent the egg cell from ripening, which is the main way that combined pills work. • CERAZETTE is different from most POPs in having a dose that in most cases prevents the egg cell from ripening. As a result, CERAZETTE is a highly effective contraceptive. • 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. On the other hand, you may not have any bleeding at all. 2. BEFORE YOU USE CERAZETTE CERAZETTE, like other hormona Læs hele dokumentet
1 [Organon] Proprietary SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Cerazette ® 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 75 microgram desogestrel. Excipient (s) with known effect: Each tablet contains approximately 55 mg of lactose monohydrate. For the full list of excipients, see section 6.1. 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 Contraceptive. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology To achieve contraceptive effectiveness, Cerazette must be used as directed (see ‘How to take Cerazette’ and ‘How to start Cerazette’). Special populations _Renal impairment_ No clinical studies have been performed in patients with renal impairment. _ _ _Hepatic impairment _ No clinical studies have been performed in patients with hepatic insufficiency. Since the metabolism of steroid hormones might be impaired in patients with severe hepatic disease, the use of Cerazette in these women is not indicated as long as liver function values have not returned to normal (see section 4.3). _ _ _Paediatric population _ The safety and efficacy of Cerazette in adolescents below 18 years has not been established. No data are available. 2 [Organon] Proprietary Method of administration Oral use. HOW TO TAKE CERAZETTE Tablets must be taken every day at about the same time so that the interval between two tablets always is 24 hours. The first tablet should be taken on the first day of menstrual bleeding. Thereafter one tablet each day is to be taken continuously, without taking any notice on possible bleeding. A new blister is started directly the day after the previous one. 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- Læs hele dokumentet