Land: Storbritannien
Sprog: engelsk
Kilde: MHRA (Medicines & Healthcare Products Regulatory Agency)
Desogestrel
Organon Pharma (UK) Ltd
G03AC09
Desogestrel
75microgram
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 07030201; GTIN: 5013257001718
UNITED KINGDOM USER PACKAGE LEAFLET OF CERAZETTE CERAZETTE® 75 MICROGRAM FILM-COATED TABLETS DESOGESTREL READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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, please ask your doctor, pharmacist or Family Planning Nurse. This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. If you get any side effects, talk to your doctor, pharmacist or Family Planning Nurse. This includes any possible side effects not listed in this leaflet. WHAT IS IN THIS LEAFLET: 1. What Cerazette is and what it is used for 2. What you need to know before you take Cerazette Do not take… Warnings and precautions Pregnancy and breast-feeding 3. How to take Cerazette Starting your first pack Changing from other methods After a baby If you forget to take Cerazette 4. Possible side effects 5. How to store Cerazette 6. Contents of the pack and other information 1. WHAT CERAZETTE IS AND WHAT IT IS USED FOR Cerazette is used to prevent pregnancy. 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). 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 Læs hele dokumentet
OBJECT 1 CERAZETTE 75 MICROGRAM FILM-COATED TABLET Summary of Product Characteristics Updated 27-Jan-2017 | Merck Sharp & Dohme Limited 1. Name of the medicinal product Cerazette ® 75 microgram film-coated tablets. 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 Contraception. 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. 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 th Læs hele dokumentet