Država: Irska
Jezik: engleski
Izvor: HPRA (Health Products Regulatory Authority)
Desogestrel
Merck Sharp & Dohme Ireland (Human Health) Limited
G03AC; G03AC09
Desogestrel
75 microgram(s)
Film-coated tablet
Product subject to prescription which may be renewed (B)
Progestogens; desogestrel
Not marketed
1998-08-14
PACKAGE LEAFLET: INFORMATION FOR THE USER 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 or pharmacist. 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 or pharmacist. 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 3. How 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. Cerazette contains a small amount of one type of female sex hormone, the progestogen DESOGESTREL . For this reason Cerazette is called a progestogen-only-pill (POP). Contrary to the combined pill, the POP does not contain an oestrogen hormone next to the progestogen. Most POPs work primarily by preventing the sperm cells from entering the womb but do not always prevent the egg cell from ripening, which is the primary action of combined pills. Cerazette is distinct from most POPs in having a dose that in most cases is high enough to prevent the egg cell 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. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE CERAZETTE Cerazette, like other hormonal contraceptives, does not protect against HIV infection (AIDS) or any other sexually transmi Pročitajte cijeli dokument
Health Products Regulatory Authority 23 November 2020 CRN009XRJ Page 1 of 9 SUMMARY OF PRODUCT CHARACTERISTICS 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 55mg 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 Health Products Regulatory Authority 23 November 2020 CRN009XRJ Page 2 of 9 _No preceding hormonal contraceptive use [in the past month]_ Tablet-taking has to star Pročitajte cijeli dokument