País: Irlanda
Idioma: anglès
Font: HPRA (Health Products Regulatory Authority)
DESOGESTREL
Imbat Limited
G03AC09
DESOGESTREL
75 Microgram
Film Coated Tablet
Product subject to prescription which may be renewed (B)
desogestrel
Authorised
2014-06-13
Page 1 of 2 PACKAGE LEAFLET: INFORMATION FOR THE USER CERAZETTE ® 75 MICROGRAM FILM-COATED TABLETS (desogestrel) Your medicine is available using the above name but will be referred to as Cerazette throughout this leaflet. 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 CERAZETT Llegiu el document complet
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Cerazette 75 microgram film-coated tablet 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 75 micrograms desogestrel. Excipient of known effect: lactose monohydrate. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet. _Product imported from United Kingdom:_ 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 As per PA1286/048/001 5 PHARMACOLOGICAL PROPERTIES As per PA1286/048/001 6 PHARMACEUTICAL PARTICULARS 6.1 LIST OF EXCIPIENTS Tablet Core Silica, Colloidal anhydrous All-rac- -tocopherol Lactose monhydrate Maize starch Povidone Stearic acid Film coating Hypromellose Macrogol 400 Talc Titanium dioxide (E 171) 6.2 INCOMPATIBILITIES Not applicable. H E A L T H P R O D U C T S R E G U L A T O R Y A U T H O R I T Y ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ _D_ _a_ _t_ _e_ _ _ _P_ _r_ _i_ _n_ _t_ _e_ _d_ _ _ _2_ _2_ _/_ _1_ _0_ _/_ _2_ _0_ _1_ _4_ _C_ _R_ _N_ _ _ _2_ _1_ _5_ _3_ _7_ _8_ _5_ _p_ _a_ _g_ _e_ _ _ _n_ _u_ _m_ _b_ _e_ _r_ _:_ _ _ _1_ 6.3 SHELF LIFE The shelf life expiry date of this product is the date shown on the blister strips and outer carton of the product as marked in the country of origin. Use within 1 month from the date of first opening of the sachet. 6.4 SPECIAL PRECAUTIONS FOR STORAGE Store in the original sachet in order to protect from light and moisture. For storage conditions after first opening the sachet, see section 6.3. 6.5 NATURE AND CO Llegiu el document complet