Kraj: Irlandia
Język: angielski
Źródło: HPRA (Health Products Regulatory Authority)
CYPROTERONE ACETATE; Ethinylestradiol
Imbat Limited
G03HB; G03HB01
CYPROTERONE ACETATE; Ethinylestradiol
2/35 milligram(s)
Film-coated tablet
Product subject to prescription which may be renewed (B)
Antiandrogens and estrogens; cyproterone and estrogen
Authorised
2012-07-13
Page 1 of 2 PACKAGE LEAFLET: INFORMATION FOR THE USER DIANETTE ® 2MG/35 MICROGRAM COATED TABLETS (cyproterone acetate/ethinylestradiol) Your medicine is available using the above name but will be referred to as Dianette throughout this leaflet. READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING 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, 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 signs of illness 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. IN THIS LEAFLET 1. What Dianette is and what it is used for 2. What you need to know before you take Dianette Do not use Dianette Warnings and precautions Dianette and venous and arterial blood clots Dianette and cancer Bleeding between periods What to do if no bleeding occurs during the gap week Other medicines and Dianette Taking Dianette with food and drink Laboratory tests Pregnancy Breast-feeding Driving and using machines Dianette contains lactose and sucrose 3. How to take Dianette When can you start with the first strip? If you take more Dianette than you should If you forget to take Dianette What to do in the case of vomiting or severe diarrhoea If you stop taking Dianette 4. Possible side effects 5. How to store Dianette 6. Contents of the pack and other information 1. WHAT DIANETTE IS AND WHAT IT IS USED FOR Dianette is used to treat skin conditions such as acne, very oily skin and excessive hair growth in women of reproductive age. Due to its contraceptive properties it should only be prescribed for you if your doctor considers that treatment with a hormonal contraceptive is appropriate. You should only take Dianette if your skin condition has not improved after use of other anti-acne treatments, including topical treatments Przeczytaj cały dokument
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Dianette 2 mg/35 microgram coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 2.0mg cyproterone acetate and 0.035mg ethinylestradiol. Excipients with known effect: lactose and sucrose For the full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Coated Tablet _Product imported from the UK:_ Beige, sugar-coated, biconvex tablets. 4 CLINICAL PARTICULARS As per PA 1410/003/001 5 PHARMACOLOGICAL PROPERTIES As per PA 1410/003/001 6 PHARMACEUTICAL PARTICULARS 6.1 LIST OF EXCIPIENTS Lactose Maize starch Povidone Talc Magnesium stearate (E572) Sucrose Polyethylene glycol 6000 Calcium carbonate (E170) Titanium dioxide (E171) Glycerol (E422) Montan glycol wax Yellow ferric oxide pigment (E172) 6.2 INCOMPATIBILITIES Not applicable. 6.3 SHELF LIFE The shelf-life expiry date of this product is the date shown on the blister and outer carton of the product as marketed in the country of origin. 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_ _ _ _1_ _2_ _/_ _0_ _3_ _/_ _2_ _0_ _1_ _8_ _C_ _R_ _N_ _ _ _2_ _2_ _0_ _1_ _5_ _3_ _3_ _p_ _a_ _g_ _e_ _ _ _n_ _u_ _m_ _b_ _e_ _r_ _:_ _ _ _1_ 6.4 SPECIAL PRECAUTIONS FOR STORAGE Do not store above 25ºC. 6.5 NATURE AND CONTENTS OF CONTAINER Blister strips of 21 tablets in an outer cardboard carton. Pack sizes: 63 tablets and 21 tablets 6.6 SPECIAL PRECAUTIONS FOR DISPOSAL OF A USED MEDICINAL PRODUCT OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCT AND OT Przeczytaj cały dokument