国: アイルランド
言語: 英語
ソース: HPRA (Health Products Regulatory Authority)
CYPROTERONE ACETATE ; ETHINYLESTRADIOL
LTT Pharma Limited
G03HB01
CYPROTERONE ACETATE ; ETHINYLESTRADIOL
2/35 mg/mcg
Coated Tablets
Oral use
blister strips of 21 tablets
Product subject to prescription which may be renewed (B)
Bayer Pharma AG
Antiandrogens and estrogens
cyproterone and estrogen
Treatment of moderate to severe acne related to androgen-sensitivity (with or without seborrhoea) and/or hirsutism, in women of reproductive age. For the treatment of acne, Dianette should only be used after topical therapy or systemic antibiotic treatments have failed.
Authorised
2015-03-27
_This medicine is subject to additional monitoring. This will allow quick _ _identification of new safety information. You can help by reporting any side_ _effects you may get. See the end of section 4 for how to report side effects._ IN THIS LEAFLET: What Dianette is and what it is used for What you need to know before you take Dianette Do not take 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 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 Possible side effects How to store Dianette Contents of the pack and other information 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 and antibiotics. WHAT YOU NEED TO KNOW BEFORE YOU TAKE DIANETTE DO NOT TAKE DIANETTE: • if you have a severe or multiple risk factor(s) for blood clots (see ‘Dianette and blood clots’ and consult your doctor who will decide whether you may use Dianette) _GENERAL NOTES_ Before you can begin taking Dianette, your doctor will ask you some questions about your personal health history and that of your close relatives. The doctor will also measure your blood pressure, and depending upon your personal situation, may also carry out some other tests. In this leafl 完全なドキュメントを読む
SUMMARY OF PRODUCT CHARACTERISTICS This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4 of the package leaflet for how to report adverse reactions. 1 NAME OF THE MEDICINAL PRODUCT Dianette 2mg/35 microgram coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 2.0mg cyproterone acetate and 0.035mg ethinylestradiol. Excipients with known effect: contains lactose and sucrose For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Coated tablet (tablet). _Product imported from Poland:_ Beige, sugar-coated, biconvex tablets. 4 CLINICAL PARTICULARS As per PA1410/003/001 5 PHARMACOLOGICAL PROPERTIES As per PA1410/003/001 6 PHARMACEUTICAL PARTICULARS 6.1 LIST OF EXCIPIENTS TABLET CORE: Lactose monohydrate Maize starch Povidone 25 000 Talc Magnesium stearate (E572) FILM COATING: Sucrose Povidone 700 000 Macrogol 6000 Calcium carbonate (E170) Talc Glycerol 85% Titanium dioxide (E171) Iron oxide yellow (E172) Montan glycol wax 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_ _7_ _/_ _0_ _3_ _/_ _2_ _0_ _1_ _5_ _C_ _R_ _N_ _ _ _2_ _1_ _5_ _8_ _6_ _1_ _3_ _p_ _a_ _g_ _e_ _ _ _n_ _u_ _m_ _b_ _e_ _r_ _:_ _ _ _1_ 6.2 INCOMPATIBILITIES Not applicable. 6.3 SHELF LIFE The shelf life expiry date for this product shall be the date shown on the blister and outer package of the product on the market i 完全なドキュメントを読む