国家: 爱尔兰
语言: 英文
来源: HPRA (Health Products Regulatory Authority)
PRAMOCAINE HYDROCHLORIDE HYDROCORTISONE ACETATE BENZYL BENZOATE BISMUTH OXIDE BALSAM PERU ZINC OXIDE BISMUTH SUBGALLATE
Pfizer Healthcare Ireland
Suppositories
2000-03-15
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Anugesic HC Suppositories 2 QUALITATIVE AND QUANTITATIVE COMPOSITION For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Suppository The product is a buff coloured suppository. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Anugesic HC Suppositories are indicated for the comprehensive symptomatic treatment of severe and acute discomfort or pain associated with internal and external haemorrhoids, proctitis, cryptitis, anal fissures, pruritus ani and perianal sinuses. Also indicated post-operatively in ano-rectal surgical procedures. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Intrarectal. ADULTS: Remove plastic cover and insert one suppository into the anus at night, in the morning and after each evacuation. Not to be taken orally. ELDERLY (over 65 years): As for adults. CHILDREN: Not recommended. 4.3 CONTRAINDICATIONS Tubercular, fungal and viral lesions including herpes simplex, vaccinia and varicella. History of sensitivity to any of the constituents. Each 2.8 g suppository contains: Pramocaine Hydrochloride 27 mg Hydrocortisone Acetate 5 mg Benzyl Benzoate 33 mg Bismuth oxide 24 mg Balsam Peru 49 mg Zinc Oxide 296 mg Bismuth Subgallate 59 mg IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 31/01/2012_ _CRN 2110627_ _page number: 1_ 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE As with all products containing topical steroids the possibility of systemic absorption should be borne in mind. Prolonged or excessive use may produce systemic corticosteroid effects, and use for periods longer than seven days is not recommended. Following symptomatic relief definitive diagnosis should be established. 4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS 阅读完整的文件