Valsts: Īrija
Valoda: angļu
Klimata pārmaiņas: HPRA (Health Products Regulatory Authority)
HYDROCORTISONE ACETATE ; BENZYL BENZOATE ; BISMUTH OXIDE ; BALSAM PERU ; ZINC OXIDE ; BISMUTH SUBGALLATE
Church & Dwight UK Limited
C05AA01
HYDROCORTISONE ACETATE ; BENZYL BENZOATE ; BISMUTH OXIDE ; BALSAM PERU ; ZINC OXIDE ; BISMUTH SUBGALLATE
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Suppositories
Product not subject to medical prescription
hydrocortisone
Marketed
1990-03-30
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Anusol HC Suppositories 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 2.8g suppository contains: For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Suppository Off white suppositories. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Anusol HC Suppositories are indicated for the symptomatic relief of external and internal 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 wrapper and insert one suppository into the anus at night, in the morning and after each evacuation, up to a maximum of three a day. Not to be taken orally. ELDERLY (OVER 65 YEARS): As for adults. CHILDREN: Not recommended. 4.3 CONTRAINDICATIONS Hypersensitivity to the active substance(s) or to any of the excipients listed in section 6.1 Hydrocortisone Acetate 10 mg Benzyl Benzoate 33 mg Bismuth oxide 24 mg Balsam Peru 49 mg Zinc Oxide 296 mg Bismuth Subgallate 59 mg 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_ _ _ _3_ _1_ _/_ _0_ _7_ _/_ _2_ _0_ _1_ _7_ _C_ _R_ _N_ _ _ _2_ _1_ _9_ _0_ _5_ _9_ _7_ _p_ _a_ _g_ _e_ _ _ _n_ _u_ _m_ _b_ _e_ _r_ _:_ _ _ _1_ Tubercular, fungal, bacterial and viral lesions including herpes simplex, vaccinia and varicella. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Patients with rectal bleeding or blood in the stool should talk to Izlasiet visu dokumentu