Valsts: Īrija
Valoda: angļu
Klimata pārmaiņas: HPRA (Health Products Regulatory Authority)
HYDROCORTISONE ACETATE, BENZYL BENZOATE, BISMUTH OXIDE, BALSAM PERU, ZINC OXIDE, BISMUTH SUBGALLATE
McNeil Healthcare (Ireland) Ltd
C05AA01
HYDROCORTISONE ACETATE, BENZYL BENZOATE, BISMUTH OXIDE, BALSAM PERU, ZINC OXIDE, BISMUTH SUBGALLATE
%w/w
Suppositories
Product not subject to medical prescription
Corticosteroids
Transfer Pending
2000-03-30
HYDROCORTISONE ACETATE, ZINC OXIDE, BISMUTH OXIDE, BISMUTH SUBGALLATE, BALSAM PERU, BENZYL BENZOATE ■ This medicine is used for the relief of internal piles, anal itching, anal inflammation and anal fissures. It can also be used following ano- rectal surgery. ■ This medicine is for use in adults over the age of 18 years. ■ DO NOT USE THIS MEDICINE: ■ If you have had a BAD REACTION to Anusol or any of the ingredients in it. _See section 6_ c ■ If you have FUNGAL, VIRAL OR BACTERIAL SKIN SORES. _See section 2_ c ■ SPEAK TO YOUR DOCTOR: ■ If you have RECTAL BLEEDING which has not been diagnosed as piles. _See section 2_ c ■ If your symptoms have worsened or not improved within 7 days of using this product. _See section _ _2_ c ■ FOLLOW THE INSTRUCTIONS ON HOW TO USE THIS PRODUCT CAREFULLY. _See section 3_ c This medicine has been prescribed for you by your doctor. Do not pass it onto others. It may harm them even if their symptoms are the same as yours. NOW READ THIS WHOLE LEAFLET CAREFULLY BEFORE YOU USE THIS MEDICINE. Keep the leaflet: you might need it again. 1 WHAT THE MEDICINE IS FOR Anusol HC Suppositories help to relieve the pain, swelling, itch and irritation of internal piles, it helps relieve anal inflammation, anal fissures and anal itching. It can also be used following ano-rectal surgery. It contains the following ingredients: HYDROCORTISONE ACETATE is a mild steroid which helps reduce inflammation. ZINC OXIDE and BISMUTH SALTS are mildly astringent and antiseptic. They soothe and protect raw areas. BALSAM PERU is mildly antiseptic and has a protective action on sore areas and may help healing. BENZYL BENZOATE has mild antiseptic properties. This product is for use by adults over the age of 18 years. 2 BEFORE USING THIS MEDICINE This medicine is s Izlasiet visu dokumentu
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 Tubercular, fungal, bacterial and viral lesions including herpes simplex, vaccinia and varicella. 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_ _ _ _2_ _0_ _/_ _0_ _3_ _/_ _2_ _0_ _1_ _7_ _C_ _R_ _N_ _ _ _2_ _1_ _7_ _6_ _9_ _1_ _7_ _p_ _a_ _g_ _e_ _ _ _n_ _u_ _m_ _b_ _e_ _r_ _:_ _ _ _1_ 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Patients with rectal bleeding or blood in the stool should talk to Izlasiet visu dokumentu