Země: Irsko
Jazyk: angličtina
Zdroj: HPRA (Health Products Regulatory Authority)
HYDROCORTISONE ACETATE, BENZYL BENZOATE, BISMUTH SUBGALLATE, BISMUTH OXIDE, BALSAM PERU, ZINC OXIDE
McNeil Healthcare (Ireland) Ltd
D07BA
HYDROCORTISONE ACETATE, BENZYL BENZOATE, BISMUTH SUBGALLATE, BISMUTH OXIDE, BALSAM PERU, ZINC OXIDE
N/A
Ointment
Product not subject to medical prescription
CORTICOSTEROIDS, WEAK, COMB WITH ANTISEPTICS
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 and external 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 Ointment helps to relieve the pain, swelling, itch and irritation of internal and external piles, it helps relieves 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 Přečtěte si celý dokument
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Anusol HC Ointment 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 100g of ointment contains: Excipient: Wool Fat 8.00 g For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Ointment A smooth, homogeneous buff coloured ointment with the characteristic odour of Balsam Peru. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Anusol HC Ointment is 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 Topical. ADULTS: Thoroughly cleanse the affected area, dry and apply ointment on a gauze dressing. Apply ointment to the affected area at night, in the morning and after each evacuation. For internal conditions use rectal nozzle provided and clean it after each use. Do not use for longer than 7 days, unless on the advice of a doctor. 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. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Patients with rectal bleeding or blood in the stool should talk to their doctor before using this product as these conditions may be the symptom of a more serious underlying disorder. Hydrocortisone Acetate 0.25 g Benzyl Benzoate 1.25 g Bismuth Subgallate 2.25 g Bismuth oxide 0.875 g Balsam Peru 1.875 g Zinc Oxide 10.75 g HEALTH PRODUCTS REGULATORY AUTHORITY ______________________________________________________________________________________________ Přečtěte si celý dokument