국가: 아일랜드
언어: 영어
출처: HPRA (Health Products Regulatory Authority)
Bismuth oxide; Zinc oxide; Balsam peru; Bismuth subgallate
SOFIBEL
C05AX; C05AX04
Bismuth oxide; Zinc oxide; Balsam peru; Bismuth subgallate
1
Suppository
Product not subject to medical prescription
Other agents for treatment of hemorrhoids and anal fissures for topical use; zinc preparations
Marketed
1990-04-03
Health Products Regulatory Authority 21 March 2019 CRN008XRC Page 1 of 6 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Anusol Suppositories 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each Suppository contains: Bismuth oxide anhydrous 24 mg Zinc Oxide 296 mg Balsam Peru 49 mg Bismuth Subgallate 59 mg For a full list of excipients, see Section 6.1. 3 PHARMACEUTICAL FORM Suppository White or off white suppositories having the characteristic odour of Balsam Peru. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Indicated for the symptomatic relief of uncomplicated internal haemorrhoids, or post-operatively after ano-rectal procedures using surgical or sclerosing techniques. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION ADULTS AND CHILDREN 12 YEARS AND OVER: Remove wrapper and insert into the anus at night, in the morning and after each evacuation. Not to be taken orally. CHILDREN UNDER 12 YEARS: Not recommended, except under medical advice. THE ELDERLY: As for adults. 4.3 CONTRAINDICATIONS Hypersensitivity to the active substance(s) or to any of the excipients listed in section 6.1 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. If symptoms persist or worsen patients should stop use and consult their doctor. Health Products Regulatory Authority 21 March 2019 CRN008XRC Page 2 of 6 4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTIONS None known. 4.6 FERTILITY, PREGNANCY AND LACTATION There are no adequate and well-controlled clinical studies of fixed combinations of balsam peru, bismuth oxide, bismuth subgallate and zinc oxide in pregnant or breast-feeding women. This product should not be used during pregnancy and lactation unless the potential benefit of treatment to the mother outweighs the possible risk to the developing foetus or nursing infant. 4.7 EFFECTS ON ABILITY TO DRIVE AND USE MACHINES 전체 문서 읽기