国家: 爱尔兰
语言: 英文
来源: HPRA (Health Products Regulatory Authority)
Bismuth oxide; Balsam peru; Zinc oxide
SOFIBEL
C05AX; C05AX04
Bismuth oxide; Balsam peru; Zinc oxide
2.14/1.8/1 gram(s)
Cream
Product not subject to medical prescription
Other agents for treatment of hemorrhoids and anal fissures for topical use; zinc preparations
Marketed
1990-04-03
ANUSOL® cream ZINC OXIDE, BISMUTH OXIDE, BALSAM PERU ■ This medicine is used for the relief of internal and external piles and other minor ano-rectal conditions such as anal itching. ■ 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 Cream or any of the ingredients in it. _See _ _section 6 _ ■ SPEAK TO YOUR DOCTOR: ■ If you have RECTAL BLEEDING or blood in your stool which has not been diagnosed as piles. _See section 2 _ ■ FOLLOW THE INSTRUCTIONS ON HOW TO USE THIS PRODUCT CAREFULLY. _See section 3 _ 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 Cream is a medicine which is used to relieve the pain, swelling, itch and irritation of internal and external piles (haemorrhoids) and other minor ano-rectal conditions such as anal itching and fissures as diagnosed by a doctor. It can be used post-operatively following ano- rectal surgery as advised by a doctor. Anusol Cream has a vanishing base which means it is rapidly absorbed. The cream can also provide lubrication when used with suppositories. It contains the following ingredients: ZINC OXIDE which is an astringent which soothes and protects raw areas and helps reduce swelling. It also acts as an antiseptic. BALSAM PERU which is mildly antiseptic and has a protective action on sore areas and may help healing. BISMUTH OXIDE which is astringent and antiseptic and also protects raw, irritated areas around the anal area. This product is for use by adults over the age of 18 years old. 2 BEFORE USING THIS MEDICINE This medicine is suitable for most people but a few people should not use it. If you are in any doubt, talk to your doctor or pharmacist. DO NOT USE THIS MEDICINE ■ If you are allergic to Anusol Cream or any of the other ingredients of this medicine (listed in section 6.1). If the above applies to you, GET ADVICE FROM A DOCTOR OR PHARMACIST WITHOUT USING ANUSOL CREA 阅读完整的文件
Health Products Regulatory Authority 21 March 2019 CRN008XRC Page 1 of 5 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Anusol Cream 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 100 g of cream contains: Active substances: Bismuth oxide 2.14 g Zinc Oxide 10.75 g Balsam Peru 1.80 g Excipients: Propylene Glycol 8.00 g Methyl Parahydroxybenzoate (E218) 0.11 g Propy Parahydroxybenzoate (E216) 0.01 g For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Cream A smooth, homogeneous, buff coloured cream with the characteristic odour of Balsam Peru. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Anusol Cream provides antiseptic, astringent and emollient properties which help to relieve discomfort associated with minor ano-rectal conditions. Anusol Cream also provides lubricating properties for use with suppositories. Indicated for the symptomatic relief of uncomplicated internal and external haemorrhoids, pruritus ani, proctitis and fissures as diagnosed by a doctor. Also indicated post-operatively in ano-rectal surgical procedures and after incision of thrombosed sclerosed ano-rectal veins as advised by a doctor. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION ADULTS AND CHILDREN 12 YEARS AND OVER: Apply to the affected area at night, in the morning and after each evacuation until the condition is controlled. Thoroughly cleanse the affected area, dry and apply cream. Anusol Cream is prepared in a vanishing cream base and may be gently smoothed onto the affected area without the need to apply a gauze dressing. For internal conditions use rectal nozzle provided and clean it after each use. Not to be taken orally. CHILDREN UNDER 12 YEARS: Not recommended, except under medical advice. THE ELDERLY: As for adults. 4.3 CONTRAINDICATIONS Health Products Regulatory Authority 21 March 2019 CRN008XRC Page 2 of 5 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 Not to be taken orally. Patients with rectal bl 阅读完整的文件