Ország: Málta
Nyelv: angol
Forrás: Medicines Authority
balsam peru 1.875 % (w/v), bismuth oxide 0.875 % (w/v), bismuth subgallate 2.25 % (w/v), zinc oxide 10.75 % (w/v)
McNeil Products Limited
C05AX04
balsam peru, zinc oxide
ointment
Authorised
2006-08-10
ZINC OXIDE, BISMUTH OXIDE, BISMUTH SUBGALLATE, 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 or any of the ingredients in it. _See section 6_ c ■ SPEAK TO YOUR DOCTOR: ■ If you have RECTAL BLEEDING which has not been diagnosed as piles. _See section 2_ c ■ FOLLOW THE INSTRUCTIONS ON HOW TO USE THIS PRODUCT CAREFULLY. _See section 3_ c 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 Ointment is a medicine which is used to relieve the swelling, itch and irritation of internal and external piles (haemorrhoids) and other minor ano-rectal conditions such as anal itching and fissures. It can be used post-operatively following ano-rectal surgery. 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 SALTS 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. X DO NOT USE THIS MEDICINE… ■ If you have ever had a BAD REACTION to Anusol or any of its ingredients. If the above applies to you, GET ADVICE FROM A DOCTOR OR PHARMACIST WITHOUT USING ANUSOL. TALK TO YOUR DOCTOR OR PHARMACIST… ■ If you have RECTAL BLEEDING or if YOU ARE IN DOUBT WHETHER ANY BLEEDING YOU HAVE EXPERIENCED IS CAUSED BY PILES Olvassa el a teljes dokumentumot
Page 1 of 4 SUMMARY OF PRODUCT CHARACTERISTICS PRODUCT SUMMARY 1. NAME OF THE MEDICINAL PRODUCT Anusol Ointment 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each 100g ointment contains: Zinc Oxide 10.75 g Bismuth Subgallate 2.25 g Balsam Peru 1.875 g Bismuth Oxide 0.875 g 3. PHARMACEUTICAL FORM A light buff coloured ointment. 4. CLINICAL PARTICULARS 4.1. THERAPEUTIC INDICATIONS Symptomatic relief of uncomplicated internal and external haemorrhoids, pruritus ani, proctitis and fissures. Also indicated post operatively in ano- rectal surgical procedures and after incision of thrombosed or sclerosed ano- rectal veins. Anusol Ointment provides antiseptic, astringent and emollient properties which help to relieve discomfort associated with minor ano-rectal conditions. 4.2. POSOLOGY AND METHOD OF ADMINISTRATION Topical. ADULTS AND ELDERLY (OVER 65 YEARS): 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 ointment. Anusol Ointment should be applied on a gauze dressing. For internal conditions use rectal nozzle provided. Remove the nozzle cap. Clean the nozzle after each use. Not to be taken orally. CHILDREN: Not recommended 4.3. CONTRAINDICATIONS Known hypersensitivity to any of the constituents. Page 2 of 4 4.4. SPECIAL WARNINGS AND PRECAUTIONS FOR USE None known. 4.5. INTERACTIONS WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION None known. 4.6. PREGNANCY AND LACTATION Whilst formal studies on the effect of this product during pregnancy have not been conducted, there is no epidemiological evidence of adverse effects either Olvassa el a teljes dokumentumot