Država: Malta
Jezik: engleski
Izvor: Medicines Authority
balsam peru 49 mg, bismuth oxide 24 mg, bismuth subgallate 59 mg, zinc oxide 296 mg
McNeil Products Limited
C05AX04
balsam peru, zinc oxide
suppository
Authorised
2006-08-10
ZINC OXIDE, BISMUTH OXIDE, BISMUTH SUBGALLATE, BALSAM PERU ■ This medicine is used for the relief of internal piles and other related conditions. ■ 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 Suppositories help to relieve the swelling, itch and irritation of internal piles (haemorrhoids) and other related conditions, such as anal itching. It contains the following ingredients: 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. This product is for use by adults over the age of 18 years. 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 have ever had a BAD REACTION to Anusol or any of its ingredients. If this 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. If any of these bullet points apply to you, TALK TO A DOCTOR OR PHARMACIST. IF YOU ARE PREGNANT OR BREAST-FEEDING ■ If you are pregnant, you can use this product but, as with all medicines at this time, you should discuss it with your doctor fi rst. ■ If you are breast-feeding you can u Pročitajte cijeli dokument
Page 1 of 4 SUMMARY OF PRODUCT CHARACTERISTICS PRODUCT SUMMARY 1. NAME OF THE MEDICINAL PRODUCT Anusol Suppositories 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each suppository contains: Zinc oxide 296 mg Bismuth subgallate 59 mg Balsam peru 49 mg Bismuth oxide 24 mg 3. PHARMACEUTICAL FORM Suppository 4. CLINICAL PARTICULARS 4.1. THERAPEUTIC INDICATIONS For the relief of internal haemorrhoids and other related ano-rectal conditions. 4.2. POSOLOGY AND METHOD OF ADMINISTRATION Anal insertion ADULTS Remove wrapper and insert one suppository into the anus at night, in the morning and after each evacuation. Not to be taken orally. ELDERLY (OVER 65 YEARS) As for adults CHILDREN Not recommended. Page 2 of 4 4.3. CONTRAINDICATIONS History of sensitivity to any of the constituents. 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 human pregnancy have not been conducted, there is no epidemiological evidence of adverse effect, either to the pregnant mother or foetus. 4.7. EFFECTS ON ABILITY TO DRIVE AND USE MACHINES None known. 4.8. UNDESIRABLE EFFECTS Rarely, sensitivity reactions. Patients may occasionally experience transient burning on application, especially if the anoderm is not intact. 4.9. OVERDOSE Treatment of a large acute overdose should include gastric lavage, purgation with magnesium sulphate and complete bed rest. If necessary, give oxygen and general supportive measures. Pročitajte cijeli dokument