Šalis: Airija
kalba: anglų
Šaltinis: HPRA (Health Products Regulatory Authority)
PREDNISOLONE CAPROATE, CINCHOCAINE HYDROCHLORIDE
B & S Healthcare
C05AA04
PREDNISOLONE CAPROATE, CINCHOCAINE HYDROCHLORIDE
1.5/5 mg/g
Rectal Ointment
Product subject to prescription which may not be renewed (A)
Corticosteroids
Authorised
2006-08-18
PATIENT INFORMATION LEAFLET SCHERIPROCT ® 1.5MG/G + 5MG/G RECTAL OINTMENT (prednisolone/cinchocaine hydrochloride) READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE. Keep this leaflet. You may need to read it again. If you have any further questions, ask your doctor or pharmacist. This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. If you experience any side effect and this becomes serious, tell your doctor or pharmacist. The name of your medicine is Scheriproct ® 1.5mg/g + 5mg/g Rectal Ointment, but it will be referred to as Scheriproct throughout this leaflet. IN THIS LEAFLET: 1. WHAT SCHERIPROCT IS AND WHAT IT IS USED FOR 2. BEFORE YOU USE SCHERIPROCT 3. HOW TO USE SCHERIPROCT 4. POSSIBLE SIDE EFFECTS 5. HOW TO STORE SCHERIPROCT 6. FURTHER INFORMATION 1. WHAT SCHERIPROCT IS AND WHAT IT IS USED FOR . Scheriproct contains a substance which reduces inflammation (prednisolone), and a local anaesthetic (cinchocaine) which relieves pain. This medicine is used for the relief of the inflammation, swelling, itching and soreness of piles (haemorrhoids) and to relieve itching of the anus (back passage). It is used short- term usually for 5 to 7 days. 2. BEFORE YOU USE SCHERIPROCT . DO NOT USE SCHERIPROCT IF YOU: are allergic (hypersensitive) to prednisolone caproate, cinchocaine hydrochloride, other local anaesthetics or any of the other ingredients of Scheriproct. have a viral infection (e.g. herpes, shingles, chicken-pox) have any bacterial or fun Perskaitykite visą dokumentą
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Scheriproct 1.5mg/g + 5mg/g Rectal Ointment 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each gram of ointment contains 1.9 mg prednisolone caproate equivalent to 1.5 mg of predninsolone and 5 mg of cinchocaine hydrochloride. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Rectal ointment. _Product imported from Portugal:_ Colourless to faintly yellow homogenous translucent ointment. 4 CLINICAL PARTICULARS As per PA1407/002/001 5 PHARMACOLOGICAL PROPERTIES As per PA1407/002/001 6 PHARMACEUTICAL PARTICULARS 6.1 LIST OF EXCIPIENTS Octyldodecanol Castor oil Castor oil, hydrogenated Polyethylene glycol – 400 – monoricinoleate Chypre perfume oil 6.2 INCOMPATIBILITIES Not applicable. 6.3 SHELF LIFE The shelf-life expiry date of this product shall be the date shown on the container and outer package of the product on the market in the country of origin. 6.4 SPECIAL PRECAUTIONS FOR STORAGE Do not store above 25°C. HEALTH PRODUCTS REGULATORY AUTHORITY ________________________________________________________________________________________________________________________ _Date Printed 27/01/2016_ _CRN 2168557_ _page number: 1_ 6.5 NATURE AND CONTENTS OF CONTAINER 30g tube and a rectal ointment applicator contained in an outer cardboard carton. Pack size 30g. 6.6 SPECIAL PRECAUTIONS FOR DISPOSAL OF A USED MEDICINAL PRODUCT OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCT AND OTHER HANDLING OF THE PRODUCT No special requirements. 7 PARALLEL PRODUCT AUTHORISATION HOLDER B&S Healthcare Unit 4 Bradfield Road Ruislip Middlesex HA4 0NU United Kingdom HEALTH PRODUCTS REGULATORY AUTHORITY ________________________________________________________________________________________________________________________ _Date Printed 27/01/2016_ _CRN 2168557_ _page number: 2_ 8 Perskaitykite visą dokumentą