Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Prednisolone; Cinchocaine hydrochloride
Bayer Limited
C05AA; C05AA04
Prednisolone; Cinchocaine hydrochloride
1 mg/1 milligram(s)
Suppository
Product subject to prescription which may not be renewed (A)
Corticosteroids; prednisolone
Marketed
1978-04-01
Bayer Limited The Atrium Blackthorn Road Dublin 18 Telephone: +353 1 2999313 Fax: +353 1 2061456 www.bayer.ie 15660 PATIENT INFORMATION LEAFLET SCHERIPROCT ® 1.5 MG/G + 5 MG/G RECTAL OINTMENT SCHERIPROCT ® 1 MG + 1 MG SUPPOSITORIES 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. 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 fungal infections of the skin for which you are not receiving treatment TAKE SPECIAL CARE WITH SCHERIPROCT Long-term continuous treatment should be avoided because it can cause the skin to thin and deteriorate in the affected area (see section 4. “Possible Side Effects”) and some of the medicine may be absorbed into the blood stream. If the area treated with Scheriproct is also infected your doctor should prescribe another me Read the complete document
HealthProductsRegulatoryAuthority 16April2019 CRN008LLS Page1of4 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Scheriproct1mg+1mgsuppositories 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Eachsuppositorycontainsprednisolonecaproateequivalentto1mgprednisoloneand1mgcinchocainehydrochloride. Forafulllistofexcipients,seesection6.1. 3 PHARMACEUTICAL FORM Suppository Whitetoyellowishsuppositories. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Inthemanagementofsymptomsofinternalorexternalhaemorrhoids,analfissuresandproctitis. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION TheanalregionshouldbecleanedthoroughlybeforeusingScheriproct,whichisbestappliedafterdefaecation. Onesuppositorydailyasdirected.Ifsymptomsaresevereonesuppositorytwoorthreetimesonthefirstday. Onlyonthefirst daymaymorethan1suppositorybeusedifthesymptomsaresevere. Durationoftreatmentshouldnotusuallyexceed1week. Specifictreatmentoftheconditiongivingrisetothehaemorrhoidsmayberequired. 4.3 CONTRAINDICATIONS Useinthepresenceofuntreatedinfectionsofbacterial,viral,tuberculousorfungalorigin. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Additionalspecifictherapyisrequiredinbacterialand/orfungalinfections. Therehavebeenafewreportsintheliteratureofthedevelopmentofcataractsinpatientswhohavebeenusingcorticosteroids forprolongedperiodsoftime.Althoughitisnotpossibletoruleoutsystemiccorticosteroidsasaknownfactor,prescribers shouldbeawareofthepossibleroleofcorticosteroidsincataractdevelop Read the complete document