Country: South Africa
Language: English
Source: South African Health Products Regulatory Authority (SAHPRA)
Adcock Ingram Limited
See ingredients
SUPPOSITORY
EACH SUPPOSITORY CONTAINS CINCHOCAINE HYDROCHLORIDE 1,0 mg PREDNISOLONE HEXANOATE 1,3 mg
Registered
2000-03-08
19 April 2022 SIGNED: S.R APPROVED PATIENT INFORMATION LEAFLET FOR [SCHERIPROCT SUPPOSITORIES] SCHEDULING STATUS S4 SCHERIPROCT SUPPOSITORIES (1,3 mg Prednisolone hexanoate / 1,0 mg cinchocaine hydrochloride per 1 g) READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING SCHERIPROCT SUPPOSITORIES • Keep this leaflet. You may need to read it again. • If you have further questions, please ask your doctor, pharmacist, nurse or other health care provider. • SHERIPROCT SUPPOSITORIES has been prescribed for you personally and you should not share your medicine with other people. It may harm them, even if their symptoms are the same as yours. WHAT IS IN THIS LEAFLET 1. What SCHERIPROCT SUPPOSITORIES is and what it is used for 2. What you need to know before you use SCHERIPROCT SUPPOSITORIES 3. How to use SCHERIPROCT SUPPOSITORIES 4. Possible side effects 5. How to store SCHERIPROCT SUPPOSITORIES 6. Contents of the pack and other information 19 April 2022 SIGNED: S.R 1. WHAT SCHERIPROCT SUPPOSITORIES IS AND WHAT IT IS USED FOR SCHERIPROCT SUPPOSITORIES contains a substance called prednisolone, which reduces inflammation and also a local anaesthetic (chinchocaine) which relieves pain. This medicine is used for the short term (usually 5 – 7 days) symptomatic relief of peri-anal (located around the anus, the opening of the rectum to the outside of the body) discomfort, inflammation and itching caused by thrombosed haemorrhoids (piles), anal fissure (a small tear in the thin, moist tissue (mucosa) that lines the anus) and pruritus ani (irritating, itchy sensation around the anus). 2. WHAT YOU NEED TO KNOW BEFORE YOU USE SCHERIPROCT SUPPOSITORIES DO NOT USE SCHERIPROCT SUPPOSITORIES • if you are hypersensitive (allergic) to (prednisolone heaxanoate or chinchocaine hydrochloride) or any of the other ingredients of SCHERIPROCT SUPPOSITORIES (listed in section 6). • if you have a viral infection (e.g. herpes, shingles, chicken-pox). • if you have any bacterial or fungal infections of the skin or elsewhere for wh Read the complete document
19 April 2022 SIGNED: S.R APPROVED PROFESSIONAL INFORMATION FOR SCHERIPROCT SUPPOSITORIES SCHEDULING STATUS S4 1. NAME OF THE MEDICINE SCHERIPROCT SUPPOSITORIES 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 1 suppository contains prednisolone hexanoate 1,3 mg and cinchocaine hydrochloride 1 mg. For full list of excipients, see section 6.1. _ _ 3. PHARMACEUTICAL FORM Yellowish-white suppositories without cosmetic defects 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Short term (5 – 7 days) symptomatic relief of perianal discomfort, inflammation and itching caused by thrombosed haemorrhoids, anal fissure and pruritus ani. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION POSOLOGY The anal region should be cleaned thoroughly before using SCHERIPROCT SUPPOSITORIES , which is best inserted after defaecation. Unless otherwise prescribed by the doctor, generally insert one suppository daily high into the rectum. If symptoms are severe, insert one suppository two to three times on the first day. _ _ There is usually a rapid improvement, but this should not mislead one into stopping treatment too soon. 4.3 CONTRAINDICATIONS • Hypersensitivity to prednisolone hexanoate, cinchocaine hydrochloride or to any of the other excipients of SCHERIPROCT SUPPOSITORIES . • Viral infections, primary bacterial or fungal infections in the treatment area. • Virus diseases (e.g. vaccinia, chickenpox). • Secondary infections of the skin in the absence of appropriate anti-infective therapy. • Known sensitivity to local anaesthetics. • Corticosteroids have been shown to be teratogenic in animals Corticosteroids have been shown to be teratogenic in animals following dermal application. As these agents are absorbed percutaneously, teratogenicity following topical application cannot be excluded. Therefore, SCHERIPROCT SUPPOSITORIES should not be used during pregnancy. • Tuberculous or syphilitic processes in the area to be treated 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE This product should not be used continuously for more than Read the complete document