SCHERIPROCT OINTMENT

Country: South Africa

Language: English

Source: South African Health Products Regulatory Authority (SAHPRA)

Available from:

Adcock Ingram Limited

Dosage:

See ingredients

Pharmaceutical form:

OINTMENT

Composition:

EACH 100,0 g OINTMENT CONTAINS CINCHOCAINE HYDROCHLORIDE 0,5 g PREDNISOLONE HEXANOATE 0,19 g

Authorization status:

Registered

Authorization date:

2000-03-08

Patient Information leaflet

19 April 2022
SIGNED:
S.R
APPROVED PATIENT INFORMATION LEAFLET FOR SCHERIPROCT OINTMENT
SCHEDULING STATUS
S4
SCHERIPROCT OINTMENT
(1,9 mg Prednisolone hexanoate / 5,0 mg cinchocaine hydrochloride per
1 g of ointment)
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING
SCHERIPROCT
OINTMENT
•
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 OINTMENT
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 OINTMENT
is and what it is used for
2. What you need to know before you use
SCHERIPROCT OINTMENT
3. How to use
SCHERIPROCT OINTMENT
4. Possible side effects
5. How to store
SCHERIPROCT OINTMENT
6. Contents of the pack and other information
19 April 2022
SIGNED:
S.R
1. WHAT SCHERIPROCT OINTMENT IS AND WHAT IT IS USED FOR
SCHERIPROCT OINTMENT
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 OINTMENT
DO NOT USE SCHERIPROCT OINTMENT
•
if you are hypersensitive (allergic) to (prednisolone heaxanoate or
chinchocaine hydrochloride)
or any of the other ingredients of
SCHERIPROCT OINTMENT
(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 which you are not
currently being treated.
WARNINGS AND P

Summary of Product characteristics

19 April 2022
SIGNED:
S.R
APPROVED PROFESSIONAL INFORMATION FOR SCHERIPROCT OINTMENT
SCHEDULING STATUS
S4
1. NAME OF THE MEDICINE
SCHERIPROCT OINTMENT
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
1 g ointment contains prednisolone hexanoate 1,9 mg and cinchocaine
hydrochloride 5 mg.
For full list of excipients, see section 6.1.
_ _
3. PHARMACEUTICAL FORM
Colourless to faintly yellowish translucent ointment
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Short term (5 to 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 OINTMENT
, which is best
applied after defaecation.
Unless otherwise prescribed by the doctor, generally apply in a thin
layer twice daily. On the first day, for
faster symptomatic relief,
SHERIPROCT OINTMENT
may be applied three to four times. Smear a little
ointment (about the size of a pea) around the anus and in the anal
ring with a finger and use the finger-tip to
_ _
19 April 2022
SIGNED:
S.R
overcome the resistance of the sphincter. Before applying within the
rectum, the enclosed applicator should be
screwed on to the tube (For use and cleaning of the applicator, see
section 6.6). However, for very inflamed
and hence painful lesions it is advisable initially to apply the
ointment internally with the finger.
Protruding lumps should be thickly smeared and carefully pressed back
with the finger.
4.3 CONTRAINDICATIONS
•
Hypersensitivity to prednisolone hexanoate, cinchocaine hydrochloride
or to any of the other
excipients of
SCHERIPROCT OINTMENT.
•
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 followin