SCHERIPROCT prednisolone hexanoate and cinchocaine hydrochloride suppository strip pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

prednisolone hexanoate, Quantity: 1.3 mg; cinchocaine hydrochloride, Quantity: 1 mg

Available from:

AFT Pharmaceuticals Pty Ltd

Pharmaceutical form:

Suppository

Composition:

Excipient Ingredients: Hard fat

Administration route:

Rectal

Units in package:

6 suppositories, 12 suppositories

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Symptomatic relief of pain and irritation associated with haemorrhoids, superficial anal fissures and proctitis.

Product summary:

Visual Identification: Yellowish-white suppositories.; Container Type: Strip Pack; Container Life Time: 30 Months; Container Temperature: Store at 2 to 8 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2000-05-08

Patient Information leaflet

1
SCHERIPROCT
®
OINTMENT AND SUPPOSITORIES
_ _
CONSUMER MEDICINE INFORMATION
PLEASE READ THIS LEAFLET CAREFULLY
BEFORE YOU START YOUR TREATMENT.
KEEP THIS LEAFLET. You may want to
read it again.
WHAT IS IN THIS LEAFLET?
This leaflet answers some common
questions about Scheriproct
®
. It
does not contain all the available
information.
It does not take the place of talking
to your doctor or pharmacist.
Your doctor has weighed the risks of
you using Scheriproct
®
against the
benefits he/she expects it will have
for you.
IF YOU HAVE ANY CONCERNS ABOUT
THIS MEDICINE, ASK YOUR DOCTOR OR
PHARMACIST.
WHAT SCHERIPROCT ® IS
USED FOR
The active ingredient in Scheriproct
®
is a type of cortisone and belongs to
the group of medicines called
corticosteroids.
Scheriproct
®
is the brand name for
agents containing the substances
prednisolone hexanoate and
cinchocaine hydrochloride.
Scheriproct
®
is used in the treatment
of haemorrhoids(piles), tears of the
anal tissue, and similar conditions.
The active ingredients reduce the
inflammation and pain associated
with such problems.
Your doctor however, may have
prescribed Scheriproct
®
for another
purpose.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY SCHERIPROCT
®
HAS BEEN PRESCRIBED FOR YOU.
A doctor’s prescription is required for
Scheriproct
®
.
BEFORE YOU USE
SCHERIPROCT
®
_WHEN YOU MUST NOT USE IT_
_ _
DO NOT USE SCHERIPROCT
®
IF YOU
HAVE EVER HAD AN ALLERGIC REACTION
TO:
•
Prednisolone hexanoate or
cinchocaine hydrochloride
•
Any of the ingredients in
Scheriproct
®
listed at the end of
this leaflet for the product you
are using.
_DO NOT USE SCHERIPROCT_
_®_
_ IF _
_YOU HAVE_:
•
TB OR SYPHILIS IN THE AREA TO
BE TREATED
•
A VIRAL DISEASE (E.G.
CHICKENPOX)
•
TRAUMATISED SKIN
•
A BACTERIAL OR FUNGAL SKIN
INFECTION (SUCH AS THRUSH)
UNLESS YOU ARE ALSO BEING
TREATED FOR THIS OR UNLESS
YOUR DOCTOR TELLS YOU.
ASK YOUR DOCTOR TO BE SURE YOU DO
NOT HAVE ANY OF THESE CONDITIONS.
DO NOT USE SCHERIPROCT
®
IF YOU ARE
IN THE FIRST TRIMESTER OF PREGNANCY.
DO

Summary of Product characteristics

SCHERIPROCT PI
Page 1 of 8
AUSTRALIAN PRODUCT INFORMATION - SCHERIPROCT
®
(PREDNISOLONE HEXANOATE AND CINCHOCAINE HYDROCHLORIDE) OINTMENT AND
SUPPOSITORIES
1.
NAME OF THE MEDICINE
Prednisolone hexanoate and cinchocaine hydrochloride.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
The active ingredients of Scheriproct are synthetic corticosteroids,
prednisolone hexanoate and
cinchocaine hydrochloride.
Scheriproct 1 g ointment contains 1.9 mg prednisolone hexanoate
(equivalent to 1.5 mg of
prednisolone) and 5 mg cinchocaine
hydrochloride in an ointment base.
Scheriproct suppository, 1 suppository contains 1.3 mg prednisolone
hexanoate (equivalent to 1mg
of prednisolone) and 1 mg cinchocaine hydrochloride in a hard fat
base.
Excipients with known effect: Contains benzoates. For the full list of
excipients, see Section 6.1
LIST OF EXCIPIENTS.
3.
PHARMACEUTICAL FORM
_SCHERIPROCT OINTMENT_
Colourless to slightly yellow translucent ointment.
_SCHERIPROCT SUPPOSITORIES_
Yellowish-white suppositories.
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
Symptomatic relief of pain and irritation associated with
haemorrhoids, superficial anal fissures
and proctitis.
4.2.
DOSE AND METHOD OF ADMINISTRATION
The anal region should be cleaned thoroughly before using Scheriproct,
which is best applied after
defecation. There is usually a rapid improvement, but this should not
mislead one into
stopping
treatment too soon. To avoid relapses, Scheriproct should be continued
for at least one
week,
though less frequently (ointment once a day or one suppository every
other day), even when the
symptoms have completely disappeared. However, duration of treatment
should, as far
as
possible, not exceed 4 weeks.
_SCHERIPROCT OINTMENT_
Unless otherwise prescribed by the doctor, generally, apply twice
daily, on the first day, for faster
SCHERIPROCT PI
Page 2 of 8
symptomatic relief, up 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 fingertip to overcome the resista