PROCTOSEDYL OINTMENT

Country: Malaysia

Language: English

Source: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Active ingredient:

CINCHOCAINE; FRAMYCETIN SULPHATE; HYDROCORTISONE; Aesculin

Available from:

DKSH MALAYSIA SDN BHD

INN (International Name):

CINCHOCAINE; FRAMYCETIN SULPHATE; HYDROCORTISONE; Aesculin

Units in package:

15gm1Units Units

Manufactured by:

Bausch Health Companies Inc.

Patient Information leaflet

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
1
PROCTOSEDYL
®
OINTMENT
Cinchocaine Hydrochloride / Hydrocortisone / Framycetin Sulphate /
Aesculin (5mg/ 5mg/ 10mg/ 10mg)
WHAT IS IN THIS LEAFLET
1.
What Proctosedyl Ointment is used
for
2.
How Proctosedyl Ointment works
3.
Before you use Proctosedyl
Ointment
4.
How to use Proctosedyl Ointment
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of Proctosedyl
Ointment
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
WHAT PROCTOSEDYL OINTMENT IS USED
FOR
Proctosedyl Ointment can be used for
short term relief of:
•
Pain, irritation, discharge and itching
related with enlarged or swollen vessels
around your back passage
(haemorrhoids)
•
Pre and post-surgery to remove
haemorrhoid.
•
Postnatal (after given birth)
haemorrhoidal conditions.
HOW PROCTOSEDYL OINTMENT WORKS
Proctosedyl Ointment contain four
different medicines called:
Hydrocortisone, Cinchocaine
Hydrochloride, Framycetin Sulphate and
Aesculin.
•
Cinchocaine Hydrochloride belongs to
a group of medicines called local
anaesthetics. It works by causing
numbness in the area to which it is
applied. This stops you feeling pain in
this area and helps lessen the spams of
the back passage.
•
Hydrocortisone belongs to a group of
medicines called corticosteroids. It
works by lowering the production of
substances that cause inflammation. This
helps lower swelling, itching and
discharge.
•
Framycetin Sulphate belongs to a
group of medicines called antibiotics. It
used to treat local infections.
BEFORE YOU USE PROCTOSEDYL OINTMENT
_-When you must not use it _
Do not use Proctosedyl Ointment if:
•
You are allergic (hypersensitive) to
Cinchocaine Hydrochloride,
hydrocortisone or to any of the other
listed ingredients.
•
Signs of an allergic reaction include: a
rash, swallowing or breathing problems,
swelling of your lips, face, throat, or
tongue.
•
You are pregnant
•
You have any kind of infection
Do not use this medicine if any of the
above ap

Summary of Product characteristics

PROCTOSEDYL®
Ointment
Cinchocaine Hydrochloride
Hydrocortisone
Framycetin Sulphate
Aesculin
SANOFI LOGO
PRESENTATION
Proctosedyl
is
available
as
an
odourless,
yellowish white, translucent, greasy ointment.
Each gram of ointment contains the following
active ingredients:
Cinchocaine Hydrochloride ............. 5mg
Hydrocortisone ...............................5mg
Framycetin Sulphate
..................10mg
Aesculin .......................................... 10mg
PHARMACOLOGY (SUMMARY OF
PHARMACODYNAMICS AND PHARMACOKINETICS)
Framycetin Sulphate
Framycetin Sulphate is administered topically in
the treatment of infections of the skin due to
susceptible
organisms
such
as
Staphylococci.
Application to the skin have been reported to
produce no detectable levels in the blood and
urine or sufficient absorption to cause systemic
toxicity.
However,
application
to
areas
of
denuded skin (e.g. in serious burns) has resulted
in
significant
absorption
and
it
has
been
reported to occur from wounds and inflamed
skin. Once absorbed, it is rapidly excreted by the
kidneys
in
the
active
form:
30-50%
of
a
parenteral dose has been detected in the urine.
Due
to
its
known
toxicological
profile
contraindicating
its
parenteral
use
and
its
excellent activity, Framycetin is well suited for
topical use.
Hydrocortisone
Hydrocortisone is absorbed through the skin,
particularly
in
denuded
areas
when
applied
topically. It acts locally as an anti-inflammatory
agent. When absorbed systematically, it has a
biological half-life of about 100 minutes and is
more than 90% bound to plasma proteins. It is
metabolized in the liver and most body tissues to
hydrogenated and degraded forms which are
then excreted in the urine as glucuronides with a
small proportion of unchanged Hydrocortisone.
Cinchocaine Hydrochloride
Cinchocaine Hydrochloride is a local anaesthetic
suitable for surface anaesthesia. It has a more
prolonged
action
than
Lignocaine.
Like
other
local
anaesthetics
of
the
amide
type
it
is
metabolized in the liver.
Aesculin
Aesculin is used for ext