PROCTOSEDYL SUPPOSITORY

Country: Malaysia

Language: English

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

Active ingredient:

FRAMYCETIN SULPHATE; CINCHOCAINE; HYDROCORTISONE; Aesculin

Available from:

DKSH MALAYSIA SDN BHD

INN (International Name):

FRAMYCETIN SULPHATE; CINCHOCAINE; HYDROCORTISONE; Aesculin

Units in package:

12Units Units

Manufactured by:

PT AVENTIS PHARMA

Patient Information leaflet

_ Consumer Medication Information Leaflet (RiMUP) _
PROCTOSEDYL
®
SUPPOSITORY
Cinchocaine Hydrochloride / Hydrocortisone / Framycetin Sulphate /
Aesculin (5mg/ 5mg/ 10mg/ 10mg)
1
WHAT IS IN THIS LEAFLET
1.
What
Proctosedyl
Suppository
is
used for
2.
How
Proctosedyl
Suppository
works
3.
Before
you
use
Proctosedyl
Suppository
4.
How to use Proctosedyl Suppository
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of Proctosedyl
Suppository
8.
Product Description
9.
Manufacturer
and
Product
Registration Holder
10.
Date of revision
WHAT PROCTOSEDYL SUPPOSITORY IS USED
FOR
Proctosedyl Suppository 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 SUPPOSITORY WORKS
Proctosedyl Suppository contains of 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 spasm 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
SUPPOSITORY
_-When you must not use it _
Do not use Proctosedyl Suppository if:
•
You
are
allergic (hypersensitive) to
Cinchocaine
Hydrochloride,
hydrocortisone or to any 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

Summary of Product characteristics

Proctosedyl 
Suppository 
Cinchocaine Hydrochloride 
Hydrocortisone 
Framycetin Sulphate (Soframycin) 
Aesculin 

SANOFI Logo 

Presentation 
Proctosedyl is available as smooth off‐white 
suppositories. 
Each suppository contains the following active 
ingredients: 
Cinchocaine Hydrochloride 5mg 
Hydrocortisone 5mg 
Framycetin Sulphate (Soframycin) 10mg 
Aesculin 10mg 

Pharmacology (Summary of 
Pharmacodynamics and Pharmacokinetics) 
Framycetin Sulphate 
Framycetin  Sulphate  is  administered  topically 
in the treatment of infection of the skin due to 
susceptible  organism  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 glucoronides with  a  small  proportion  of  unchanged 
Hydrocortisone. 

Cinchocaine Hydr