PROCTOSEDYL SUPPOSITORY

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

DIBUCAINE HCl; ESCULOSIDE; HYDROCORTISONE; NEOMYCIN B SULPHATE

Available from:

OPELLA HEALTHCARE SINGAPORE PTE. LTD.

ATC code:

C05AA01

Dosage:

5 mg

Pharmaceutical form:

SUPPOSITORY

Composition:

DIBUCAINE HCl 5 mg; ESCULOSIDE 10 mg; HYDROCORTISONE 5 mg; NEOMYCIN B SULPHATE 10 mg

Administration route:

RECTAL

Prescription type:

Prescription Only

Manufactured by:

HANDOK PHARMACEUTICALS CO LTD

Authorization status:

ACTIVE

Authorization date:

1988-06-08

Patient Information leaflet

---.---.---

        
 
    !" 
#
!  ##$  !%$ 
#  !
 &!" !
 '   !   () "
'"  "    * +
    
!! ! !# 
  '* , '! 
   #    
 * )'$ !
 #   # '"
  !"$     #  
 * ,! !!
  !!  
   $ '!! 
'!$  #!## !    -!! #*
        
#"   
'  ! * " 
   .#" ) 
    #  ##! $
 '  !
*   !$ !
!#  #$   #  .#% #  "  )
 ) )) * , 
"  # "  !!#"
)  #*
       
/  !##  )
! !! # '       "
!# ! !    0
   $   !"$
  #!  '$
 !  !!"* ,
!   !#" 0"  !!#
) !!#'    #*
"!   !" 
!! " !!# !#"
#  ) 
   1 !
   &!" 2 #   3! #" 
    ! 


Summary of Product characteristics

PROCTOSEDYL
Hydrocortisone, Dibucaine hydrochloride, Neomycin
B Sulfate, Esculoside
Suppository
SANOFI LOGO
COMPOSITION:
Each
suppository
contains
the
following active
Ingredients:
Dibucaine hydrochloride................5mg
Hydrocortisone................................5mg
Neomycin B sulfate.......................10mg
Esculoside........................................10mg
IDENTIFICATION:
Suppositories: smooth, off-white suppositories
PHARMACOLOGICAL
ACTION:
The
local
anaesthetic
dibucaine
hydrochloride
prevents
or
relieves
the
severe pain sometimes encountered in strangulated
haemorrhoids, fissures and perianal haematomata,
whilst the corticosteroid acts as a decongestant, anti-
inflammatory and anti-pruritic agent and by so doing
eliminates
itching,
inflammation
and
mucous
discharge. The broad spectrum antibiotic, neomycin
sulphate, will eradicate most infections which may
already be present or arise in lesions of the anorectal
area.
INDICATIONS:
a)
For the treatment of internal and external
haemorrhoids
b)
Haemorrhoids
in
pregnancy
and
post-
partum
c)
Anal pruritus, peri-anal eczema, anal fissures
and proctitis
d)
Post-haemorrhoidectomy
application
to
relieve pain and discomfort
CONTRA-INDICATIONS: Known hyper-sensitivity to any of
the ingredients. In pregnant animals administration
of corticosteroid can cause abnormalities of foetal
development. The relevance of this finding to human
beings has not been established. However, topical
steroids should not be used extensively in pregnancy,
ie
in
large
amounts
of
for
long
periods.
Hydrocortisone may pass into human breast milk.
This product should not be used in pregnancy or
lactation unless considered essential by the physician.
Topical
corticosteroid
preparations
are
contra-
indicated in the
presence of untreated infections of
viral, bacterial, tuberculous, parasitic or fungal origin.
DOSAGE
AND
DIRECTION
FOR
USE:
A
suppository
is
inserted morning and evening and after each stool.
SIDE EFFECT AND SPECIAL PRECAUTIONS:
Long
term
continuous
treatment
with
topical
co