ACOLIC SYRUP

Country: Malaysia

Language: English

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

Active ingredient:

DICYCLOMINE HYDROCHLORIDE; POLYMETHYLSILOXANE,ACTIVATED/SIMETHICONE

Available from:

ROYCE PHARMA MANUFACTURING SDN. BHD.

INN (International Name):

DICYCLOMINE HYDROCHLORIDE; POLYMETHYLSILOXANE,ACTIVATED/SIMETHICONE

Units in package:

1000 ml; 30ml mL; 60ml mL; 120ml mL; 100 ml mL; 90 ml mL

Manufactured by:

ROYCE PHARMA MANUFACTURING SDN. BHD.

Summary of Product characteristics

1
4
ACOLIC SYRUP
(Dicyclomine hydrochloride with
Simethicone - Antispasmodic / Antiflatulent)
PRESENTATION:
An orange colour syrup with banana flavour syrup.
EACH 5ML CONTAINS: Dicyclomine hydrochloride 5mg
Simethicone 50mg
PRESERVATIVES:
Methyl paraben 0.1%w/v
Propyl paraben 0.01%w/v
Sodium benzoate 0.1%w/v
PHARMACOLOGICAL INFORMATION:
Dicyclomine HCl relieves smooth muscle spasm of the gastro-
intestinal tract. Simethicone - an antiflatulance.
D i c y c l o m i n e
H C I
i s
r e a d i l y
a b s o r b e d
f r o m
t h e
gastro-intestinal
tract. It is excreted in the urine, partly as a metabolite.
INDICATION:
A c o l i c
s y r u p
i s
i n d i c a t e d
f o r
t h e
t r e a t m e n t
o f
functional
c o n d i t i o n s
i n v o l v i n g
s m o o t h
m u s c l e
s p a s m
o f
the
g a s t r o - i n t e s t i n a l
t r a c t .
T h e
c o m m o n e s t
o f
t h e s e
are:
i r r i t a b l e
c o l o n
( m u c o u s
c o l i t i s ,
s p a s t i c
c o l o n )
spastic
c o n s t i p a t i o n ,
infant colic. Acolic
s y r u p
c a n
a l s o
b e
used
a s
a d j u n c t i v e
m e d i c a t i o n
i n
a
n u m b e r
o f
organic
gastro-intestinal
c o n d i t i o n s
t o
r e l i e v e
a s s o c i a t e d
smooth,
m u s c l e ,
e . g .
c o l i t i s ,
d i v e r t i c u l o s i s
a n d
diverticulitis,
r e g i o n a l
enteritis, gastritis,
p e p t i c
u l c e r ,
u l c e r a t i v e
colitis,
cholelithiasis
and cholecystitis (but no biliary colic).
DOSAGE AND ADMINISTRATION:
Not recommended for
u s e
i n
i n f a n t
u n d e r
t h e
a g e
o f
6
months.
Adults
:Two
to
four
5ml
measures
3
or
4
times
daily
before
or
after meals.
Children: 2 to 12 years: Two 5ml measures three times daily.
SYMPTOMS AND TREATMENT OF OVERDOSE:
The
signs
and
symptoms
of
overdose
are
headache,
nausea, vomiting, blurred vision, dilated pupils, bot, dry skin,
dizziness, dryness of the mouth, difficulty in swallowing, CNS
stimulation. Treatment
s h o u l d
c o n s i s t
o f
g a s t r i c
l a v a g e ,
e m e t i c s
and activated charcoal.
Barbiturates
may
be
used
either
ora