AXCEL DICYCLOMINE-S SYRUP

Quốc gia: Malaysia

Ngôn ngữ: Tiếng Anh

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

Thành phần hoạt chất:

POLYMETHYLSILOXANE,ACTIVATED/SIMETHICONE; DICYCLOMINE HYDROCHLORIDE

Sẵn có từ:

KOTRA PHARMA (M) SDN. BHD.

INN (Tên quốc tế):

POLYMETHYLSILOXANE,ACTIVATED/SIMETHICONE; DICYCLOMINE HYDROCHLORIDE

Các đơn vị trong gói:

100 ml; 60 ml; 120 ml

Sản xuất bởi:

KOTRA PHARMA (M) SDN. BHD.

Tờ rơi thông tin

AXCEL DICYCLOMINE-S SYRUP
Dicyclomine Hydrochloride/Simethicone (5mg/50mg)
1
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
WHAT IS IN THIS LEAFLET
1.
What Axcel Dicyclomine-S Syrup
is used for.
2.
How Axcel Dicyclomine-S Syrup
works.
3.
Before
you
use
Axcel
Dicyclomine-S Syrup.
4.
How to take Axcel Dicyclomine-
S Syrup.
5.
While you are using it.
6.
Side effects.
7.
Storage
and
disposal
of
Axcel
Dicyclomine-S Syrup.
8.
Product description.
9.
Manufacturer
and
Product
Registration Holder.
10.
Date of revision.
WHAT AXCEL DICYCLOMINE-S SYRUP IS
USED FOR
Axcel Dicyclomine-S Syrup is used
for the relief of gastrointestinal colic,
flatulence and abdominal discomfort
due to entrapped gas.
HOW
AXCEL
DICYCLOMINE-S
SYRUP
WORKS
Dicyclomine
is
a
medicine
for
reducing
cramps
and
pain
in
the
digestive tract.
Simethicone
lowers
surface
tension
cause bubbles of gas in the digestive
tract
to
coalesce,
thus
aiding
their
elimination.
BEFORE YOU USE AXCEL DICYCLOMINE-S
SYRUP
_-When you must not use it _
Do
not
take
Axcel
Dicyclomine-S
Syrup if:
•
The
infants
younger
than
6
months.
•
You have closed angle glaucoma
(a buildup of pressure in the eye).
•
You have urinary tract or stomach
and intestinal obstruction.
•
You have unstable cardiovascular
(heart or blood vessel) status in
acute
bleeding
or
backflow
of
gastric
content
leading
to
esophagus (food pipe) irritation.
•
You
suffer
from
reduced
intestinal movement or paralysis.
•
You are allergic or hypersensitive
to
Dicyclomine
and
other
ingredients.
•
The ambient temperature is high
especially in children.
_-Before you start to use it _
Tell your doctor if you:
•
Have
fever,
asthma
or
hiatal
hernia (part of the stomach pushes
upward into the chest).
•
Have
serious
liver
or
kidney
disease, acute heart attack or high
blood pressure.
•
Are
elderly
and
in
conditions
characterized
by
a
faster
than
normal
heart
rate
&
debilitate
individuals
with
long
term
obstructive lung disease.
•
Are pregnant.
•
Are allergic to any medicines.
_ _
_-Taking other medicines _

Đặc tính sản phẩm

COMPOSITION:
Each 5ml contains
Dicyclomine hydrochloride 5mg
Simethicone 50mg
0.1%
w/v
Methylparaben
as
preservative
PRESENTATION:
Orange coloured and orange flavoured syrup.
INDICATIONS:
Relief
of
gastro-intestinal
colic,
flatulence
&
abdominal discomfort due to entrapped gas.
PHARMACOLOGY:
_Mechanism of Action:_
Dicyclomine Hydrochloride is a tertiary amine
with antimuscarinic effects similar to but weaker
than
those
atropine;
it
also
has
a
direct
anti-spasmodic
action.
Simethicone
lowers
surface
tension
and
when
administered
by
mouth
causes
bubbles
of
gas
in
the
gastro-intestinal tract to coalesce, thus aiding
their dispersion.
_Pharmacokinetics: _
Dicyclomine is used in gastrointestinal spasm,
particularly
that
associated
with
the
irritable
bowel syndrome, and is also given in association
with antacids as an adjunct in the treatment of
peptic
ulcer.
Simethicone
is
used
to
relieve
flatulence
and
abdominal
discomfort
due
to
excess gastrointestinal gas and also used as
defoaming agent in radiography or endoscopy of
the gastrointestinal tract.
DOSAGE AND ADMINISTRATION:
To be taken orally, 15 minutes before meal.
Adults : 10 - 20ml, 3 - 4 times a day;
Children (2 - 12 years) : 10ml, 3 - 4 times daily,
(6 months - 2 years) : 5 - 10ml, 3 - 4 times daily,
total daily dose should not exceeding 40ml.
CONTRAINDICATION:
Contraindicated in patients with closed-angle
glaucoma, urinary or GI obstruction, intestinal
atony,
paralytic
ileus,
hypersensitivity
to
Dicyclomine, unstable cardiovascular status in
acute
hemorrhage
and
reflux
oesophagitis.
PRECAUTION:
Due to the risk of provoking hyperpyrexia, it should not be
given to patients, especially children when the ambient
temperature is high. It should also be used cautiously in
patient with fever, asthma, hiatal hernia, serious hepatic or
renal disease. Precaution in acute myocardial infarction,
hypertension. Elderly and in conditions characterized by
tachycardia & in debilitate patients with COPD.
_Use in Pregnancy and Lactation:_
The
safety
use
of Axcel
Dicyclomine-S
Syr