Salmax CR Tablet 4mg

Country: Malaysia

Bahasa: Inggeris

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

Beli sekarang

Risalah maklumat Risalah maklumat (PIL)
26-08-2019
Ciri produk Ciri produk (SPC)
26-08-2019

Bahan aktif:

SALBUTAMOL

Boleh didapati daripada:

Duopharma Marketing Sdn. Bhd.

INN (Nama Antarabangsa):

SALBUTAMOL

Unit dalam pakej:

56Tablet Tablets

Dikeluarkan oleh:

DUOPHARMA MANUFACTURING (BANGI) SDN BHD

Risalah maklumat

                                SALMAX CR
®
Salbutamol Sulphate (4 mg)
1
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
WHAT IS IN THIS LEAFLET
1.
What Salmax CR is used for
2.
How Salmax CR works
3.
Before you use Salmax CR
4.
How to use Salmax CR
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of Salmax CR
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
WHAT SALMAX CR IS USED FOR
Salmax
CR
helps
you
breathe
more
easily. Salmax CR works by opening up
the airways tubes in your lungs when
your
chest
is
tight
or
when
you
are
wheezing.
Ask
your
doctor
if
you
have
any
questions
about
why
Salmax
CR
has
been
prescribed
for
you.
Your
doctor
may
have
prescribed
it
for
another
purpose.
HOW SALMAX CR WORKS
Salmax
CR
belongs
to
a
group
of
medicines
called
bronchodilators.
Because
the
medicine
in
your
tablet
gives relief from your chest symptoms, it
is often called a 'reliever'.
There are other types of medicines that
prevent
wheezing
or
chest
tightness.
These medicines are called 'preventers'
and must be used every day. Your doctor
may
tell
you
to
use
a
'preventer'
in
addition to your Salmax CR.
BEFORE YOU USE SALMAX CR
-
_When you must not use it _
Do not take Salmax CR if you have ever
had an allergic reaction to:
•
Salbutamol sulphate
•
Any of the ingredients listed at the
end of this leaflet.
Do not take this medicine after the expiry
date
printed
on
the
pack
or
if
the
packaging
is
torn
or
shows
signs
of
tampering.
If
it
has
expired
or
is
damaged, return it to your pharmacist for
disposal.
-
_Before you start to use it _
Tell your doctor if you are allergic to any
other medicines or any foods, dyes or
preservatives.
Tell your doctor if you have or have had
any of the following medical conditions:
•
Stop taking Salmax CR or any other
asthma medicine for any reason
•
High thyroid level
•
Heart condition
•
Liver condition
•
Diabetes
If you have not told your doctor about
any of these things, tell them before you
take Salmax CR.
-
_Taking other medicines _
Tell your doctor or 
                                
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Ciri produk

                                PRODUCT DESCRIPTION
Salmax CR Tablet 4mg are white, hexagonal-shaped
tablet embossed with 4 on one side and plain on the
other side.
COMPOSITION
Each Salmax CR Tablet 4mg contains 4 mg of Salbutamol
as sulphate in a controlled release delivery system.
Preservative: none
PHARMACODYNAMICS
Salbutamol is a direct-acting sympathomimetic agent
with
predominantly
beta-adrenergic
activity
and
a
selective action on beta receptors in bronchial smooth
muscle. This preference for beta receptor stimulation
results in its bronchodilating action being relatively more
prominent than its effect on the heart.
The action of Salbutamol is believed to result from
increased
production
of
cyclic
adenosine
3',
5'-monophosphate (c-AMP) caused by the activation of
enzyme adenyl cyclase which catalyzes the conversion
of adenosine triphosphate (ATP) to c-AMP. Increased
c-AMP
concentrations
relax
the
bronchial
smooth
muscle and inhibit the release of mediators of immediate
hypersensitivity
from
cells,
especially
mast
cells.
Salbutamol
relaxes
bronchial
smooth
muscle
in
the
lungs, thereby relieving bronchospasm, increasing vital
capacity,
decreasing
residual
volume
and
reducing
airway resistance.
PHARMACOKINETICS
Salbutamol is readily absorbed from the gastro-intestinal
tract. It undergoes first-pass metabolism in the liver
and possibly in the gut wall, producing an inactive
sulphate conjugate as the main metabolite. It is rapidly
excreted in the urine as metabolites and unchanged
drug; there is some excretion in the faeces. Following
oral administration, the onset of action is within 30
minutes.
with
a
peak
effect
between
5
to
6
hours
after the dose. The plasma half-life of Salbutamol is
about 2 to 7 hours. For controlled-release preparations,
the duration of action is up to 12 hours.
INDICATIONS
Salbutamol is indicated for the symptomatic treatment of
bronchial asthma. It is also indicated for the treatment of
reversible
bronchospasm
associated
with
bronchitis,
pulmonary
emphysema,
bronchiectasis and
other
obstructive pulmonary disease.
SID
                                
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