Salmate Inhalation Aerosol BP CFC-free 100mcg

Country: Malaysia

Language: English

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

Active ingredient:

SALBUTAMOL SULPHATE

Available from:

MEDISPEC (M) SDN.BHD

INN (International Name):

SALBUTAMOL SULPHATE

Units in package:

1units Units

Manufactured by:

Jewim Pharmaceutical (Shandong) Co., Ltd

Patient Information leaflet

SALMATE INHALATION AEROSOL BP CFC-FREE 100MCG
Salbutamol (as sulphate BP) 100mcg per actuation
1
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
WHAT IS IN THIS LEAFLET
1.
What Salmate is used for
2.
How Salmate works
3.
Before you use Salmate
4.
How to use Salmate
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of Salmate
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
WHAT SALMATE IS USED FOR
Salmate
contains
a
medicine
called
salbutamol. This belongs to a group of
medicines called bronchodilators.
Salmate
provides
short-acting
(4
to
6
hours) bronchodilatation with fast onset
(within 5 minutes) in reversible airways
obstruction.
It is particularly suitable for the relief
and prevention of asthma symptoms. It
should
be
used
to
relieve
symptoms
when they occur, and to prevent them in
those
circumstances
recognised
by
the
patient to precipitate an asthma attack
(e.g.
before
exercise
or
unavoidable
allergen exposure).
Salmate is particularly valuable as relief
medication in mild, moderate or severe
asthma, provided that reliance on it does
not
delay
the
introduction
and
use
of
regular inhaled corticosteroid therapy.
HOW SALMATE WORKS
Salbutamol
works
by
relaxing
the
muscles of the airways of the lungs, to
help improve the ease of breathing in
patients
with
reversible
obstructive
airway disease.
BEFORE YOU USE SALMATE_ _
_- When you must not use it _
_ _
•
you
are
allergic
(hypersensitive)
to
salbutamol
sulphate
or
any
of
the
inactive ingredients.
_ _
_ _
_ _
_ _
_ _
_ _
-
_Before you start to use it _
TALK TO YOUR DOCTOR BEFORE YOU START TO
USE THIS MEDICINE IF YOU HAVE:

heart
disease
or
high
blood
pressure;

epilepsy
or
another
seizure
disorder;

diabetes;

an
overactive
thyroid
(hyperthyroidism);

difficulty swallowing;
IMPORTANT POINTS TO REMEMBER WHILE
YOU ARE USING THIS MEDICINE:
• Do not use your inhaler more often than
the doctor told you to.Tell your doctor if
your
medicine
does
not
seem
to
be
working as well as usual, as yo

Summary of Product characteristics

SALMATE INHALATION AEROSOL BP CFC-FREE 100MCG
NAME
Salbutamol Inhalation Aerosol BP CFC-free
STRENGTH
400 doses, each dose contains 100mcg Salbutamol (as sulphate BP)
DOSAGE FORM
Aerosol
PRODUCT DESCRIPTION
Salbutamol Inhalation Aerosol CFC-free is a kind of white or slight
yellow suspension mixed
with just right quantity of propellant and kept in a pressurized
canister with a metered valve
system.
PHARMACODYNAMICS
Salbutamol is a selective β
2
-adrenoceptor agonist. At therapeutic doses it acts on the
β
2
-adrenoceptors of bronchial muscle providing short acting (4-6 hours)
bronchodilatation
with a fast onset (within 5 minutes) in reversible airways
obstruction.
PHARMACOKINETICS
The inspired aerosol’s effect begins to act in 5 minutes and results
in maximum plasma
concentrations occurring within 2 to 4 hours. The total effective
period lasts for 4-6 hours.
Salbutamol has an elimination half-life of 3-8 hours. Approximately
72% of the inhaled dose
is excreted within 24 hours in the urine, and consists of 28% as
unchanged drug and 44% as
metabolite.
INDICATION
Salbutamol provides short-acting (4 to 6 hour) bronchodilation with
fast onset (within 5
minutes) in reversible airway obstruction.
It is particularly suitable for the relief and prevention of asthma
symptoms. Salbutamol should
be used to relieve symptoms when they occur, and to prevent them in
those circumstances
recognised by the patient to precipitate an asthma attack (e.g. before
exercise or unavoidable
allergen exposure).
Salbutamol is particularly valuable as relief medication in mild,
moderate or severe asthma,
provided that reliance on it does not delay the introduction and use
of regular inhaled
corticosteroid therapy.
RECOMMENDED DOSE
RELIEF OF ACUTE BRONCHOSPASM:
Adults: 100 or 200 micrograms.
Children:
100
micrograms.
The
dose
may
be
increased
to
200
micrograms
if
required.
PREVENTION OF ALLERGEN or EXERCISE-INDUCED BRONCHOSPASM:
Adults: 200 micrograms before challenge or exertion.
Children: 100 micrograms before challenge or exertion. The do