VENTAMOL EXPECTORANT

Country: Malaysia

Language: English

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

Active ingredient:

SALBUTAMOL SULPHATE; GUAIPHENESIN/GUAICOL GLYCEROL ETHER

Available from:

HOVID BERHAD

INN (International Name):

SALBUTAMOL SULPHATE; GUAIPHENESIN/GUAICOL GLYCEROL ETHER

Units in package:

100 ml; 3.6 L

Manufactured by:

HOVID BERHAD

Patient Information leaflet

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
VENTAMOL EXPECTORANT_ _
Salbutamol/Guaiphenesin (1.2mg/50mg per 5ml)
1
WHAT IS IN THIS LEAFLET
1.
What
Ventamol
Expectorant
is
used for
2.
How Ventamol Expectorant works
3.
Before
you
use
Ventamol
Expectorant
4.
How to use Ventamol Expectorant
5.
While
you
are
using
Ventamol
Expectorant
6.
Side effects
7.
Storage and disposal of Ventamol
Expectorant
8.
Product description
9.
Manufacturer
and
Product
Registration Holder
10.
Date of revision
WHAT VENTAMOL EXPECTORANT IS USED
FOR
This medicine contains:

salbutamol which helps to relieve
chest
tightness
or
wheezing
to
breathe more easily.

guaifenesin which helps to reduce
the viscosity of thick sputum.
HOW VENTAMOL EXPECTORANT WORKS

salbutamol belongs to a group of
medicines
called
bronchodilators
which work by opening the lungs
airways to make it easier for air to
get in and out. This will help to
relieve
chest
tightness,
wheezing
and cough.

guaifenesin is an expectorant which
works by increasing the production
of
respiratory
fluid,
thinning
and
facilitating the removal of mucus.
BEFORE YOU USE VENTAMOL EXPECTORANT
_- When you must not use it _
_ _
Do not take this medicine if:

you
are
hypersensitive
to
salbumatol sulphate or guaifenesin
or any of the other ingredients of
Ventamol Expectorant .

you are taking beta-blockers such
as propranolol.
_ _
_- Before you start to use it _
_ _
Tell your doctor if:

you have high blood pressure or
are diabetic

you suffer from thyroid disease

you
have
a
history
of
heart
problems

you
are
breastfeeding
or
plan
to
breastfeed.

you
are
pregnant,
think
you
are
pregnant, or plan to get pregnant.

you
are
taking
other
medicines,
including
those
available
to
buy
without a prescription, herbal and
complementary medicines.

you have allergies to any other
medicines, foods, dyes or
preservatives.
_- Taking other medicines _
_ _
Talk to your doctor or pharmacist if you
are taking any other medicines in any
form
including
any
that
you
buy
or
ob

Summary of Product characteristics

VENTAMOL EXPECTORANT
VIVEN02-var
DESCRIPTION
Strawberry flavoured, colourless, transparent liquid.
COMPOSITION
Each 5 mL contains:
Salbutamol (as sulphate)
1.2 mg
Guaiphenesin
50.0 mg
PHARMACODYNAMICS
Salbutamol is a direct-acting sympathomimetic amine. It acts
relatively selectively on beta-2 adrenergic receptors in the
lungs to relax bronchial smooth muscle, thereby relieving
bronchospasm and reducing airway resistance.
Guaiphenesin has an expectorant action which increases the
output of respiratory tract fluid by reducing adhesiveness and
surface tension. The increased flow of less viscid secretions
promotes ciliary action and facilitates the removal of mucus.
This changes a dry, unproductive cough to a cough that is
productive and less frequent.
PHARMACOKINETICS
Salbutamol and guaiphenesin are readily absorbed from the
gastrointestinal tract. Major route of excretion is via renal
system.
INDICATIONS
•
To reduce the viscosity of tenacious sputum.
•
To
reduce
bronchospasm
and
airway
resistance
in
asthmatic patients.
CONTRAINDICATIONS
•
Should not be used in hypersensitive patients.
•
Ventamol Expectorant and beta-blocking drugs such as
propranolol should not be prescribed together.
WARNINGS AND PRECAUTIONS
•
Use of this medication should be carefully considered
when the following medical problems exist: cardiovascular
disorders, including coronary insufficiency and hypertension;
diabetes mellitus; hyperthyroidism; thyrotoxicosis.
•
Tocolysis: Serious adverse reactions including death have
been
reported
after
administration
of
terbutaline
/
salbutamol to women in labor. In the mother, these include
increased
heart
rate,
transient
hyperglycaemia,
hypokalaemia, cardiac arrhythmias, pulmonary oedema
and myocardial ischaemia. Increased fetal heart rate and
neonatal hypoglycaemia may occur as a result of maternal
administration.
PREGNANCY AND LACTATION
Safety for use in pregnancy and lactation has not been
established.
Adequate and well-controlled studies in humans have not
been done.
It is not known whet