Healol Salbutamol Inhaler (Salbutamol 100mcgdose)

Country: Malaysia

Language: English

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

Active ingredient:

SALBUTAMOL SULPHATE

Available from:

HEALOL PHARMACEUTICALS SDN. BHD.

INN (International Name):

SALBUTAMOL SULPHATE

Units in package:

1units Units

Manufactured by:

LABORATORIO ALDO-UNION S.L.

Patient Information leaflet

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
HEALOL SALBUTAMOL INHALER
Salbutamol 100mcg/dose
1
WHAT IS IN THIS LEAFLET
1.
What Healol Salbutamol Inhaler
is used for
2.
How Healol Salbutamol Inhaler
works
3.
Before you use Healol
Salbutamol Inhaler
4.
How to use Healol Salbutamol
Inhaler
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of Healol
Salbutamol Inhaler
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
11.
Serial number
WHAT IS HEALOL SALBUTAMOL INHALER
USED FOR
Healol Salbutamol Inhaler is used to
treat breathing problems in people
with asthma and similar conditions.
This includes relieving and
preventing asthma brought on by
exercise or other ‘triggers’. These are
things, which bring on asthma
symptoms in some people. Common
triggers include house dust, pollen,
cats, dogs and cigarette smoke.
Healol Salbutamol Inhaler contains a
propellant called HFA 134a. This is
less harmful to the environment than
older inhalers.
HOW HEALOL SALBUTAMOL INHALER
WORKS
Healol Salbutamol Inhaler belongs to
a group of medicines called
bronchodilators.

Bronchodilators help the
airways in your lungs to
stay open. This makes it
easier for air to get in and
out.

They help to relieve chest
tightness, wheezing and
cough.
BEFORE YOU USE HEALOL SALBUTAMOL
INHALER
_-When you must not use it _
If you are allergic (hypersensitive) to
salbutamol sulphate or the other
ingredient
_Tetrafluoroethane_
(
_HFA _
_134a propellant_
)
_-Before you start to use it _
Check with your doctor, nurse or
pharmacist before taking your
medicine if:

You have high blood
pressure.

You have an overactive
thyroid gland.

You have a history of heart
problems such as an
irregular or fast heartbeat or
angina.
_-Taking other medications _
Tell your doctor if you are taking any
other medicines, including any that
you buy without a prescription from
a pharmacy, supermarket or health
food shop. Remember to take this
medicine with you if you have to go
to hospital. In particu

Summary of Product characteristics

LAB. ALDO-UNION, S.L.
HEALOL SALBUTAMOL INHALER (HEALOL-MALASIA)
1+1 NEGRO
17 / 09 / 2019
TRAZADA
185 x 270 mm
C. BARRAS:
SIN PLEGAR
OFFSET
60g
11370
81226
510460/C-19
510460/B-18
633
PACKAGE INSERT
For the use of Registered Medical Practitioner or Hospital or a
Laboratory only.
NAME OF PRODUCT
HEALOL SALBUTAMOL Inhaler (Salbutamol 100 mcg/dose).
NAME AND STRENGTH OF ACTIVE INGREDIENT
Each actuation delivers
Salbutamol ……..100 mcg
Suspended in Propellant 134a……….q.s
DOSAGE FORM
Pressurized Inhalation.
PRODUCT DESCRIPTION
HEALOL SALBUTAMOL
Inhaler is a white homogenous suspension aerosol for inhalation, in
propellant HFA – 134a, supplied
in a
pressurized container.
Nature and content: Aluminium container with 200 actuations, each
containing 100 micrograms of salbutamol, fitted
with a metered-dose valve, activator-oral adapter, and cap.
PHARMACODYNAMICS/PHARMACOKINETICS
Pharmacodynamics
Salbutamol is a selective β2 adrenoceptor agonist. At therapeutic
doses it acts on the β2 adrenoceptors of bronchial
muscle, with little or no action on the β1 adrenoceptors of cardiac
muscle. It is suitable for the management and
prevention of attack in asthma.
Pharmacokinetics
Salbutamol MDI provides short-acting (4 to 6 hour) bronchodilation
with fast onset (within 5 minutes) in reversible
airway obstruction.
Salbutamol administered intravenously has a half-life of 4 to 6 hours
and is cleared partly renally and partly by
metabolism to the inactive 4' -O'-sulphate (phenolic sulphate) which
is also excreted primarily in the urine. The faeces
are a minor route of excretion. The majority of a dose of salbutamol
given intravenously, orally or by inhalation is
excreted within 72 hours. Salbutamol is bound to plasma proteins to
the extent of 10%.
After administration by the inhaled route between 10 and 20% of the
dose reaches the lower airways. The remainder
is retained in the delivery system or is deposited in the oropharynx
from where it is swallowed. The fraction deposited
in the airways is absorbed into the pulmonary