FLIXOTIDE EVOHALER 50MCG

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

FLUTICASONE PROPIONATE

Boleh didapati daripada:

GLAXOSMITHKLINE PHARMACEUTICAL SDN. BHD.

INN (Nama Antarabangsa):

FLUTICASONE PROPIONATE

Unit dalam pakej:

1Units Units

Dikeluarkan oleh:

GLAXO WELLCOME S.A.

Risalah maklumat

_Consumer Medication Information Leaflet (RiMUP)_
_ _
1
FLIXOTIDE EVOHALER
Fluticasone Propionate (50mcg, 125mcg)
WHAT IS IN THIS LEAFLET
1.
What FLIXOTIDE is used for
2.
How FLIXOTIDE works
3.
Before you use FLIXOTIDE
4.
How to use FLIXOTIDE
5.
While you are using it
6.
Side Effects
7.
Storage and Disposal of
FLIXOTIDE
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of Revision
WHAT FLIXOTIDE IS USED FOR
The name of your medicine is
Flixotide Evohaler.
Flixotide Evohaler delivers your
medicine as an aerosol spray for
you to inhale directly into your
lungs where it is needed.
Your doctor has chosen this
medicine to suit you and your
condition.
Flixotide Evohaler is used to
treat and prevent asthma in
people who need regular
treatment.
HOW FLIXOTIDE WORKS
Fluticasone propionate is one of
a group of medicines called
corticosteroids which are often
referred to simply a steroids.
Corticosteroids are used to treat
asthma because they have an
anti- inflammatory action. They
reduce the swelling and irritation
in the walls of the small air
passages in the lungs and so ease
breathing problems.
Corticosteroids also help to
prevent attacks of asthma.
Fluticasone propionate should
not be confused with other
steroids such as anabolic steroids
misused by some athletes and
taken as tablets or injection.
BEFORE YOU USE FLIXOTIDE
-
_When you must not use it_
_ _
_ _
•
If you are allergic to
Flixotide, fluticasone
propionate or any of the
other ingredients in this
medicine.
Do not use this medicine to treat
a sudden attack of breathlessness
-
it will not help you. You will
need a different kind of
medicine. If you have more than
one medicine be careful not to
confuse them.
-
_Before you start to use it_
_ _
_ _
If you answer 'yes' to any of the
following questions tell your
doctor about this before taking
your medicine.
•
Are you pregnant or likely to
become pregnant soon?
•
Are you breast-feeding?
•
Are you being or have you
ever been treated for
tuberculosis (TB), a bacterial
infection tha

Ciri produk

CONFIDENTIAL
[GSK logo]
FLIXOTIDE EVOHALER
FLUTICASONE PROPIONATE
QUALITATIVE AND QUANTITATIVE COMPOSITION
Fluticasone propionate 50 and 125 micrograms.
_FLIXOTIDE_
50 Evohaler and 125 Evohaler are pressurised metered-dose inhalers
which
deliver 50 micrograms and 125 micrograms of fluticasone propionate per
actuation into
the mouthpiece of a specially designed actuator.
Each canister of
_FLIXOTIDE_
50 Evohaler supplies 120 actuations.
Each canister of
_FLIXOTIDE_
125 Evohaler supplies 120 actuations.
CLINICAL INFORMATION
INDICATIONS
ASTHMA
_FLIXOTIDE_
has a marked anti-inflammatory effect in the lungs.
It reduces symptoms and exacerbations of asthma in patients previously
treated with
bronchodilator alone or with other prophylactic therapy.
Severe asthma requires regular medical assessment as death may occur.
Patients with
severe asthma have constant symptoms and frequent exacerbations, with
limited physical
capacity, and PEF values below 60% predicted at baseline with greater
than 30%
variability, usually not returning entirely to normal after a
bronchodilator. These patients
will require high dose inhaled (
_see Dosage and Administration_
) or oral corticosteroid
therapy. Sudden worsening of symptoms may require increased
corticosteroid dosage
which should be administered under urgent medical supervision.
•
ADULTS
Prophylactic management in:
-
Mild asthma (PEF values greater than 80% predicted at baseline with
less than 20%
variability): Patients requiring intermittent symptomatic
bronchodilator asthma
medication on more than an occasional basis.
CONFIDENTIAL
-
Moderate asthma (PEF values 60-80% predicted at baseline with 20-30%
variability):
Patients requiring regular asthma medication and patients with
unstable or worsening
asthma on currently available prophylactic therapy or bronchodilator
alone.
-
Severe asthma (PEF values less than 60% predicted at baseline with
greater than 30%
variability): Patients with severe chronic asthma. On introduction of
inhaled
_FLIXOTIDE_
many patients who are dependent on s