FLUTIMATE 50 Fluticasone Pressurised Metered-Dose Inhaler 50mcgdose (CFC-Free)

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

FLUTICASONE PROPIONATE

Boleh didapati daripada:

MEDISPEC (M) SDN.BHD

INN (Nama Antarabangsa):

FLUTICASONE PROPIONATE

Unit dalam pakej:

1units Units

Dikeluarkan oleh:

Jewim Pharmaceutical (Shandong) Co., Ltd

Risalah maklumat

FLUTIMATE 50 FLUTICASONE PRESSURISED METERED-
DOSE INHALER 50MCG/DOSE (CFC-FREE)
Fluticasone propionate 50mcg
1
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
WHAT IS IN THIS LEAFLET
1.
What Flutimate 50 is used for
2.
How Flutimate 50 works
3.
Before you use Flutimate 50
4.
How to use Flutimate 50
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of Flutimate
50
8.
Product Description
9.
Manufacturer
and
Product
Registration Holder
10.
Date of revision
WHAT FLUTIMATE 50
IS USED FOR
It contains a medicine called fluticasone
propionate. This medicine belongs to a
group of medicines known as
corticosteroids,
frequently
called
“steroids”.
They
are
not
“anabolic
steroids”
which
are
the
steroids
sometimes misused by athletes. It is used
as
preventive
treatment
in
asthma
patients.
HOW FLUTIMATE 50
WORKS
Fluticasone
propionate
given
by
inhalation at recommended doses has a
potent glucocorticoid anti-inflammatory
action
within
the
lungs,
resulting
in
reduced symptoms and exacerbations of
asthma. There is a significant reduction
of
symptoms
of
chronic
obstructive
pulmonary
disease
(COPD)
and
an
improvement in lung function regardless
of
patient
age,
gender,
lung
baseline
function, smoking status or atopy status.
This
can
result
in
a
significant
improvement in the quality of life.
BEFORE YOU USE FLUTIMATE 50_ _
_- When you must not use it _
• Do not use your Flutimate 50 if you
have
ever
had
an
allergic
reaction
to
fluticasone
propionate
or
any
of
the
ingredients
listed
at
the
end
of
this
leaflet.
See
“Side
Effects”
section
for
symptoms of an allergic reaction.
• Do not use your Flutimate 50 if you are
pregnant, trying to become pregnant or
breastfeeding,
unless
your
doctor
says
you should.
It is important that asthma is managed
well during pregnancy and you should
not stop your medicine without asking
your doctor.
Your doctor will discuss the risks and
benefits of using your Flutimate 50 if
you are pregnant or breastfeeding.
• Do not use your Flutimate 50 after the
expiry date (EXP) pr

Ciri produk

Pneumonia in patients with COPD
An increase in the incidence of pneumonia, including pneumonia
requiring hospitalisation, has been observed in patients
with COPD receiving inhaled corticosteroids. There is some evidence of
an increased risk of pneumonia with increasing
steroid dose but this has not been demonstrated conclusively across
all studies.
There is no conclusive clinical evidence for intra-class differences
in the magnitude of the pneumonia risk among inhaled
corticosteroid products.
Physicians should remain vigilant for the possible development of
pneumonia in patient with COPD as the clinical
features of such infections overlap with the symptoms of COPD
exacerbations.
Risk factors for pneumonia in patients with COPD include current
smoking status, older age, low body mass index
(BMI) and severe COPD.
Adverse events are listed as follows by system organ class and
frequency. Incidence is defined as: very common,
common, uncommon, rare, very rare, including case reports. Very
common, common, less common are usually obtained
by the clinical trial data. Rare and very rare adverse events are
usually spontaneous information.
Common: Pneumonia (in COPD patients)
March 2020