SYMBICORT TURBUHALER 160/4.5MCG/DOSE

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

BUDESONIDE; FORMOTEROL FUMARATE

Boleh didapati daripada:

ASTRAZENECA SDN. BHD.

INN (Nama Antarabangsa):

BUDESONIDE; FORMOTEROL FUMARATE

Unit dalam pakej:

1 Units

Dikeluarkan oleh:

ASTRAZENECA AB

Risalah maklumat

_ CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
SYMBICORT TURBUHALER
80/4.5 MCG/DOSE, 160/4.5 MCG/DOSE
Budesonide/formoterol fumarate dihydrate (80/4.5 mcg/dose)
Budesonide/formoterol fumarate dihydrate (160/4.5 mcg/dose)
_ _
1
WHAT IS IN THIS LEAFLET
1.
What Symbicort
Turbuhaler is used for
2.
How Symbicort Turbuhaler
works
3.
Before you use Symbicort
Turbuhaler
4.
How to use Symbicort
Turbuhaler
5.
While you are using it
6.
Side effects
7.
Storage & Disposal of
Symbicort Turbuhaler
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of Revision
11.
Serial number
WHAT SYMBICORT TURBUHALER
IS USED FOR
Symbicort Turbuhaler is an
inhaler that is used to treat
asthma in adults, adolescents
aged 12-17 years and children
aged 6 years and above. It is
also used to treat the symptoms
of Chronic Obstructive
Pulmonary Disease (COPD) in
adults aged 18 years and older.
_ASTHMA _
Symbicort Turbuhaler can be
prescribed for asthma in two
different ways.
-
Some people can take
Symbicort Turbuhaler
when they need it – they
use Symbicort Turbuhaler
as an anti-inflammatory
”reliever” to treat their
symptoms when their
asthma gets worse and to
help prevent symptoms
from happening (eg before
exercise or exposure to
other triggers such as
allergens).
-
Some people need to take
Symbicort Turbuhaler
everyday – they use their
Symbicort Turbuhaler as a
daily maintenance
preventer to help maintain
control of their asthma
symptoms and help prevent
asthma attacks.
_CHRONIC OBSTRUCTIVE _
_PULMONARY DISEASE (COPD) _
Symbicort Turbuhaler can also
be used to treat the symptoms
of COPD in adults. COPD is a
long-term disease of the
airways in the lungs, which is
often caused by cigarette
smoking.
HOW SYMBICORT TURBUHALER
WORKS
Symbicort Turbuhaler is an
inhaler. It contains two
different medicines:
budesonide and formoterol
fumarate dihydrate.
•
Budesonide belongs to a
group of medicines called
‘corticosteroids’. It works by
reducing and preventing
swelling and inflammation in
your lungs.
•
Formoter

Ciri produk

1
SYMBICORT TURBUHALER

, 80/4.5

G/INHALATION
SYMBICORT TURBUHALER

, 160/4.5

G/INHALATION
_Budesonide/Formoterol fumarate dihydrate _
_ _
INHALATION POWDER.
WHITE POWDER.
QUALITATIVE AND QUANTITATIVE COMPOSITION
SYMBICORT TURBUHALER 80/4.5 MICROGRAMS/INHALATION
Each delivered dose (the dose that leaves the mouthpiece) contains:
budesonide 80
micrograms/inhalation and formoterol fumarate dihydrate 4.5
micrograms/inhalation,
Each metered dose contains: budesonide 100 micrograms/inhalation and
formoterol fumarate
dihydrate 6 micrograms/inhalation.
Excipient with known effect: Lactose monohydrate 810 micrograms per
delivered dose.
SYMBICORT TURBUHALER 160/4.5 MICROGRAMS/INHALATION
Each delivered dose (the dose that leaves the mouthpiece) contains:
budesonide 160
micrograms/inhalation and formoterol fumarate dihydrate 4.5
micrograms/inhalation.
Each metered dose contains: budesonide 200 micrograms/inhalation and
formoterol fumarate
dihydrate 6 micrograms/inhalation.
Excipient with known effect: Lactose monohydrate 730 micrograms per
delivered dose.
CLINICAL PARTICULARS
THERAPEUTIC INDICATION
ASTHMA
Symbicort Turbuhaler is indicated for the treatment of asthma, to
achieve overall asthma
control, including the relief of symptoms and the reduction of the
risk of exacerbations (see
Section Posology and Method of Administration).
NOTE
: Symbicort (80/4.5 micrograms/inhalation) is not appropriate in
patients with severe
asthma.
CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD)_ _
Symbicort Turbuhaler is indicated in adults, aged 18 years and older,
for the symptomatic
2
treatment of patients with COPD with FEV
1
< 70% predicted normal (post bronchodilator)
and an exacerbation history despite regular bronchodilator therapy.
POSOLOGY AND METHOD OF ADMINISTRATION
Route of administration
For inhalation use
Posology
ASTHMA
Symbicort Turbuhaler can be used according to different treatment
approaches:
A.
Symbicort anti-inflammatory reliever therapy (patients with mild
disease).
B.
Symbicort anti-inflammatory reliever plu