Symbicort Turbuhaler 3209mcgdose

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

FORMOTEROL FUMARATE; BUDESONIDE

Boleh didapati daripada:

ASTRAZENECA SDN. BHD.

INN (Nama Antarabangsa):

FORMOTEROL FUMARATE; BUDESONIDE

Unit dalam pakej:

1Units Units

Dikeluarkan oleh:

ASTRAZENECA AB

Risalah maklumat

_ CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
SYMBICORT TURBUHALER
320/9 MCG/DOSE
Budesonide/formoterol fumarate dihydrate (320/9 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 & Product
Registration Holder
10.
Date of Revision
WHAT SYMBICORT TURBUHALER
IS USED FOR
Symbicort Turbuhaler is an
inhaler that is used to treat
asthma in adults and
adolescents aged 12-17 years.
It is also used to treat the
symptoms of Chronic
Obstructive Pulmonary Disease
(COPD) in adults aged 18
years and older.
_ASTHMA _
For asthma, your doctor will
prescribe two asthma inhalers:
Symbicort Turbuhaler and a
separate ‘reliever inhaler’.
•
Use your Symbicort
Turbuhaler every day. This
helps to prevent asthma
symptoms from happening.
•
Use your ‘reliever inhaler’
when you get asthma
symptoms, to make it
easier to breathe again.
Do not use Symbicort
Turbuhaler as a reliever
inhaler.
_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.
•
Formoterol fumarate
dihydrate belongs to a group
of medicines called ‘long-
acting β
2
adrenoceptor
agonists’ or
‘bronchodilators’. It works
by relaxing the muscles in
your airways. This helps
you
to breathe more easily.
BEFORE YOU USE SYMBICORT
TURBUHALER
_- When you must not use it: _
Do not use Symbicort
Turbuhaler if:
•
If you are aller

Ciri produk

1
SYMBICORT TURBUHALER

320/9 ΜG/DOSE
_budesonide/formoterol fumarate dihydrate _
INHALATION POWDER
WHITE POWDER
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each delivered dose (the dose that leaves the mouthpiece) contains:
budesonide 320
micrograms/inhalation and formoterol fumarate dihydrate 9
micrograms/inhalation.
Each metered dose contains: budesonide 400 micrograms/inhalation and
formoterol
fumarate dihydrate 12 micrograms/inhalation.
Excipient with known effect: Lactose monohydrate 491 micrograms per
delivered
dose.
CLINICAL PARTICULARS
THERAPEUTIC INDICATIONS
ASTHMA
Symbicort Turbuhaler is indicated in the regular treatment of asthma
where use of a
combination (inhaled corticosteroid and long-acting β
2
adrenoceptor agonist) is
appropriate:
-
patients not adequately controlled with inhaled corticosteroids and
“as needed”
inhaled short-acting β
2
adrenoceptor agonists
or
-
patients already adequately controlled on both inhaled corticosteroids
and long-
acting β
2
adrenoceptor agonists.
CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD)
Symbicort Turbuhaler is indicated in adults, aged 18 years and older,
for the
symptomatic 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
2
Posology
ASTHMA
Symbicort Turbuhaler is not intended for the initial management of
asthma. The
dosage of the components of Symbicort is individual and should be
adjusted to the
severity of the disease. This should be considered not only when
treatment with
combination products is initiated but also when the maintenance dose
is adjusted. If
an individual patient should require a combination of doses other than
those available
in the combination inhaler, appropriate doses of β
2
adrenoceptor agonists and/or
corticosteroids by individual inhalers should be prescribed.
_RECOMMENDED DOSES: _
_Adults (18 years and older): _
1 inhalation twice daily. Some