Symbicort Rapihaler 1604.5 microgramsactuation pressurised inhalation suspension

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

BUDESONIDE; FORMOTEROL FUMARATE DIHYDRATE

Boleh didapati daripada:

ASTRAZENECA SDN. BHD.

INN (Nama Antarabangsa):

BUDESONIDE; FORMOTEROL FUMARATE DIHYDRATE

Unit dalam pakej:

120 ACTUATIONS

Dikeluarkan oleh:

ASTRAZENECA DUNKERQUE PRODUCTION (AZDP)

Risalah maklumat

_ CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
SYMBICORT RAPIHALER
80/4.5 MCG/ACTUATION & 160/4.5 MCG
ACTUATION
Budesonide/formoterol fumarate dihydrate (80/4.5mcg/actuation &
160/4.5mcg/actuation)
_ _
1
WHAT IS IN THIS LEAFLET
1.
What Symbicort Rapihaler
is used for
2.
How Symbicort Rapihaler
works
3.
Before you use Symbicort
Rapihaler
4.
How to use Symbicort
Rapihaler
5.
While you are using it
6.
Side effects
7.
Storage & Disposal of
Symbicort Rapihaler
8.
Product Description
9.
Manufacturer & Product
Registration Holder
10.
Date of Revision
WHAT SYMBICORT RAPIHALER IS
USED FOR
Symbicort Rapihaler is an
inhaler that is used to treat
asthma in adults, adolescents
and children aged 6 years and
older. It is also used to treat the
symptoms of Chronic
Obstructive Pulmonary Disease
(COPD) in adults aged 18
years and older.
_ASTHMA _
Symbicort Rapihaler is
prescribed as a daily
maintenance dose and a
separate ‘reliever inhaler’ is
needed for symptom relief.
•
They use Symbicort
Rapihaler every day. This
helps to prevent asthma
symptoms from happening.
•
They use their ‘reliver
inhaler’ when they get
asthma symptoms, to make
it easier to breathe again.
_CHRONIC OBSTRUCTIVE _
_PULMONARY DISEASE (COPD) _
Symbicort Rapihaler 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 RAPIHALER
WORKS
Symbicort Rapihaler 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
RAPIHALER
_- When you must not use it: _
Symbicort Rapihaler should
not be u

Ciri produk

SYMBICORT RAPIHALER®
80/4.5 AND 160/4.5 MICROGRAMS/ACTUATION, PRESSURISED INHALATION,
SUSPENSION
QUALITATIVE AND QUANTITATIVE COMPOSITION
Symbicort Rapihaler 80/4.5 micrograms/actuation:
Each
delivered
dose
(ex-actuator)
contains:
budesonide
80
micrograms/actuation
and
formoterol fumarate dihydrate 4.5 micrograms/actuation.
This is equivalent to a metered dose containing budesonide 100
micrograms/actuation and
formoterol fumarate dihydrate 6 micrograms/actuation.
Symbicort Rapihaler 160/4.5 micrograms/actuation:
Each
delivered
dose
(ex-actuator)
contains:
budesonide
160
micrograms/actuation
and
formoterol fumarate dihydrate 4.5 micrograms/actuation.
This is equivalent to a metered dose containing budesonide 200
micrograms/actuation and
formoterol fumarate dihydrate 6 micrograms/actuation.
CLINICAL PARTICULARS
THERAPEUTIC INDICATIONS
ASTHMA
Symbicort Rapihaler is indicated in the regular treatment of asthma
where use of a combination
(inhaled corticosteroid and long-acting β2 adrenoceptor agonist) is
appropriate:
- patients not adequately controlled with inhaled corticosteroids and
“as needed” inhaled short-
acting β2 adrenoceptor agonists.
or
- patients already adequately controlled on both inhaled
corticosteroids and long-acting β2
adrenoceptor agonists.
CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD)
Symbicort Rapihaler is indicated in adults, aged 18 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
GENERAL INFORMATION
The patient should be instructed that Symbicort Rapihaler must be used
regularly even when
asymptomatic for optimal benefit.
The medication from Symbicort Rapihaler is delivered to the lungs as
the patient inhales.
Therefore a correct handling of Symbicort Rapihaler is very important.
The patients should be
instructed accordingly (see “Other advices/instruction for use”).
The patient should be instructed to use Symb