Symbicort® Turbohaler; 200 micrograms/6 micrograms/inhalation, inhalation powder

Quốc gia: Ai-len

Ngôn ngữ: Tiếng Anh

Nguồn: HPRA (Health Products Regulatory Authority)

Thành phần hoạt chất:

Budesonide; Formoterol fumatrate dihydrate

Sẵn có từ:

AstraZeneca UK Limited

Mã ATC:

R03AK

INN (Tên quốc tế):

Budesonide; Formoterol fumatrate dihydrate

Liều dùng:

200/6 microgram(s)

Dạng dược phẩm:

Powder for Inhalation

Loại thuốc theo toa:

Product subject to prescription which may be renewed (B)

Khu trị liệu:

Adrenergics in combination with corticosteroids or other drugs, excl. anticholinergics

Tình trạng ủy quyền:

Marketed

Ngày ủy quyền:

2001-02-23

Tờ rơi thông tin

BODY TEXT SIZE
12.0 pt
SMALLEST TEXT SIZE
6.0 pt
601025-A02
19-03-18
PS12355
AZL030H
6794
N/A
NL
Symbicort 200/6mcg Leaflet:
Patient IE/MT
Black
Technical Info
Profile
Package leaflet: Information for the user
Symbicort
®
Turbohaler
®
200 micrograms/
6 micrograms/
inhalation, inhalation powder
Budesonide/formoterol fumarate dihydrate
Read all of this leaflet carefully before you start
using this medicine because it contains important
information for you.
•
Keep this leaflet. You may need to read it again.
•
If you have any further questions, ask your doctor or
pharmacist.
•
This medicine has been prescribed for you only.
Do not pass it on to others. It may harm them, even if
their signs of illness are the same as yours.
•
If you get any side effects, talk to your doctor or pharmacist. This
includes
any possible side effects not listed in this leaflet. See section 4.
What is in this leaflet:
1. What Symbicort Turbohaler is and what it is used for
2. What you need to know before you use Symbicort Turbohaler
3. How to use Symbicort Turbohaler
4. Possible side effects
5. How to store Symbicort Turbohaler
6. Contents of the pack and other information
1. What Symbicort Turbohaler is and what it is used for
Symbicort Turbohaler is an inhaler that is used to treat asthma in
adults and
adolescents aged 12 to 17 years. It is also used to treat the symptoms
of
Chronic Obstructive Pulmonary Disease (COPD) in adults aged 18 years
and older. 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 beta
2
adrenoceptor agonists’ or ‘bronchodilators’. It works by
relaxing the muscles in your airways. This helps you to breathe more
easily.
Asthma
Symbicort Turbohaler can be prescribed for asthma in two different
ways.
a) Some people are prescribed two

Đặc tính sản phẩm

Health Products Regulatory Authority
17 January 2019
CRN008NMZ
Page 1 of 17
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Symbicort® Turbohaler; 200 micrograms/6 micrograms/inhalation,
inhalation
powder
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
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.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Inhalation powder.
White powder.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
ASTHMA
Symbicort Turbohaler is indicated in adults and adolescents (12 years
and older) for
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 Turbohaler is indicated in adults, aged 18 years and older,
for the
symptomatic treatment of patients with COPD with forced expiratory
volume in
1 second (FEV
1
) <70% predicted normal (post-bronchodilator) and an exacerbation
history despite regular bronchodilator therapy (see also section 4.4).
Health Products Regulatory Authority
17 January 2019
CRN008NMZ
Page 2 of 17
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Route of administration: For inhalation use.
Posology
ASTHMA
Symbicort Turbohaler 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
trea