Symbicort Turbohaler, 400 micrograms/12 micrograms/inhalation, inhalation powder

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Budesonide; Formoterol fumatrate dihydrate

Available from:

AstraZeneca UK Limited

INN (International Name):

Budesonide; Formoterol fumatrate dihydrate

Dosage:

400/12 microgram(s)

Pharmaceutical form:

Powder for Inhalation

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

O3AK07

Authorization status:

Marketed

Authorization date:

2003-03-21

Patient Information leaflet

Package leaflet: Information for the user
Symbicort
®
Turbohaler
®
400 micrograms/
12 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
include
s
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
For asthma, your doctor will prescribe two asthma inhalers:
Symbicort Turbohaler and a separate ‘reliever inhaler’.
•
Use Symbicort Turbohaler every day. This helps to prevent asthma
symptoms from happening.
•
Use your ‘reliever inhaler’ when you get asthma sym

Summary of Product characteristics

Health Products Regulatory Authority
17 January 2019
CRN008NMZ
Page 1 of 15
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Symbicort Turbohaler, 400 micrograms/12 micrograms/inhalation,
inhalation powder
2 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.
Excipients with known effect
Lactose monohydrate 491 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 aged 12 to
17 years, 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).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Health Products Regulatory Authority
17 January 2019
CRN008NMZ
Page 2 of 15
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
treat