Symbicort Turbohaler 400/12 micrograms/inhalation, inhalation powder

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

FORMOTEROL, BUDESONIDE

Available from:

AstraZeneca AB SE-151 85, Södertälje, Sweden

ATC code:

R03AK07

INN (International Name):

FORMOTEROL 12 µg BUDESONIDE 400 µg

Pharmaceutical form:

INHALATION POWDER

Composition:

FORMOTEROL 12 µg BUDESONIDE 400 µg

Prescription type:

POM

Therapeutic area:

DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES

Authorization status:

Authorised

Authorization date:

2011-04-06

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
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
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 sympto

Summary of Product characteristics

Page 1 of 16
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.
Excipient 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%
Page 2 of 16
predicted normal (post-bronchodilator) and an exacerbation history
despite regular
bronchodilator therapy (see also section 4.4).
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 treatment with combination
products is initiated but
also when the maintenance dose is adjusted. If an individual patient
should require a
combination of dos