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

Země: Irsko

Jazyk: angličtina

Zdroj: HPRA (Health Products Regulatory Authority)

Aktivní složka:

Budesonide; Formoterol fumatrate dihydrate

Dostupné s:

AstraZeneca AB

ATC kód:

R03AK07

INN (Mezinárodní Name):

Budesonide; Formoterol fumatrate dihydrate

Dávkování:

400 mcg/12 microgram(s)

Léková forma:

Inhalation powder

Druh předpisu:

Product subject to prescription which may be renewed (B)

Terapeutické oblasti:

formoterol and budesonide

Stav Autorizace:

Marketed

Datum autorizace:

2003-03-21

Informace pro uživatele

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

Charakteristika produktu

Health Products Regulatory Authority
03 March 2021
CRN009ZTG
Page 1 of 10
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
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