Symbicort Turbohaler, 100 micrograms /6 micrograms/inhalation, inhalation powder

Pajjiż: Irlanda

Lingwa: Ingliż

Sors: HPRA (Health Products Regulatory Authority)

Ingredjent attiv:

Formoterol fumarate dihydrate; Budesonide

Disponibbli minn:

AstraZeneca UK Limited

Kodiċi ATC:

R03AK

INN (Isem Internazzjonali):

Formoterol fumarate dihydrate; Budesonide

Dożaġġ:

100/6 microgram(s)

Għamla farmaċewtika:

Powder for Inhalation

Tip ta 'preskrizzjoni:

Product subject to prescription which may be renewed (B)

Żona terapewtika:

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

L-istatus ta 'awtorizzazzjoni:

Marketed

Data ta 'l-awtorizzazzjoni:

2001-02-23

Fuljett ta 'informazzjoni

Package leaflet: Information for the user
Symbicort
®
Turbohaler
®
100 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,
adolescents and children aged 6 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.
This medicine is not suitable for people with severe asthma. It can be
prescribed for asthma in two different ways.
a) Some people are prescribed two asthma inhalers:
Symbicort Turbohaler and a separate ‘reliever inhaler’.
•
They use Symbicort Turbohaler every day. This helps to prevent asthma
symptoms from happening.
•
They use their ‘reliever inhaler’ when they get asthma

Karatteristiċi tal-prodott

Health Products Regulatory Authority
17 January 2019
CRN008NMZ
Page 1 of 16
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Symbicort Turbohaler, 100 micrograms /6 micrograms/inhalation,
inhalation powder
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each delivered dose (the dose that leaves the mouthpiece) contains:
budesonide 80
micrograms/inhalation and formoterol fumarate dihydrate 4.5
micrograms/inhalation.
Each metered dose contains: budesonide 100 micrograms/inhalation and
formoterol
fumarate dihydrate 6 micrograms/inhalation.
Excipient with known effect:
Lactose monohydrate 810 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
Symbicort Turbohaler is indicated in adults, adolescents, and children
aged 6 years
and older.
Symbicort Turbohaler is indicated in 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 β2 adrenoceptor agonists.
NOTE: Symbicort Turbohaler (100 micrograms/6 micrograms/inhalation) is
not
appropriate in patients with severe asthma.
Health Products Regulatory Authority
17 January 2019
CRN008NMZ
Page 2 of 16
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Route of administration: For inhalation use.
Posology
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 doses other than
those
available in the combination