Symbicort forte Turbuhaler 320 mikrogram/9 mikrogram/inhalation Inhalationspulver

Maa: Ruotsi

Kieli: ruotsi

Lähde: Läkemedelsverket (Medical Products Agency)

Aktiivinen ainesosa:

budesonid; formoterolfumaratdihydrat

Saatavilla:

Northern Medical Group ApS

ATC-koodi:

R03AK07

INN (Kansainvälinen yleisnimi):

budesonide; formoterol

Annos:

320 mikrogram/9 mikrogram/inhalation

Lääkemuoto:

Inhalationspulver

Koostumus:

formoterolfumaratdihydrat 9 mikrog Aktiv substans; laktosmonohydrat Hjälpämne; budesonid 320 mikrog Aktiv substans

Prescription tyyppi:

Receptbelagt

Valtuutuksen tilan:

Avregistrerad

Valtuutus päivämäärä:

2018-01-31

Pakkausseloste

1
PACKAGE LEAFLET
2
PACKAGE LEAFLET: INFORMATION FOR THE USER
SYMBICORT FORTE TURBUHALER 320 MICROGRAMS/9 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 forte Turbuhaler is and what it is used for
2.
What you need to know before you use Symbicort forte Turbuhaler
3.
How to use Symbicort forte Turbuhaler
4.
Possible side effects
5.
How to store Symbicort forte Turbuhaler
6.
Contents of the pack and other information
1.
WHAT SYMBICORT FORTE TURBUHALER IS AND WHAT IT IS USED FOR
Symbicort forte Turbuhaler is an inhaler that is used to treat asthma
in adults and adolescents aged 12-
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
forte Turbuhaler and a separate
‘reliever inhaler’.

Use Symbicort forte Turbuhaler every day. This helps to prevent asthma
symptoms from happenin

Valmisteyhteenveto

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Symbicort forte Turbuhaler, 320 micrograms/9 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 forte Turbuhaler is indicated in adults, and adolescents
aged 12-17 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 forte Turbuhaler 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 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