Symbicort 80 mikrogram/2,25 mikrogram/puff Inhalationsspray, suspension

Land: Sverige

Språk: svenska

Källa: Läkemedelsverket (Medical Products Agency)

Aktiva substanser:

budesonid; formoterolfumaratdihydrat

Tillgänglig från:

AstraZeneca AB

ATC-kod:

R03AK07

INN (International namn):

budesonide; formoterol

Dos:

80 mikrogram/2,25 mikrogram/puff

Läkemedelsform:

Inhalationsspray, suspension

Sammansättning:

formoterolfumaratdihydrat 2,25 mikrog Aktiv substans; budesonid 80 mikrog Aktiv substans

Receptbelagda typ:

Receptbelagt

Produktsammanfattning:

Förpacknings: Inhalator, 60 doser; Inhalator, 120 doser

Bemyndigande status:

Godkänd

Tillstånd datum:

2020-07-20

Bipacksedel

1
PACKAGE LEAFLET
2
PACKAGE LEAFLET: INFORMATION FOR THE USER
SYMBICORT 80 MICROGRAMS/2.25 MICROGRAMS/ACTUATION PRESSURISED
INHALATION, SUSPENSION
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 is and what it is used for
2.
What you need to know before you use Symbicort
3.
How to use Symbicort
4.
Possible side effects
5.
How to store Symbicort
6.
Contents of the pack and other information
1.
WHAT SYMBICORT IS AND WHAT IT IS USED FOR
WHAT SYMBICORT IS
Symbicort is an inhaler that is used to treat asthma in adults and
adolescents aged 12-17 years. It contains
two different medicines: budesonide and formoterol fumarate dihydrate.

Budesonide belongs to a group of medicines called
‘corticosteroids’.

Formoterol fumarate dihydrate belongs to a group of medicines called
‘long-acting beta
2
adrenoceptor
agonists’ or ‘bronchodilators’.
WHAT SYMBICORT IS USED TO TREAT
Symbicort is used to treat asthma, and can be prescribed alone or with
a separate reliever inhaler:
Some people are prescribed two asthma inhalers: Symbicort inhaler and
a separate ‘reliever inhaler’

They use Symbicort every day. This helps to prevent signs of asthma.

They use their ‘reliever inhaler’ when they get signs of asthma,
to make it easier to breathe again.
Some people are prescribed Symbicort as their only asthma inhaler

They use Symbicort every day. This helps to prevent signs of asthma.

They also use Symbicort when they need ex

Produktens egenskaper

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1
.
NAME OF THE MEDICINAL PRODUCT
Symbicort, 80 micrograms/2.25 micrograms/actuation pressurised
inhalation, suspension.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each actuation delivers: budesonide 80 micrograms and formoterol
fumarate dihydrate 2.25 micrograms
(delivered, ex-actuator). This is equivalent to budesonide 100
micrograms and formoterol fumarate dihydrate
3 micrograms (metered).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Pressurised inhalation, suspension.
White suspension in an aluminium canister fitted into a red actuator
with a grey dust cap.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
ASTHMA
Symbicort is indicated in adults and adolescents (12 years and older)
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.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Route of administration: 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 combination of doses other than
those available in the combination
inhaler, appropriate doses of β
2
adrenoceptor agonists and/or corticosteroids by individual inhalers
should be
prescribed.
The dose should be titrated to the lowest dose at which effective
control of symptoms is maintained. Patients
should be regularly reassessed by their prescriber/healthcare provider
so that the dosage of Symbicort
remains optimal.