Fusacomb Easyhaler 50 mikrogram/500 mikrogram/dos Inhalationspulver

Χώρα: Σουηδία

Γλώσσα: Σουηδικά

Πηγή: Läkemedelsverket (Medical Products Agency)

Δραστική ουσία:

flutikasonpropionat; salmeterolxinafoat

Διαθέσιμο από:

Orion Corporation

Φαρμακολογική κατηγορία (ATC):

R03AK06

INN (Διεθνής Όνομα):

fluticasone propionate; salmeterol

Δοσολογία:

50 mikrogram/500 mikrogram/dos

Φαρμακοτεχνική μορφή:

Inhalationspulver

Σύνθεση:

laktosmonohydrat Hjälpämne; flutikasonpropionat 500 mikrog Aktiv substans; salmeterolxinafoat 73 mikrog Aktiv substans

Τρόπος διάθεσης:

Receptbelagt

Περίληψη προϊόντος:

Förpacknings: Inhalator, 1 x 60 doser (utan fodral); Inhalator, 2 x 60 doser (utan fodral); Inhalator, 3 x 60 doser (med fodral); Inhalator, 2 x 60 doser (med fodral); Inhalator, 3 x 60 doser (utan fodral); Inhalator, 1 x 60 doser (med fodral)

Καθεστώς αδειοδότησης:

Godkänd

Ημερομηνία της άδειας:

2018-06-08

Φύλλο οδηγιών χρήσης

1
QR code to www.oeh.fi/ xxxx [to be completed nationally].
Scan this code or visit www.oeh.fi/ xxxx [to be completed nationally]
to see instructions on how to use
Easyhaler
PACKAGE LEAFLET: INFORMATION FOR THE USER
Fusacomb Easyhaler 50 microgram/250 microgram/dose, inhalation powder
Fusacomb Easyhaler 50 microgram/500 microgram/dose, inhalation powder
Salmeterol/fluticasone propionate
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING 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 Fusacomb Easyhaler is and what it is used for
2.
What you need to know before you use Fusacomb Easyhaler
3.
How to use Fusacomb Easyhaler
4.
Possible side effects
5.
How to store Fusacomb Easyhaler
6.
Contents of the pack and other information
1.
WHAT FUSACOMB EASYHALER IS AND WHAT IT IS USED FOR
Fusacomb Easyhaler contains two medicines, salmeterol and fluticasone
propionate:

Salmeterol is a long-acting bronchodilator. Bronchodilators help the
airways in the lungs to stay
open. This makes it easier for air to get in and out. The effects last
for at least 12 hours.

Fluticasone propionate is a corticosteroid which reduces swelling and
irritation in the lungs.
The doctor has prescribed this medicine to help prevent breathing
problems such as:

Asthma
2

Chronic Obstructive Pulmonary Disease (COPD). Fusacomb Easyhaler, at a
dose of
50/500 micrograms, reduces the number of flare ups of COPD symptoms.
You must use Fusacomb Easyhaler every day as directed by your doctor.
This will make sure that it
works properly in controlling your asthma or COPD.
Fusacom

Αρχείο Π.Χ.Π.

1
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Fusacomb Easyhaler 50 microgram/250 microgram/dose, inhalation powder
Fusacomb Easyhaler 50 microgram/500 microgram/dose, inhalation powder
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Fusacomb Easyhaler 50 microgram/250 microgram: Each delivered dose
(the dose that leaves the
mouthpiece) contains salmeterol xinafoate corresponding to 48
micrograms of salmeterol and
238 micrograms fluticasone propionate.
This corresponds to a metered dose of salmeterol xinafoate
corresponding to 50 micrograms of
salmeterol and 250 micrograms fluticasone propionate.
Fusacomb Easyhaler 50 microgram/500 microgram: Each delivered dose
(the dose that leaves the
mouthpiece) contains salmeterol xinafoate corresponding to 48
micrograms of salmeterol and
476 micrograms fluticasone propionate.
This corresponds to a metered dose of salmeterol xinafoate
corresponding to 50 micrograms of
salmeterol and 500 micrograms fluticasone propionate.
Excipient with known effect: Lactose monohydrate 17 mg per delivered
dose
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Inhalation powder in a device metered inhaler (Easyhaler) which is
white with a purple cap.
White powder.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
_ASTHMA_
Fusacomb Easyhaler is indicated in the regular treatment of asthma
where use of a combination
product
_ _
(long-acting

2
agonist
_ _
and inhaled corticosteroid) is
_ _
appropriate:
-
patients not adequately controlled with inhaled corticosteroids and
‘as needed’ inhaled short-
acting

2
agonist
or
-
patients already adequately controlled on both inhaled corticosteroid
and long-acting

2
agonist.
_CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD)_
Fusacomb Easyhaler is indicated for the symptomatic treatment of
patients with COPD, with a FEV
1
<60% predicted normal (pre-bronchodilator) and a history of repeated
exacerbations, who have
significant symptoms despite regular bronchodilator therapy.
3
4.2
POSOLOGY AND METHOD