Salfuler Easyhaler 50 mikrogram/500 mikrogram/dos Inhalationspulver

Pays: Suède

Langue: suédois

Source: Läkemedelsverket (Medical Products Agency)

Ingrédients actifs:

flutikasonpropionat; salmeterolxinafoat

Disponible depuis:

Orion Corporation

Code ATC:

R03AK06

DCI (Dénomination commune internationale):

fluticasone propionate; salmeterol

Dosage:

50 mikrogram/500 mikrogram/dos

forme pharmaceutique:

Inhalationspulver

Composition:

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

Type d'ordonnance:

Receptbelagt

Descriptif du produit:

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

Statut de autorisation:

Godkänd

Date de l'autorisation:

2018-06-08

Notice patient

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
Salfuler 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 Salfuler Easyhaler is and what it is used for
2.
What you need to know before you use Salfuler Easyhaler
3.
How to use Salfuler Easyhaler
4.
Possible side effects
5.
How to store Salfuler Easyhaler
6.
Contents of the pack and other information
1.
WHAT SALFULER EASYHALER IS AND WHAT IT IS USED FOR
Salfuler 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

Chronic Obstructive Pulmonary Disease (COPD). Salfuler Easyhaler, at a
dose of
50/500 micrograms, reduces the number of flare ups of COPD symptoms.
2
You must use Salfuler Easyhaler every day as directed by your doctor.
This will make sure that it
works properly in controlling your asthma or COPD.
Salfuler Easyhaler helps to stop breathlessness and wheeziness coming
on. How

Résumé des caractéristiques du produit

1
1.
NAME OF THE MEDICINAL PRODUCT
Salfuler Easyhaler 50 microgram/500 microgram/dose, inhalation powder
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Salfuler 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)
White powder.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
_ASTHMA_
Salfuler 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)_
Salfuler 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.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Patients should be made aware that Salfuler Easyhaler must be used
daily for optimum benefit, even
when asymptomatic.
2
Patients should be regularly reassessed by a doctor, so that the
strength of salmeterol/fluticasone
propionate inhaler they are receiving remains optimal
_ _
and is only changed on medical advice.
THE
DOSE SHOULD BE TITRATED TO THE LOWEST DOSE AT WHICH EFFECTIVE CONTROL
OF SYMPTOMS IS MAINTAINED.
Salfuler Easyhaler is not available on the market at strengths lower