Fluterolo Easyhaler 50 mikrogram/250 mikrogram/dos Inhalationspulver

Country: Sweden

Language: Swedish

Source: Läkemedelsverket (Medical Products Agency)

Active ingredient:

flutikasonpropionat; salmeterolxinafoat

Available from:

Orion Corporation

ATC code:

R03AK06

INN (International Name):

fluticasone propionate; salmeterol

Dosage:

50 mikrogram/250 mikrogram/dos

Pharmaceutical form:

Inhalationspulver

Composition:

flutikasonpropionat 250 mikrog Aktiv substans; laktosmonohydrat Hjälpämne; salmeterolxinafoat 73 mikrog Aktiv substans

Prescription type:

Receptbelagt

Product summary:

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)

Authorization status:

Godkänd

Authorization date:

2018-06-08

Patient Information leaflet

1
PACKAGE LEAFLET
2
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
Fluterolo Easyhaler 50 microgram/250 microgram/dose, inhalation powder
Fluterolo 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 Fluterolo Easyhaler is and what it is used for
2.
What you need to know before you use Fluterolo Easyhaler
3.
How to use Fluterolo Easyhaler
4.
Possible side effects
5.
How to store Fluterolo Easyhaler
6.
Contents of the pack and other information
1.
WHAT FLUTEROLO EASYHALER IS AND WHAT IT IS USED FOR
Fluterolo 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). Fluterolo Easyhaler, at
a dose of
50/500 micrograms, reduces the number of flare ups of COPD symptoms.
3
You must use Fluterolo Easyhaler every day as directed by your doctor.
This will make sure that it
works properly in controlling

Summary of Product characteristics

1
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Fluterolo Easyhaler 50 microgram/250 microgram/dose, inhalation powder
Fluterolo Easyhaler 50 microgram/500 microgram/dose, inhalation powder
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Fluterolo 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.
Fluterolo 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_
Fluterolo Easyhaler is indicated in the regular treatment of asthma in
adults and adolescents 12 years
and over 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)_
Fluterolo 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
POSO