Flutiform K-haler 50 mikrogram/5 mikrogram/puff Inhalationsspray, suspension

Country: Sweden

Language: Swedish

Source: Läkemedelsverket (Medical Products Agency)

Active ingredient:

flutikasonpropionat; formoterolfumaratdihydrat

Available from:

Mundipharma AB

ATC code:

R03AK11

INN (International Name):

fluticasone propionate; formoterol

Dosage:

50 mikrogram/5 mikrogram/puff

Pharmaceutical form:

Inhalationsspray, suspension

Composition:

flutikasonpropionat 50 mikrog Aktiv substans; formoterolfumaratdihydrat 5 mikrog Aktiv substans; etanol, vattenfri Hjälpämne

Prescription type:

Receptbelagt

Product summary:

Förpacknings: Inhalator, 120 puffar; Inhalator, 3 x 120 puffar

Authorization status:

Avregistrerad

Authorization date:

2018-07-06

Patient Information leaflet

1
PACKAGE LEAFLET
2
PACKAGE LEAFLET: INFORMATION FOR THE USER
FLUTIFORM K-HALER 50 MICROGRAM /5 MICROGRAM PER ACTUATION PRESSURISED
INHALATION, SUSPENSION
FLUTIFORM K-HALER 125 MICROGRAM /5 MICROGRAM PER ACTUATION PRESSURISED
INHALATION, SUSPENSION
fluticasone propionate/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
FLUTIFORM K-HALER
is and what it is used for
2.
What you need to know before you use
FLUTIFORM K-HALER
3.
How to use
FLUTIFORM K-HALER
4.
Possible side effects
5.
How to store
FLUTIFORM K-HALER
6.
Contents of the pack and other information
1.
WHAT FLUTIFORM K-HALER IS AND WHAT IT IS USED FOR
Please note:-
FLUTIFORM K-HALER
pressurised inhalation, suspension is the full name of the product,
however throughout
this leaflet it is referred to as
FLUTIFORM K-HALER
or simply as an inhaler, sometimes together with a
reference to a specific strength.
FLUTIFORM K-HALER
is an inhaler (a pressurised inhalation suspension) which contains two
active
ingredients:

Fluticasone propionate which belongs to a group of medicines called
steroids. Steroids help to reduce
swelling and inflammation in the lungs.

Formoterol fumarate dihydrate which belongs to a group of medicines
called long-acting beta
2
agonists.
Long-acting beta
2
agonists are long-acting bronchodilators which help the airways in
your lungs to stay
open, making it easier for you to breathe.
Together these two active ingredients help to improve your breathing.
It

Summary of Product characteristics

1
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Flutiform K-haler 50 microgram/5 microgram per actuation pressurised
inhalation, suspension.
Flutiform K-haler 125 microgram/5 microgram per actuation pressurised
inhalation, suspension.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each metered dose (ex-valve) contains:
•
50 micrograms of fluticasone propionate and 5 micrograms of formoterol
fumarate dihydrate. This is
equivalent to a delivered dose (ex-actuator) of approximately 46
micrograms of fluticasone propionate
and 4.5 micrograms of formoterol fumarate dihydrate.
•
125 micrograms of fluticasone propionate and 5 micrograms of
formoterol fumarate dihydrate. This is
equivalent to a delivered dose (ex-actuator) of approximately 115
micrograms of fluticasone propionate
and 4.5 micrograms of formoterol fumarate dihydrate.
Excipient with known effect
_Each actuation contains 1 mg ethanol._
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Pressurised inhalation, suspension
The canister contains white to off-white liquid suspension. The
canister is sealed inside a pale grey breath-
triggered actuator with an integrated dose indicator and an orange
mouthpiece cover.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
This fixed-dose combination of fluticasone propionate and formoterol
fumarate (Flutiform K-haler) is
indicated in the regular treatment of asthma where the use of a
combination product (an inhaled
corticosteroid and a long -acting β
2
agonist) is appropriate:
•
For patients not adequately controlled with inhaled corticosteroids
and ‘as required’ inhaled short-acting
β
2
agonist.
Or
•
For patients already adequately controlled on both an inhaled
corticosteroid and a long-acting β
2
agonist.
Flutiform K-haler is indicated in adults and adolescents aged 12 years
and above.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Patients will need to be trained on the use of the inhaler and their
asthma should be regularly reassessed by a
doctor, so tha