Abriff K-haler 125 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:

125 mikrogram/5 mikrogram/puff

Pharmaceutical form:

Inhalationsspray, suspension

Composition:

etanol, vattenfri Hjälpämne; formoterolfumaratdihydrat 5 mikrog Aktiv substans; flutikasonpropionat 125 mikrog Aktiv substans

Prescription type:

Receptbelagt

Product summary:

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

Authorization status:

Avregistrerad

Authorization date:

2019-04-11

Patient Information leaflet

                                1
PACKAGE LEAFLET
2
PACKAGE LEAFLET: INFORMATION FOR THE USER
ABRIFF K-HALER 50 MICROGRAM /5 MICROGRAM PER ACTUATION PRESSURISED
INHALATION, SUSPENSION
ABRIFF 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

is and what it is used for
2.
What you need to know before you use

3.
How to use

4.
Possible side effects
5.
How to store

6.
Contents of the pack and other information
1.
WHAT  IS AND WHAT IT IS USED FOR
Please note:-

pressurised inhalation, suspension is the full name of the product,
however throughout
this leaflet it is referred to as

or simply as an inhaler, sometimes together with a reference
to a specific strength.

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 is advised that you sh
                                
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Summary of Product characteristics

                                MARKNADSFÖRS EJ FÖR NÄRVARANDE.
_Produktinformation_
                                
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Documents in other languages

Patient Information leaflet Patient Information leaflet English 14-03-2019
Public Assessment Report Public Assessment Report English 12-05-2020