Fobumix Easyhaler 80 mikrogram/4,5 mikrogram/inhalation Inhalationspulver

Riik: Rootsi

keel: rootsi

Allikas: Läkemedelsverket (Medical Products Agency)

Toimeaine:

budesonid; formoterolfumaratdihydrat

Saadav alates:

Orion Corporation

ATC kood:

R03AK07

INN (Rahvusvaheline Nimetus):

budesonide; formoterol

Annus:

80 mikrogram/4,5 mikrogram/inhalation

Ravimvorm:

Inhalationspulver

Koostis:

laktosmonohydrat Hjälpämne; formoterolfumaratdihydrat 4,5 mikrog Aktiv substans; budesonid 80 mikrog Aktiv substans

Retsepti tüüp:

Receptbelagt

Toote kokkuvõte:

Förpacknings: Inhalator, 120 doser; Inhalator, 60 doser med fodral; Inhalator, 120 doser med fodral; Inhalator, 60 doser; Inhalator, 180 (3 x 60) doser; Inhalator, 360 (3 x 120) doser

Volitamisolek:

Godkänd

Loa andmise kuupäev:

2017-01-13

Infovoldik

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 PATIENT
FOBUMIX EASYHALER, 80 MICROGRAMS/4.5 MICROGRAMS/INHALATION, INHALATION
POWDER
Budesonide/formoterol fumarate dihydrate
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 Fobumix Easyhaler 80/4.5 is and what it is used for
2.
What you need to know before you use Fobumix Easyhaler 80/4.5
3.
How to use Fobumix Easyhaler 80/4.5
4.
Possible side effects
5.
How to store Fobumix Easyhaler 80/4.5
6.
Contents of the pack and other information
1.
WHAT FOBUMIX EASYHALER 80/4.5 IS AND WHAT IT IS USED FOR
Fobumix Easyhaler is an inhaler that is used to treat asthma in adults
aged 18 years and older. It
contains two different medicines: budesonide and formoterol fumarate
dihydrate.

Budesonide belongs to a group of medicines called
‘corticosteroids’. It works by reducing and
preventing swelling and inflammation in your lungs.

Formoterol fumarate dihydrate belongs to a group of medicines called
‘long-acting
beta
2
adrenoceptor agonists’ or ‘bronchodilators’. It works by
relaxing the muscles in your
airways. This helps you to breathe more easily.
This medicine is not suitable for people with severe asthma.
Fobumix Easyhaler is indicated for use in adults 18 years of age and
older only.
Fobumix Easyhaler is NOT indicated for use in children 12 years of age
and younger or adolescent

Toote omadused

1
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Fobumix Easyhaler, 80 micrograms/4.5 micrograms/inhalation, inhalation
powder.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each delivered dose (the dose that leaves the mouthpiece) contains:
budesonide
80 micrograms/inhalation and formoterol fumarate dihydrate 4.5
micrograms/inhalation.
With the Fobumix Easyhaler device the delivered dose (the dose that
leaves the mouthpiece) contains
a similar quantity of active substance as the metered dose.
Excipients with known effect: Lactose monohydrate 4000 micrograms 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 red cap.
White to yellowish powder.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Fobumix Easyhaler is indicated in adults 18 years of age and older
only.
Fobumix Easyhaler 80 micrograms/4.5 micrograms/inhalation is indicated
for the regular treatment of
asthma where use of a combination (inhaled corticosteroid and
long-acting β
2
adrenoceptor agonist) is
appropriate:
-
patients not adequately controlled with inhaled corticosteroids and
“as needed” inhaled
short-acting β
2
adrenoceptor agonists.
or
-
patients already adequately controlled on both inhaled corticosteroids
and long-acting β
2
adrenoceptor agonists.
NOTE:
Fobumix Easyhaler 80 micrograms/4.5 micrograms/inhalation is not
appropriate in patients with
severe asthma.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Fobumix Easyhaler is indicated in adults 18 years of age and older
only.
Fobumix Easyhaler is not indicated for use in children, 12 years of
age and younger or adolescents, 13
to 17 years of age.
Fobumix Easyhaler is not intended for the initial management of
asthma. The dosage of the
components of Fobumix Easyhaler is individual and should be adjusted
to the severity of the disease.
This should be considered not only when treatment with combination
products is initiated but also
when t