Fobumix Easyhaler 320 mikrogram/9 mikrogram/inhalation Inhalationspulver

מדינה: שוודיה

שפה: שוודית

מקור: Läkemedelsverket (Medical Products Agency)

מרכיב פעיל:

budesonid; formoterolfumaratdihydrat

זמין מ:

Orion Corporation

קוד ATC:

R03AK07

INN (שם בינלאומי):

budesonide; formoterol

כמות:

320 mikrogram/9 mikrogram/inhalation

טופס פרצבטיות:

Inhalationspulver

הרכב:

laktosmonohydrat Hjälpämne; formoterolfumaratdihydrat 9 mikrog Aktiv substans; budesonid 320 mikrog Aktiv substans

סוג מרשם:

Receptbelagt

leaflet_short:

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

מצב אישור:

Godkänd

תאריך אישור:

2017-01-13

עלון מידע

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, 320 MICROGRAMS/9 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 320/9 is and what it is used for
2.
What you need to know before you use Fobumix Easyhaler 320/9
3.
How to use Fobumix Easyhaler 320/9
4.
Possible side effects
5.
How to store Fobumix Easyhaler 320/9
6.
Contents of the pack and other information
1.
WHAT FOBUMIX EASYHALER 320/9 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 is also
used to treat the symptoms of Chronic Obstructive Pulmonary Disease
(COPD) 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.
Fobumix Easyhaler is indicated for use in adults 18 years of age and
older only.
Fobumix Easyhaler is NOT indicated for use

מאפייני מוצר

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Fobumix Easyhaler, 320 micrograms/9 micrograms/inhalation, inhalation
powder.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each delivered dose (the dose that leaves the mouthpiece) contains:
budesonide
320 micrograms/inhalation and formoterol fumarate dihydrate 9
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 7600 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.
ASTHMA
Fobumix Easyhaler 320 micrograms/9 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.
CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD)
Fobumix Easyhaler 320 micrograms/9 micrograms/inhalation is indicated
in adults, aged 18 years and older,
for the symptomatic treatment of patients with COPD with FEV
1
< 70% predicted normal (post-
bronchodilator) and an exacerbation history despite regular
bronchodilator therapy (see also section 4.4).
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.
ASTHMA
Fobumix Easyhaler is not intended for the initia