Fobumix Easyhaler 160 mikrogram/4,5 mikrogram/inhalation Inhalationspulver

Ország: Svédország

Nyelv: svéd

Forrás: Läkemedelsverket (Medical Products Agency)

Aktív összetevők:

budesonid; formoterolfumaratdihydrat

Beszerezhető a:

Orion Corporation

ATC-kód:

R03AK07

INN (nemzetközi neve):

budesonide; formoterol

Adagolás:

160 mikrogram/4,5 mikrogram/inhalation

Gyógyszerészeti forma:

Inhalationspulver

Összetétel:

laktosmonohydrat Hjälpämne; budesonid 160 mikrog Aktiv substans; formoterolfumaratdihydrat 4,5 mikrog Aktiv substans

Recept típusa:

Receptbelagt

Termék összefoglaló:

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

Engedélyezési státusz:

Godkänd

Engedély dátuma:

2017-01-13

Betegtájékoztató

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, 160 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 160/4.5 is and what it is used for
2.
What you need to know before you use Fobumix Easyhaler 160/4.5
3.
How to use Fobumix Easyhaler 160/4.5
4.
Possible side effects
5.
How to store Fobumix Easyhaler 160/4.5
6.
Contents of the pack and other information
1.
WHAT FOBUMIX EASYHALER 160/4.5 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 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 indic

Termékjellemzők

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Fobumix Easyhaler, 160 micrograms/4.5 micrograms/inhalation,
inhalation powder.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each delivered dose (the dose that leaves the mouthpiece) contains:
budesonide
160 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 3800 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 160 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.
CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD)
Fobumix Easyhaler 160 micrograms/4.5 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.
2
ASTHMA
Fobumix Easyhaler is not intended for