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

Χώρα: Σουηδία

Γλώσσα: Σουηδικά

Πηγή: Läkemedelsverket (Medical Products Agency)

Δραστική ουσία:

budesonid; formoterolfumaratdihydrat

Διαθέσιμο από:

Orion Corporation

Φαρμακολογική κατηγορία (ATC):

R03AK07

INN (Διεθνής Όνομα):

budesonide; formoterol

Δοσολογία:

160 mikrogram/4,5 mikrogram/inhalation

Φαρμακοτεχνική μορφή:

Inhalationspulver

Σύνθεση:

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

Τρόπος διάθεσης:

Receptbelagt

Περίληψη προϊόντος:

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

Καθεστώς αδειοδότησης:

Godkänd

Ημερομηνία της άδειας:

2016-01-22

Φύλλο οδηγιών χρήσης

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
BUFOLER 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 Bufoler Easyhaler 160/4.5 is and what it is used for
2.
What you need to know before you use Bufoler Easyhaler 160/4.5
3.
How to use Bufoler Easyhaler 160/4.5
4.
Possible side effects
5.
How to store Bufoler Easyhaler 160/4.5
6.
Contents of the pack and other information
1.
WHAT BUFOLER EASYHALER 160/4.5 IS AND WHAT IT IS USED FOR
Bufoler 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.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE BUFOLER EASYHALER 160/4.5
DO NOT USE BUFOLER EASYHALER 160/4.5:
2
-
if

Αρχείο Π.Χ.Π.

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Bufoler 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 Easyhaler device the delivered dose (ex-actuator) contains
similar quantity of active
substance as the metered dose (ex-reservoir).
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).
White to yellowish powder.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Bufoler Easyhaler is indicated in adults 18 years of age and older
only.
ASTHMA
Bufoler Easyhaler 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)
Bufoler Easyhaler is indicated 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
Bufoler Easyhaler is indicated in adults 18 years of age and older
only.
Bufoler Easyhaler is not indicated for use in children, 12 years of
age and younger or adolescents, 13
to 17 years of age.
2
ASTHMA
Bufoler Easyhaler is not intended for the initial management of
asthma. The dosage of the
components of Bufoler Easyhaler is individual and should be adjusted
to the severity of the disease.
This should be