Bufomide Easyhaler 320 mikrogram/9 mikrogram/inhalation Inhalationspulver

Land: Zweden

Taal: Zweeds

Bron: Läkemedelsverket (Medical Products Agency)

Werkstoffen:

budesonid; formoterolfumaratdihydrat

Beschikbaar vanaf:

Orion Corporation

ATC-code:

R03AK07

INN (Algemene Internationale Benaming):

budesonide; formoterol

Dosering:

320 mikrogram/9 mikrogram/inhalation

farmaceutische vorm:

Inhalationspulver

Samenstelling:

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

Prescription-type:

Receptbelagt

Product samenvatting:

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

Autorisatie-status:

Godkänd

Autorisatie datum:

2017-01-13

Bijsluiter

1
QR code to www.xxxx [to be completed nationally].
Scan this code or visit www.xxxx [to be completed nationally] to see
instructions on how to use
Easyhaler
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
BUFOMIDE 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 Bufomide Easyhaler 320/9 is and what it is used for
2.
What you need to know before you use Bufomide Easyhaler 320/9
3.
How to use Bufomide Easyhaler 320/9
4.
Possible side effects
5.
How to store Bufomide Easyhaler 320/9
6.
Contents of the pack and other information
1.
WHAT BUFOMIDE EASYHALER 320/9 IS AND WHAT IT IS USED FOR
Bufomide Easyhaler is an inhaler that is used to treat asthma in
adults and adolescents aged 12 - 17
years. 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.
ASTHMA
For asthma, your doctor will prescribe two asthma inhalers: Bufomide
Easyhaler 320/9 and a separate
‘reliever in

Productkenmerken

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Bufomide 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 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 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).
White to yellowish powder.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
ASTHMA
Bufomide Easyhaler 320 micrograms/9 micrograms/inhalation is indicated
in adults and adolescents
(12 years and older) 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)
Bufomide Easyhaler 320 micrograms/9 micrograms/inhalation is indicated
in adults, aged 18 years
and older, for the symptomatic treatment of patients with COPD with
forced expiratory volume in
1 second (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
ASTHMA
Bufomide Easyhaler is not intended for the initial management of
asthma. The dosage of the
components of Bufomide 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 i