Bufori Easyhaler 160 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:

160 mikrogram/4,5 mikrogram/inhalation

Ravimvorm:

Inhalationspulver

Koostis:

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

Retsepti tüüp:

Receptbelagt

Toote kokkuvõte:

Förpacknings: Inhalator, 60 doser; Inhalator, 60 doser med fodral; Inhalator, 120 doser; Inhalator, 120 doser med fodral; Inhalator, 180 (3 x 60) doser; Inhalator, 320 (3 x 120) doser

Volitamisolek:

Godkänd

Loa andmise kuupäev:

2016-11-02

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
BUFORI 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 Bufori Easyhaler 160/4.5 is and what it is used for
2.
What you need to know before you use Bufori Easyhaler 160/4.5
3.
How to use Bufori Easyhaler 160/4.5
4.
Possible side effects
5.
How to store Bufori Easyhaler 160/4.5
6.
Contents of the pack and other information
1.
WHAT BUFORI EASYHALER 160/4.5 IS AND WHAT IT IS USED FOR
Bufori 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
Bufori Easyhaler 160/4.5 can be prescribed for asthma in two different
ways.
A) SOME PEOPLE ARE PRES

Toote omadused

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Bufori 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
ASTHMA
Bufori Easyhaler 160 micrograms/4.5 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)
Bufori 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 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
Bufori Easyhaler is not intended for the initial management of asthma.
The dosage of the components
of Bufori 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
init