Bufar Easyhaler 80 mikrogram/4,5 mikrogram/inhalation Inhalationspulver

Land: Sverige

Språk: svenska

Källa: Läkemedelsverket (Medical Products Agency)

Aktiva substanser:

budesonid; formoterolfumaratdihydrat

Tillgänglig från:

Orion Corporation

ATC-kod:

R03AK07

INN (International namn):

budesonide; formoterol

Dos:

80 mikrogram/4,5 mikrogram/inhalation

Läkemedelsform:

Inhalationspulver

Sammansättning:

formoterolfumaratdihydrat 4,5 mikrog Aktiv substans; budesonid 80 mikrog Aktiv substans; laktosmonohydrat Hjälpämne

Receptbelagda typ:

Receptbelagt

Produktsammanfattning:

Förpacknings: Inhalator, 3 x 60 doser; Inhalator, 60 doser; Inhalator, 60 doser med fodral; Inhalator, 120 doser; Inhalator, 120 doser med fodral; Inhalator, 3 x 120 doser

Bemyndigande status:

Godkänd

Tillstånd datum:

2016-03-31

Bipacksedel

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
BUFAR EASYHALER, 80 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 BUFAR Easyhaler 80/4.5 is and what it is used for
2.
What you need to know before you use BUFAR Easyhaler 80/4.5
3.
How to use BUFAR Easyhaler 80/4.5
4.
Possible side effects
5.
How to store BUFAR Easyhaler 80/4.5
6.
Contents of the pack and other information
1.
WHAT BUFAR EASYHALER 80/4.5 IS AND WHAT IT IS USED FOR
BUFAR Easyhaler is an inhaler that is used to treat asthma in adults,
adolescents and children aged 6
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.
This medicine is not suitable for people with severe asthma. It can be
prescribed for asthma in two
different ways.
A) SOME PEOPLE ARE PRESCRIBED TWO ASTHMA INHALERS: BUFAR EASYHALER
80/4.5 AND A SEPARATE
‘RELIEVER INHALER’

They use BU

Produktens egenskaper

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
BUFAR Easyhaler, 80 micrograms/4.5 micrograms/inhalation, inhalation
powder.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each delivered dose (the dose that leaves the mouthpiece) contains:
budesonide
80 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 4000 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
BUFAR Easyhaler 80 micrograms/4.5 micrograms/inhalation is indicated
in adults, adolescents and
children aged 6 years and older.
BUFAR Easyhaler 80 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.
NOTE:
BUFAR Easyhaler 80 micrograms/4.5 micrograms/inhalation is not
appropriate in patients with
severe asthma.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
ASTHMA
BUFAR Easyhaler is not intended for the initial management of asthma.
The dosage of the
components of BUFAR 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 initiated but also
when the maintenance dose is adjusted. If an individual patient should
require a combination of doses
2
other than those available in the combination inhaler, appropriate
doses of β
2
adrenoceptor ag