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

Nchi: Uswidi

Lugha: Kiswidi

Chanzo: Läkemedelsverket (Medical Products Agency)

Viambatanisho vya kazi:

budesonid; formoterolfumaratdihydrat

Inapatikana kutoka:

Orion Corporation

ATC kanuni:

R03AK07

INN (Jina la Kimataifa):

budesonide; formoterol

Kipimo:

160 mikrogram/4,5 mikrogram/inhalation

Dawa fomu:

Inhalationspulver

Tungo:

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

Dawa ya aina:

Receptbelagt

Bidhaa muhtasari:

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

Idhini hali ya:

Godkänd

Idhini ya tarehe:

2016-11-02

Taarifa za kipeperushi

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
FIXBUFO 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 Fixbufo Easyhaler 160/4.5 is and what it is used for
2.
What you need to know before you use Fixbufo Easyhaler 160/4.5
3.
How to use Fixbufo Easyhaler 160/4.5
4.
Possible side effects
5.
How to store Fixbufo Easyhaler 160/4.5
6.
Contents of the pack and other information
1.
WHAT FIXBUFO EASYHALER 160/4.5 IS AND WHAT IT IS USED FOR
Fixbufo 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
Fixbufo Easyhaler 160/4.5 can be prescribed for asthma in two
different ways.
A) SOME PEOPLE ARE PRESCRIBED TWO ASTHMA INHALERS: FIXBUFO EASYHALER
160/4.5 AND A SEPARATE
‘RELIEVER INHALER’.

They use Fixbufo Easyhaler every day. This helps to prevent asthma

Tabia za bidhaa

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Fixbufo 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
Fixbufo 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)
Fixbufo 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
Fixbufo Easyhaler is not intended for the initial management of
asthma. The dosage of the
components of Fixbufo 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