Bufomix Easyhaler, 320 micrograms/9 micrograms/inhalation, inhalation powder

Land: Malta

Taal: Engels

Bron: Medicines Authority

Werkstoffen:

FORMOTEROL FUMARATE, DIHYDRATE, BUDESONIDE

Beschikbaar vanaf:

Orion Corporation Orionintie 1, FI-02200 Espoo, Finland

ATC-code:

R03AK07

INN (Algemene Internationale Benaming):

FORMOTEROL FUMARATE DIHYDRATE 9 µg BUDESONIDE 320 µg

farmaceutische vorm:

INHALATION POWDER

Samenstelling:

FORMOTEROL FUMARATE DIHYDRATE 9 µg BUDESONIDE 320 µg

Prescription-type:

POM

Therapeutisch gebied:

DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES

Autorisatie-status:

Withdrawn

Autorisatie datum:

2014-04-16

Bijsluiter

PAGE 1 OF 9
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
BUFOMIX 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 Bufomix Easyhaler 320/9 is and what it is used for
2.
What you need to know before you use Bufomix Easyhaler 320/9
3.
How to use Bufomix Easyhaler 320/9
4.
Possible side effects
5.
How to store Bufomix Easyhaler 320/9
6.
Contents of the pack and other information
1.
WHAT BUFOMIX EASYHALER 320/9 IS AND WHAT IT IS USED FOR
Bufomix 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: Bufomix
Easyhaler 320/9 and a
separate ‘reliever inhaler’.

Use Bufomix Easyhaler every day. This helps to prevent asthma symptoms
from happening.

Use your ‘reliever inhaler’ when you get asth

Productkenmerken

PAGE 1 OF 14
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Bufomix 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 a 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
Bufomix Easyhaler 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)
Bufomix Easyhaler is indicated in adults, aged 18 years and older, for
the symptomatic treatment of
patients with COPD with forced expiratory volume in 1 (FEV
1
) < 70% predicted normal (post-
bronchodilator) and an exacerbation history despite regular
bronchodilator therapy (see also section
4.4).
PAGE 2 OF 14
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
ASTHMA
Bufomix Easyhaler is not intended for the initial management of
asthma. The dosage of the
components of Bufomix 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