Bufomix Easyhaler, 160 micrograms/4.5 micrograms/inhalation, inhalation powder

País: Malta

Língua: inglês

Origem: Medicines Authority

Ingredientes ativos:

FORMOTEROL FUMARATE, DIHYDRATE, BUDESONIDE

Disponível em:

Orion Corporation Orionintie 1, FI-02200 Espoo, Finland

Código ATC:

R03AK07

DCI (Denominação Comum Internacional):

FORMOTEROL FUMARATE DIHYDRATE 4.5 µg BUDESONIDE 160 µg

Forma farmacêutica:

INHALATION POWDER

Composição:

FORMOTEROL FUMARATE DIHYDRATE 4.5 µg BUDESONIDE 160 µg

Tipo de prescrição:

POM

Área terapêutica:

DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES

Status de autorização:

Withdrawn

Data de autorização:

2014-04-16

Folheto informativo - Bula

PAGE 1 OF 10
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
BUFOMIX 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 Bufomix Easyhaler 160/4.5 is and what it is used for
2.
What you need to know before you use Bufomix Easyhaler 160/4.5
3.
How to use Bufomix Easyhaler 160/4.5
4.
Possible side effects
5.
How to store Bufomix Easyhaler 160/4.5
6.
Contents of the pack and other information
1.
WHAT BUFOMIX EASYHALER 160/4.5 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
Bufomix Easyhaler 160/4.5 can be prescribed for asthma in two
different ways.
A) SOME PEOPLE ARE PRESCRIBED TWO ASTHMA INHALERS: BUFOMIX EASYHALER
160/4.5 AND A
SEPARATE ‘RELIEVER INHALER’.

They use Bufomix Easyhaler every day. This helps to prev

Características técnicas

Page 1 of 16
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Bufomix 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 a 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
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 second (FEV
1
) < 70% predicted normal
(post-bronchodilator) and an exacerbation history despite regular
bronchodilator therapy (see also
section 4.4).
Page 2 of 16
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
adjus