Bufomix Easyhaler Inhalation Powder 80/4.5mcg

Country: Malta

Bahasa: Inggeris

Sumber: Medicines Authority

Bahan aktif:

BUDESONIDE, FORMOTEROL FUMARATE, DIHYDRATE

Boleh didapati daripada:

Orion Corporation Orionintie 1, FI-02200 Espoo, Finland

Kod ATC:

R03AK07

INN (Nama Antarabangsa):

BUDESONIDE 80 µg FORMOTEROL FUMARATE DIHYDRATE 4.5 µg

Borang farmaseutikal:

INHALATION POWDER

Komposisi:

BUDESONIDE 80 µg FORMOTEROL FUMARATE DIHYDRATE 4.5 µg

Jenis preskripsi:

POM

Kawasan terapeutik:

DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES

Status kebenaran:

Withdrawn

Tarikh kebenaran:

2016-07-05

Risalah maklumat

Page 1 of 10
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
BUFOMIX 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 Bufomix Easyhaler 80/4.5 is and what it is used for
2.
What you need to know before you use Bufomix Easyhaler 80/4.5
3.
How to use Bufomix Easyhaler 80/4.5
4.
Possible side effects
5.
How to store Bufomix Easyhaler 80/4.5
6.
Contents of the pack and other information
1.
WHAT BUFOMIX EASYHALER 80/4.5 IS AND WHAT IT IS USED FOR
Bufomix 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: BUFOMIX EASYHALER
80/4.5 AND A SEPARATE
‘RELIEVER INHALER’

They use Bufomix Easyhaler every day. This helps to prevent asthma
symptoms from
happening.

They use their ‘reliever inhaler’ when t

Ciri produk

Page 1 of 15
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Bufomix 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
Bufomix Easyhaler 80 micrograms/4.5 micrograms/inhalation is indicated
in adults, adolescents and
children aged 6 years and older.
Bufomix 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: Bufomix Easyhaler 80 micrograms/4.5 micrograms/inhalation is not
appropriate in patients
with severe asthma.
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
Page 2 of 15
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 other than those available in the combination
inhaler, appropr