Bufomix Easyhaler, 80 micrograms/4.5 micrograms/inhalation, inhalation powder

País: Irlanda

Idioma: anglès

Font: HPRA (Health Products Regulatory Authority)

ingredients actius:

Budesonide; Formoterol fumarate dihydrate

Disponible des:

Orion Corporation

Codi ATC:

R03AK; R03AK07

Designació comuna internacional (DCI):

Budesonide; Formoterol fumarate dihydrate

Dosis:

80/4.5 microgram(s)

formulario farmacéutico:

Inhalation powder

tipo de receta:

Product subject to prescription which may be renewed (B)

Área terapéutica:

Adrenergics in combination with corticosteroids or other drugs, excl. anticholinergics; formoterol and budesonide

Estat d'Autorització:

Marketed

Data d'autorització:

2016-04-29

Informació per a l'usuari

1
QR Code to URL: oeh.fi/bfie
Scan this code or visit www. oeh.fi/bfie to see instructions on how to
use Easyhaler
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.

Fitxa tècnica

Health Products Regulatory Authority
17 September 2020
CRN009YG7
Page 1 of 12
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 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