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

Țară: Irlanda

Limbă: engleză

Sursă: HPRA (Health Products Regulatory Authority)

Ingredient activ:

Budesonide; Formoterol fumarate dihydrate

Disponibil de la:

Orion Corporation

Codul ATC:

R03AK; R03AK07

INN (nume internaţional):

Budesonide; Formoterol fumarate dihydrate

Dozare:

160/4.5 microgram(s)

Forma farmaceutică:

Inhalation powder

Tip de prescriptie medicala:

Product subject to prescription which may be renewed (B)

Zonă Terapeutică:

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

Statutul autorizaţiei:

Marketed

Data de autorizare:

2014-04-11

Prospect

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, 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.

Caracteristicilor produsului

Health Products Regulatory Authority
17 September 2020
CRN009YG7
Page 1 of 13
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).
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 init