BUFAR EASYHALER 80/4.5 Microgram Powder for Inhalation

País: Irlanda

Língua: inglês

Origem: HPRA (Health Products Regulatory Authority)

Ingredientes ativos:

BUDESONIDE, FORMOTEROL FUMARATE DIHYDRATE

Disponível em:

Orion Corporation

Código ATC:

R03AK07

DCI (Denominação Comum Internacional):

BUDESONIDE, FORMOTEROL FUMARATE DIHYDRATE

Dosagem:

80/4.5 Microgram

Forma farmacêutica:

Powder for Inhalation

Tipo de prescrição:

Product subject to prescription which may be renewed (B)

Área terapêutica:

Adrenergics in combination with corticosteroids or other drugs, excl. anticholinergics

Status de autorização:

Authorised

Data de autorização:

2016-03-11

Folheto informativo - Bula

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PACKAGE LEAFLET
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PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
BUFAR 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 Bufar Easyhaler 80/4.5 is and what it is used for
2.
What you need to know before you use Bufar Easyhaler 80/4.5
3.
How to use Bufar Easyhaler 80/4.5
4.
Possible side effects
5.
How to store Bufar Easyhaler 80/4.5
6.
Contents of the pack and other information
1.
WHAT BUFAR EASYHALER 80/4.5 IS AND WHAT IT IS USED FOR
Bufar 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.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE BUFAR EASYHALER 80/4.5
DO NOT USE BUFAR EASYHALER 80/4.5:
-
if you are allergic to budesonide, formoterol or to the other
ingredient of this medicine (listed in section
6) which is lactose (which contains small amounts of milk protein).
WARNINGS AND PRECAUTIONS
Talk to your docto

Características técnicas

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Bufar 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
Bufar Easyhaler 80 micrograms/4.5 micrograms/inhalation is indicated
in adults, adolescents and children aged 6 years
and older.
Bufar 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
2
adrenoceptor agonist) is appropriate:
-
patients not adequately controlled with inhaled corticosteroids and
“as needed” inhaled short
-
acting
2
adrenoceptor agonists.
or
-
patients already adequately controlled on both inhaled corticosteroids
and long
-
acting
2
adrenoceptor agonists.
NOTE: Bufar Easyhaler 80 micrograms/4.5 micrograms/inhalation is not
appropriate in patients with severe asthma.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
ASTHMA
Bufar Easyhaler is not intended for the initial management of asthma.
The dosage of the components of Bufar
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 those available in
the combination inhaler, appropriate doses of
2
adrenoceptor agonists and/or co