Bufar Easyhaler Inhalation Powder 320/9 mcg/inhalation

Kraj: Malta

Język: angielski

Źródło: Medicines Authority

Składnik aktywny:

FORMOTEROL FUMARATE, DIHYDRATE, BUDESONIDE

Dostępny od:

Orion Corporation Orionintie 1, FI-02200 Espoo, Finland

Kod ATC:

R03AK07

INN (International Nazwa):

FORMOTEROL FUMARATE DIHYDRATE 9 µg BUDESONIDE 320 µg

Forma farmaceutyczna:

INHALATION POWDER

Skład:

FORMOTEROL FUMARATE DIHYDRATE 9 µg BUDESONIDE 320 µg

Typ recepty:

POM

Dziedzina terapeutyczna:

DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES

Status autoryzacji:

Withdrawn

Data autoryzacji:

2014-04-16

Ulotka dla pacjenta

Page 1 of 9
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
BUFAR EASYHALER, 320 MICROGRAMS/9 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 320/9 is and what it is used for
2.
What you need to know before you use Bufar Easyhaler 320/9
3.
How to use Bufar Easyhaler 320/9
4.
Possible side effects
5.
How to store Bufar Easyhaler 320/9
6.
Contents of the pack and other information
1.
WHAT BUFAR EASYHALER 320/9 IS AND WHAT IT IS USED FOR
Bufar 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.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE BUFAR EASYHALER 320/9
DO NOT USE BUFAR EASYHALER 320/9:
-
if you are allergic to budesonide, formoterol or the other ingredient
of this medicine (listed in
section 6), which is lactose (which contains small amounts of milk
protein).
WARNINGS AND PR

Charakterystyka produktu

PAGE 1 OF 14
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Bufar Easyhaler, 320 micrograms/9 micrograms/inhalation, inhalation
powder.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each delivered dose (the dose that leaves the mouthpiece) contains:
budesonide
320 micrograms/inhalation and formoterol fumarate dihydrate 9
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 7600 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
Bufar Easyhaler is indicated in adults and adolescents aged 12-17
years, 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)
Bufar Easyhaler is indicated in adults, aged 18 years and older, for
the symptomatic treatment of
patients with COPD with FEV
1
< 70% predicted normal(post-bronchodilator) and an exacerbation
history despite regular bronchodilator therapy (see also section 4.4).
PAGE 2 OF 14
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 o