Bufar Easyhaler Inhalation Powder 80/4.5mcg

Země: Malta

Jazyk: angličtina

Zdroj: Medicines Authority

Aktivní složka:

BUDESONIDE, FORMOTEROL FUMARATE, DIHYDRATE

Dostupné s:

Orion Corporation Orionintie 1, FI-02200 Espoo, Finland

ATC kód:

R03AK07

INN (Mezinárodní Name):

BUDESONIDE 80 µg FORMOTEROL FUMARATE DIHYDRATE 4.5 µg

Léková forma:

PROLONGED-RELEASE TABLET

Složení:

BUDESONIDE 80 µg FORMOTEROL FUMARATE DIHYDRATE 4.5 µg

Druh předpisu:

POM

Terapeutické oblasti:

DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES

Stav Autorizace:

Withdrawn

Datum autorizace:

2016-07-05

Informace pro uživatele

Page 1 of 9
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 doctor or pha

Charakteristika produktu

Page 1 of 15
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 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: 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.
Page 2 of 15
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 o