AirBuFo® Forspiro® 320 microgram/9 microgram/dose inhalation powder, pre-dispensed

Country: Malta

Language: English

Source: Medicines Authority

Available from:

Rowex Ltd Newtown Bantry, Co. Cork, , Ireland

ATC code:

R03AK07

INN (International Name):

FORMOTEROL FUMARATE DIHYDRATE 9 µg BUDESONIDE 320 µg

Pharmaceutical form:

INHALATION POWDER, PRE-DISPENSED

Composition:

FORMOTEROL FUMARATE DIHYDRATE 9 µg BUDESONIDE 320 µg

Prescription type:

POM

Therapeutic area:

DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES

Authorization status:

Authorised

Authorization date:

2023-08-09

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
AIRBUFO
® FORSPIRO
® 320 MICROGRAM/9 MICROGRAM/DOSE INHALATION POWDER, PRE-DISPENSED
budesonide/formoterol fumarate dihydrate
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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 AirBuFo
®
Forspiro
®
is and what it is used for
2.
What you need to know before you use AirBuFo
®
Forspiro
®
3.
How to use AirBuFo
®
Forspiro
®
4.
Possible side effects
5.
How to store AirBuFo
®
Forspiro
®
6.
Contents of the pack and other information
1.
WHAT AIRBUFO
® FORSPIRO
®
IS AND WHAT IT IS USED FOR
AirBuFo
®
Forspiro
®
is an inhaler that is used to treat asthma in adults and adolescents
aged 12 to 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
For asthma, your doctor will prescribe two asthma inhalers: AirBuFo
®
Forspiro
®
and a separate ‘reliever
inhaler’.
•
Use AirBuFo
®
Forspiro
®
every day. This helps to prevent asthma symptoms from happening.
•
Use your ‘reliever inhaler’ when you g

Summary of Product characteristics

Page 1 of 13
SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
AirBuFo
®
Forspiro
®
320 microgram/9 microgram/dose inhalation powder, pre-dispensed
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each delivered dose (inhaled dose) contains 320 micrograms of
budesonide and 9 micrograms of formoterol fumarate
dihydrate.
Each metered dose (pre-dispensed dose contained in the blister)
contains 346.3 micrograms of budesonide and 10.8
micrograms of formoterol fumarate dihydrate.
Excipient with known effect
Each delivered dose contains 7.9 mg lactose (as monohydrate) and each
metered dose contains 9.1 mg lactose (as
monohydrate).
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Inhalation powder, pre-dispensed.
White to off-white or slightly yellow powder with no agglomerates.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
ASTHMA
AirBuFo
®
Forspiro
®
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)
AirBuFo
®
Forspiro
®
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
Route of administration: For inhalation use
Posology
ASTHMA
AirBuFo
®
Forspiro
®
is not intended for the initial management of asthma. The required
dose of the components of AirBuFo
®
Forspiro
®
is individual and should be adjusted to the severity of the disease.
This should be considered