AirBuFo Forspiro 160 microgram/4.5 microgram/dose inhalation powder, pre-dispensed

País: Irlanda

Idioma: anglès

Font: HPRA (Health Products Regulatory Authority)

ingredients actius:

Budesonide; Formoterol fumarate dihydrate

Disponible des:

Rowex Ltd

Codi ATC:

R03AK; R03AK07

Designació comuna internacional (DCI):

Budesonide; Formoterol fumarate dihydrate

Dosis:

160 microg/4.5 Mcg/Dose

formulario farmacéutico:

Inhalation powder, pre-dispensed

tipo de receta:

Product subject to prescription which may be renewed (B)

Área terapéutica:

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

Estat d'Autorització:

Marketed

Data d'autorització:

2018-05-18

Informació per a l'usuari

PACKAGE LEAFLET: INFORMATION FOR THE USER
AIRBUFO
® FORSPIRO
® 160 MICROGRAM/4.5 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 12-17 YEARS
.
•
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
AirBuFo
®
Forspiro
®
can be prescribed for asthma in two different ways.
a)
Some people are prescribed two asthma inhalers.
AirBuFo
®
Forspiro
®
and a separate “reliever
inhaler”.
•
They use
AirBuFo
®
Forspiro
®
every day. This helps to prevent asthma symptoms from
happening.
•

Fitxa tècnica

Health Products Regulatory Authority
26 May 2023
CRN00DLCQ
Page 1 of 15
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
AirBuFo Forspiro 160 microgram/4.5 microgram/dose inhalation powder,
pre-dispensed
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each delivered dose (inhaled dose) contains 160 micrograms of
budesonide and 4.5 micrograms of formoterol fumarate
dihydrate.
Each metered dose (pre-dispensed dose contained in the blister)
contains 194.7 micrograms of budesonide and
6.1 micrograms of formoterol fumarate dihydrate.
Excipient with known effect
Lactose monohydrate: 5.4 mg per metered doseand 4.4 mg per delivered
dose.
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 (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)
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 each component of AirBuFo
Forspiro is individual and should be adjusted to the severity of the
disease. This should be considered not only when