Bronx Airmaster 50 microgram/250 microgram/ dose inhalation powder, pre-dispensed

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Salmeterol; Fluticasone propionate

Available from:

Neutec Inhaler Ireland Limited

ATC code:

R03AK06

INN (International Name):

Salmeterol; Fluticasone propionate

Dosage:

50 microgram / 250 microgram(s)/dose

Pharmaceutical form:

Inhalation powder, pre-dispensed

Therapeutic area:

salmeterol and fluticasone

Authorization date:

2020-04-03

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
BRONX AIRMASTER 50 MICROGRAM/100 MICROGRAM/ DOSE INHALATION POWDER,
PRE-DISPENSED
BRONX AIRMASTER 50 MICROGRAM/250 MICROGRAM/ DOSE INHALATION POWDER,
PRE-DISPENSED
salmeterol/fluticasone propionate
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, pharmacist or
nurse.
-
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, pharmacist or nurse.
This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Bronx Airmaster is and what it is used for
2.
What you need to know before you use Bronx Airmaster
3.
How to use Bronx Airmaster
4.
Possible side effects
5.
How to store Bronx Airmaster
6.
Contents of the pack and other information
1.
WHAT BRONX AIRMASTER IS AND WHAT IT IS USED FOR
Bronx Airmaster contains two medicines, salmeterol and fluticasone
propionate:
•
Salmeterol is a long-acting bronchodilator. Bronchodilators help the
airways in the lungs to stay
open. This makes it easier for air to get in and out. The effects last
for at least 12 hours.
•
Fluticasone propionate is a corticosteroid which reduces swelling and
irritation in the lungs.
BRONX
AIRMASTER IS USED TO TREAT ADULTS AND ADOLESCENTS 12 YEARS OF AGE AND
OLDER.
The doctor has prescribed this medicine to help prevent breathing
problems such as:
•
Asthma
You must use Bronx Airmaster everyday as directed by your doctor. This
will make sure that it works
properly in controlling your asthma.
BRONX AIRMASTER HELPS TO PREVENT BREATHLESSNESS AND WHEEZINESS.
HOWEVER, BRONX AIRMASTER
SHOULD NOT BE USED TO RELIEVE AN ATTACK OF BREATHLESSNESS OR WHEEZING.
IF YOU ARE EXPERIENCING A
SUDDEN ATTACK OF BREATHLESSNESS OR WHEEZING, YOU NEED TO

Summary of Product characteristics

Health Products Regulatory Authority
11 July 2022
CRN00CFTT
Page 1 of 14
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Bronx Airmaster 50 microgram/250 microgram/ dose inhalation powder,
pre-dispensed
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each single inhalation provides a delivered dose (the dose leaving the
mouthpiece) of 45 micrograms of salmeterol (as
salmeterol xinafoate) and 229 micrograms of fluticasone propionate.
This corresponds to a pre-metered dose of
50 micrograms of salmeterol (as salmeterol xinafoate) and 250
micrograms fluticasone propionate.
Excipient with known effect
Each delivered dose contains approximately 13 milligrams of lactose
(as monohydrate).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Inhalation powder, pre-dispensed.
Moulded plastic device containing a foil strip with 60 regularly
placed blisters. Each blister contains pre-dispensed dose of
white to off white inhalation powder.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Bronx Airmaster is indicated in adults and adolescents 12 years of age
and older.
_ASTHMA_
Bronx Airmaster is indicated in the regular treatment of asthma where
use of a combination product (long- acting β
2
agonist
and inhaled corticosteroid) is appropriate:
- patients not adequately controlled with inhaled corticosteroids and
'as needed' inhaled short-acting β
2
agonist
or
- patients already adequately controlled on both inhaled
corticosteroid and long-acting β
2
agonist
Note: Bronx Airmaster 50 microgram /100 microgram strength is not
appropriate in adults and children with severe asthma.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Patients are to be made aware that Bronx Airmaster must be used daily
for optimal benefit, even when asymptomatic.
Patients should be regularly reassessed by a doctor, so that the
strength of Bronx Airmaster they are receiving remains optimal
and is only changed on medical advice. THE DOSE SHOULD BE TITRATED TO
THE LOWEST DOSE AT WHICH EFFECTIVE CONTROL OF
SYMPTOMS IS