AirFluSal MDI 25 microgram/125 microgram/dose pressurised inhalation, suspension

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

SALMETEROL XINAFOATE; Fluticasone propionate

Available from:

Rowex Ltd

ATC code:

R03AK; R03AK06

INN (International Name):

SALMETEROL XINAFOATE; Fluticasone propionate

Dosage:

25 microgram/125 microgram(s)

Pharmaceutical form:

Pressurised inhalation, suspension

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Adrenergics in combination with corticosteroids or other drugs, excl. anticholinergics; salmeterol and fluticasone

Authorization status:

Not marketed

Authorization date:

2017-05-12

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
AIRFLUSAL
® MDI 25 MICROGRAM/125 MICROGRAM/DOSE PRESSURISED INHALATION,
SUSPENSION
AIRFLUSAL
® MDI 25 MICROGRAM/250 MICROGRAM/DOSE PRESSURISED INHALATION,
SUSPENSION
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 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 AirFluSal
®
MDI is and what it is used for
2. What you need to know before you use AirFluSal
®
MDI
3. How to use AirFluSal
®
MDI
4. Possible side effects
5. How to store AirFluSal
®
MDI
6. Contents of the pack and other information
1. WHAT AIRFLUSAL
® MDI IS AND WHAT IT IS USED FOR
AirFluSal
®
MDI 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.
AirFluSal
®
MDI is not recommended for use by children.
The doctor has prescribed this medicine to help prevent breathing
problems such as asthma.
You must use AirFluSal
®
MDI every day as directed by your doctor. This will make sure that it
works
properly in controlling your asthma.
AirFluSal
®
MDI helps to stop breathlessness and wheeziness coming on. However,
AirFluSal
®
MDI
should not be used to relieve a sudden attack of breathlessness or
wheezing. If this happens you need
to use a fast-acting ‘reliever’ (‘rescue’) inhaler, su

Summary of Product characteristics

Health Products Regulatory Authority
22 August 2022
CRN00CW8N
Page 1 of 13
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
AirFluSal MDI 25 microgram/125 microgram/dose pressurised inhalation,
suspension
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each metered dose (ex valve) contains 25 micrograms of salmeterol (as
salmeterol xinafoate) and 125 micrograms of
fluticasone propionate. This is equivalent to a delivered dose (ex
actuator) of 21 micrograms of salmeterol and 110 micrograms
of fluticasone propionate.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Pressurised inhalation, suspension.
The container contains a white homogeneous suspension.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
AirFluSal MDI 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
AirFluSal MDI is not recommended for use in children.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Method of administration: Inhalation use.
Patients should be made aware that AirFluSal MDI must be used daily
for optimum benefit, even when asymptomatic.
Patients should be regularly reassessed by a doctor, so that the
strength of AirFluSal MDI 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 MAINTAINED. WHERE THE
CONTROL OF SYMPTOMS IS MAINTAINED WITH THE LOWEST STRENGTH OF
AIRFLUSAL MDI (25 MICROGRAMS/125 MICROGRAMS) GIVEN
TWICE DAILY THEN THE NEXT STEP WOULD BE TO SWITCH TO A DIFFERENT
SALMETEROL/FLUTICASONE INHALED PRODUCT IN A LOWER
STRENGTH (25 MICROGRAMS/50 MICROGRAMS).
Where the control of symptoms is maintained with the lowest strength
of the combination given twice daily then the nex