AirFluSal® Forspiro® 50 microgram/250 microgram/dose, inhalation powder, predispensed

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Salmeterol; Fluticasone propionate

Available from:

Rowex Ltd

ATC code:

R03AK; R03AK06

INN (International Name):

Salmeterol; Fluticasone propionate

Dosage:

50 microg/250 microgram(s)

Pharmaceutical form:

Inhalation powder, pre-dispensed

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:

Marketed

Authorization date:

2014-11-14

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
AIRFLUSAL
® FORSPIRO
®
50 MICROGRAM/250 MICROGRAM/DOSE, INHALATION POWDER,
PREDISPENSED
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
®
Forspiro
®
is and what it is used for
2. What you need to know before you use AirFluSal
®
Forspiro
®
3. How to use AirFluSal
®
Forspiro
®
4. Possible side effects
5. How to store AirFluSal
®
Forspiro
®
6. Contents of the pack and other information
1.
WHAT AIRFLUSAL
® FORSPIRO
®
IS AND WHAT IT IS USED FOR
AirFluSal
®
Forspiro
®
is used to treat:

asthma.
This medicine contains two active substances.

Salmeterol: a long-acting substance that widens the airways

Fluticasone: a corticosteroid which reduces swelling and inflammation
in the lungs.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE AIRFLUSAL
® FORSPIRO
®
DO NOT USE AIRFLUSAL
® FORSPIRO
®

if you are ALLERGIC to salmeterol, fluticasone or to the other
ingredient of this medicine
(listed in section 6).
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before using AirFluSal
®
Forspiro
®
if you have:

heart disease, including an irregular or fast heartbeat

overactive thyroid gland

high blood pressure

diabetes mellitus

low potassium in your blood

tuberculosis now or in the past, or other lung infections.
Contact your doctor if you experience blurred vision or other visual
disturbances.
AirFluSal
®
Forspiro
®
prevents the onset of breathlessness and wheezing.

Summary of Product characteristics

Health Products Regulatory Authority
13 April 2021
CRN008SSP
Page 1 of 17
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
AirFluSal® Forspiro® 50 microgram/250 microgram/dose, inhalation
powder, predispensed
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each metered dose of AirFluSal
®
Forspiro
®
provides:
For 50 microgram/250 microgram/dose, inhalation powder, predispensed:
50 micrograms of salmeterol (as salmeterol xinafoate) and 250
micrograms of fluticasone propionate
Corresponding with a delivered dose of:
45 micrograms of Salmeterol (as salmeterol xinafoate) and 233
micrograms of fluticasone propionate
Excipient with known effect: lactose monohydrate: 12.20 mg per metered
dose
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Inhalation powder, pre-dispensed.
White, homogenous powder.
The pre-dispensed powder, contained in blister, is delivered by a
purple plastic dry-powder inhalation device.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
_ASTHMA_
AirFluSal
®
Forspiro
®
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.
_CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD)_
AirFluSal
®
Forspiro
®
is indicated for the symptomatic treatment of patients with COPD, with
a FEV
1
<60% predicted normal
(pre-bronchodilator) and a history of repeated exacerbations, who have
significant symptoms despite regular bronchodilator
therapy.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Method of administration:
AirFluSal
®
Forspiro
®
is for inhalation use only.
Patients should be made aware that AirFluSal
®
Forspiro
®
must be used daily for optimum benefit, even when asymptomatic.
Patients should be regularly reassessed by a doctor, so that the
strength of Air