AirFluSal® Forspiro® 50 microgram/500 microgram/dose, inhalation powder, predispensed

Страна: Ірландія

мова: англійська

Джерело: HPRA (Health Products Regulatory Authority)

Активний інгредієнт:

Salmeterol; Fluticasone propionate

Доступна з:

Rowex Ltd

Код атс:

R03AK; R03AK06

ІПН (Міжнародна Ім'я):

Salmeterol; Fluticasone propionate

Дозування:

50 microg/500 microgram(s)/dose

Фармацевтична форма:

Inhalation powder, pre-dispensed

Тип рецепту:

Product subject to prescription which may be renewed (B)

Терапевтична области:

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

Статус Авторизація:

Marketed

Дата Авторизація:

2014-11-14

інформаційний буклет

PACKAGE LEAFLET: INFORMATION FOR THE USER
AIRFLUSAL
® FORSPIRO
® 50 MICROGRAM/500 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

chronic obstructive pulmonary disease (COPD)
This disease is characterized by continuous breathing difficulties
caused by narrowed
airways, often accompanied with coughing and phlegm. This medicine
reduces the
number of flare ups of COPD symptoms.
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


Характеристики продукта

Health Products Regulatory Authority
13 April 2021
CRN008SSP
Page 1 of 16
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
AirFluSal® Forspiro® 50 microgram/500 microgram/dose, inhalation
powder, predispensed
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each metered dose of AirFluSal
®
Forspiro
®
provides:
For 50 microgram/500 microgram/dose, inhalation powder, predispensed:
50 micrograms of salmeterol (as salmeterol xinafoate) and 500
micrograms of fluticasone propionate
Corresponding with a delivered dose of:
45 micrograms of Salmeterol (as salmeterol xinafoate) and 465
micrograms of fluticasone propionate
Excipient with known effect: lactose monohydrate: 11.95 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 Ai