Fostair 100 microgram/6 microgram per actuation pressurised inhalation solution

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Beclometasone dipropionate anhydrous; Formoterol fumarate dihydrate

Available from:

Chiesi Limited

INN (International Name):

Beclometasone dipropionate anhydrous; Formoterol fumarate dihydrate

Dosage:

100/6 microgram(s)

Pharmaceutical form:

Pressurised inhalation, solution

Prescription type:

Product subject to prescription which may be renewed (B)

Authorization status:

Not marketed

Authorization date:

2017-09-01

Patient Information leaflet

1
PACKAGE LEAFLET:
INFORMATION FOR THE USER
FOSTAIR 100/6 MICROGRAMS PER ACTUATION PRESSURISED INHALATION SOLUTION
beclometasone dipropionate/ formoterol fumarate dihydrate
For use in adults.
_ _
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CON-
TAINS 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 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 with your doctor, or pharmacist or
nurse. This includes any possi-
ble side effects not listed in this leaflet.
WHAT IS IN THIS LEAFLET:
1.
What Fostair is and what it is used for.
2.
What you need to know before you use Fostair
3.
How to use Fostair
4.
Possible side effects
5.
How to store Fostair
6.
Content of the pack and other information
1.
WHAT FOSTAIR IS AND WHAT IT IS USED FOR
Fostair is a pressurised inhalation solution containing two active
substances which are in-
haled through your mouth and delivered directly into your lungs.
The two active substances are beclometasone dipropionate and
formoterol fumarate dihy-
drate. Beclometasone dipropionate belongs to a group of medicines
called corticosteroids
which have an anti-inflammatory action reducing the swelling and
irritation in your lungs.
Formoterol fumarate dihydrate belongs to a group of medicines called
long-acting bronchodi-
lators which relax the muscles in your airways and helps you to
breathe more easily..
Together these two active substances make breathing easier, by
providing relief from symp-
toms such as shortness of breath, wheezing and cough in patients with
asthma or COPD
and also help to prevent the symptoms of asthma.
Asthma
Fostair is indicated in the regular treatment of asthma in adult
patients in whom:_ _

asthma is not adequately controlled by using inhaled corticosteroids
and “as needed” short-
ac

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Fostair 100 microgram/6 microgram per actuation pressurised inhalation
solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each metered dose (ex-valve) contains:
100 micrograms of beclometasone dipropionate and 6 micrograms of
formoterol fumarate dihydrate. This is equivalent
to a delivered dose (ex-actuator) of 84.6 micrograms of beclometasone
dipropionate and 5.0 micrograms of formoterol
fumarate dihydrate.
For the full list of excipients see section 6.1.
3 PHARMACEUTICAL FORM
Pressurised inhalation, solution.
Colourless to yellowish solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Asthma
Fostair is indicated in the regular treatment of asthma where use of a
combination product (inhaled corticosteroid and
long-acting beta
2
-agonist) is appropriate:
- patients not adequately controlled with inhaled corticosteroids and
'as needed'
inhaled rapid-acting beta
2
-agonist or
- patients already adequately controlled on both inhaled
corticosteroids and long-acting beta
2
-agonists.
COPD
Symptomatic treatment of patients with severe COPD (FEV
1
< 50% predicted normal) and a history of repeated
exacerbations, who have significant symptoms despite regular therapy
with long-acting bronchodilators.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
FOSTAIR is for inhalation use.
POSOLOGY
A
STHMA
F
OSTAIR
is not intended for the initial management of asthma. The dosage of
the components of Fostair is individual
and should be adjusted to the severity of
the disease.
This should be considered not
only when treatment
with
combination products
is
initiated but
also when the dose is
adjusted.
If
an individual
patient
should require a
combination of doses other than those available in the combination
inhaler, appropriate doses of beta
2
-agonists and/or
corticosteroids by individual inhalers should be prescribed.
Beclometasone dipropionate in Fostair is characterised by an extrafine
particle size distribution which results in a more
potent
effect
than formulatio