Fostair 200 microgram/6 microgram per actuation pressurised inhalation solution

Land: Irland

Språk: engelska

Källa: HPRA (Health Products Regulatory Authority)

Aktiva substanser:

Beclometasone dipropionate anhydrous; Formoterol fumarate dihydrate

Tillgänglig från:

Chiesi Farmaceutici S.p.A.

ATC-kod:

R03AK; R03AK08

INN (International namn):

Beclometasone dipropionate anhydrous; Formoterol fumarate dihydrate

Dos:

200/6 µg/µg

Läkemedelsform:

Pressurised inhalation, solution

Terapiområde:

Adrenergics in combination with corticosteroids or other drugs, excl. anticholinergics; formoterol and beclometasone

Bemyndigande status:

Not marketed

Tillstånd datum:

2018-04-13

Bipacksedel

C
ONFIDENTIAL
Chiesi Farmaceutici S.p.A. Parma-Italy
1.3.1 PL 0871-0874
BDP+FORMOTEROL 200/6 MICROGRAMS PER ACTUATION PRESSURISED INHALATION
SOLUTION
1
PACKAGE LEAFLET:
INFORMATION FOR THE USER
FOSTAIR 200/6 MICROGRAMS PER ACTUATION PRESSURISED INHALATION SOLUTION
For use in adults
Beclometasone dipropionate/ formoterol fumarate dihydrate
_ _
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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, 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, pharmacist or
nurse. This includes any
possible side effects not listed in this leaflet. See section4.
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.
Contents 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, which belongs to a group of medicines
called corticosteroids
that have an anti-inflammatory action reducing the swelling and
irritation in your lungs.
Formoterol fumarate dihydrate, which belongs to a group of medicines
called long-acting
bronchodilators that relax the muscles in your airways and helps you
to breathe more easily.
These two active substances make breathing easier. They also help to
prevent asthma
symptoms such as shortness of breath, wheezing and coughing.
FOSTAIR IS USED TO TREAT ASTHMA IN ADULTS._ _
If you are prescribed Fostair it is likely that either:_ _

your asthma is not adequately controlled by using inhaled
corticos

Produktens egenskaper

Health Products Regulatory Authority
09 April 2021
CRN00C8YZ
Page 1 of 12
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Fostair 200 microgram/6 microgram per actuation pressurised inhalation
solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each metered dose (ex-valve) contains:
200 micrograms of beclometasone dipropionate and 6 micrograms of
formoterol fumarate dihydrate. This is equivalent to a
delivered dose (ex-actuator) of 177.7 micrograms of beclometasone
dipropionate and 5.1 micrograms of formoterol fumarate
dihydrate.
For the full list of excipients see section 6.1.
3 PHARMACEUTICAL FORM
Pressurised inhalation solution.
The canister contains a colourless to yellowish solution.
The canisters are fitted into a plastic actuator incorporating a
mouthpiece and fitted with dust cap.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
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.
Fostair is indicated in adults.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
FOSTAIR 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 formulations of beclometasone dipropionate