Fostair 200 microgram/6 microgram per actuation pressurised inhalation solution

Šalis: Airija

kalba: anglų

Šaltinis: HPRA (Health Products Regulatory Authority)

Veiklioji medžiaga:

Beclometasone dipropionate anhydrous; Formoterol fumarate dihydrate

Prieinama:

Chiesi Limited

ATC kodas:

R03AK; R03AK08

INN (Tarptautinis Pavadinimas):

Beclometasone dipropionate anhydrous; Formoterol fumarate dihydrate

Dozė:

200/6 Mcg/Acutuation

Vaisto forma:

Pressurised inhalation, solution

Recepto tipas:

Product subject to prescription which may be renewed (B)

Gydymo sritis:

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

Autorizacija statusas:

Not marketed

Leidimo data:

2018-04-13

Pakuotės lapelis

C
ONFIDENTIAL
Chiesi Farmaceutici S.p.A. Parma-Italy
1.3.1 PL 0871-0874 (V 5.0) 2017-06
BDP+FORMOTEROL 200/6 MICROGRAMS PER ACTUATION PRESSURISED INHALATION
SOLUTION
1
PACKAGE LEAFLET:
INFORMATION FOR THE USER
{TRADE NAME} 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 section 4.
WHAT IS IN THIS LEAFLET:
1.
What {Trade name} is and what it is used for
2.
What you need to know before you use {Trade name}
3.
How to use {Trade name}
4.
Possible side effects
5.
How to store {Trade name}
6.
Contents of the pack and other information
1.
WHAT {TRADE NAME} IS AND WHAT IT IS USED FOR
{Trade name} is a pressurised inhalation solution containing two
active substances which are
inhaled 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.
{TRADE NAME} IS USED TO TREAT ASTHMA IN ADULTS._ _
If you are prescribed {Trade name} it is likely that either:_ _

your a

Prekės savybės

Health Products Regulatory Authority
29 January 2019
CRN008LSK
Page 1 of 19
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.
Health Products Regulatory Authority
29 January 2019
CRN008LSK
Page 2 of 19
Beclometasone dipropionate in Fostair is characterised by an extrafine
particle size
distribution which re