Fostair 200micrograms/dose / 6micrograms/dose inhaler

Land: Storbritannien

Språk: engelska

Källa: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktiva substanser:

Beclometasone dipropionate; Formoterol fumarate dihydrate

Tillgänglig från:

Chiesi Ltd

ATC-kod:

R03AK08

INN (International namn):

Beclometasone dipropionate; Formoterol fumarate dihydrate

Dos:

200microgram ; 6microgram

Läkemedelsform:

Pressurised inhalation

Administreringssätt:

Inhalation

Klass:

No Controlled Drug Status

Receptbelagda typ:

Valid as a prescribable product

Produktsammanfattning:

BNF: 03020000; GTIN: 5028613002971

Bipacksedel

_200/6 MICROGRAMS PER ACTUATION PRESSURISED INHALATION SOLUTION_
_BECLOMETASONE DIPROPIONATE/ FORMOTEROL FUMARATE DIHYDRATE_
For use in adults
Package Leaflet: Information for the user
00352/RE
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, 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 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.
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
corticosteroids and “as needed” short-acting
bronchodilators or
• your asthma responds well to both corticosteroids and long-acting
bronchodilators
2. WHAT YOU NEE

Produktens egenskaper

OBJECT 1
FOSTAIR 200/6 INHALATION SOLUTION
Summary of Product Characteristics Updated 13-Jun-2017 | Chiesi
Limited
1. Name of the medicinal product
Fostair 200/6 micrograms 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 a 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
dipropi