Foster 100/6 micrograms per actuation pressurised inhalation solution.

Country: Malta

Lingwa: Ingliż

Sors: Medicines Authority

Ingredjent attiv:

BECLOMETASONE DIPROPIONATE, FORMOTEROL FUMARATE, DIHYDRATE

Disponibbli minn:

Chiesi Farmaceutici S.p.A Via Palermo 26/A, 43122 Parma, Italy

Kodiċi ATC:

R03AK08

INN (Isem Internazzjonali):

BECLOMETASONE DIPROPIONATE 100 µg FORMOTEROL FUMARATE DIHYDRATE 6 µg

Għamla farmaċewtika:

PRESSURISED INHALATION, SOLUTION

Kompożizzjoni:

BECLOMETASONE DIPROPIONATE 100 µg FORMOTEROL FUMARATE DIHYDRATE 6 µg

Tip ta 'preskrizzjoni:

POM

Żona terapewtika:

DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES

Sommarju tal-prodott:

Licence number in the source country: NOT APPLICAPABLE

L-istatus ta 'awtorizzazzjoni:

Authorised

Data ta 'l-awtorizzazzjoni:

2021-03-22

Fuljett ta 'informazzjoni

C
ONFIDENTIAL
Chiesi Farmaceutici S.p.A. Parma-Italy
1.3.1 PL 0871-0874 (V9.1) 2023-10
BDP+FORMOTEROL 100/6 MICROGRAMS PER ACTUATION PRESSURISED INHALATION
SOLUTION
1
PACKAGE LEAFLET:
INFORMATION FOR THE USER
FOSTER 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 include any possi-
ble side effects not listed in this leaflet.
WHAT IS IN THIS LEAFLET:
1.
What Foster is and what it is used for.
2.
What you need to know before you use {Trade name}
3.
How to use Foster
4.
Possible side effects
5.
How to store Foster
6.
Content of the pack and other information
1.
WHAT FOSTER IS AND WHAT IT IS USED FOR
Foster 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
Foster is indicated in the

Karatteristiċi tal-prodott

C
ONFIDENTIAL
CTD-1.3.1 Foster
1.3.1 SMPC (V.10.1) 2023-10
BDP+ FORMOTEROL 100 + 6
µ
G PRESSURISED INHALATION SOLUTION
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Foster 100/6 micrograms 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
Foster 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
Foster is for inhalation use.
C
ONFIDENTIAL
CTD-1.3.1 Foster
1.3.1 SMPC (V.10.1) 2023-10
BDP+ FORMOTEROL 100 + 6
µ
G PRESSURISED INHALATION SOLUTION
POSOLOGY
A
STHMA
Foster is not intended for the initial management of asthma. The
dosage of the components of Foster 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