FOSTER 2006

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

BECLOMETASONE DIPROPIONATE ANHYDROUS; FORMOTEROL FUMARATE DIHYDRATE

Available from:

KAMADA LTD, ISRAEL

ATC code:

R03AK08

Pharmaceutical form:

PRESSURISED SOLUTION

Composition:

FORMOTEROL FUMARATE DIHYDRATE 6 MCG/ACTUATION; BECLOMETASONE DIPROPIONATE ANHYDROUS 200 MCG/ACTUATION

Administration route:

INHALATION

Prescription type:

Required

Manufactured by:

CHIESI FARMACEUTICI S.P.A, ITALY

Therapeutic area:

FORMOTEROL AND BECLOMETASONE

Therapeutic indications:

Foster 200/6 is indicated in the regular treatment of asthma in adults where use of a combination product (inhaled corticosteroid and long-acting beta2-agonist) is appropriate:- patients not adequately controlled with inhaled corticosteroids and 'as needed' inhaled rapid-acting beta2-agonist or- patients already adequately controlled on both inhaled corticosteroids and long-acting beta2-agonists.

Authorization date:

2020-05-27

Patient Information leaflet

PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE
PHARMACISTS’ REGULATIONS )PREPARATIONS( – 1986
The medicine is dispensed with a doctor’s prescription only
Foster
®
200/6
Pressurised solution for inhalation
The active ingredients and their quantities:
Each actuation releases:
Beclometasone dipropionate 200 mcg and Formoterol
fumarate dihydrate 6 mcg.
• Inactive ingredients: see section 6 in the leaflet.
Read this leaflet carefully in its entirety before using the
medicine. This leaflet contains concise information about the
medicine. If you have further questions, refer to the doctor or
pharmacist.
This medicine has been prescribed to treat your ailment. Do
not pass it on to others. It may harm them even if it seems to
you that their ailment is similar.
The medicine is not intended for use in children and
adolescents below the age of 18.
1. WHAT IS THE MEDICINE INTENDED FOR?
Foster 200/6 is intended to treat asthma in adults, 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 short-acting beta-2-agonist, or
• Patients already adequately controlled by combined treatment
with inhaled corticosteroids and long acting beta-2 agonist.
Therapeutic group:
Foster 200/6 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 in Foster 200/6 are Beclometasone
dipropionate and Formoterol fumarate dihydrate.
Beclometasone dipropionate belongs to a group called
corticosteroids (also referred to as steroids), which have an
anti-inflammatory action, and reduce swelling and irritation
in the lungs.
Formoterol fumarate dihydrate belongs to a group called beta
agonists, which are long-acting bronchodilators that relax the
muscles in airways and by doing this, making it easier to breathe.
These two active substances make breathing easier. They
also help to prev

Summary of Product characteristics

FOSTER
®
200/6
1.
NAME OF THE MEDICINAL PRODUCT
Foster 200/6
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 solution for inhalation.
The canisters are fitted into a plastic actuator incorporating a
mouthpiece and fitted with a dust cap.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Foster 200/6 is indicated in the regular treatment of asthma in adults
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.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
Foster
200/6 is not intended for the initial management of asthma. The dosage
of the components of
Foster 200/6 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 Foster 200/6 is characterised by an
extrafine particle size distribution
which results in a more potent effect than formulations of
beclometasone dipropionate with a non-
extrafine particle size distribution (100 micrograms of beclometasone
dipropionate extrafine in Foster
are equivalent to 250 micrograms of beclometasone dipropionate in a
non-extrafine formulatio