Fostair 100 microgram/6 microgram per actuation pressurised inhalation solution

Страна: Ірландія

мова: англійська

Джерело: HPRA (Health Products Regulatory Authority)

Активний інгредієнт:

Beclometasone dipropionate; Formoterol fumarate dihydrate

Доступна з:

Chiesi Farmaceutici S.p.A.

Код атс:

R03AK08

ІПН (Міжнародна Ім'я):

Beclometasone dipropionate; Formoterol fumarate dihydrate

Дозування:

100 /6 µg/µg

Фармацевтична форма:

Pressurised inhalation, solution

Терапевтична области:

formoterol and beclometasone

Статус Авторизація:

Not marketed

Дата Авторизація:

2017-09-01

інформаційний буклет

1.3.1 PL 0871-0874 (V9.1) 2022-11
BDP+FORMOTEROL 100/6 MICROGRAMS PER ACTUATION PRESSURISED INHALATION
SOLUTION
1
PACKAGE LEAFLET:
INFORMATION FOR THE USER
FOSTAIR 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 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.
Content 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 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
Fostair is indicated in the regular treatment of asthma in adult
patients in w

Характеристики продукта

Health Products Regulatory Authority
07 November 2023
CRN00D904
Page 1 of 14
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Fostair 100 microgram/6 microgram 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
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.
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
Fostair is for inhalation use.
POSOLOGY
ASTHMA
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
p