Fostair Nexthaler 100 micrograms/6 micrograms per metered dose inhalation powder

Страна: Ирландия

Язык: английский

Источник: HPRA (Health Products Regulatory Authority)

Активный ингредиент:

Beclometasone dipropionate anhydrous; Formoterol fumarate dihydrate

Доступна с:

Chiesi Farmaceutici S.p.A.

код АТС:

R03AK; R03AK08

ИНН (Международная Имя):

Beclometasone dipropionate anhydrous; Formoterol fumarate dihydrate

дозировка:

100/6 µg/µg

Фармацевтическая форма:

Inhalation powder

Терапевтические области:

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

Статус Авторизация:

Not marketed

Дата Авторизация:

2018-01-19

тонкая брошюра

C
ONFIDENTIAL
CTD 1.3.1
1.3.1 PL 0873 2021-04 120 INHALATIONS
1
CHF 1535 NEXTHALER
® 100 MICROGRAMS/6 MICROGRAMS PER INHALATION INHALATION POWDER
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
FOSTAIR NEXTHALER 100 MICROGRAMS/6 MICROGRAMS PER INHALATION
INHALATION POWDER
FOR USE IN ADULTS
beclometasone dipropionate anhydrous/formoterol fumarate dihydrate
_ _
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING 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, nurse or
pharmacist.
-
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 to your doctor, nurse or pharmacist.
This includes any
possible side effects not listed in this leaflet.
WHAT IS IN THIS LEAFLET
1.
What Fostair Nexthaler is and what it is used for
2.
What you need to know before you use Fostair Nexthaler
3.
How to use Fostair Nexthaler
4.
Possible side effects
5.
How to store Fostair Nexthaler
6.
Contents of the pack and other information
1.
WHAT FOSTAIR NEXTHALER IS AND WHAT IT IS USED FOR
Fostair Nexthaler is a powder that is inhaled through your mouth and
delivered deeply into
your lungs. It contains two active ingredients: beclometasone
dipropionate anhydrous and
formoterol fumarate dihydrate.
-
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
bronchodilators. These relax the muscles in your airways, widening the
airways so that it is
easier for you to breathe air in and out of your lungs.
These two active substances make breathing easier by providing relief
from symptoms such as
shortness of breath, wheezing and coughing in patients with asthma or
COPD and also help to
prevent asthma sym

Характеристики продукта

Health Products Regulatory Authority
25 March 2022
CRN00CS6Q
Page 1 of 16
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Fostair Nexthaler 100 micrograms/6 micrograms per metered dose
inhalation powder
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each metered dose of 10 mg inhalation powder contains:
100 micrograms of beclometasone dipropionate anhydrous and 6
micrograms of formoterol fumarate dihydrate.
This is equivalent to a delivered dose of 81.9 micrograms of
beclometasone dipropionate anhydrous and 5.0 micrograms of
formoterol fumarate dihydrate.
Excipients with known effect:
Each inhalation contains 9.9 mg lactose monohydrate.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Inhalation powder.
The multidose inhaler contains a white or almost white powder.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Asthma
Fostair Nexthaler 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 short-acting beta
2
-agonist or
-patients already adequately controlled on both inhaled
corticosteroids and long-acting beta
2
-agonists.
Fostair Nexthaler is indicated for adult patients.
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 Nexthaler is for inhalation use.
ASTHMA
Fostair Nexthaler is not intended for the initial management of
asthma. The dosage of Fostair Nexthaler 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, ap