Fostair Nexthaler 200 micrograms/12 micrograms per metered dose inhalation powder

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Beclometasone dipropionate; Formoterol fumarate dihydrate

Available from:

Chiesi Farmaceutici S.p.A.

ATC code:

R03AK08

INN (International Name):

Beclometasone dipropionate; Formoterol fumarate dihydrate

Dosage:

200 micrograms/ 12 microgram(s)

Pharmaceutical form:

Inhalation powder

Therapeutic area:

formoterol and beclometasone

Authorization status:

Not marketed

Authorization date:

2020-04-24

Patient Information leaflet

C
ONFIDENTIAL
CTD 1.3.1
1.3.1 PL 0873 (V1.1) 07-2020
1
CHF 1535 NEXTHALER
® 200 MICROGRAMS/12 MICROGRAMS PER INHALATION INHALATION POWDER
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
FOSTAIR NEXTHALER 200 MICROGRAMS/12 MICROGRAMS PER INHALATION
INHALATION POWDER
beclometasone dipropionate /formoterol fumarate dihydrate
_ _
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, 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, pharmacist or nurse.
This includes any
possible side effects not listed in this leaflet. See section 4.
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 substances: beclometasone
dipropionate 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 symptoms.
Asthma
Fostair Nexthaler

Summary of Product characteristics

Health Products Regulatory Authority
27 April 2020
CRN008VWX
Page 1 of 14
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Fostair Nexthaler 200 micrograms/12 micrograms per metered dose
inhalation powder
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each metered dose contains:
200 micrograms of beclometasone dipropionate and 12 micrograms of
formoterol fumarate dihydrate.
This is equivalent to a delivered dose (the dose leaving the
mouthpiece) of 173.9 micrograms of beclometasone dipropionate
and 10.4 micrograms of formoterol fumarate dihydrate.
Excipients with known effect:
Each metered dose contains 19.75 mg lactose.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Inhalation powder.
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 (FEV1 < 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
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, appropriate doses of
beta
2
-agonists and/or corticosteroids by individual
inhalers should b