Fostair Nexthaler 200 micrograms/6 micrograms per metered dose inhalation powder

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Beclometasone dipropionate anhydrous; Formoterol fumarate dihydrate

Available from:

Chiesi Limited

ATC code:

R03AK; R03AK08

INN (International Name):

Beclometasone dipropionate anhydrous; Formoterol fumarate dihydrate

Dosage:

200/6 Mcg/Acutuation

Pharmaceutical form:

Powder for Inhalation

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

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

Authorization status:

Not marketed

Authorization date:

2018-04-13

Patient Information leaflet

C
ONFIDENTIAL
CTD 1.3.1
1.3.1 PL 0873 (V 1.10) 20167-038
1
CHF 1535 NEXTHALER
® 200 ΜG /6 ΜG PER INHALATION INHALATION POWDER
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
{TRADE NAME} 200 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 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, nurse or pharmacist.
This includes any
possible side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What {Trade name} is and what it is used for
2.
What you need to know before you use {Trade name}
3.
How to use {Trade name}
4.
Possible side effects
5.
How to store {Trade name}
6.
Contents of the pack and other information
1.
WHAT {TRADE NAME} IS AND WHAT IT IS USED FOR
{Trade name} is a powder that is inhaled through your mouth and
delivered deeply into your
lungs. It contains two active substances: beclometasone dipropionate
anhydrous and
formoterol fumarate dihydrate.
-
Beclometasone dipropionate anhydrous belongs to a group of medicines
commonly
referred to as steroids (technically corticosteroids). Steroids both
treat and prevent
symptoms of asthma. They reduce the inflammation, swelling and
irritation in the small
air passages of the 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. They also help to
prevent asthma
symptoms, such as shortness of breath, wheezing and

Summary of Product characteristics

HealthProductsRegulatoryAuthority
27February2019
CRN008LR6
Page1of14
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
FostairNexthaler200micrograms/6microgramspermetereddoseinhalationpowder
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Eachmetereddoseof10mginhalationpowdercontains:
200microgramsofbeclometasonedipropionateanhydrousand6microgramsofformoterolfumaratedihydrate.
Thisisequivalenttoadelivereddose(thedoseleavingthemouthpiece)
of158.8microgramsofbeclometasonedipropionate
anhydrousand4.9microgramsofformoterolfumaratedihydrate.
Excipientwithknowneffect:
Eachmetereddosecontains9.8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
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inadults.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
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�