Fostair NEXThaler 100/6

Country: United Kingdom

Language: English

Source: myHealthbox

Active ingredient:

dipropionate anhydrous, formoterol fumarate dihydrate.

Available from:

Chiesi GmbH

ATC code:

R03AK08

INN (International Name):

dipropionate anhydrous, formoterol fumarate dihydrate.

Dosage:

200 micrograms/6 micrograms for metered dose

Pharmaceutical form:

Inhalation powder.

Administration route:

Inhalation use

Units in package:

1, 2 or 3 Nexthaler inhalers which provide 120 inhalations each

Prescription type:

POM - Prescription Only Medicine

Manufactured by:

Chiesi Farmaceutici

Therapeutic group:

rugs for obstructive airway diseases; Adrenergics in combination with corticosteroids or other drugs, excl. anticholinergics.

Therapeutic indications:

Fostair NEXThaler is indicated in the regular treatment of asthma 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 short-acting beta2-agonist or - patients already adequately controlled on both inhaled corticosteroids and long-acting beta2-agonists. Fostair NEXThaler is indicated in adults. Note: there are no relevant clinical data on the use of Fostair NEXThaler for the treatment of acute asthma attacks.

Authorization status:

Authorised

Authorization date:

2015-12-03

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
100 MICROGRAMS/
6 MICROGRAMS PER ACTUATION 
INHALATION POWDER  

BECLOMETASONE DIPROPIONATE ANHYDROUS/ 
FORMOTEROL FUMARATE DIHYDRATE
FOR USE IN ADULTS
Pag. 1/2
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 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 by providing relief
from symptoms such as shortness of 
breath, wheezing and

Summary of Product characteristics

)RVWDLU1(;7KDOHU
6XPPDU\RI3URGXFW&KDUDFWHULVWLFV8SGDWHG'HF_&KLHVL/LPLWHG
1DPHRIWKHPHGLFLQDOSURGXFW
)RVWDLU1(;7KDOHUPLFURJUDPVPLFURJUDPVSHUDFWXDWLRQLQKDODWLRQSRZGHU
4XDOLWDWLYHDQGTXDQWLWDWLYHFRPSRVLWLRQ
(DFKPHWHUHGGRVHRIPJLQKDODWLRQSRZGHUFRQWDLQV
PLFURJUDPVRIEHFORPHWDVRQHGLSURSLRQDWHDQK\GURXVDQGPLFURJUDPVRIIRUPRWHUROIXPDUDWHGLK\GUDWH
7KLVLVHTXLYDOHQWWRDGHOLYHUHGGRVHRIPLFURJUDPVRIEHFORPHWDVRQHGLSURSLRQDWHDQK\GURXVDQG
PLFURJUDPVRIIRUPRWHUROIXPDUDWHGLK\GUDWH
([FLSLHQWZLWKNQRZQHIIHFW
(DFKPHWHUHGGRVHFRQWDLQVPJODFWRVHPRQRK\GUDWH
)RUWKHIXOOOLVWRIH[FLSLHQWVVHHVHFWLRQ
3KDUPDFHXWLFDOIRUP
,QKDODWLRQSRZGHU
7KHPXOWLGRVHLQKDOHUFRQWDLQVDZKLWHRUDOPRVWZKLWHSRZGHU
&OLQLFDOSDUWLFXODUV
7KHUDSHXWLFLQGLFDWLRQV
)RVWDLU1(;7KDOHULVLQGLFDWHGLQWKHUHJXODUWUHDWPHQWRIDVWKPDZKHUHXVHRIDFRPELQDWLRQSURGXFWLQKDOHG
FRUWLFRVWHURLGDQGORQJDFWLQJEHWD

DJRQLVWLVDSSURSULDWH
SDWLHQWVQRWDGHTXDWHO\FRQWUROOHGZLWKLQKDOHGFRUWLFRVWHURLGVDQG
DVQHHGHG LQKDOHGVKRUWDFWLQJEHWD

DJRQLVWRU
SDWLHQWVDOUHDG\DGHTXDWHO\FRQWUROOHGRQERWKLQKDOHGFRUWLFRVWHURLGVDQGORQJDFWLQJEHWD

DJRQLVWV
)RVWDLU1(;7KDOHULVLQGLFDWHGLQDGXOWV
1RWHWKHUHDUHQRUHOHYDQWFOLQLFDOGDWDRQWKHXVHRI)RVWDLU1(;7KDOHUIRUWKHWUHDWPHQWRIDFXWHDVWKPDDWWDFNV
3RVRORJ\DQGPHWKRGRIDGPLQLVWUDWLRQ
3RVRORJ\
7KHGRVDJHRI)RVWDLU1(;7KDOHULVLQGLYLGXDODQGVKRXOGEHDGMXVWHGWRWKHVHYHULW\RIWKHGLVHDVH7KLVVKRXOGEH
FRQVLGHUHGQRWRQO\ZKHQWUHDWPHQWZLWKFRPELQDWLRQSURGXFWVLVLQLWLDWHGEXWDOVRZKHQWKHGRVHLVDGMXVWHG,IDQ
LQGLYLGXDOSDWLHQWVKRXOGUHTXLUHDFRPELQDWLRQRIGRVHVRWKHUWKDQWKRVHDYDLODEOHLQWKHFRPELQDWLRQLQKDOHU
DSSURSULDWHGRVHVRIEHWD

DJRQLVWVDQGRUFRUWLFRVWHURLGVE\LQGLYLGXDOLQKDOHUVVKRXOGEHSUHVFULEHG
%HFDXVHRILWVH[WUDILQHSDUWLFOHVL]HGLVWULEXWLRQGRVHDGMXVWPHQWLVUHTXLUHGZKHQSDWLHQWVDUHWUDQVIHUUHGWR)RVWDLU
1(;7KDO