Fostair NEXThaler 100micrograms/dose / 6micrograms/dose dry powder inhaler

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Beclometasone dipropionate; Formoterol fumarate dihydrate

Available from:

Chiesi Ltd

ATC code:

R03AK08

INN (International Name):

Beclometasone dipropionate; Formoterol fumarate dihydrate

Dosage:

100microgram/1dose ; 6microgram/1dose

Pharmaceutical form:

Inhalation powder

Administration route:

Inhalation

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 03020000; GTIN: 5028613002926

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
100 MICROGRAMS/
6 MICROGRAMS PER ACTUATION
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 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 coughing in patients with asthma or COPD and also
help to prevent asthma symptoms.
ASTHMA:
Fostair NEXThaler is used to treat asthma i

Summary of Product characteristics

OBJECT 1
FOSTAIR NEXTHALER 100/6
Summary of Product Characteristics Updated 04-Sep-2017 | Chiesi
Limited
1. Name of the medicinal product
Fostair NEXThaler 100 micrograms/6 micrograms per actuation 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.
Note: there are no relevant clinical data on the use of Fostair
NEXThaler for the treatment of acute
asthma attacks.
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
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 t