Flixotide Evohaler 250 micrograms per metered dose, Pressurised Inhalation Suspension.

国: マルタ

言語: 英語

ソース: Malta Medicines Authority

有効成分:

FLUTICASONE PROPIONATE

から入手可能:

Glaxo SmithKline Ireland Limited 12, Riverwalk, Citywest Business Campus, Dublin 24, Ireland

ATCコード:

R03BA05

INN（国際名）:

FLUTICASONE PROPIONATE 250 µg

医薬品形態:

PRESSURISED INHALATION, SUSPENSION

構図:

FLUTICASONE PROPIONATE 250 µg

処方タイプ:

POM

治療領域:

DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES

認証ステータス:

Authorised

承認日:

2006-09-22

情報リーフレット

GSK LOGO
PACKAGE LEAFLET: INFORMATION FOR THE USER
FLIXOTIDE EVOHALER 125 MICROGRAMS PER METERED DOSE
PRESSURISED INHALATION SUSPENSION
FLIXOTIDE EVOHALER 250 MICROGRAMS PER METERED DOSE
PRESSURISED INHALATION SUSPENSION fluticasone
propionate
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, pharmacist or nurse.
This includes
any possible side-effects not listed in the leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1 What Flixotide is and what it is used for
2 What you need to know before you use Flixotide
3 How to use Flixotide
4 Possible side effects
5 How to store Flixotide
6 Contents of the pack and further information
1
WHAT FLIXOTIDE IS AND WHAT IT IS USED FOR
Flixotide contains fluticasone propionate which belongs to a group of
medicines
called corticosteroids (often just called steroids). Flixotide works
by reducing swelling
and irritation in the lungs. It has an anti-inflammatory action. Only
a very small dose
is needed as it is inhaled straight to the lungs.
Flixotide helps to prevent asthma attacks in people who need regular
treatment. This
is why it is sometimes called a 'preventer'. It needs to be used
regularly, every day.
Flixotide will not help treat sudden asthma attacks where you feel
breathless.
•
A different medicine is used for treating sudden attacks (called a
‘reliever’).
•
If you have more than one medicine, be careful not to confuse them.
Flixotide also reduces symptoms in chronic obstructive pulmonary
disease (COPD)
when used in combination with other medicines called long acting
bronchodilators.
Only the 250 mcg strength Flixotide Evohaler is suitable for the
treatment of

製品の特徴

Page 1 of 12
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Flixotide Evohaler 250 micrograms per metered dose, Pressurised
Inhalation Suspension.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each metered dose contains 250 micrograms of fluticasone propionate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Pressurised inhalation, suspension (pressurised inhalation).
Pressurised inhalation suspension supplied in an aluminium can with
metering valve and a red (60
dose) or pink (120 dose) actuator.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Flixotide Evohaler is indicated for the treatment and prevention of
asthma and COPD.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Flixotide Evohaler is for inhalation by oral inhalation only.
Patients should be made aware of the prophylactic nature of therapy
with inhaled fluticasone
propionate and that it should be taken regularly even when they are
asymptomatic. The onset of
therapeutic effect is 4 to 7 days, although some benefit may be
apparent as soon as 24 hours for
patients who have not previously received inhaled steroids.
The dosage of fluticasone propionate should be adjusted according to
the individual response.
If patients find that relief with short-acting bronchodilator
treatment becomes less effective or they
need more inhalations than usual, medical attention must be sought.
It is intended that each prescribed dose is given by a minimum of 2
inhalations.
In patients who find co-ordination of a pressurised metered-dose
inhaler difficult a spacer may be
used with Flixotide Evohaler or inhaler
Page 2 of 12
ASTHMA:-
_Adults and adolescents over 16 years of age:- _
−
100 to 1000 micrograms twice daily.
Patients should be given a starting dose of inhaled fluticasone
propionate which is appropriate for the
severity of their disease:-
Mild asthma:
up to 250 micrograms twice daily.
Moderate asthma:
250 to 500 micrograms twice daily.
Severe asthma:
500 to 1000 micrograms twice daily.
The dose may then be adjusted until c