Flixotide Evohaler 50 micrograms per metered dose, Pressurised Inhalation Suspension

Riik: Iirimaa

keel: inglise

Allikas: HPRA (Health Products Regulatory Authority)

Toimeaine:

Fluticasone propionate

Saadav alates:

GlaxoSmithKline (Ireland) Limited

ATC kood:

R03BA; R03BA05

INN (Rahvusvaheline Nimetus):

Fluticasone propionate

Annus:

50 microgram(s)

Ravimvorm:

Pressurised inhalation, suspension

Retsepti tüüp:

Product subject to prescription which may be renewed (B)

Terapeutiline ala:

Glucocorticoids; fluticasone

Volitamisolek:

Marketed

Loa andmise kuupäev:

2000-12-20

Infovoldik

Reason for Update: Type II GDS v36 update – storage conditions and
other minor amendments
Market: IE
Agency Approval Date:
Text Date: 04 May 2021
Text Issue and Draft No.: Issue 8 draft 1
GSK LOGO
PACKAGE LEAFLET: INFORMATION FOR THE USER
FLIXOTIDE Evohaler
50 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. 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 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 other information
1
WHAT FLIXOTIDE IS AND WHAT IT IS USED FOR
Flixotide contains fluticasone propionate which belongs to a group of
medicines
called corticosteroids (a group of synthetic hormones, 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 wit

Toote omadused

Health Products Regulatory Authority
20 August 2021
CRN00CFTX
Page 1 of 10
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Flixotide Evohaler 50 micrograms per metered dose, Pressurised
Inhalation Suspension
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each metered dose contains 50 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 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.
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 unti