Flixotide Evohaler 125 micrograms per metered dose pressurised inhalation, suspension

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

FLUTICASONE PROPIONATE

Available from:

PCO Manufacturing Ltd.

ATC code:

R03BA; R03BA05

INN (International Name):

FLUTICASONE PROPIONATE

Dosage:

125 microgram(s)

Pharmaceutical form:

Pressurised inhalation, suspension

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Glucocorticoids; fluticasone

Authorization status:

Authorised

Authorization date:

2001-07-07

Patient Information leaflet

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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 E

Summary of Product characteristics

Health Products Regulatory Authority
13 January 2022
CRN00CPZ2
Page 1 of 2
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Flixotide Evohaler 125 micrograms per metered dose pressurised
inhalation suspension
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each metered dose contains 125 micrograms of fluticasone propionate.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Pressurised inhalation, suspension (Pressurised Inhalation).
_Product imported from Greece, Norway and the Netherlands:_
Pressurised inhalation suspension supplied in an aluminium can with
metering valve and actuator.
4 CLINICAL PARTICULARS
As per PA1077/044/014
5 PHARMACOLOGICAL PROPERTIES
As per PA1077/044/014
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Norflurane (Hydrofluroalkane (HFA 134a))
6.2 INCOMPATIBILITIES
Not applicable.
6.3 SHELF LIFE
The shelf-life expiry date of this product shall be the date shown on
the container and outer package of the product on the
market in the country of origin.
6.4 SPECIAL PRECAUTIONS FOR STORAGE
Do not store above 30°C.
Do not refrigerate or freeze.
Store in the original package.
Protect from frost and direct sunlight.
The canister contains a pressurised liquid. Do not expose to
temperatures higher than 50°C. Do not pierce, burn or break the
canister, even when apparently empty.
Replace the mouthpiece cover firmly and snap it into position.
Health Products Regulatory Authority
13 January 2022
CRN00CPZ2
Page 2 of 2
As with most inhaled medications in pressurised canisters, the
therapeutic effect of this medication may decrease when the
canister is cold.
6.5 NATURE AND CONTENTS OF CONTAINER
The suspension is contained in an aluminium pressurised can with a
metering valve. The can is fitted into a plastic actuator
incorporating an atomising orifice and fitted with a dustcap. Pack
size: 120 metered doses per inhaler.
6.6 SPECIAL PRECAUTIONS FOR DISPOSAL AND OTHER HANDLING
Patients should be carefully instructed in the correct use of the
inhaler.
Shake before use.