Flixotide 50micrograms/dose Evohaler

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Fluticasone propionate

Available from:

GlaxoSmithKline UK Ltd

ATC code:

R03BA05

INN (International Name):

Fluticasone propionate

Dosage:

50microgram/1dose

Pharmaceutical form:

Pressurised inhalation

Administration route:

Inhalation

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 03020000; GTIN: 5000124441050

Patient Information leaflet

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PACKAGE LEAFLET: INFORMATION FOR THE USER
FLIXOTIDE 50 MICROGRAMS EVOHALER
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, nurse or pharmacist.
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
Fluticasone propionate belongs to a group of medicines called
corticosteroids (often
just called steroids). A very small dose of steroid is needed when it
is inhaled. This is
because it is inhaled straight to your lungs.
Flixotide works by reducing swelling and irritation in the lungs. It
has what is called an
‘anti-inflammatory action’.
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.
2
WHAT YOU NEED TO KNOW BEFORE YOU USE FLIXOTIDE
DO NOT USE:
•
if you are allergic to fluticasone propionate or the other ingredients
of this
medicine (listed in section 6)
WARNINGS AND PRECAUTIONS
Talk to your doctor, nurse or pharmacist before taking Flixotide if:
•
you have ever been treated for tuberculosis (TB)
•
you are usin

Summary of Product characteristics

OBJECT 1
FLIXOTIDE 50 MICROGRAMS EVOHALER
Summary of Product Characteristics Updated 19-Jan-2018 |
GlaxoSmithKline UK
1. Name of the medicinal product
Flixotide 50 micrograms Evohaler
Flixotide 125 micrograms Evohaler
Flixotide 250 micrograms Evohaler
2. Qualitative and quantitative composition
Flixotide 50 micrograms Evohaler, Flixotide 125 micrograms Evohaler
and Flixotide 250 micrograms
Evohaler are pressurised inhalation, suspensions, delivering either
50, 125 or 250 micrograms of
fluticasone propionate per actuation, respectively.
3. Pharmaceutical form
Pressurised inhalation, suspension
Flixotide Evohaler does not contain any chlorofluorocarbons (CFCs).
4. Clinical particulars
4.1 Therapeutic indications
Fluticasone propionate given by inhalation offers prophylactic
treatment for asthma.
_Adults: _
Mild asthma: Patients requiring intermittent symptomatic
bronchodilator asthma medication on a regular
daily basis.
Moderate asthma: Patients with unstable or worsening asthma despite
prophylactic therapy or
bronchodilator alone.
Severe asthma: Patients with severe chronic asthma and those who are
dependent on systemic
corticosteroids for adequate control of symptoms. On introduction of
inhaled fluticasone propionate many
of these patients may be able to reduce significantly, or to
eliminate, their requirement for oral
corticosteroids.
_Children:_
Any child who requires prophylactic medication, including patients not
controlled on currently available
prophylactic medication.
4.2 Posology and method of administration
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.
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.
Flixtide Evohaler is for oral inhalation use only. Flixotide Evohaler
may be used with a Volumatic spacer
device by patients who find it difficult to synchronis