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FLUTICASONE PROPIONATE250 MCG CFC -FREE INHALER

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PACKAGE LEAFLET: INFORMATION FOR THE USER
FLIXOTIDE® 250 micrograms EVOHALER®
FLUTICASONE PROPIONATE 250 micrograms CFC-free
INHALER
(fluticasone propionate)
This product is available in the above name and strength but will
be referred to as Flixotide throughout the remainder of this leaflet.
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.

 If you are over 16 years of age and are on higher doses
(above 1,000 micrograms daily) you should take your
medicine via the Volumatic® large-volume spacer device to
help reduce side-effects in the mouth and throat. Your doctor,
nurse or pharmacist will be able to advise you about this.
 Some people find it difficult to release a puff of medicine just
after they start to breathe in. The Volumatic spacer device
helps to overcome this problem. Your doctor, nurse or
pharmacist will be able to advise you about this.
 It takes a few days for this medicine to work and it is very
important that you use it regularly.
Adults and Children over 16 years of age
Mild asthma
 The usual starting dose is 100 micrograms twice a day.
Moderate to severe asthma
 The usual starting dose is 250 to 500 micrograms twice a day.
 The most taken should be 1000 micrograms twice a day.
Flixotide Evohaler 125 and 250 micrograms are not
recommended for children below 16 years of age.
It is recommended that children being treated with steroids,
including Flixotide Evohaler have their height checked regularly
by their doctor.
Your doctor may give you a Flixotide 250 microgram Evohaler if
your dose is increased.
If you are using high doses of an inhaled steroid for a long
time you may sometimes need extra steroids for example
during stressful circumstances such as a road traffic
accident or before an operation. Your doctor may decide to
give you extra steroid medicines during this time.
Patients who have been on high doses of steroids, including
Flixotide Evohaler for a long time, must not stop taking their
medicine suddenly without talking to their doctor. Suddenly
stopping treatment can make you feel unwell and may cause
symptoms such as vomiting, drowsiness, nausea, headache,
tiredness, loss of appetite, low blood sugar level and fitting.

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.

Instructions for use
Your doctor, nurse or pharmacist should show you how to use
your inhaler. They should check how you use it from time to time.
Not using the Flixotide Evohaler properly or as prescribed, may
mean that the medicine will not help your asthma as it should.
The medicine is contained in a pressurised canister in a plastic
casing with a mouthpiece.

2. What you need to know before you use Flixotide

Testing your inhaler

Do not use:
 if you are allergic to fluticasone propionate or any of the other
ingredients of this medicine (listed in section 6).

1

When using the inhaler for the first time, test that it is working.
Remove the mouthpiece cover by
gently squeezing the sides with
your thumb and forefinger and pull
apart.

2

To make sure that it works, shake
it well, point the mouthpiece away from you and press the
canister to release a puff into the air. If you have not used the
inhaler for a week or more, release two puffs of medicine into
the air.

Warnings and precautions
Talk to your doctor, nurse or pharmacist before taking if:
 you have ever been treated for tuberculosis (TB).
 you are using Flixotide at the same time as taking steroid
tablets. Also if you have just finished taking steroid tablets. In
both cases, you should carry a steroid warning card until your
doctor tells you not to carry one.
If you are not sure if any of the above applies to you, talk to your
doctor, nurse or pharmacist before using Flixotide.
Other medicines and Flixotide
Tell your doctor, nurse or pharmacist if you are taking, have
recently taken or might take any other medicines, including
medicines obtained without a prescription. This includes herbal
medicines. Remember to take this medicine with you if you have
to go into hospital.
In particular tell your doctor or pharmacist if you are taking any of
the following:
 a type of antiviral medicine known as a ‘protease
inhibitor’ (such as ritonavir)
 medicines used to treat fungal infections (such as
ketoconazole).
If you are not sure if any of the above applies to you, talk to your
doctor or pharmacist before using Flixotide
Using Flixotide with food and drink
You can use Flixotide at any time of day, with or without food.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant
or are planning to have a baby, ask your doctor for advice before
taking this medicine.
Driving and using machines
Flixotide is not likely to affect you being able to drive or use any
tools or machines.
3.

How to use Flixotide

Flixotide comes in three different strengths. Your doctor will have
decided which strength you need. Always use Flixotide exactly as
your doctor has told you. Check with your doctor, nurse or
pharmacist if you are not sure.
Using this medicine
The medicine in Flixotide should be inhaled using a special kind
of inhaler called an Evohaler.
 Make sure that you have one and can use it properly.
 Instructions on how to use the inhaler are given as a step-bystep guide.

Using your inhaler
It is important to start to breathe as slowly as possible just before
using your inhaler.
1 Stand or sit upright when using your
inhaler.
2 Remove the mouthpiece cover (as
shown in the first picture). Check inside and outside to make sure that the
mouthpiece is clean and free of
objects.
3 Shake the inhaler 4 or 5 times to
ensure that any loose objects are
removed and that the contents of the
inhaler are evenly mixed.
4 Hold the inhaler upright with your
thumb on the base, below the
mouthpiece. Breathe out as far as is
comfortable. Do not breathe in again
yet.
5 Place the mouthpiece in your mouth
between your teeth. Close your lips
around it. Do not bite.
6 Breathe in through your mouth. Just
after starting to breathe in, press
down on the top of the canister to
release a puff of medicine. Do this
while still breathing in steadily and
deeply.
7 Hold your breath, take the inhaler
from your mouth and your finger from
the top of the inhaler. Continue
holding your breath for a few
seconds, or as long as is comfortable.
8 If your doctor has told you to take two puffs, wait about half a
minute before you take another puff by repeating steps 3 to 7.
9 Afterwards, rinse your mouth with water and spit it out.
10 After use always replace the mouthpiece cover straight away
to keep out dust. Replace the cover by firmly pushing and
clicking into position.

Practise in front of a mirror for the first few times. If you see a
‘mist’ coming from the top of your inhaler or the sides of your
mouth you should start again.
Older children or people with weak hands may find it easier to
hold the inhaler with both hands. Put the two forefingers on top of
the inhaler and both thumbs on the bottom below the mouthpiece.
If this does not help, a special device called a HaleraidTM may
make it easier. Your doctor, nurse or pharmacist will be able to
advise you.
Cleaning your Evohaler
To stop your inhaler blocking, it is important to clean it at least
once a week.
To clean your inhaler:
 Remove the mouthpiece cover.
 Do not remove the metal canister from the plastic casing at
any time.
 Wipe the inside and outside of the mouthpiece and the plastic
casing with a dry cloth or tissue.
 Replace the mouthpiece cover.
Do not put the metal canister in water.
If you use more Flixotide than you should
If you use more than you should, talk to your doctor as soon as
possible.
It is important that you take your dose as stated on the
pharmacist’s label or as advised by your doctor. You should not
increase or decrease your dose without seeking medical advice.
If you forget to use Flixotide
 Take the next dose when it is due.
 Do not take a double dose to make up for the forgotten dose.
If you stop using Flixotide
 Do not stop treatment even if you feel better unless told to
do so by your doctor.
If you have any further questions on the use of this product, ask
your doctor, nurse or pharmacist.
4.

Possible side effects

Like all medicines, this medicine can cause side effects, although
not everybody gets them.
If you notice any of the following serious side effects, stop
using this medicine and talk to your doctor straight away.
You may need urgent medical treatment.
 allergic reactions (may affect up to 1 in 100 people) – the
signs include skin rashes, redness, itching or weals like nettle
rash or hives
 severe allergic reactions (may affect up to 1 in 10,000 people)
- the signs include swelling of your face, lips, mouth, tongue or
throat which may cause difficulty in swallowing or breathing,
itchy rash, feeling faint and light headed and collapse
 your breathing or wheezing gets worse straight after using
your inhaler
Other side effects include:
Very common (may affect more than 1 in 10 people)
 thrush in the mouth and throat

Although the frequency is not known, the following side effects
may also occur:
 depression, feeling restless or nervous. These effects are
more likely to occur in children
Talk to your doctor as soon as possible if:
 after 7 days of using Flixotide your shortness of breath or
wheezing does not get better, or gets worse
 you or your child is on high doses of inhaled steroid and
become unwell with vague symptoms such as tummy ache,
sickness, diarrhoea, headache or drowsiness. This can
happen during an infection such as a viral infection or stomach
upset. It is important that your steroid is not stopped suddenly
as this could make your asthma worse and could also cause
problems with the body’s hormones
Reporting of side effects If you get any side effects, talk to your
doctor, pharmacist or nurse. This includes any possible side
effects not listed in this leaflet. You can also report side effects
directly via the Yellow Card Scheme at: www.mhra.gov.uk/
yellowcard By reporting side effects you can help provide more
information on the safety of this medicine.
5.

How to store Flixotide

 Keep out of the sight and reach of children.
 Clean your inhaler on a weekly basis and if it becomes
blocked as described under ‘Cleaning’,
 Do not use Flixotide Evohaler after the expiry date, which is
stated on the label and carton after ‘EXP’. The expiry date
refers to the last day of that month.
 Do not store above 30°C. Avoid direct sunlight and heat.
Protect from frost. Do not refrigerate
 If the inhaler gets very cold, take the metal canister out of the
plastic case and warm it in your hands for a few minutes
before use. Never use anything else to warm it up.
 The metal canister is pressurised. Do not puncture, break or
burn it even when apparently empty.
 Medicines should not be disposed of via wastewater or
household waste. Ask your pharmacist how to dispose of
medicines no longer required. These measures will help to
protect the environment.
 If you are told to stop taking this medicine, return the inhaler to
your pharmacist to be destroyed.
6.

Contents of the pack and other information

What Flixotide contains
 Each actuation contains 250 micrograms of the active
substance is fluticasone propionate
 The other ingredient is HFA 134a
What Flixotide Evohaler looks like and contents of the pack
Flixotide is a pressurised metered dose inhaler; the outer case is
reddish-brown, with a peach coloured mouthpiece/cap. Each
canister contains 120 metered actuations.
Manufacturer:
This product is manufactured by:
Glaxo Wellcome GmbH & Co. KG, Industriestr. 32-36, 23843 Bad
Oldesloe, Germany.
or

Common (may affect up to 1 in 10 people)
 sore tongue or throat
 hoarseness of voice

Glaxo Wellcome S.A., 3,09400 Aranda de Duero (Burgos), Spain.

Problems with your mouth and throat can be reduced by doing
certain things straight after inhaling your dose. These are
brushing your teeth, rinsing your mouth or gargling with water and
spitting it out. Tell your doctor if you have these problems with
your mouth or throat, but do not stop treatment unless you are
told to.

Glaxo Wellcome S.A., Severo Ochoa, 2, 28760 Tres Cantos,
Madrid, Spain.

The following side effects have also been reported in patients with
Chronic Obstructive Pulmonary Disease (COPD):
 Pneumonia and bronchitis (lung infection). Tell your doctor if
you notice any of the following symptoms: increased sputum
production, change in sputum colour, fever, chills, increased
cough, increased breathing problems
 Bruising
Rare (may affect up to 1 in 1,000 people)
 thrush (candidiasis) in the oesophagus
Very rare (may affect up to 1 in 10,000 people)
 sleeping problems or feeling worried, over-excited and
irritable. These effects are more likely to occur in young
people
 joint pains
 indigestion
 level of sugar (glucose) in your blood may be increased
 the way steroids are produced by your body may be affected
when using Flixotide. This is more likely to happen if you use
high doses for a long period of time (e.g. 400 micrograms daily
in children). This can cause:
- young people to grow more slowly
- something called ‘Cushing’s syndrome’. This happens when
you have too much steroid in your body and it can cause thinning of your bones and eye problems (such as cataracts and
glaucoma which is high pressure in the eye)
Your doctor will help stop this happening by making sure you
use the lowest dose of steroid which controls your symptoms.

or

It is procured from within the EU and repackaged by the Product
Licence holder: G. Pharma Ltd, Dakota Avenue, Salford
M50 2PU.
POM

PL 16369/0717
Flixotide® 250 micrograms Evohaler
22/01/2015
Flixotide® and Evohaler® are registered trademarks of
GlaxoSmithKline Group of Companies

Expand Transcript

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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