Flixotide 125mcg Evohaler Inhaler 1 UK

Package Leaflet: Information for the user

Flixotide 125 micrograms Evohaler^TM
Flixotide 250 micrograms Evohaler^TM
fluticasone propionate
Read all of this leaflet carefully before you start taking this
medicine.
 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 symptoms are the same as yours.
 If any of the side effects gets serious, or if you notice any side effects
not listed in this leaflet, please tell your doctor, nurse or pharmacist.
In this leaflet:
1 What Flixotide is and what it is used for
2 Before you use Flixotide
3 How to use Flixotide
4 Possible side effects
5 How to store Flixotide
6 Further 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 Before you use Flixotide
Do not use Flixotide if you are allergic (hypersensitive) to:
 fluticasone propionate or the other ingredient HFA 134a.
Take special care with Flixotide
Check with your doctor, nurse or pharmacist before taking your medicine 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.
Taking other medicines
Please tell your doctor, nurse or pharmacist if you are taking or have
recently taken 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
Talk to your doctor before using this medicine if you are pregnant, might
become pregnant or are breast-feeding.
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. You should 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-by-step guide.
 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.
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.

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.
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.
10 After use always replace
the mouthpiece cover
straight away to keep out dust.
Replace the cover by firmly
pushing and clicking into
position.
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.
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, Flixotide 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 (affects less than 1 in 100 people) - the signs include
skin rashes, redness, itching or weals like nettle rash or hives
 severe allergic reactions (affects less than 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 (affects more than 1 in 10 people)
 thrush in the mouth and throat
Common (affects less than 1 in 10 people)
 sore tongue or throat
 hoarseness of voice
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.
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.
Very rare (affects less than 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.
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.
If any of the side effects gets serious, or if you notice any side effects not
listed in this leaflet, please tell your doctor, nurse or pharmacist.
5 How to store Flixotide
 Keep out of the reach and sight 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. Protect from frost and direct sunlight.
 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 Further information
What Flixotide contains
The active substance is fluticasone propionate
 The other ingredient is HFA 134a.
What Flixotide Evohaler looks like and contents of the pack
 Flixotide Evohaler comprises an aluminium alloy can sealed with a
metering valve, actuator and dust cap.
 Each canister contains 60 or 120 doses of 125 or 250 micrograms of fluticasone propionate.
Marketing Authorisation Holder:
Glaxo Wellcome UK Limited trading as:
Allen & Hanburys
Stockley Park West
Uxbridge
Middlesex
UB11 1BT
Manufacturer:
Glaxo Wellcome S.A.
Aranda de Duero
Burgos
Spain.
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0800 198 5000 (UK Only)
Please be ready to give the following information:
Product name Flixotide 125 mcg Evohaler
Flixotide 250 mcg Evohaler
Reference numbers 10949/0265
This is a service provided by the Royal National Institute of Blind People.
Leaflet date: June 2011
Flixotide and Evohaler are trademarks of the GlaxoSmithKline group of
companies.
© 2011 GlaxoSmithKline group of companies