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FLIXOTIDE 250MICROGRAM CFC-FREE INHALER

Active substance(s): FLUTICASONE PROPIONATE / FLUTICASONE PROPIONATE / FLUTICASONE PROPIONATE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Flixotide™ 250 microgram Evohaler™ /
Fluticasone Propionate 250 microgram Evohaler™ /
Flixotide™ 250 microgram CFC-free Inhaler





(fluticasone propionate)
This product is available as any of the above names but will be referred to as Flixotide
throughout the following leaflet. Please note this leaflet also contains information about
other strength (Flixotide™ 125 microgram Evohaler™).
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.
2.
3.
4.
5.
6.

What Flixotide is and what it is used for
What you need to know before you use Flixotide
How to use Flixotide
Possible side effects
How to store Flixotide
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



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 VolumaticTM largevolume 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 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 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 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.

Do not use:


Testing your inhaler
if you are allergic to fluticasone propionate or any of the other ingredients of this
medicine (listed in section 6).

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) or
cobicistat containing products which may increase the effects of fluticasone
propionate. Your doctor may wish to monitor you carefully if you are taking these
medicines.
 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.

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.
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.

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.

5 Place the mouthpiece in your mouth between your teeth.
Close your lips around it. Do not bite.

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.

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.

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.

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.

Your doctor will help stop this happening by making sure you use the lowest dose of
steroid which controls your symptoms.

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.

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
 nosebleeds
Talk to your doctor as soon as possible if:

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 Haleraid TM 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.




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



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 medicine, 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

Common (may affect up to 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
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)

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







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 after the expiry date printed on the carton or canister label. The expiry
date refers to the last day of that month.
Do not store above 30°C. Do not refrigerate or freeze. Protect from frost and direct
sunlight. Do not expose to temperatures higher than 50°C.
If your 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.
If the inhaler fails to work properly or shows signs of any deterioration, you should
seek the advice of your pharmacist who will tell you what to do.

6. Contents of the pack and other information
Your medicine is called Flixotide. It contains 250 micrograms of the active ingredient
fluticasone propionate per actuation (puff).
The active ingredient in this Flixotide is exactly the same as in your previous Flixotide
250 microgram inhaler. The only differences that you might notice are the taste and
feel of the spray in your mouth, and the sound of the inhaler on using it. This is due to
the change in CFC-free propellant. This does not affect the way your medicine works.
Flixotide also contains Norflurane (HFA 134a).
Flixotide contains the same medicine as Flixotide 250 microgram inhaler but may taste
slightly different because the propellant gas is different.
Flixotide is available as a pressurised metered dose aerosol inhaler of 120-metered
actuations (puffs).
PL: 15814/0200

POM

This product is manufactured by Glaxo Wellcome Production, Zone Industrielle 2, 23
rue Lavoisier 27091 Evreux, Cedex 9, France OR Glaxo Wellcome Production, Zone
Industrielle 2, 23 rue Lavoisier 27000 Evreux, France and is procured from within the
EU and repackaged by the Product Licence holder: O.P.D. Laboratories Ltd., Unit 6
Colonial Way, Watford, Herts WD24 4PR.
Leaflet revision and issue date (Ref.) 13.06.2017.
Flixotide and Evohaler are trademarks of the GlaxoSmithKline group of companies.

To request a copy of this leaflet in Braille, large
print or audio please call 01923 332 796.

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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