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FLIXOTIDE 125 CFC-FREE INHALER

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

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Flixotide®125 micrograms Evohaler
Flixotide® 125 CFC-Free Inhaler
(fluticasone propionate)
Patient Information Leaflet
Your medicine is known by one of the above names but will be referred to
as Flixotide throughout 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.
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 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



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.
Testing your inhaler
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.

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.

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.

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-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 VolumaticTM
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.

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 Haleraid® 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 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)
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
• nosebleeds
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 all medicines out of the sight and reach of children.
Do not use Flixotide after the expiry date which is stated on the label
and carton. The expiry date refers to the last day of the month.
Do not store above 30°C. Protect from frost and direct sunlight. Do
not refrigerate or freeze.
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.
If the inhaler fails to work properly or shows signs of deterioration,
you should seek the advice of your pharmacist who will tell you what
to do.
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
• The active ingredient is fluticasone propionate
• Each metered actuation contains 125 micrograms of the active
ingredient, fluticasone propionate.
• The other ingredient is HFA 134a.
What Flixotide looks like and contents of the pack
Flixotide Evohaler comprises a pressurised metered dose inhaler with a
plastic reddish-brown body and an orange cap. The metal canister emits
white to off-white suspension.
Each canister contains 120 metered actuations.
Who makes and repackages your medicine?
PL 10383/0792

Flixotide 125 CFC-Free Inhaler/
Flixotide 125 micrograms Evohaler

POM

Your medicine is manufactured by Glaxo Wellcome S.A. Burgos, Spain.
Procured from within the EU and repackaged by the Product License
holder: Primecrown Ltd., 4/5 Northolt Trading Estate, Belvue Road,
Northolt, Middlesex, UB5 5QS.
Leaflet date: 10.05.2017
Flixotide®, Evohaler® and Haleraid® are trademarks of the Glaxo Group
Limited, United Kingdom.

Blind or partially sighted?
Is this leaflet hard to see or read?
Call 020 8839 3000 to obtain the
leaflet in a format suitable for you.

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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