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FLUTICASONE PROPIONATE 125 MICROGRAMS CFC FREE INHALER

Active substance(s): FLUTICASONE PROPIONATE

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FLIXOTIDE™ 125 MICROGRAMS EVOHALER™/
FLIXOTIDE™ 125 MICROGRAMS CFC-FREE INHALER
FLUTICASONE PROPIONATE 125 MICROGRAMS CFC FREE INHALER
(fluticasone propionate)



Adults and Children over 16 years of age

PATIENT INFORMATION LEAFLET

Mild asthma
• The usual starting dose is 100 micrograms twice a day.

This product is available using one of the above names but will be referred to as Flixotide
Evohaler in this leaflet.

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.

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.

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.

What is in this leaflet:
1. What Flixotide Evohaler is and what it is used for
2. What you need to know before you use Flixotide Evohaler
3. How to use Flixotide Evohaler
4. Possible side effects
5. How to store Flixotide Evohaler
6. Contents of the pack and other information
1.

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.

WHAT FLIXOTIDE EVOHALER 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.

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.

Flixotide Evohaler works by reducing swelling and irritation in the lungs. It has what is called an
‘anti-inflammatory action’.

The medicine is contained in a pressurised canister in a plastic casing with a mouthpiece.

Flixotide Evohaler 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.

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.

Flixotide Evohaler 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 EVOHALER

Do not use:


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.

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

Using your inhaler

Warnings and precautions

It is important to start to breathe as slowly as possible just before using your inhaler.

Talk to your doctor, nurse or pharmacist before taking if:
• you have ever been treated for tuberculosis (TB).
• you are using Flixotide Evohaler 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 Evohaler.

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.

Other medicines and Flixotide Evohaler

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 Evohaler.

Using Flixotide Evohaler with food and drink

You can use Flixotide Evohaler 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 Evohaler is not likely to affect you being able to drive or use any tools or machines.

3.

HOW TO USE FLIXOTIDE EVOHALER

Flixotide Evohaler comes in three different strengths. Your doctor will have decided which
strength you need. Always use Flixotide Evohaler 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 Evohaler 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.

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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.

Talk to your doctor as soon as possible if:


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.



Reporting of side effects

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.

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.

Cleaning your Evohaler

5.

To
To




stop your inhaler blocking, it is important to clean it at least once a week.
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 Evohaler 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 Evohaler






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 Evohaler


Do not stop treatment even if you feel better unless told to do so by your doctor.

6.

If you have any further questions on the use of this medicine, ask your doctor, nurse or
pharmacist.

4.

after 7 days of using Flixotide Evohaler 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

HOW TO STORE FLIXOTIDE EVOHALER

Keep out of the sight and reach of children.
Clean your inhaler on a weekly basis as described under ‘Cleaning’.
If your inhaler becomes blocked, it should be washed as described under ‘Cleaning’.
Do not store above 30°C. Do not refrigerate or freeze. 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.
Warning: The metal canister is pressurised. Do not puncture, break or burn it even if you
think it is empty.
Do not use the inhaler after the expiry date shown on the pack and label. The expiry date
refers to the last day of that month.
If your inhaler shows any signs of deterioration or if it doesn't work properly, take it back to
your pharmacist.
If you are told to stop taking this medicine, take any inhalers which you haven’t finished
back to your pharmacist for safe disposal.
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.

CONTENTS OF THE PACK AND OTHER INFORMATION

What Flixotide Evohaler contains


POSSIBLE SIDE EFFECTS

Each metered actuation or puff provides 125 micrograms of the active ingredient fluticasone
propionate.
It also contains a propellant, 1,1,1, 2-tetrafluoroethane (HFA 134a).

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.

What Flixotide Evohaler looks like and contents of the pack


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)


Manufactured by: Glaxo Wellcome Production, Z.I. No 2 – 23, Rue Lavoisier, 27091 Evreux,
Cedex 9, France.
Or
Glaxo Wellcome S.A., Aranda de Duero – Burgos, Spain.

Product Licence holder: BR Lewis Pharmaceuticals Ltd., Kirk Sandall, Doncaster, DN3 1QR.

• 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.

PL No: 08929/0014

Other formats:

POM

To listen to or request a copy of this leaflet in Braille, large print or audio please call
01302 365000 and ask for Regulatory Department.
Please be ready to give the following information:
Product name - Flixotide 125 micrograms Evohaler
Or
Flixotide 125 micrograms CFC-Free Inhaler
Or
Fluticasone Propionate 125 micrograms CFC Free Inhaler
Reference number 08929/0014

The following side effects have also been reported in patients with Chronic Obstructive
Pulmonary Disease (COPD):



Manufacturer:

Procured from within the EU and repackaged by: Doncaster Pharmaceuticals Group Ltd.,
Kirk Sandall, Doncaster, DN3 1QR.

thrush in the mouth and throat

Common (may affect up to 1 in 10 people)





Flixotide Evohaler 125 micrograms consists of a two piece, two tone orange, ‘L’ shaped,
moulded plastic inhaler comprising an aluminium alloy can seal with a metering valve,
actuator and dust cap.
Each inhaler provides 120 metered actuations (puffs).

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)

Leaflet revision date: 22.09.15

Very rare (may affect up to 1 in 10,000 people)

Flixotide™, Evohaler™, Haleraid™ and Volumatic™ are trademarks of the GlaxoSmithKline
Group of companies.








thrush (candidiasis) in the oesophagus

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 Evohaler.
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

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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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