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FLIXOTIDE 125MICROGRAM EVOHALER

Active substance(s): FLUTICASONE PROPIONATE

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PACKAGE LEAFLET: INFORMATION FOR THE USER
FLIXOTIDE™ 125 microgram EVOHALER™ / FLUTICASONE PROPIONATE 125 microgram EVOHALER™
(fluticasone propionate)
This product is available as either 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™ 250 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. 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)
• 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-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.
• 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.
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.
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 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 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. Protect from frost and direct sunlight. Do not refrigerate or freeze.
• 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 and should not be punctured, broken or burnt, 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. Each actuation contains 125 micrograms of fluticasone propionate.
Flixotide also contains a CFC-free propellant 1,1,1,2-tetrafluroethane (HFA 134a). Flixotide delivers your medicine
as an aerosol spray for you to inhale, through your mouth, directly into your lungs where it is needed. It contains
the same medicine as Flixotide Inhaler but may taste slightly different because the propellant gas is different.
Flixotide is available as a pressurised metered dose inhaler with an orange body and a peach cap. Each canister
contains 120 actuations (puffs).
PL No: 15814/0278

POM

This product is manufactured by Glaxo Wellcome Production, 23 Rue Lavoisier, Zone Industrielle, 2 Evreux,
France OR Glaxo Wellcome S.A., Avenida de Extremadura, 3 Aranda de Duero (Burgos), Spain OR A. Menarini
Manufacturing Logistics and Services Srl, Via Sette Santi, 3 Firenze, Italy.
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.) 01.10.2015.
To request a copy of this leaflet in Braille, large print or audio please call 01923 332 796.
Flixotide and Evohaler are trademarks of the GlaxoSmithKline group of companies.

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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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