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Add/Amend to correct the statement of active content and excipients in Section 6.

Mock up

Previously assessed against UK PIL dated February 2017


(fluticasone propionate)

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

This product is available using above name but will be referred to as Flixotide Evohaler in this
leaflet. Other strength of 250 micrograms is also available.

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

By Aneela Mahmood at 2:13 pm, Jun 29, 2017

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.

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.

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

Your doctor may give you a Flixotide 250 microgram Evohaler if your dose is increased.


Flixotide Evohaler 125 micrograms is not recommended for children below 16 years of
It is recommended that children being treated with steroids, including Flixotide Evohaler have
their height checked regularly by their doctor.

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.


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’.
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.

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

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.


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.

Do not use:


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.

Warnings and precautions

Using your inhaler


Testing your inhaler


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

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.

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

Stand or sit upright when using your inhaler.


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.


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.


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.


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


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.


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


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.

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) 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 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.



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
• 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.

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Talk to your doctor as soon as possible if:

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.

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:

Cleaning your Evohaler

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

By reporting side effects, you can help provide more information on the safety of this medicine.

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
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

If you stop using Flixotide Evohaler


Take the next dose when it is due.
Do not take a double dose to make up for the forgotten dose.
Do not stop treatment even if you feel better unless told to do so by your doctor.


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

thrush in the mouth and throat

Blind or partially sighted?
Is this leaflet hard to see or read?
Call +44 (0) 1302 365000 (Regulatory)

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
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.

Please be ready to give the following
Product name:
Flixotide 125 micrograms Evohaler
Reference No: 21828/0484

Although the frequency is not known, the following side effects may also occur:


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

Rare (may affect up to 1 in 1,000 people)

Flixotide Evohaler is manufactured by:
Glaxo Wellcome S.A., Avda. Extremadura, 3, Pol. Ind. Allendeduero, Aranda de Duero, 09400 Burgos,

Leaflet revision date: 06.06.17

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


PL No: 21828/0484

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.

Flixotide Evohaler is one, two-piece, two tone orange ‘L’ shaped, moulded, plastic evohaler
comprising an aluminium alloy pressurised canister sealed with a metering valve. The canister is
fitted into a plastic actuator incorporating an atomising mouthpiece and fitted with a dustcap.
Each inhaler provides 120 metered actuations.

Product Licence holder: Landmark Pharma Ltd., 7 Regents Drive, Prudhoe, Northumberland, NE42 6PX.

Common (may affect up to 1 in 10 people)

The active substance is fluticasone propionate. Each metered actuation provides 125 micrograms
of fluticasone propionate.
The other ingredient is a CFC-free propellant: Norflurane (HFA 134a).

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

Other side effects include:
Very common (may affect more than 1 in 10 people)


What Flixotide Evohaler looks like and contents of the pack

Like all medicines, this medicine can cause side effects, although not everybody gets them.


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 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.
The metal canister contains a pressurised liquid. Do not puncture, break or burn, even when
apparently empty.
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.
If your inhaler shows any signs of deterioration or if it doesn't work properly, take it back to your
If you are told to stop taking this medicine, return the inhaler to your pharmacist to be destroyed.
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.

What Flixotide Evohaler contains

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


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

depression, feeling restless or nervous. These effects are more likely to occur in children

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Further information

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