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FLUTICASONE PROPIONATE 125 MICROGRAMS EVOHALER

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

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ADDITIONAL MANUFACTURERS PRODUCT DESCRIPTION
UK PIL DATED APRIL 2014 REPORTING OF SIDE EFFECTS

DT

Q.A.
APPROVED:

CUSTOMER
APPROVED:

04/12/14

DATE:

DATE:

CUSTOMER:

Waymade

PRE-PRESS NO.:

02-1808

PRODUCT:

Flixotide 125 Evohaler

ARTWORKER:

CODE:

6464/1561E

DATE OF PROOF:

PROOF HISTORY:
v.2 - waymade - 04/12/14

Vusż‹
Leaflet Flat Size = 296 x 317

TVT CHECKED

ARIAL REGULAR FONT SIZE 8
ARIAL BOLD FONT SIZE 10
BRIDGED TO
TRANSTEC 6464/2327 2328 2329

Pg 4

Talk to your doctor as soon as possible if:

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
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 Evohaler
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 125 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. 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.
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 your inhaler fails to work properly or shows any signs of deterioration, consult your pharmacist who will tell
you what to do.

6. Contents of the pack and other information
What Flixotide 125 Evohaler contains
The active substance is fluticasone propionate
The other ingredient is HFA 134a.
What Flixotide 125 Evohaler looks like and contents of the pack
Flixotide 125 micrograms Evohaler/Fluticasone Propionate 125 micrograms Evohaler is an aerosol metered
dose inhaler with an orange plastic body and a light orange removable cap.
Each canister contains 125 micrograms of fluticasone propionate.
Each canister provides 120 puffs.
POM

PL No: 6464/1561

This product is manufactured by Glaxo Wellcome Production, 23 Rue Lavoisier, Zone Industrielle, 2 , Evreux,
France and/or Glaxo Wellcome S.A., Avenida de Extremadura, 3 Aranda de Duero, Burgos, Spain and/or A.
Menarini Manufacturing Logistics and Services Srl , Via Sette Santi, 3 - Firenze ,Italy and procured from
within the EU and repackaged by the Product Licence holder who is:
Waymade Plc, Miles Gray Road, Basildon, Essex SS14 3FR
Leaflet revision and issue date (Ref.) 04.12.2014
Flixotide and Evohaler are registered trademarks of Glaxo Group Limited.

Pg 1

FLIXOTIDE®

EVOHALER®/

125 micrograms
FLUTICASONE PROPIONATE 125 micrograms EVOHALER®
(fluticasone propionate)
Patient Information Leaflet
This product is known as the above names but will be referred to as Flixotide 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 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. 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.
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.
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:

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 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.
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 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 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.

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.
Pg 2 !

WARNING!

WE CANNOT ACCEPT RESPONSIBILITY FOR ANY ERRORS IN THIS PROOF AFTER APPROVAL. THE ARTWORK RECEIVED HAS BEEN SIGNIFICANTLY
ADJUSTED, REVISED OR RESET BY US FROM DISK OR HARD COPY. WHILST WE TAKE EXTREME CARE AT ALL TIMES TO ENSURE ACCURACY, THE FINAL RESPONSIBILITY
MUST BE TAKEN BY OUR CUSTOMER. IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING FULL APPROVAL OF DESIGN AND TEXT.

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WARNING!

THE COLOURS SHOWN ON THIS PROOF ARE FOR GENERAL REPRESENTATION PURPOSES ONLY. THEY ARE NOT ACCURATE AND MUST NOT BE
USED AS A COLOUR MATCH FOR THE FINISHED JOB. PLEASE REFER TO THE PANTONE COLOUR GUIDES FOR ACCURATE COLOUR REFERENCES.

ADDITIONAL MANUFACTURERS PRODUCT DESCRIPTION
UK PIL DATED APRIL 2014 REPORTING OF SIDE EFFECTS

CUSTOMER:

Waymade

PRE-PRESS NO.:

02-1808

PRODUCT:

Flixotide 125 Evohaler

ARTWORKER:

CODE:

6464/1561E

DATE OF PROOF:

DT

Q.A.
APPROVED:

CUSTOMER
APPROVED:

04/12/14

DATE:

DATE:

PROOF HISTORY:
v.2 - waymade - 04/12/14

Vusż‹
Leaflet Flat Size = 296 x 317

TVT CHECKED

ARIAL REGULAR FONT SIZE 8
ARIAL BOLD FONT SIZE 10
BRIDGED TO
TRANSTEC 6464/2327 2328 2329

Pg 2

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.

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

2

Pg 3

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.

Adults and Children over 16 years of age
Mild asthma

The usual starting dose is 100 micrograms twice a day.

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

4. Possible side effects

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.

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.

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.

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.

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.

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

thrush in the mouth and throat

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.

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.

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

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 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).

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.

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)

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.

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

9

Afterwards, rinse your mouth with water and spit it out.

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

10 After use always replace the mouthpiece cover straight away to keep out dust. Replace the cover
by firmly pushing and clicking into position.



depression, feeling restless or nervous. These effects are more likely to occur in children.
Pg 4 !

Pg 3 !

WARNING!

WE CANNOT ACCEPT RESPONSIBILITY FOR ANY ERRORS IN THIS PROOF AFTER APPROVAL. THE ARTWORK RECEIVED HAS BEEN SIGNIFICANTLY
ADJUSTED, REVISED OR RESET BY US FROM DISK OR HARD COPY. WHILST WE TAKE EXTREME CARE AT ALL TIMES TO ENSURE ACCURACY, THE FINAL RESPONSIBILITY
MUST BE TAKEN BY OUR CUSTOMER. IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING FULL APPROVAL OF DESIGN AND TEXT.

¥uhuGK
,}6sZ²

¦h6Zƒ

WARNING!

THE COLOURS SHOWN ON THIS PROOF ARE FOR GENERAL REPRESENTATION PURPOSES ONLY. THEY ARE NOT ACCURATE AND MUST NOT BE
USED AS A COLOUR MATCH FOR THE FINISHED JOB. PLEASE REFER TO THE PANTONE COLOUR GUIDES FOR ACCURATE COLOUR REFERENCES.

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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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