Skip to Content

FLIXOTIDE 250 MICROGRAM EVOHALER

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

View full screen / Print PDF » Download PDF ⇩
Transcript
1
62000000002812
GSK-ESP-Aranda-ESARA

Package leaflet: Information for the user

Flixotide evohaler

125 micrograms Evohaler®

N/A

Adults and Children over 16 years of age

250 micrograms Evohaler®
fluticasone propionate

02-01-XX-273-02

Read all of this leaflet carefully before you start taking this
medicine because it contains important information for you.

N/A
N/A
1
K

N/A

• 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
2
3
4
5
6

What Flixotide is and what it is used for
What you need to know before you use Flixotide
How to use Flixotide
Possible side effects
How to store Flixotide
Contents of the pack and other information

1 What Flixotide is and what it is used for

N/A

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

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
2

Stand or sit upright when using your inhaler.
R emove 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.

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

4

5

6

Shake the inhaler
Hold the inhaler upright with
4 or 5 times to ensure
your thumb on the base, below
that any loose objects
the mouthpiece. Breathe out as far as is
are removed and that the
comfortable. Do not breathe in again yet.
contents of the inhaler are
evenly mixed.

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.

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.
62000000002812

Page 1 of 2
8.0pt

8.8pt
8.0pt

90%
N

Page 1 of 2

PHARMA CODE N° 5292

United Kingdom-GBR

• 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.

1
62000000002812
GSK-ESP-Aranda-ESARA

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.

United Kingdom-GBR
Flixotide evohaler

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.

N/A
02-01-XX-273-02

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.

N/A

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.

1
K

N/A

N/A

PHARMA CODE N° 5292

N/A

• 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:
• a fter 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

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
• T ake 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
• D
 o 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

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
• K eep this medicine 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 this medicine 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.
• 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.
• Do not throw away any medicines via wastewater or household waste. Ask
your pharmacist how to throw away medicines you no longer use. These
measures will help 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
• T he active substance is fluticasone propionate.
• The other ingredient is HFA 134a.

What Flixotide Evohaler looks like and contents of the pack
• F lixotide Evohaler comprises an aluminium alloy can sealed with a
metering valve, actuator and dust cap.
• Each canister contains 60 or 120 doses of 125 or 250 micrograms of
fluticasone propionate.

Marketing Authorisation Holder:
Glaxo Wellcome UK Limited
Stockley Park West
Uxbridge
Middlesex
UB11 1BT

Manufacturer:
Glaxo Wellcome S.A.
Aranda de Duero
Burgos
Spain.

Other formats:
To listen to or request a copy of this leaflet in Braille, large print or audio
please call, free of charge:

0800 198 5000 (UK Only)
Please be ready to give the following information:
Product name Flixotide 125 mcg Evohaler
Flixotide 250 mcg Evohaler
Reference numbers 10949/0265
This is a service provided by the Royal National Institute of Blind People.

This leaflet was last revised in December 2014

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

• s leeping problems or feeling worried, over-excited and irritable. These
effects are more likely to occur in young people
• joint pains
• indigestion

Flixotide and Evohaler are registered trade marks of the GSK group of companies.
© 2014 GSK group of companies. All rights reserved.

62000000002812

Page 2 of 2
8.0pt

8.8pt
8.0pt

90%
N

Page 2 of 2

Expand view ⇕

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.

Hide