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ALIFLUS 125 EVOHALER

Active substance(s): FLUTICASONE PROPIONATE / SALMETEROL XINAFOATE / FLUTICASONE PROPIONATE / SALMETEROL XINAFOATE

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Transcript
Ref: 0901/041016/1/F

Uncommon (affects less than 1 person in 100)
• Increases in the amount of sugar (glucose) in
your blood (hyperglycaemia). If you have
diabetes, more frequent blood sugar
monitoring and possibly adjustment of your
usual diabetic treatment may be required.
• Cataract (cloudy lens in the eye).
• Very fast heartbeat (tachycardia).
• Feeling shaky (tremor) and fast or uneven
heart beat (palpitations) - these are usually
harmless and get less as treatment continues.
• Chest pain.
• Feeling worried (this effect mainly occurs in
children).
• Disturbed sleep.
• Allergic skin rash.
Rare (affects less than 1 person in 1000)
• Breathing difficulties or wheezing that get
worse straight after taking Seretide. If this
happens stop using your Seretide inhaler.
Use your fast-acting ‘reliever’ inhaler to
help your breathing and tell your doctor
straight away.
• Seretide may affect the normal production of
steroid hormones in the body, particularly if you
have taken high doses for long periods of time.
The effects include:
− Slowing of growth in children and
adolescents
− Thinning of the bones
− Glaucoma
− Weight gain
− Rounded (moon shaped) face (Cushing’s
Syndrome)
Your doctor will check you regularly for any of
these side effects and make sure you are taking
the lowest dose of Seretide to control your
asthma.
• Behavioural changes, such as being unusually
active and irritable (these effects mainly occur
in children).
• Uneven heart beat or heart gives an extra beat
(arrhythmias). Tell your doctor, but do not stop
taking Seretide unless the doctor tells you to
stop.
• A fungal infection in the oesophagus (gullet),
which might cause difficulties in swallowing.
Frequency not known, but may also occur:
• Depression or aggression. These effects are
more likely to occur in children.
Reporting of side effects
If you get any side effects, talk to your doctor or
pharmacist. 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 SERETIDE
Keep out of the sight and reach of children.
Straight after use, replace the mouthpiece cover
firmly and click it into position. Do not use
excessive force.
• The canister contains a pressurised liquid.
Do not expose to temperatures higher than
50°C, protect from direct sunlight.
• Do not store above 25°C.
• As with most inhaled medicinal products in
pressurised canisters, the therapeutic effect of
this medicinal product may decrease when the
canister is cold
• Do not use Seretide after the expiry date which
is stated on the label and carton.
• The metal canister contains a pressurised liquid.
Do not puncture, break or burn it even if you
think it is 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

6. CONTENTS OF THE PACK AND OTHER
INFORMATION
What Seretide contains
• Each metered dose (ex valve) contains 25
micrograms of salmeterol (as salmeterol
xinafoate) and 250 micrograms of fluticasone
propionate. This is equivalent to a delivered
dose (ex actuator) of 21 micrograms of
salmeterol and 220 micrograms of fluticasone
propionate.
Also contains Norflurane (HFA 134a).
• Each metered dose (ex valve) contains 25
micrograms of salmeterol (as salmeterol
xinafoate) and 125 micrograms of fluticasone
propionate. This is equivalent to a delivered
dose (ex actuator) of 21 micrograms of
salmeterol and 110 micrograms of fluticasone
propionate.
Also contains Norflurane (HFA 134a).
What Seretide looks like and contents of the
pack
• Seretide Evohaler is available supplied to you
as a pressurised metered-dose inhaler with a
metal canister covered with a purple plastic
device and a lighter purple cap
• The pressurised canister contains a white to off
white suspension for inhalation.
• The device is packed in cartons containing one
Evohaler.
Manufacturer and Licence Holder
This medicine is manufactured by Glaxo Wellcome
Production, ZI, n.2-23, Rue Lavoisier, 27000
Evreux, France and is procured from within the EU
and repackaged by the Product Licence Holder:
Lexon (UK) Limited, Unit 18, Oxleasow Road, East
Moons Moat, Redditch, Worcestershire, B98 0RE.
If you have any questions or are not sure about
anything, ask your doctor or pharmacist. They will
have additional information about this medicine
and will be able to advise you.

POM

PL 15184/0900 Seretide 125 Evohaler /
Alifius 125 Evohaler
PL 15184/0901 Seretide 250 Evohaler /
Alifius 250 Evohaler

Seretide, Alifius, Evohaler, Haleraid and Volumatic
are registered trademarks of the GlaxoSmithKline
Group of Companies.
Leaflet revision date: 04/10/16

Blind or partially sighted?
Is this leaflet hard to see or read?
Phone Lexon (UK) Limited,
Tel: 01527 505414 for help.

PATIENT INFORMATION LEAFLET

SERETIDE® 125 EVOHALER / ALIFLUS ® 125 EVOHALER
SERETIDE® 250 EVOHALER / ALIFLUS ® 250 EVOHALER
(salmeterol xinafoate / fluticasone propionate)
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 or pharmacist.
• This medicine has been prescribed for you only.
Do not pass it on to others. It may harm them,
even if their symptoms and signs of illness are
the same as yours.
• If you get any side effects talk to your doctor or
pharmacist. This includes any possible side
effects not listed in this leaflet. See section 4.
Your medicine is called Seretide 125 Evohaler /
Alifius 125 Evohaler or Seretide 250 Evohaler /
Alifius 250 Evohaler and will be referred to as
Seretide throughout the rest of this leaflet.
Please note that this leaflet also contains
information about other strengths of this medicine
Seretide 25/50 Evohaler / Alifius 25/50 Evohaler
What is in this leaflet:
1. What Seretide is and what it is used for
2. What you need to know before you use
Seretide
3. How to use Seretide
4. Possible side effects
5. How to store Seretide
6. Contents of the pack and other information
1. WHAT SERETIDE IS AND WHAT IT IS USED
FOR
Seretide contains two medicines, salmeterol and
fluticasone propionate:
• Salmeterol is a long-acting bronchodilator.
Bronchodilators help the airways in the lungs to
stay open. This makes it easier for air to get in
and out. The effects last for at least 12 hours.
• Fluticasone propionate is a corticosteroid which
reduces swelling and irritation in the lungs.
The doctor has prescribed this medicine to help
prevent breathing problems such as asthma.
You must use Seretide every day as directed by
your doctor. This will make sure that it works
properly in controlling your asthma.
Seretide helps to stop breathlessness and
wheeziness coming on. However Seretide
should not be used to relieve a sudden attack
of breathlessness or wheezing. If this happens
you need to use a fast-acting ‘reliever’
(‘rescue’) inhaler, such as salbutamol. You
should always have your fast-acting ‘rescue’
inhaler with you.
2. WHAT YOU NEED TO KNOW BEFORE YOU
USE SERETIDE
Do not take Seretide:
If you are allergic to salmeterol, fluticasone
propionate or to the other ingredient norflurane
(HFA 134a).
Warnings and precautions
Talk to your doctor before using Seretide if you
have:
• Heart disease, including an irregular or fast
heart beat
• Overactive thyroid gland
• High blood pressure
• Diabetes mellitus (Seretide may increase your
blood sugar)
• Low potassium in your blood
• Tuberculosis (TB) now, or in the past, or other
lung infections

Other medicines and Seretide
Tell your doctor or pharmacist if you are taking,
have recently taken, or might take any other
medicines. This includes medicines for asthma or
any medicines obtained without a prescription.
This is because Seretide may not be suitable to be
taken with some other medicines.
Tell your doctor if you are taking the following
medicines, before starting to use Seretide:
• β blockers (such as atenolol, propranolol and
sotalol). β blockers are mostly used for high
blood pressure or other heart conditions.
• Medicines to treat infections (such as ritonavir,
ketoconazole, itraconazole and erythromycin).
Some of these medicines may increase the
amount of fluticasone propionate or salmeterol
in your body. This can increase your risk of
experiencing side effects with Seretide,
including irregular heart beats, or may make
side effects worse.
• Corticosteroids (by mouth or by injection). If
you have had these medicines recently, this
might increase the risk of this medicine
affecting your adrenal gland.
• Diuretics, also known as ‘water tablets’ used to
treat high blood pressure.
• Other bronchodilators (such as salbutamol).
• Xanthine medicines. These are often used to
treat asthma.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you
may be pregnant or are planning to have a baby,
ask your doctor or pharmacist for advice before
taking this medicine.
Driving and using machines
Seretide is not likely to affect your ability to drive
or use machines.
3. HOW TO USE SERETIDE
Always use this medicine exactly as your doctor or
pharmacist has told you. Check with your doctor or
pharmacist if you are not sure.
• Use your Seretide every day, until your doctor
advises you to stop. Do not take more than the
recommended dose. Check with your doctor or
pharmacist if you are not sure.
• Do not stop taking Seretide or reduce the dose
of Seretide without talking to your doctor first
• Seretide should be inhaled through the mouth
into the lungs.
Adults and adolescents aged 12 years and
over
• Seretide 25/50 Evohaler - 2 puffs twice a day
• Seretide 25/125 Evohaler - 2 puffs twice a day
• Seretide 25/250 Evohaler - 2 puffs twice a day
Children 4 to 12 years of age
• Seretide 25/50 Evohaler - 2 puffs twice a day
• Seretide is not recommended for use in children
below 4 years of age.
Your symptoms may become well controlled using
Seretide twice a day. If so, your doctor may decide
to reduce your dose to once a day. The dose may
change to:
• once at night - if you have night-time
symptoms
• once in the morning - if you have daytime
symptoms.

It is very important to follow your doctor’s
instructions on how many puffs to take and how
often to take your medicine.
If you are using Seretide for asthma, your doctor
will want to regularly check your symptoms. If
your asthma or breathing gets worse tell your
doctor straight away. You may find that you feel
more wheezy, your chest feels tight more often or
you may need to use more of your fast-acting
‘reliever’ medicine. If any of these happen, you
should continue to take Seretide but do not
increase the number of puffs you take. Your chest
condition may be getting worse and you could
become seriously ill. See your doctor as you may
need additional treatment.
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
Seretide Evohaler properly or as prescribed
may mean that it will not help your asthma as it
should.
• The medicine is contained in a pressurised
canister in a plastic casing with a mouthpiece.
• There is a counter on the back of the Evohaler
which tells you how many doses are left. Each
time you press the canister, a puff of medicine
is released and the counter will count down by
one.
• Take care not to drop the inhaler as this may
cause the counter to count down.
Testing your inhaler
1. When using your
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. Repeat
these steps, shaking the inhaler before
releasing each puff, until the counter reads 120.
If you have not used your 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 loose 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.

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

6. Breathe in through your
mouth slowly and deeply.
Just after starting to breathe
in, press firmly 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. Wait about half a minute between taking each
puff of medicine and then repeat steps 3 to 7.
9 Afterwards, rinse your mouth with water and
spit it out, and/or brush your teeth. This may
help to stop you getting thrush and becoming
hoarse.
10 After use always replace the mouthpiece cover
straight away to keep out dust. When the
mouthpiece cover is fitted correctly it will ‘click’
into position. If it does not ‘click’ into place, turn
the mouthpiece cover the other way round and
try again. Do not use too much force.
Do not rush steps 4, 5, 6 and 7. It is important that
you breathe in as slowly as possible just before
using your inhaler. You should use your inhaler
whilst standing in front of a mirror for the first few
times. If you see “mist” coming from the top of
your inhaler or the sides of your mouth, you
should start again from step 3.
As with all inhalers, caregivers should ensure that
children prescribed Seretide Evohaler use correct
inhalation technique, as described above.
If you or your child find it difficult to use the
Evohaler, either your doctor or other healthcare
provider may recommend using a spacer device
such as the Volumatic® or AeroChamber Plus®
with your inhaler. Your doctor, nurse, pharmacist or
other healthcare provider should show you how to
use the spacer device with your inhaler and how
to care for your spacer device and will answer any
questions you may have. It is important that if you
are using a spacer device with your inhaler that
you do not stop using it without talking to your
doctor or nurse first. It is also important that
you do not change the type of spacer device that
you use without talking to your doctor.

If you stop using a spacer device or change the
type of spacer device that you use your doctor
may need to change the dose of medicine
required to control your asthma. Always talk to
your doctor before making any changes to your
asthma treatment.
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. A
special device called a Haleraid® may also make it
easier.
You should get a replacement when the counter
shows the number 020. Stop using the inhaler
when the counter shows 000 as any puffs left in
the device may not be enough to give you a full
dose. Never try to alter the numbers on the
counter or detach the counter from the metal
canister.
Cleaning your inhaler
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. It will ‘click’ into
place when fitted correctly. If it does not ‘click’
into place, turn the mouthpiece cover the other
way round and try again. Do not use too much
force.
Do not put the metal canister in water.
If you use more Seretide than you should
It is important to use the inhaler as instructed. If
you accidentally take a larger dose than
recommended, talk to your doctor or pharmacist.
You may notice your heart beating faster than
usual and that you feel shaky. You may also have
dizziness, a headache, muscle weakness and
aching joints.
If you have used larger doses for a long period of
time, you should talk to your doctor or pharmacist
for advice. This is because larger doses of
Seretide may reduce the amount of steroid
hormones produced by the adrenal gland.
If you forget to use Seretide
Do not take a double dose to make up for a
forgotten dose. Just take your next dose at the
usual time.
If you stop using Seretide
It is very important that you take your Seretide
every day as directed. Keep taking it until your
doctor tells you to stop. Do not stop or
suddenly reduce your dose of Seretide. This
could make your breathing worse.
In addition, if you suddenly stop taking Seretide or
reduce your dose of Seretide this may (very rarely)
cause you to have problems with your adrenal
gland (adrenal insufficiency) which sometimes
causes side effects.
These side effects may include any of the
following:
• Stomach pain
• Tiredness and loss of appetite, feeling sick
• Sickness and diarrhoea
• Weight loss
• Headache or drowsiness
• Low levels of sugar in your blood
• Low blood pressure and seizures (fits)

When your body is under stress such as from
fever, trauma (such as a car accident), infection, or
surgery, adrenal insufficiency can get worse and
you may have any of the side effects listed above.
If you get any side effects, talk to your doctor or
pharmacist. To prevent these symptoms occurring,
your doctor may prescribe extra corticosteroids in
tablet form (such as prednisolone).
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. To
reduce the chance of side effects, your doctor will
prescribe the lowest dose of Seretide to control
your asthma.
Allergic reactions: you may notice your
breathing suddenly gets worse immediately
after using Seretide. You may be very wheezy
and cough or be short of breath. You may also
notice itching, a rash (hives) and swelling (usually
of the face, lips, tongue or throat), or you may
suddenly feel that your heart is beating very fast or
you feel faint and light headed (which may lead to
collapse or loss of consciousness). If you get any
of these effects or if they happen suddenly
after using Seretide, stop using Seretide and
tell your doctor straight away. Allergic reactions
to Seretide are uncommon (they affect less than 1
person in 100).
Other side effects are listed below:
Very Common
(affects more than 1 person in 10)
• Headache - this usually gets better as
treatment continues.
• Increased number of colds have been reported
in patients with COPD.
Common (affects less than 1 person in 10)
• Thrush (sore, creamy-yellow, raised patches)
in the mouth and throat. Also sore tongue and
hoarse voice and throat irritation. Rinsing your
mouth out with water and spitting it out
immediately and/or brushing your teeth after
taking each dose of your medicine may help.
Your doctor may prescribe an anti-fungal
medication to treat the thrush.
• Aching, swollen joints and muscle pain.
• Muscle cramps.
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: increase in sputum production,
change in sputum colour, fever, chills,
increased cough, increased breathing
problems.
• Throat irritation. Rinsing your mouth out with
water and spitting it out immediately after
taking each puff may help.
• Bruising and fractures.
• Inflammation of sinuses (a feeling of tension or
fullness in the nose, cheeks and behind the
eyes, sometimes with a throbbing ache)
• A reduction in the amount of potassium in the
blood (you may get an uneven heartbeat,
muscle weakness, cramp).

Ref:0901/041016/1/B

Ref: 0901/041016/2/F

Uncommon (affects less than 1 person in 100)
• Increases in the amount of sugar (glucose) in
your blood (hyperglycaemia). If you have
diabetes, more frequent blood sugar
monitoring and possibly adjustment of your
usual diabetic treatment may be required.
• Cataract (cloudy lens in the eye).
• Very fast heartbeat (tachycardia).
• Feeling shaky (tremor) and fast or uneven
heart beat (palpitations) - these are usually
harmless and get less as treatment continues.
• Chest pain.
• Feeling worried (this effect mainly occurs in
children).
• Disturbed sleep.
• Allergic skin rash.
Rare (affects less than 1 person in 1000)
• Breathing difficulties or wheezing that get
worse straight after taking Seretide. If this
happens stop using your Seretide inhaler.
Use your fast-acting ‘reliever’ inhaler to
help your breathing and tell your doctor
straight away.
• Seretide may affect the normal production of
steroid hormones in the body, particularly if you
have taken high doses for long periods of time.
The effects include:
− Slowing of growth in children and
adolescents
− Thinning of the bones
− Glaucoma
− Weight gain
− Rounded (moon shaped) face (Cushing’s
Syndrome)
Your doctor will check you regularly for any of
these side effects and make sure you are taking
the lowest dose of Seretide to control your
asthma.
• Behavioural changes, such as being unusually
active and irritable (these effects mainly occur
in children).
• Uneven heart beat or heart gives an extra beat
(arrhythmias). Tell your doctor, but do not stop
taking Seretide unless the doctor tells you to
stop.
• A fungal infection in the oesophagus (gullet),
which might cause difficulties in swallowing.
Frequency not known, but may also occur:
• Depression or aggression. These effects are
more likely to occur in children.
Reporting of side effects
If you get any side effects, talk to your doctor or
pharmacist. 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 SERETIDE
Keep out of the sight and reach of children.
Straight after use, replace the mouthpiece cover
firmly and click it into position. Do not use
excessive force.
• The canister contains a pressurised liquid.
Do not expose to temperatures higher than
50°C, protect from direct sunlight.
• Do not store above 25°C.
• As with most inhaled medicinal products in
pressurised canisters, the therapeutic effect of
this medicinal product may decrease when the
canister is cold’
• Do not use Seretide after the expiry date which
is stated on the label and carton.
• The metal canister contains a pressurised liquid.
Do not puncture, break or burn it even if you
think it is 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
6. CONTENTS OF THE PACK AND OTHER
INFORMATION
What Seretide contains
• Each metered dose (ex valve) contains 25
micrograms of salmeterol (as salmeterol
xinafoate) and 250 micrograms of fluticasone
propionate. This is equivalent to a delivered
dose (ex actuator) of 21 micrograms of
salmeterol and 220 micrograms of fluticasone
propionate.
Also contains Norflurane (HFA 134a).
• Each metered dose (ex valve) contains 25
micrograms of salmeterol (as salmeterol
xinafoate) and 125 micrograms of fluticasone
propionate. This is equivalent to a delivered
dose (ex actuator) of 21 micrograms of
salmeterol and 110 micrograms of fluticasone
propionate.
Also contains Norflurane (HFA 134a).
What Seretide looks like and contents of the
pack
• Seretide Evohaler is available supplied to you
as a pressurised metered-dose inhaler with a
metal canister covered with a purple plastic
device and a lighter purple cap
• The pressurised canister contains a white to off
white suspension for inhalation.
• The device is packed in cartons containing one
Evohaler.
Manufacturer and Licence Holder
This medicine is manufactured by Glaxo Wellcome
S.A. Avenida de Extremadura, 3 - 09400, Aranda
de Duero, Burgos, Spain and is procured from
within the EU and repackaged by the Product
Licence Holder: Lexon (UK) Limited, Unit 18,
Oxleasow Road, East Moons Moat, Redditch,
Worcestershire, B98 0RE.
If you have any questions or are not sure about
anything, ask your doctor or pharmacist. They will
have additional information about this medicine
and will be able to advise you.

POM

PL 15184/0900 Seretide 125 Evohaler /
Alifius 125 Evohaler
PL 15184/0901 Seretide 250 Evohaler /
Alifius 250 Evohaler

Seretide, Alifius, Evohaler, Haleraid and Volumatic
are registered trademarks of the GlaxoSmithKline
Group of Companies.
Leaflet revision date: 04/10/16

Blind or partially sighted?
Is this leaflet hard to see or read?
Phone Lexon (UK) Limited,
Tel: 01527 505414 for help.

PATIENT INFORMATION LEAFLET

SERETIDE® 125 EVOHALER / ALIFLUS ® 125 EVOHALER
SERETIDE® 250 EVOHALER / ALIFLUS ® 250 EVOHALER
(salmeterol xinafoate / fluticasone propionate)
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 or pharmacist.
• This medicine has been prescribed for you only.
Do not pass it on to others. It may harm them,
even if their symptoms and signs of illness are
the same as yours.
• If you get any side effects talk to your doctor or
pharmacist. This includes any possible side
effects not listed in this leaflet. See section 4.
Your medicine is called Seretide 125 Evohaler /
Alifius 125 Evohaler or Seretide 250 Evohaler /
Alifius 250 Evohaler and will be referred to as
Seretide throughout the rest of this leaflet.
Please note that this leaflet also contains
information about other strengths of this medicine
Seretide 25/50 Evohaler / Alifius 25/50 Evohaler
What is in this leaflet:
1. What Seretide is and what it is used for
2. What you need to know before you use
Seretide
3. How to use Seretide
4. Possible side effects
5. How to store Seretide
6. Contents of the pack and other information
1. WHAT SERETIDE IS AND WHAT IT IS USED
FOR
Seretide contains two medicines, salmeterol and
fluticasone propionate:
• Salmeterol is a long-acting bronchodilator.
Bronchodilators help the airways in the lungs to
stay open. This makes it easier for air to get in
and out. The effects last for at least 12 hours.
• Fluticasone propionate is a corticosteroid which
reduces swelling and irritation in the lungs.
The doctor has prescribed this medicine to help
prevent breathing problems such as asthma.
You must use Seretide every day as directed by
your doctor. This will make sure that it works
properly in controlling your asthma.
Seretide helps to stop breathlessness and
wheeziness coming on. However Seretide
should not be used to relieve a sudden attack
of breathlessness or wheezing. If this happens
you need to use a fast-acting ‘reliever’
(‘rescue’) inhaler, such as salbutamol. You
should always have your fast-acting ‘rescue’
inhaler with you.
2. WHAT YOU NEED TO KNOW BEFORE YOU
USE SERETIDE
Do not take Seretide:
If you are allergic to salmeterol, fluticasone
propionate or to the other ingredient norflurane
(HFA 134a).
Warnings and precautions
Talk to your doctor before using Seretide if you
have:
• Heart disease, including an irregular or fast
heart beat
• Overactive thyroid gland
• High blood pressure
• Diabetes mellitus (Seretide may increase your
blood sugar)
• Low potassium in your blood
• Tuberculosis (TB) now, or in the past, or other
lung infections

Other medicines and Seretide
Tell your doctor or pharmacist if you are taking,
have recently taken, or might take any other
medicines. This includes medicines for asthma or
any medicines obtained without a prescription.
This is because Seretide may not be suitable to be
taken with some other medicines.
Tell your doctor if you are taking the following
medicines, before starting to use Seretide:
• β blockers (such as atenolol, propranolol and
sotalol). β blockers are mostly used for high
blood pressure or other heart conditions.
• Medicines to treat infections (such as ritonavir,
ketoconazole, itraconazole and erythromycin).
Some of these medicines may increase the
amount of fluticasone propionate or salmeterol
in your body. This can increase your risk of
experiencing side effects with Seretide,
including irregular heart beats, or may make
side effects worse.
• Corticosteroids (by mouth or by injection). If
you have had these medicines recently, this
might increase the risk of this medicine
affecting your adrenal gland.
• Diuretics, also known as ‘water tablets’ used to
treat high blood pressure.
• Other bronchodilators (such as salbutamol).
• Xanthine medicines. These are often used to
treat asthma.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you
may be pregnant or are planning to have a baby,
ask your doctor or pharmacist for advice before
taking this medicine.
Driving and using machines
Seretide is not likely to affect your ability to drive
or use machines.
3. HOW TO USE SERETIDE
Always use this medicine exactly as your doctor or
pharmacist has told you. Check with your doctor or
pharmacist if you are not sure.
• Use your Seretide every day, until your doctor
advises you to stop. Do not take more than the
recommended dose. Check with your doctor or
pharmacist if you are not sure.
• Do not stop taking Seretide or reduce the dose
of Seretide without talking to your doctor first
• Seretide should be inhaled through the mouth
into the lungs.
Adults and adolescents aged 12 years and
over
• Seretide 25/50 Evohaler - 2 puffs twice a day
• Seretide 25/125 Evohaler - 2 puffs twice a day
• Seretide 25/250 Evohaler - 2 puffs twice a day
Children 4 to 12 years of age
• Seretide 25/50 Evohaler - 2 puffs twice a day
• Seretide is not recommended for use in children
below 4 years of age.
Your symptoms may become well controlled using
Seretide twice a day. If so, your doctor may decide
to reduce your dose to once a day. The dose may
change to:
• once at night - if you have night-time
symptoms
• once in the morning - if you have daytime
symptoms.

It is very important to follow your doctor’s
instructions on how many puffs to take and how
often to take your medicine.
If you are using Seretide for asthma, your doctor
will want to regularly check your symptoms. If
your asthma or breathing gets worse tell your
doctor straight away. You may find that you feel
more wheezy, your chest feels tight more often or
you may need to use more of your fast-acting
‘reliever’ medicine. If any of these happen, you
should continue to take Seretide but do not
increase the number of puffs you take. Your chest
condition may be getting worse and you could
become seriously ill. See your doctor as you may
need additional treatment.
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
Seretide Evohaler properly or as prescribed
may mean that it will not help your asthma as it
should.
• The medicine is contained in a pressurised
canister in a plastic casing with a mouthpiece.
• There is a counter on the back of the Evohaler
which tells you how many doses are left. Each
time you press the canister, a puff of medicine
is released and the counter will count down by
one.
• Take care not to drop the inhaler as this may
cause the counter to count down.
Testing your inhaler
1. When using your
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. Repeat
these steps, shaking the inhaler before
releasing each puff, until the counter reads 120.
If you have not used your 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 loose 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.

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

6. Breathe in through your
mouth slowly and deeply.
Just after starting to breathe
in, press firmly 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. Wait about half a minute between taking each
puff of medicine and then repeat steps 3 to 7.
9 Afterwards, rinse your mouth with water and
spit it out, and/or brush your teeth. This may
help to stop you getting thrush and becoming
hoarse.
10 After use always replace the mouthpiece cover
straight away to keep out dust. When the
mouthpiece cover is fitted correctly it will ‘click’
into position. If it does not ‘click’ into place, turn
the mouthpiece cover the other way round and
try again. Do not use too much force.
Do not rush steps 4, 5, 6 and 7. It is important that
you breathe in as slowly as possible just before
using your inhaler. You should use your inhaler
whilst standing in front of a mirror for the first few
times. If you see “mist” coming from the top of
your inhaler or the sides of your mouth, you
should start again from step 3.
As with all inhalers, caregivers should ensure that
children prescribed Seretide Evohaler use correct
inhalation technique, as described above.
If you or your child find it difficult to use the
Evohaler, either your doctor or other healthcare
provider may recommend using a spacer device
such as the Volumatic® or AeroChamber Plus®
with your inhaler. Your doctor, nurse, pharmacist or
other healthcare provider should show you how to
use the spacer device with your inhaler and how
to care for your spacer device and will answer any
questions you may have. It is important that if you
are using a spacer device with your inhaler that
you do not stop using it without talking to your
doctor or nurse first. It is also important that
you do not change the type of spacer device that
you use without talking to your doctor.

If you stop using a spacer device or change the
type of spacer device that you use your doctor
may need to change the dose of medicine
required to control your asthma. Always talk to
your doctor before making any changes to your
asthma treatment.
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. A
special device called a Haleraid® may also make it
easier.
You should get a replacement when the counter
shows the number 020. Stop using the inhaler
when the counter shows 000 as any puffs left in
the device may not be enough to give you a full
dose. Never try to alter the numbers on the
counter or detach the counter from the metal
canister.
Cleaning your inhaler
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. It will ‘click’ into
place when fitted correctly. If it does not ‘click’
into place, turn the mouthpiece cover the other
way round and try again. Do not use too much
force.
Do not put the metal canister in water.
If you use more Seretide than you should
It is important to use the inhaler as instructed. If
you accidentally take a larger dose than
recommended, talk to your doctor or pharmacist.
You may notice your heart beating faster than
usual and that you feel shaky. You may also have
dizziness, a headache, muscle weakness and
aching joints.
If you have used larger doses for a long period of
time, you should talk to your doctor or pharmacist
for advice. This is because larger doses of
Seretide may reduce the amount of steroid
hormones produced by the adrenal gland.
If you forget to use Seretide
Do not take a double dose to make up for a
forgotten dose. Just take your next dose at the
usual time.
If you stop using Seretide
It is very important that you take your Seretide
every day as directed. Keep taking it until your
doctor tells you to stop. Do not stop or
suddenly reduce your dose of Seretide. This
could make your breathing worse.
In addition, if you suddenly stop taking Seretide or
reduce your dose of Seretide this may (very rarely)
cause you to have problems with your adrenal
gland (adrenal insufficiency) which sometimes
causes side effects.
These side effects may include any of the
following:
• Stomach pain
• Tiredness and loss of appetite, feeling sick
• Sickness and diarrhoea
• Weight loss
• Headache or drowsiness
• Low levels of sugar in your blood
• Low blood pressure and seizures (fits)

When your body is under stress such as from
fever, trauma (such as a car accident), infection, or
surgery, adrenal insufficiency can get worse and
you may have any of the side effects listed above.
If you get any side effects, talk to your doctor or
pharmacist. To prevent these symptoms occurring,
your doctor may prescribe extra corticosteroids in
tablet form (such as prednisolone).
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. To
reduce the chance of side effects, your doctor will
prescribe the lowest dose of Seretide to control
your asthma.
Allergic reactions: you may notice your
breathing suddenly gets worse immediately
after using Seretide. You may be very wheezy
and cough or be short of breath. You may also
notice itching, a rash (hives) and swelling (usually
of the face, lips, tongue or throat), or you may
suddenly feel that your heart is beating very fast or
you feel faint and light headed (which may lead to
collapse or loss of consciousness). If you get any
of these effects or if they happen suddenly
after using Seretide, stop using Seretide and
tell your doctor straight away. Allergic reactions
to Seretide are uncommon (they affect less than 1
person in 100).
Other side effects are listed below:
Very Common
(affects more than 1 person in 10)
• Headache - this usually gets better as
treatment continues.
• Increased number of colds have been reported
in patients with COPD.
Common (affects less than 1 person in 10)
• Thrush (sore, creamy-yellow, raised patches)
in the mouth and throat. Also sore tongue and
hoarse voice and throat irritation. Rinsing your
mouth out with water and spitting it out
immediately and/or brushing your teeth after
taking each dose of your medicine may help.
Your doctor may prescribe an anti-fungal
medication to treat the thrush.
• Aching, swollen joints and muscle pain.
• Muscle cramps.
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: increase in sputum production,
change in sputum colour, fever, chills,
increased cough, increased breathing
problems.
• Throat irritation. Rinsing your mouth out with
water and spitting it out immediately after
taking each puff may help.
• Bruising and fractures.
• Inflammation of sinuses (a feeling of tension or
fullness in the nose, cheeks and behind the
eyes, sometimes with a throbbing ache)
• A reduction in the amount of potassium in the
blood (you may get an uneven heartbeat,
muscle weakness, cramp).

Ref:0901/041016/2/B

Ref: 0901/041016/3/F

Uncommon (affects less than 1 person in 100)
• Increases in the amount of sugar (glucose) in
your blood (hyperglycaemia). If you have
diabetes, more frequent blood sugar
monitoring and possibly adjustment of your
usual diabetic treatment may be required.
• Cataract (cloudy lens in the eye).
• Very fast heartbeat (tachycardia).
• Feeling shaky (tremor) and fast or uneven
heart beat (palpitations) - these are usually
harmless and get less as treatment continues.
• Chest pain.
• Feeling worried (this effect mainly occurs in
children).
• Disturbed sleep.
• Allergic skin rash.
Rare (affects less than 1 person in 1000)
• Breathing difficulties or wheezing that get
worse straight after taking Seretide. If this
happens stop using your Seretide inhaler.
Use your fast-acting ‘reliever’ inhaler to
help your breathing and tell your doctor
straight away.
• Seretide may affect the normal production of
steroid hormones in the body, particularly if you
have taken high doses for long periods of time.
The effects include:
− Slowing of growth in children and
adolescents
− Thinning of the bones
− Glaucoma
− Weight gain
− Rounded (moon shaped) face (Cushing’s
Syndrome)
Your doctor will check you regularly for any of
these side effects and make sure you are taking
the lowest dose of Seretide to control your
asthma.
• Behavioural changes, such as being unusually
active and irritable (these effects mainly occur
in children).
• Uneven heart beat or heart gives an extra beat
(arrhythmias). Tell your doctor, but do not stop
taking Seretide unless the doctor tells you to
stop.
• A fungal infection in the oesophagus (gullet),
which might cause difficulties in swallowing.
Frequency not known, but may also occur:
• Depression or aggression. These effects are
more likely to occur in children.
Reporting of side effects
If you get any side effects, talk to your doctor or
pharmacist. 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 SERETIDE
Keep out of the sight and reach of children.
Straight after use, replace the mouthpiece cover
firmly and click it into position. Do not use
excessive force.
• The canister contains a pressurised liquid.
Do not expose to temperatures higher than
50°C, protect from direct sunlight.
• Do not store above 25°C.
• As with most inhaled medicinal products in
pressurised canisters, the therapeutic effect of
this medicinal product may decrease when the
canister is cold’
• Do not use Seretide after the expiry date which
is stated on the label and carton.
• The metal canister contains a pressurised liquid.
Do not puncture, break or burn it even if you
think it is 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
6. CONTENTS OF THE PACK AND OTHER
INFORMATION
What Seretide contains
• Each metered dose (ex valve) contains 25
micrograms of salmeterol (as salmeterol
xinafoate) and 250 micrograms of fluticasone
propionate. This is equivalent to a delivered
dose (ex actuator) of 21 micrograms of
salmeterol and 220 micrograms of fluticasone
propionate.
Also contains Norflurane (HFA 134a).
• Each metered dose (ex valve) contains 25
micrograms of salmeterol (as salmeterol
xinafoate) and 125 micrograms of fluticasone
propionate. This is equivalent to a delivered
dose (ex actuator) of 21 micrograms of
salmeterol and 110 micrograms of fluticasone
propionate.
Also contains Norflurane (HFA 134a).
What Seretide looks like and contents of the
pack
• Seretide Evohaler is available supplied to you
as a pressurised metered-dose inhaler with a
metal canister covered with a purple plastic
device and a lighter purple cap
• The pressurised canister contains a white to off
white suspension for inhalation.
• The device is packed in cartons containing one
Evohaler.
Manufacturer and Licence Holder
This medicine is manufactured by A.Menarini
Manufacturing Logistics and Services S.r.l. Via
Sette Santi, 3 Firenze, Italy and is procured from
within the EU and repackaged by the Product
Licence Holder: Lexon (UK) Limited, Unit 18,
Oxleasow Road, East Moons Moat, Redditch,
Worcestershire, B98 0RE.
If you have any questions or are not sure about
anything, ask your doctor or pharmacist. They will
have additional information about this medicine
and will be able to advise you.

POM

PL 15184/0900 Seretide 125 Evohaler /
Alifius 125 Evohaler
PL 15184/0901 Seretide 250 Evohaler /
Alifius 250 Evohaler

Seretide, Alifius, Evohaler, Haleraid and Volumatic
are registered trademarks of the GlaxoSmithKline
Group of Companies.
Leaflet revision date: 04/10/16

Blind or partially sighted?
Is this leaflet hard to see or read?
Phone Lexon (UK) Limited,
Tel: 01527 505414 for help.

PATIENT INFORMATION LEAFLET

SERETIDE® 125 EVOHALER / ALIFLUS ® 125 EVOHALER
SERETIDE® 250 EVOHALER / ALIFLUS ® 250 EVOHALER
(salmeterol xinafoate / fluticasone propionate)
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 or pharmacist.
• This medicine has been prescribed for you only.
Do not pass it on to others. It may harm them,
even if their symptoms and signs of illness are
the same as yours.
• If you get any side effects talk to your doctor or
pharmacist. This includes any possible side
effects not listed in this leaflet. See section 4.
Your medicine is called Seretide 125 Evohaler /
Alifius 125 Evohaler or Seretide 250 Evohaler /
Alifius 250 Evohaler and will be referred to as
Seretide throughout the rest of this leaflet.
Please note that this leaflet also contains
information about other strengths of this medicine
Seretide 25/50 Evohaler / Alifius 25/50 Evohaler
What is in this leaflet:
1. What Seretide is and what it is used for
2. What you need to know before you use
Seretide
3. How to use Seretide
4. Possible side effects
5. How to store Seretide
6. Contents of the pack and other information
1. WHAT SERETIDE IS AND WHAT IT IS USED
FOR
Seretide contains two medicines, salmeterol and
fluticasone propionate:
• Salmeterol is a long-acting bronchodilator.
Bronchodilators help the airways in the lungs to
stay open. This makes it easier for air to get in
and out. The effects last for at least 12 hours.
• Fluticasone propionate is a corticosteroid which
reduces swelling and irritation in the lungs.
The doctor has prescribed this medicine to help
prevent breathing problems such as asthma.
You must use Seretide every day as directed by
your doctor. This will make sure that it works
properly in controlling your asthma.
Seretide helps to stop breathlessness and
wheeziness coming on. However Seretide
should not be used to relieve a sudden attack
of breathlessness or wheezing. If this happens
you need to use a fast-acting ‘reliever’
(‘rescue’) inhaler, such as salbutamol. You
should always have your fast-acting ‘rescue’
inhaler with you.
2. WHAT YOU NEED TO KNOW BEFORE YOU
USE SERETIDE
Do not take Seretide:
If you are allergic to salmeterol, fluticasone
propionate or to the other ingredient norflurane
(HFA 134a).
Warnings and precautions
Talk to your doctor before using Seretide if you
have:
• Heart disease, including an irregular or fast
heart beat
• Overactive thyroid gland
• High blood pressure
• Diabetes mellitus (Seretide may increase your
blood sugar)
• Low potassium in your blood
• Tuberculosis (TB) now, or in the past, or other
lung infections

Other medicines and Seretide
Tell your doctor or pharmacist if you are taking,
have recently taken, or might take any other
medicines. This includes medicines for asthma or
any medicines obtained without a prescription.
This is because Seretide may not be suitable to be
taken with some other medicines.
Tell your doctor if you are taking the following
medicines, before starting to use Seretide:
• β blockers (such as atenolol, propranolol and
sotalol). β blockers are mostly used for high
blood pressure or other heart conditions.
• Medicines to treat infections (such as ritonavir,
ketoconazole, itraconazole and erythromycin).
Some of these medicines may increase the
amount of fluticasone propionate or salmeterol
in your body. This can increase your risk of
experiencing side effects with Seretide,
including irregular heart beats, or may make
side effects worse.
• Corticosteroids (by mouth or by injection). If
you have had these medicines recently, this
might increase the risk of this medicine
affecting your adrenal gland.
• Diuretics, also known as ‘water tablets’ used to
treat high blood pressure.
• Other bronchodilators (such as salbutamol).
• Xanthine medicines. These are often used to
treat asthma.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you
may be pregnant or are planning to have a baby,
ask your doctor or pharmacist for advice before
taking this medicine.
Driving and using machines
Seretide is not likely to affect your ability to drive
or use machines.
3. HOW TO USE SERETIDE
Always use this medicine exactly as your doctor or
pharmacist has told you.
Check with your doctor or pharmacist if you are
not sure.
• Use your Seretide every day, until your doctor
advises you to stop. Do not take more than the
recommended dose. Check with your doctor or
pharmacist if you are not sure.
• Do not stop taking Seretide or reduce the dose
of Seretide without talking to your doctor first
• Seretide should be inhaled through the mouth
into the lungs.
Adults and adolescents aged 12 years and
over
• Seretide 25/50 Evohaler - 2 puffs twice a day
• Seretide 125 Evohaler - 2 puffs twice a day
• Seretide 250 Evohaler - 2 puffs twice a day
Children 4 to 12 years of age
• Seretide 25/50 Evohaler - 2 puffs twice a day
• Seretide is not recommended for use in children
below 4 years of age.
Your symptoms may become well controlled using
Seretide twice a day. If so, your doctor may decide
to reduce your dose to once a day. The dose may
change to:
• once at night - if you have night-time
symptoms
• once in the morning - if you have daytime
symptoms.

It is very important to follow your doctor’s
instructions on how many puffs to take and how
often to take your medicine.
If you are using Seretide for asthma, your doctor
will want to regularly check your symptoms. If
your asthma or breathing gets worse tell your
doctor straight away. You may find that you feel
more wheezy, your chest feels tight more often or
you may need to use more of your fast-acting
‘reliever’ medicine. If any of these happen, you
should continue to take Seretide but do not
increase the number of puffs you take. Your chest
condition may be getting worse and you could
become seriously ill. See your doctor as you may
need additional treatment.
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
Seretide Evohaler properly or as prescribed
may mean that it will not help your asthma as it
should.
• The medicine is contained in a pressurised
canister in a plastic casing with a mouthpiece.
• There is a counter on the back of the Evohaler
which tells you how many doses are left. Each
time you press the canister, a puff of medicine
is released and the counter will count down by
one.
• Take care not to drop the inhaler as this may
cause the counter to count down.
Testing your inhaler
1. When using your
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. Repeat
these steps, shaking the inhaler before
releasing each puff, until the counter reads 120.
If you have not used your 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 loose 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.

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

6. Breathe in through your
mouth slowly and deeply.
Just after starting to breathe
in, press firmly 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. Wait about half a minute between taking each
puff of medicine and then repeat steps 3 to 7.
9 Afterwards, rinse your mouth with water and
spit it out, and/or brush your teeth. This may
help to stop you getting thrush and becoming
hoarse.
10 After use always replace the mouthpiece cover
straight away to keep out dust. When the
mouthpiece cover is fitted correctly it will ‘click’
into position. If it does not ‘click’ into place, turn
the mouthpiece cover the other way round and
try again. Do not use too much force.
Do not rush steps 4, 5, 6 and 7. It is important that
you breathe in as slowly as possible just before
using your inhaler. You should use your inhaler
whilst standing in front of a mirror for the first few
times. If you see “mist” coming from the top of
your inhaler or the sides of your mouth, you
should start again from step 3.
As with all inhalers, caregivers should ensure that
children prescribed Seretide Evohaler use correct
inhalation technique, as described above.
If you or your child find it difficult to use the
Evohaler, either your doctor or other healthcare
provider may recommend using a spacer device
such as the Volumatic® or AeroChamber Plus®
with your inhaler. Your doctor, nurse, pharmacist or
other healthcare provider should show you how to
use the spacer device with your inhaler and how
to care for your spacer device and will answer any
questions you may have. It is important that if you
are using a spacer device with your inhaler that
you do not stop using it without talking to your
doctor or nurse first. It is also important that
you do not change the type of spacer device that
you use without talking to your doctor.

If you stop using a spacer device or change the
type of spacer device that you use your doctor
may need to change the dose of medicine
required to control your asthma. Always talk to
your doctor before making any changes to your
asthma treatment.
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. A
special device called a Haleraid® may also make it
easier.
You should get a replacement when the counter
shows the number 020. Stop using the inhaler
when the counter shows 000 as any puffs left in
the device may not be enough to give you a full
dose. Never try to alter the numbers on the
counter or detach the counter from the metal
canister.
Cleaning your inhaler
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. It will ‘click’ into
place when fitted correctly. If it does not ‘click’
into place, turn the mouthpiece cover the other
way round and try again. Do not use too much
force.
Do not put the metal canister in water.
If you use more Seretide than you should
It is important to use the inhaler as instructed. If
you accidentally take a larger dose than
recommended, talk to your doctor or pharmacist.
You may notice your heart beating faster than
usual and that you feel shaky. You may also have
dizziness, a headache, muscle weakness and
aching joints.
If you have used larger doses for a long period of
time, you should talk to your doctor or pharmacist
for advice. This is because larger doses of
Seretide may reduce the amount of steroid
hormones produced by the adrenal gland.
If you forget to use Seretide
Do not take a double dose to make up for a
forgotten dose. Just take your next dose at the
usual time.
If you stop using Seretide
It is very important that you take your Seretide
every day as directed. Keep taking it until your
doctor tells you to stop. Do not stop or
suddenly reduce your dose of Seretide. This
could make your breathing worse.
In addition, if you suddenly stop taking Seretide or
reduce your dose of Seretide this may (very rarely)
cause you to have problems with your adrenal
gland (adrenal insufficiency) which sometimes
causes side effects.
These side effects may include any of the
following:
• Stomach pain
• Tiredness and loss of appetite, feeling sick
• Sickness and diarrhoea
• Weight loss
• Headache or drowsiness
• Low levels of sugar in your blood
• Low blood pressure and seizures (fits)

When your body is under stress such as from
fever, trauma (such as a car accident), infection, or
surgery, adrenal insufficiency can get worse and
you may have any of the side effects listed above.
If you get any side effects, talk to your doctor or
pharmacist. To prevent these symptoms occurring,
your doctor may prescribe extra corticosteroids in
tablet form (such as prednisolone).
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. To
reduce the chance of side effects, your doctor will
prescribe the lowest dose of Seretide to control
your asthma.
Allergic reactions: you may notice your
breathing suddenly gets worse immediately
after using Seretide. You may be very wheezy
and cough or be short of breath. You may also
notice itching, a rash (hives) and swelling (usually
of the face, lips, tongue or throat), or you may
suddenly feel that your heart is beating very fast or
you feel faint and light headed (which may lead to
collapse or loss of consciousness). If you get any
of these effects or if they happen suddenly
after using Seretide, stop using Seretide and
tell your doctor straight away. Allergic reactions
to Seretide are uncommon (they affect less than 1
person in 100).
Other side effects are listed below:
Very Common
(affects more than 1 person in 10)
• Headache - this usually gets better as
treatment continues.
• Increased number of colds have been reported
in patients with COPD.
Common (affects less than 1 person in 10)
• Thrush (sore, creamy-yellow, raised patches)
in the mouth and throat. Also sore tongue and
hoarse voice and throat irritation. Rinsing your
mouth out with water and spitting it out
immediately and/or brushing your teeth after
taking each dose of your medicine may help.
Your doctor may prescribe an anti-fungal
medication to treat the thrush.
• Aching, swollen joints and muscle pain.
• Muscle cramps.
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: increase in sputum production,
change in sputum colour, fever, chills,
increased cough, increased breathing
problems.
• Throat irritation. Rinsing your mouth out with
water and spitting it out immediately after
taking each puff may help.
• Bruising and fractures.
• Inflammation of sinuses (a feeling of tension or
fullness in the nose, cheeks and behind the
eyes, sometimes with a throbbing ache)
• A reduction in the amount of potassium in the
blood (you may get an uneven heartbeat,
muscle weakness, cramp).

Ref:0901/041016/3/B

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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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