Skip to Content

SERETIDE EVOHALER 25 MICROGRAM /125 MICROGRAM PER METERED DOSE PRESSURISED INHALATION SUSPENSION

Active substance: SALMETEROL XINAFOATE MICRONISED

View full screen / Print PDF » Download PDF ⇩
Transcript
2
Seretide
K

10000000118801

2587

GSK-FRA-Evreux-FREVR
United Kingdom-GBR

3

02_038_01

TEXT SIZE CONTAINED IN THIS ARTWORK
Body text size: 8.0pt
Leading: 8.5.0pt
Horizontal Scale: 85%
Smallest text size: 8.0pt
Microtext: N

Page 1 of 2

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)

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 this medicine out of the sight and reach of children.
• Do not use Seretide 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 25°C.
• The canister contains a pressurised liquid. Do not expose to temperatures higher than 50°C, protect from
direct sunlight. Do not pierce or burn the canister even when empty.
• 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 throw away medicines via wastewater or household waste. Ask your pharmacist how to throw away any
medicines you no longer use. These measures will help protect the environment.

6 Contents of the pack and other information

25 microgram/50 microgram per metered dose pressurised inhalation, suspension
25 microgram/125 microgram per metered dose pressurised inhalation, suspension
25 microgram/250 microgram per metered dose pressurised inhalation, suspension
salmeterol/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.

In this leaflet:
1
2
3
4
5
6

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

PHARMA CODE

• 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.

Package leaflet: Information for the user

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 (hypersensitive) to salmeterol, fluticasone propionate or to the other ingredient norflurane
(HFA 134a).

Warnings and precautions

What Seretide Evohaler contains

• Each metered dose contains 25 micrograms of salmeterol (as salmeterol xinafoate) and 50, 125 or 250
micrograms of fluticasone propionate.
• The other ingredient is propellant: norflurane (HFA 134a).

What Seretide Evohaler looks like and contents of the pack

• Seretide Evohaler is supplied to you in a metered dose inhaler which delivers your medicine in a pressurised
suspension for you to inhale through your mouth into your lungs.
• The pressurised canister contains a white to off white suspension for inhalation.
• The canisters are fitted into a plastic casing incorporating a mouthpiece and fitted with dustcaps.
• The devices are packed in cartons of 1, 3 or 10 Evohalers. Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Glaxo Wellcome UK Ltd
Stockley Park West
Uxbridge
Middlesex UB11 1BT
Manufacturer:
Glaxo Wellcome Production
Zone Industrielle No.2, 23 Rue Lavoisier, La Madeleine, 27000 Evreux, France.
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
Seretide Evohaler
Reference number 10949/0337
This is a service provided by the Royal National Institute of Blind People.
This leaflet was last revised in 08/2014.
Evohaler, Seretide, Haleraid and Volumatic are registered trademarks of the GlaxoSmithKline group of
companies.
AeroChamber Plus is a registered trademark of Trudell Medical International.
© 2014 GlaxoSmithKline group of companies

Your doctor will supervise your treatment more closely if you have medical conditions such as:
• 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
If you have ever had any of these conditions, tell your doctor before you use Seretide.

Other medicines and Seretide

Tell your doctor or pharmacist if you are taking or have recently taken 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 Evohaler 25/50 - 2 puffs twice a day
• Seretide Evohaler 25/125 - 2 puffs twice a day
• Seretide Evohaler 25/250 - 2 puffs twice a day

Children 4 to 12 years of age
10000000118801

• Seretide Evohaler 25/50 - 2 puffs twice a day
• Seretide is not recommended for use in children below 4 years of age.

10000000118801

2
Seretide
K

10000000118801

2587

GSK-FRA-Evreux-FREVR

TEXT SIZE CONTAINED IN THIS ARTWORK
Body text size: 8.0pt
Leading: 8.5.0pt
Horizontal Scale: 85%
Smallest text size: 8.0pt
Microtext: N

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
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.

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 stop using Seretide

3

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
problem 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 about the use of this medicine, ask your doctor, nurse or pharmacist.

4

Shake the inhaler 4 or 5 times
to ensure that any loose objects
are removed and that the contents
of the inhaler are evenly mixed.
Hold the inhaler upright with your thumb on the base,
below the mouthpiece. Breathe out as far as is comfortable.

5

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

4 Possible side effects

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
9

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.

Do not take a double dose to make up for a missed dose. Just take your next dose at the usual time.

3

4
5
6

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.

If you forget to use Seretide

Stand or sit upright when
using your inhaler.

Remove the mouthpiece cover
(as shown in the first picture).
Check inside and outside to make
sure that the mouthpiece is clean
and free of loose objects.

Page 2 of 2

Cleaning your inhaler

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.

1
2

3

02_038_01

United Kingdom-GBR

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:

6

Wait about half a minute between taking each puff of
medicine and then repeat steps 3 to 7.

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.

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.

7

Common (affects less than 1 person in 10)

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.
10000000118801

• 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).

10000000118801

FRONT PAGE

6
10000000119036
GSK-ESP-Aranda-ESARA

2 What you need to know before you use Seretide
Do not take Seretide if:

United Kingdom-GBR
Seretide
2

2587

02-01-XX-273-02

Package leaflet: Information for the user

Warnings and precautions

Your doctor will supervise your treatment more closely if you have medical
conditions such as:
• eart disease, including an irregular or fast heart beat
H
• veractive thyroid gland
O
• igh blood pressure
H
• iabetes mellitus (Seretide may increase your blood sugar)
D
• ow potassium in your blood
L
• uberculosis (TB) now, or in the past, or other lung infections
T
If you have ever had any of these conditions, tell your doctor before you
use Seretide.

25 microgram/50 microgram per metered dose
pressurised inhalation, suspension
25 microgram/125 microgram per metered dose
pressurised inhalation, suspension
25 microgram/250 microgram per metered dose
pressurised inhalation, suspension
salmeterol/fluticasone propionate

Other medicines and Seretide

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.

In this leaflet:
1
2
3
4
5
6

What Seretide is and what it is used for
What you need to know before you use Seretide
How to use Seretide
Possible side effects
How to store Seretide
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 fastacting ‘reliever’ (‘rescue’) inhaler, such as salbutamol. You should
always have your fast-acting ‘rescue’ inhaler with you.

Tell your doctor or pharmacist if you are taking or have recently taken
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

Page 1 of 2

• Seretide Evohaler 25/50 - 2 puffs twice a day
• Seretide Evohaler 25/125 - 2 puffs twice a day
• Seretide Evohaler 25/250 - 2 puffs twice a day

Children 4 to 12 years of age

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.

• Seretide Evohaler 25/50 - 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.

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.

Instructions for use

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.

• 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.

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.

3

4

Hold the inhaler upright with your
thumb on the base, below the
mouthpiece. Breathe out as far as is
comfortable.

4

5

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

6

5

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.

6

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.

7

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.
10000000119036

PHARMA CODE N° 4723

K

You are allergic (hypersensitive) to salmeterol, fluticasone propionate or to
the other ingredient norflurane (HFA 134a).

• Seretide should be inhaled through the mouth into the lungs.

Adults and adolescents aged 12 years and over

TEXT SIZE CONTAINED IN THIS ARTWORK
Body text size: 8.0pt
Leading: 8.3pt
Horizontal Scale: 85%
Smallest text size: 8pt
Microtext: N

BACK PAGE

6
10000000119036
GSK-ESP-Aranda-ESARA
United Kingdom-GBR
Seretide
2

K

2587

02-01-XX-273-02

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 missed dose. Just take your
next dose at the usual time.

Page 2 of 2

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 problem 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 about 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):

PHARMA CODE N° 4723

TEXT SIZE CONTAINED IN THIS ARTWORK
Body text size: 8.0pt
Leading: 8.3pt
Horizontal Scale: 85%
Smallest text size: 8pt
Microtext: N

• 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).

Uncommon (affects less than 1 person in 100)

• ncreases in the amount of sugar (glucose) in your blood (hyperglycaemia).
I
If you have diabetes, more frequent blood sugar monitoring and possibly
adjustment of your usual diabetic treatment may be required.
• ataract (cloudy lens in the eye).
C
• ery fast heartbeat (tachycardia).
V
• eeling shaky (tremor) and fast or uneven heart beat (palpitations) -
F
these are usually harmless and get less as treatment continues.
• hest pain.
C
• eeling worried (this effect mainly occurs in children).
F
• isturbed sleep.
D
• llergic skin rash.
A

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.

• Do not store above 25°C.
• The canister contains a pressurised liquid. Do not expose to
temperatures higher than 50°C, protect from direct sunlight. Do not
pierce or burn the canister even when empty.
• 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 throw away medicines via wastewater or household waste. Ask your
pharmacist how to throw away any medicines you no longer use. These
measures will help protect the environment.

6 Contents of the pack and other information
What Seretide Evohaler contains

• Each metered dose contains 25 micrograms of salmeterol (as salmeterol
xinafoate) and 50, 125 or 250 micrograms of fluticasone propionate.
• The other ingredient is propellant: norflurane (HFA 134a).

What Seretide Evohaler looks like and contents of the pack

• Seretide Evohaler is supplied to you in a metered dose inhaler which
delivers your medicine in a pressurised suspension for you to inhale
through your mouth into your lungs.
• The pressurised canister contains a white to off white suspension for
inhalation.
• The canisters are fitted into a plastic casing incorporating a mouthpiece
and fitted with dustcaps.
• The devices are packed in cartons of 1, 3 or 10 Evohalers. Not all pack
sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:
Glaxo Wellcome UK Ltd
Stockley Park West
Uxbridge
Middlesex UB11 1BT
Manufacturer:
Glaxo Wellcome S.A.
Avenida de Extremadura, 3 - 09400, 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)

Frequency not known, but may also occur:

Please be ready to give the following information:

Reporting of side effects

Reference number
10949/0337
This is a service provided by the Royal National Institute of Blind People.

• Depression or aggression. These effects are more likely to occur in children.
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 this medicine out of the sight and reach of children.
• Do not use Seretide 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.

Product name

Seretide Evohaler

This leaflet was last revised in 08/2014.

Evohaler, Seretide, Haleraid and Volumatic are registered trademarks of the
GlaxoSmithKline group of companies.
AeroChamber Plus is a registered trademark of Trudell Medical International.
© 2014 GlaxoSmithKline group of companies

10000000119036

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