SERETIDE ACCUHALER 50 MICROGRAM /100 MICROGRAM /DOSE INHALATION POWDER PRE-DISPENSED

Active substance: SALMETEROL XINAFOATE MICRONISED

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GSK-FRA-Evreux-FREVR

Counter
Full
Empty
60
0

Outer Case

Thumbgrip
Mouthpiece

Lever

TEXT SIZE CONTAINED IN THIS ARTWORK
Body text size: 9.0pt
Leading: 10.0pt
Horizontal Scale: 85%
Smallest text size: 8.0pt
Microtext: N

salmeterol/fluticasone propionate

02_033_01

50 microgram/100 microgram/dose inhalation powder, pre-dispensed
50 microgram/250 microgram/dose inhalation powder, pre-dispensed
50 microgram/500 microgram/dose inhalation powder, pre-dispensed

2587

®

K

Package leaflet: Information for the user

2

FRONT PAGE

Seretide

Accuhaler®

United Kingdom-GBR

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


In this leaflet:

Warnings and precautions

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

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.

BACK PAGE

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

Wipe the mouthpiece of the Accuhaler with a dry tissue to clean it.

If you stop using Seretide

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
• Chronic Obstructive Pulmonary Disease (COPD). Seretide Accuhaler, at a dose
of 50/500 micrograms, reduces the number of flare ups of COPD symptoms.
You must use Seretide every day as directed by your doctor. This will make sure
that it works properly in controlling your asthma or COPD.
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.

may harm them, even if their symptoms and signs of illness are the same as
yours.
- I f 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.

Cleaning your inhaler

Page 1 of 1

1 What Seretide is and what it is used for

10000000118754

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.

You are allergic (hypersensitive) to salmeterol, fluticasone propionate or to the
other ingredient lactose monohydrate.
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)

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 or COPD.
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 your heart 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.

• 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.

Important information about some of the ingredients of Seretide
Seretide Accuhaler contains up to 12.5 milligrams of lactose in each dose. The
amount of lactose in this medicine does not normally cause problems in people
who are lactose intolerant.

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.

For asthma

Adults and adolescents aged 12 years and over
• Seretide Accuhaler 50/100 - One inhalation twice a day
• Seretide Accuhaler 50/250 - One inhalation twice a day
• Seretide Accuhaler 50/500 - One inhalation twice a day
Children 4 to 12 years of age
• Seretide Accuhaler 50/100 - One inhalation twice a day
• Seretide is not recommended for use in children below 4 years of age.

For adults with Chronic Obstructive Pulmonary Disease (COPD)

• Seretide Accuhaler 50/500 - One inhalation twice a day
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 inhalations
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

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.
• 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
heart beat, muscle weakness, cramp).

− 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.

Uncommon (affects less than 1 person in 100)

Reporting of side effects

• 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 heart beat (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

Frequency not known, but may also occur:

• 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 after the expiry date which is stated on the label and
carton after EXP. The expiry date refers to the last day of that month.
• Do not store above 30°C.
Do not throw away medicines via wastewater or household waste. Ask your
pharmacist how to throw away medicines you no longer use. These measures will
help protect the environment.

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
Accuhaler properly or as prescribed may mean that it will not help your asthma
or COPD as it should.
• The Accuhaler device holds blisters containing Seretide as a powder.
• There is a counter on top of the Accuhaler which tells you how many doses are
left. It counts down to 0. The numbers 5 to 0 will appear in red to warn you when
there are only a few doses left. Once the counter shows 0, your inhaler is empty.

Using your inhaler

1

To open your Accuhaler, hold the outer case in
one hand and put the thumb of your other hand
on the thumbgrip. Push your thumb away from you
as far as it will go. You will hear a click. This will open
a small hole in the mouthpiece.

2

Hold your Accuhaler with the mouthpiece
towards you. You can hold it in either your right
or left hand. Slide the lever away from you as far as it
will go. You will hear a click. This places a dose of
your medicine in the mouthpiece.

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

• Each pre-dispensed dose contains 50 micrograms of salmeterol (as salmeterol
xinafoate) and 100, 250 or 500 micrograms of fluticasone propionate.
• The other ingredient is lactose monohydrate (which contains milk proteins).

What Seretide Accuhaler looks like and contents of the pack

• The Seretide Accuhaler contains a foil strip. The foil protects the powder for
inhalation from the effects of the atmosphere.
• Each dose is pre-dispensed.
• he devices are packed in cartons which hold:
T
1 x Accuhaler 28 inhalations
or 1, 2, 3 or 10 x Accuhaler each containing 60 inhalations.
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)

Every time the lever is pulled back a blister is opened inside and the powder
made ready for you to inhale. Do not play with the lever as this opens the blisters
and wastes medicine.

3
4

Hold the Accuhaler away from your mouth, breathe out as far as is
comfortable. Do not breathe into your Accuhaler.

5
6

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.

Put the mouthpiece to your lips; breathe in
steadily and deeply through the Accuhaler, not
through your nose.
Remove the Accuhaler from your mouth.
Hold your breath for about 10 seconds or for as long
as is comfortable.
Breathe out slowly.

To close the Accuhaler, slide the thumbgrip back
towards you, as far as it will go. You will hear a

click.
The lever will return to its original position and is
reset.

Your Accuhaler is now ready for you to use again.
As with all inhalers, caregivers should ensure that children prescribed Seretide
Accuhaler use correct inhalation technique, as described above.

Please be ready to give the following information:
Product name
Seretide Accuhaler
Reference number 10949/0314
This is a service provided by the Royal National Institute of Blind People.
This leaflet was last revised in 08/2014
Accuhaler and Seretide are registered trademarks of the GlaxoSmithKline group
of companies
© 2014 GlaxoSmithKline group of companies

10000000118754

10000000118754

PHARMA CODE

7

5

GSK-GBR-Ware-UKWAR
United Kingdom-GBR

PHARMA CODE N° 6680

10000000119317

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.

10000000119317

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

Seretide

Thumbgrip

Seretide contains two medicines, salmeterol and fluticasone propionate:
Lever

Counter
Full
Empty
60
0

1 What Seretide is and what it is used for
• 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
• Chronic Obstructive Pulmonary Disease (COPD). Seretide Accuhaler, at
a dose of 50/500 micrograms, reduces the number of flare ups of
COPD symptoms.

Mouthpiece

You must use Seretide every day as directed by your doctor. This will make
sure that it works properly in controlling your asthma or COPD.

Outer Case

salmeterol/fluticasone propionate

50 microgram/100 microgram/dose inhalation powder, pre-dispensed
50 microgram/250 microgram/dose inhalation powder, pre-dispensed
50 microgram/500 microgram/dose inhalation powder, pre-dispensed

JMF184

®

2587

Package leaflet: Information for the user

K

Accuhaler®

2

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.

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 lactose monohydrate.
Warnings and precautions
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:
• b blockers (such as atenolol, propranolol and sotalol). b 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.

FRONT PAGE

Page 1 of 2

TEXT SIZE CONTAINED IN THIS ARTWORK
Body text size: 9 pt
Leading: 10 pt
Horizontal Scale: 100%
Smallest text size: 8 pt
Microtext: N

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.
Important information about some of the ingredients
of Seretide
Seretide Accuhaler contains up to 12.5 milligrams of lactose in
each dose. The amount of lactose in this medicine does not
normally cause problems in people who are lactose intolerant.

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.
For asthma
Adults and adolescents aged 12 years and over
• Seretide Accuhaler 50/100 - One inhalation twice a day
• Seretide Accuhaler 50/250 - One inhalation twice a day
• Seretide Accuhaler 50/500 - One inhalation twice a day
Children 4 to 12 years of age
• Seretide Accuhaler 50/100 - One inhalation twice a day
• Seretide is not recommended for use in children below 4 years of age.
For adults with Chronic Obstructive Pulmonary Disease (COPD)
• Seretide Accuhaler 50/500 - One inhalation twice a day
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
inhalations 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 Accuhaler properly or as prescribed may mean that it will
not help your asthma or COPD as it should.
• The Accuhaler device holds blisters containing Seretide as a powder.
• There is a counter on top of the Accuhaler which tells you how many
doses are left. It counts down to 0. The numbers 5 to 0 will appear in
red to warn you when there are only a few doses left. Once the
counter shows 0, your inhaler is empty.

Using your inhaler

1

To open your Accuhaler, hold the
outer case in one hand and put
the thumb of your other hand on the
thumbgrip. Push your thumb away from
you as far as it will go. You will hear a
click. This will open a small hole in the
mouthpiece.

2

Hold your Accuhaler with the
mouthpiece towards you. You can
hold it in either your right or left hand.
Slide the lever away from you as far
as it will go. You will hear a click. This
places a dose of your medicine in the
mouthpiece.

Every time the lever is pulled back a blister is opened inside and the
powder made ready for you to inhale. Do not play with the lever as
this opens the blisters and wastes medicine.

3
4

Hold the Accuhaler away from your mouth, breathe out as far
as is comfortable. Do not breathe into your Accuhaler.

Put the mouthpiece to your lips;
breathe in steadily and deeply
through the Accuhaler, not through your
nose.
Remove the Accuhaler from your mouth.
Hold your breath for about 10 seconds or
for as long as is comfortable.
Breathe out slowly.

5

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.

6

To close the Accuhaler, slide the
thumbgrip back towards you, as far as
it will go. You will hear a click.
The lever will return to its original position
and is reset.
Your Accuhaler is now ready for you to use
again.
As with all inhalers, caregivers should ensure that children prescribed
Seretide Accuhaler use correct inhalation technique, as described above.

PHARMA CODE N° 6680

5
10000000119317
GSK-GBR-Ware-UKWAR
United Kingdom-GBR
Seretide
2

K

2587

JMF184

Cleaning your inhaler
Wipe the mouthpiece of the Accuhaler with a dry tissue to clean it.
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.
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 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 or COPD.
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 your heart 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.
• 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 heart beat, muscle weakness, cramp).

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 heart beat (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.
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 after the expiry date which is stated on the label
and carton after EXP. The expiry date refers to the last day of that
month.
• Do not store above 30°C.
Do not throw away medicines via wastewater or household waste. Ask
your pharmacist how to throw away medicines you no longer use. These
measures will help protect the environment.

6 Contents of the pack and other information

Manufacturer:
Glaxo Operations UK Ltd
Priory Street, Ware, Hertfordshire SG12 ODJ, United Kingdom.
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
Reference number

Seretide Accuhaler
10949/0314

This is a service provided by the Royal National Institute of Blind People.
This leaflet was last revised in 08/2014
Accuhaler and Seretide are registered trademarks of the GlaxoSmithKline
group of companies
© 2014 GlaxoSmithKline group of companies

What Seretide Accuhaler contains
• Each pre-dispensed dose contains 50 micrograms of salmeterol (as
salmeterol xinafoate) and 100, 250 or 500 micrograms of fluticasone
propionate.
• The other ingredient is lactose monohydrate (which contains milk
proteins).
What Seretide Accuhaler looks like and contents of the pack
• The Seretide Accuhaler contains a foil strip. The foil protects the
powder for inhalation from the effects of the atmosphere.
• Each dose is pre-dispensed.
• The devices are packed in cartons which hold:
1 x Accuhaler 28 inhalations
or 1, 2, 3 or 10 x Accuhaler each containing 60 inhalations.
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
10000000119317

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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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