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• Do not use after the expiry date printed on the
carton or accuhaler label.
• Keep this medicine out of the sight and reach of
• Do not store above 30ºC.


Ref: 0153/241012/1/F


(salmeterol xinafoate and fluticasone propionate)

If your doctor tells you to stop taking this medicine,
return any unused medicine to your pharmacist
(chemist) for safe disposal. Only keep this
medicine, if your doctor tells you to.
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
What Seretide Accuhaler contains
• Each blister contains powder for inhalation
providing 50 micrograms of fluticasone
propionate and 500 micrograms of salmeterol
(as the xinafoate), mixed with lactose
monohydrate (which acts as the carrier).
What Seretide Accuhaler looks like and
contents of the pack
• Your medicine is called Seretide Accuhaler 500,
and will be referred to as Seretide Accuhaler
throughout this Patient Information leaflet. Your
medicine contains a ‘preventer’ and a ‘protector’
in a single inhaler.
• An accuhaler is an easy to use inhaler, which is
designed to release a dose of medicine into
your lungs when you breathe in. Seretide
Accuhaler is a two tone, purple circular device
in moulded plastic containing white inhalation
powder and a dose counter indicating the
number of doses remaining with 60 regularly
spaced blisters.The blisters protect the powder
for inhalation from the effects of the
atmosphere. The device has a counter, which
tells you the number of blisters remaining. It
counts down from 60 to 0. To show when the
last five blisters have been reached the
numbers appear in red. When the counter
shows 0 your inhaler is empty and should be
disposed of.
Manufacturer and Licence Holder
Seretide Accuhaler is manufactured by Glaxo
Wellcome Operations, Priory Street, Ware,
Hertfordshire, SG12 0DJ, UK and 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.


Read all of this leaflet carefully before you
start taking this medicine.
• 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. Do
not pass it on to others. It may harm them, even
if their symptoms are the same as yours.
• If any of the side effects gets serious, or if you
notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.

Take special care with Seretide Accuhaler
Your doctor will supervise your treatment more
closely if you have medical conditions such as:
• heart disease, including an irregular or fast
• overactive thyroid gland
• high blood pressure
• diabetes mellitus (Seretide Accuhaler may
increase your blood sugar)
• low potassium in your blood
• Tuberculosis (TB) now or in the past.

Your medicine is called Seretide Accuhaler 500
and will be referred to as Seretide Accuhaler
throughout the rest of this leaflet.

If you have ever had any of these conditions, tell
your doctor before you use Seretide Accuhaler.

Please note that the leaflet also contains
information about other strengths of this medicine,
Seretide 250 and Seretide 500.
In this leaflet:
1. What Seretide Accuhaler is and what it is used
2. Before you use Seretide Accuhaler
3. How to use Seretide Accuhaler
4. Possible side effects
5. How to store Seretide Accuhaler
6. Further information
Seretide Accuhaler 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.

Taking other medicines
Please 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 Accuhaler 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
• Beta-blockers (such as atenolol, propranolol and
sotalol). Beta-blockers are mostly used for high
blood pressure or other heart conditions.
• Antiviral and antifungal medicines (such as
ritonavir, ketoconazole and itraconazole). 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
Accuhaler, including irregular heartbeats, 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.
Pregnancy and breast-feeding
If you are pregnant, planning to get pregnant or
breast-feeding, talk to your doctor before taking
Seretide Accuhaler. Your doctor will assess
whether you can take Seretide Accuhaler during
this time.

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

Driving and using machines
Seretide Accuhaler is not likely to affect your ability
to drive or use machines.

Seretide Accuhaler helps to stop
breathlessness and wheeziness coming on. It
does not work once you are breathless or
wheezy. If that happens you need to use a fast
acting ‘reliever’ medication, such as

Important information about some of the
ingredients of Seretide Accuhaler
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.

PL 15184/0153 - Seretide Accuhaler 500
Seretide and Accuhaler are registered trademarks
of the GlaxoSmithKline Group of Companies.
Leaflet revision date: 24/10/12

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

Do not take Seretide Accuhaler if:
You are allergic (hypersensitive) to salmeterol
xinafoate, fluticasone propionate or to the other
ingredient lactose monohydrate.

Use your Seretide Accuhaler every day, until
your doctor advises you to stop.
• Always use Seretide Accuhaler exactly as your
doctor has told you. Don’t exceed the
recommended dose. Check with your doctor or
pharmacist if you’re not sure

Using your inhaler

For asthma
Adults and adolescents aged 12 years and
• Seretide 50/500 Accuhaler - 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 50/500 Accuhaler - 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
• once in the morning - if you have daytime
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 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.

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
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. Hold the Accuhaler away from your mouth,
breathe out as far as is comfortable. Do not
breathe into your Seretide Accuhaler.
4. 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. This may help to stop you getting thrush
and being 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.
Cleaning your inhaler
Wipe the mouthpiece of the Seretide 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
a headache, muscle weakness and aching joints.

If you forget to use Seretide
If you forget to use your inhaler, take your next
dose when it is due.
Do not take a double dose to replace the one you
If you stop using Seretide Accuhaler
It is very important that you take your Seretide
Accuhaler every day as directed. Keep taking it
until your doctor tells you to stop. Do not stop or
suddenly reduce your dose of Seretide Accuhaler.
This could make your breathing problem worse
and very rarely side effects could occur.
These include:
• stomach pain
• tiredness and loss of appetite
• sickness and diarrhoea
• weight loss
• headache or drowsiness
• low levels of potassium in your blood
• low blood pressure and seizures.
Very rarely, if you get an infection or at times of
extreme stress (such as after a serious accident or
if you have surgery), you may get similar side
To prevent these symptoms occurring, your doctor
may prescribe extra corticosteroids (like
If you have any further questions on using the
inhaler, ask your doctor or pharmacist.
Like all medicines, Seretide Accuhaler 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 Accuhaler to
control your asthma or COPD.
Allergic reactions: you may notice your
breathing suddenly gets worse after using
Seretide Accuhaler. You may be very wheezy
and cough. You may also notice itching and
swelling (usually of the face, lips, tongue, or
throat). If you get these effects or if they
happen suddenly after using Seretide
Accuhaler, tell your doctor straight away.
Allergic reactions to Seretide Accuhaler 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
• 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. Rinsing your mouth out with
water and spitting it out immediately after
taking each puff may help. Your doctor may
prescribe an anti fungal medication to treat the
• Aching, swollen joints and muscle pain

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)
• Very fast heartbeat (tachycardia).
• Feeling shaky and fast or uneven heart beat
(palpitations) - these are usually harmless and get
less as treatment continues.
• Muscle cramps.
• Feeling worried (this effect mainly occurs in
• Throat irritation. Rinsing your mouth out with
water and spitting it out immediately after taking
each puff may help.
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 Accuhaler.
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 includes:
- slowing of growth in children and adolescents
- thinning of the bones
- cataract and glaucoma
- weight gain
- rounded (moon shaped) face (Cushing’s
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
• 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.
• Disturbed sleep and behavioural changes, such
as being unusually active and irritable (these
effects mainly occur in children).
• Uneven heartbeat or heart gives an extra beat
(arrhythmias). Tell your doctor, but do not stop
taking Seretide unless they tell you to stop.
• Rash.

Frequency not known, but may also occur:
Depression or aggression. These effects are
more likely to occur in children.

If any of the side effects become serious, or if you
notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.

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.

Ref: 0153/241012/1/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.