SERETIDE ACCUHALER 50 MICROGRAM/250 MICROGRAM/ DOSE INHALATION POWDER PRE-DISPENSED

Active substance: SALMETEROL

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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.
• Cloudy lens in the eye.
• Very fast heartbeat (tachycardia).
• Feeling shaky 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.
• 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 includes:
− 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 heartbeat or heart gives an extra beat
(arrhythmias). Tell your doctor, but do not
stop taking Seretide unless they tell you to
stop.
Frequency not known, but may also ocur:
• 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.
Reporting of side effects
If you get any side effects, talk to your doctor,
pharmacist or nurse. This includes any possible
side effects not listed in this leaflet. You can also
report side effects directly via the Yellow Card
Scheme at www.mhra.gov.uk/yellowcard.
By reporting side effects, you help provide more
information on the safety of this medicine.

5. HOW TO STORE SERETIDE ACCUHALER
• Keep out of the sight and reach of children.
• Do not use after the expiry date printed on the
carton or accuhaler label.
• Do not store above 30ºC.
Medicines should not be disposed of via
wastewater or household waste. Ask your
pharmacist how to dispose of medicines no longer
required. These measures will help to protect the
environment.
6. FURTHER INFORMATION
What Seretide Accuhaler contains
• Each blister contains 50 micrograms salmeterol
(as the xinafoate) and 250 micrograms
fluticasone propionate together with the inactive
ingredient lactose monohydrate, (which acts as
the carrier).
What Seretide Accuhaler looks like and
contents of the pack
Seretide Accuhaler is a two tone, purple, circular
device in moulded plastic containing a foil strip
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.
Manufacturer and Licence Holder
Seretide Accuhaler is manufactured by Glaxo
Wellcome Production, Zone Industrielle No. 2, 23,
rue Lavoisier 27000, France 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.

POM

PL 15184/1275

Seretide and Accuhaler are registered trademarks
of the GlaxoSmithKline Group of Companies.
Leaflet revision date: 10/12/13

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

PATIENT INFORMATION LEAFLET
®

SERETIDE ACCUHALER

Ref: 1275/101213/1/F

®

50 microgram/250 microgram/dose Inhalation powder, pre-dispensed
(salmeterol/ fluticasone propionate)
Counter
Outer Case

Mouthpiece

Full Empty
60
0

Thumbgrip
Lever

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.
Your medicine is called Seretide Accuhaler 50
microgram/250 microgram/dose Inhalation powder,
pre-dispensed and will be referred to as Seretide
Accuhaler throughout the rest of this leaflet.
Please note that this leaflet also contains
information about other strengths of this medicine
Seretide 100 Accuhaler and Seretide 500
Accuhaler.
In this leaflet:
1. What Seretide Accuhaler is and what it is used
for
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
1. WHAT SERETIDE ACCUHALER IS AND
WHAT IT IS USED FOR
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.
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
COPD.

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
salbutamol.
2. BEFORE YOU USE SERETIDE ACCUHALER
Do not take Seretide Accuhaler if:
You are allergic (hypersensitive) to salmeterol
xinafoate, fluticasone propionate or to the other
ingredient lactose monohydrate.
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
heartbeat
• 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.
If you have ever had any of these conditions, tell
your doctor before you use Seretide Accuhaler.
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
Accuhaler:
• 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.
Driving and using machines
Seretide Accuhaler is not likely to affect your ability
to drive or use machines.
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.
3. HOW TO USE SERETIDE ACCUHALER
• Use your Seretide Accuhaler every day, until
your doctor advises you to stop.
• Always use Seretide exactly as your doctor has
told you. Don’t exceed the recommended dose.
Check with your doctor or pharmacist if you’re
not sure.
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 Accuhaler 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 Accuhaler
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 Seretide
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 Seretide
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 pushed 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 Seretide 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 Seretide
Accuhaler, not through
your nose. Remove the
Seretide 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 Seretide
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 Seretide 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 Accuhaler 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 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 Accuhaler may reduce the amount of
steroid hormones produced by the adrenal gland.
If you forget to use Seretide Accuhaler
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 forgot.
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
effects.
To prevent these symptoms occurring, your doctor
may prescribe extra corticosteroids (like
prednisolone).
If you have any further questions on using the
inhaler, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
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. 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, 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 after taking each puff 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 heartbeat,
muscle weakness, cramp).

Ref: 1275/101213/1/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.

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