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salmeterol/fluticasone propionate

Package leaflet: Information for the user




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


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.
- T his 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
- 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.
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

Other medicines and 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.

Tell your doctor or pharmacist if you are taking, have recently taken, or might take
any other medicines including 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
• 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 ketoconazole, itraconazole and
erythromycin) including some medicines for HIV treatment (such as ritonavir,
cobicistat containing products). 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. Your doctor may wish to monitor you
carefully if you are taking these medicines.
• 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.

2 What you need to know before you use Seretide

Pregnancy and breastfeeding

Do not take Seretide:

If you are allergic to salmeterol, fluticasone propionate or to the other ingredient
lactose monohydrate.

Warnings and precautions

What is in this leaflet:

1 What Seretide is and what it is used for

Talk to your doctor before using Seretide if you have:
• Heart disease, including an irregular or fast heart beat
• Overactive thyroid gland
• High blood pressure
• Diabetes mellitus (Seretide may increase your blood sugar)
• Low potassium in your blood
• Tuberculosis (TB) now or in the past, or other lung infections

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.

Seretide Accuhaler contains lactose

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. The excipient lactose monohydrate contains small
amounts of milk proteins, which may cause allergic reactions.

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
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


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.


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.


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


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

The lever will return to its original position and is

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.


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

If you stop using Seretide
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It is very important that you take your Seretide every day as directed. Keep
taking it until your doctor tells you to stop. Do not stop or suddenly
reduce your dose of Seretide. This could make your breathing worse.
In addition, if you suddenly stop taking Seretide or reduce your dose of Seretide
this may (very rarely) cause you to have problems with your adrenal gland
(adrenal insufficiency) which sometimes causes side effects.
These side effects may include any of the following:
• Stomach pain
• Tiredness and loss of appetite, feeling sick
• Sickness and diarrhoea
• Weight loss
• Headache or drowsiness
• Low levels of sugar in your blood
• Low blood pressure and seizures (fits)
When your body is under stress such as from fever, trauma (such as a car
accident), infection, or surgery, adrenal insufficiency can get worse and you may
have any of the side effects listed above.

If you get any side effects, talk to your doctor or pharmacist. To prevent these
symptoms occurring, your doctor may prescribe extra corticosteroids in tablet
form (such as prednisolone).
If you have any further questions on the use of this medicine, ask your doctor, nurse
or pharmacist.

4 Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody
gets them. To reduce the chance of side effects, your doctor will prescribe the
lowest dose of Seretide to control your asthma 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 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).

Pneumonia (infection of the lung) in COPD patients. (Common side
Tell your doctor if you have any of the following while taking Seretide they
could be symptoms of a lung infection:
• fever or chills
• increased mucus production, change in mucus colour
• increased cough or increased breathing difficulties
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):
• 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.
• A fungal infection in the oesophagus (gullet), which might cause difficulties in

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: or search for MHRA Yellow Card in the
Google Play or Apple App Store.
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 this medicine 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 any 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
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

Glaxo Wellcome Production
Zone Industrielle No.2, 23 Rue Lavoisier, La Madeleine, 27000 Evreux, France.
Tel: +33 2 3223 5500; Fax: +33 2 3223 5558

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 Accuhaler
Reference number 10949/0314
This is a service provided by the Royal National Institute of Blind People.
This leaflet was last revised in November 2017.
Trade marks are owned by or licensed to the GSK group of companies.
© 2017 GSK group of companies or its licensor.

• 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
Middlesex UB11 1BT

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Further information

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