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SERETIDE 125 MICROGRAM EVOHALER

Active substance(s): FLUTICASONE PROPIONATE / SALMETEROL

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Instructions for use


SERETIDE™ 125 MICROGRAM EVOHALER™
(salmeterol xinafoate / fluticasone propionate)




PATIENT INFORMATION LEAFLET
Seretide Evohaler is available in the following strengths: 50, 125 and 250 micrograms. This leaflet only
applies to Seretide 125 microgram Evohaler but will be referred to as Seretide Evohaler throughout this
leaflet.
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.



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.

Using your inhaler

What is in this leaflet:
1. What Seretide Evohaler is and what it is used for
2. What you need to know before you use Seretide Evohaler
3. How to use Seretide Evohaler
4. Possible side effects
5. How to store Seretide Evohaler
6. Contents of the pack and other information
1.

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.

It is important to start to breathe as slowly as possible just before using your inhaler.

WHAT SERETIDE EVOHALER IS AND WHAT IT IS USED FOR

Seretide Evohaler 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.

1.

Stand or sit upright when using your inhaler.

2.

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.

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.

4.

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.

6.

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.

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.

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.

The doctor has prescribed this medicine to help prevent breathing problems such as asthma.
You must use Seretide Evohaler every day as directed by your doctor. This will make sure that it works
properly in controlling your asthma.
Seretide Evohaler helps to stop breathlessness and wheeziness coming on. However
Seretide Evohaler 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 EVOHALER

Do not take Seretide Evohaler:

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

Warnings and precautions

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 Evohaler may increase your blood sugar)

Low potassium in your blood

Tuberculosis (TB) now, or in the past, or other lung infections

Other medicines and Seretide Evohaler

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other
medicines. This includes medicines for asthma or any medicines obtained without a prescription. This is
because Seretide Evohaler 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 Evohaler:

Beta blockers (such as atenolol, propranolol and sotalol). Beta 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 Evohaler, 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 breast-feeding

If you are pregnant or breast-feeding, 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 Evohaler is not likely to affect your ability to drive or use machines.

3.

HOW TO USE SERETIDE EVOHALER

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 Evohaler 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 Evohaler or reduce the dose of Seretide Evohaler without talking to
your doctor first.

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

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.

Adults and adolescents aged 12 years and over





Seretide 50 microgram Evohaler - 2 puffs twice a day
Seretide 125 microgram Evohaler - 2 puffs twice a day
Seretide 250 microgram Evohaler - 2 puffs twice a day

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.

Children 4 to 12 years of age




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

Your symptoms may become well controlled using Seretide Evohaler 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.

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.

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 Evohaler 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 Evohaler 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.

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.

Page 1 of 2

If you use more Seretide Evohaler 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.

5.








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 Evohaler may reduce the amount of steroid
hormones produced by the adrenal gland.



If you forget to use Seretide Evohaler
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 Evohaler



It is very important that you take your Seretide Evohaler every day as directed. Keep taking it until
your doctor tells you to stop. Do not stop or suddenly reduce your dose of Seretide Evohaler.
This could make your breathing worse.
In addition, if you suddenly stop taking Seretide Evohaler or reduce your dose of Seretide Evohaler 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.



6.

HOW TO STORE SERETIDE EVOHALER

Keep out of the sight and reach of children.
Straight after use, replace the mouthpiece cover firmly and click it into position. Do not use
excessive force.
Do not store the inhaler above 25°C. Protect from frost and direct sunlight.
Do not store Seretide Evohaler in a cold place, as your medicine may not work as well.
WARNING. The metal container is pressurised. Do not puncture, break or burn it even when
apparently empty.
Do not use after the date shown as 'EXP' on the carton and canister label. The expiry date refers to
the last day of that month.
If your doctor decides to stop the treatment, return any leftover medicine to the pharmacist.
Only keep it if your doctor tells you to.
If your medicine appears discoloured or shows any other signs of deterioration, take it to your
pharmacist who will advise you.
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.

CONTENTS OF THE PACK AND OTHER INFORMATION

What Seretide Evohaler contains

Each metered actuation contains 125 micrograms of fluticasone propionate and 25 micrograms of
salmeterol (as xinafoate). It also contains a CFC-free propellant, Norflurane (HFA 134a).

What Seretide Evohaler looks like and contents of the pack

Seretide Evohaler is one, two-piece, ‘L’ shaped two tone purple moulded, plastic Evohaler comprising
an aluminium alloy pressurised container sealed with a metering valve. The container is fitted into a
plastic actuator incorporating an atomising mouthpiece and fitted with a dustcap. The container has a
counter attached.
Each container provides 120 metered actuations.

Manufacturer

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).

Seretide Evohaler is manufactured by: Glaxo Wellcome Productions, Evreux, France.

If you have any further questions on the use of this medicine, ask your doctor, nurse or pharmacist.

Procured from within the EU and repackaged by: Doncaster Pharmaceuticals Group Ltd., Kirk Sandall,
Doncaster, DN3 1QR.

4.

Product Licence holder: BR Lewis Pharmaceuticals Ltd., Kirk Sandall, Doncaster, DN3 1QR.

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 Evohaler to control
your asthma.

PL No: 08929/0115

POM

Leaflet revision and issue date: 08.06.15
Allergic reactions: you may notice your breathing suddenly gets worse immediately after
using Seretide Evohaler. 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 Evohaler, stop using Seretide Evohaler and tell your doctor straight
away. Allergic reactions to Seretide Evohaler are uncommon (they affect less than 1 person in 100).

Seretide™, Evohaler™, Haleraid™ and Volumatic™ are trademarks of the GlaxoSmithKline group of
companies.
Aerochamber Plus™ is a trademark of Trudell Medical International.

Other formats:

To listen to or request a copy of this leaflet in Braille, large print or audio, please call 01302 365000
and ask for the Regulatory Department.

Other side effects are listed below:

Very Common (affects more than 1 person in 10)



Please be ready to give the following information:
Product name:
Seretide 125 microgram Evohaler
Reference number: 08929/0115

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 antifungal 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).

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)







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 Evohaler unless the doctor tells you to stop.
A fungal infection in the oesophagus (gullet), which might cause difficulties in swallowing.

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.

Page 2 of 2

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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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