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SERETIDE 25/250 EVOHALER

Active substance: SALMETEROL

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Package leaflet: Information for the user

Seretide® 25/125 Evohaler®
Seretide® 25/250 Evohaler®
(salmeterol xinafoate, fluticasone propionate)
The products name are Seretide 25/125 Evohaler and Seretide 25/250
Evohaler but will be referred to as Seretide throughout the remainer leaflet.
Please note the leaflet also contains information about other strengths of the
medicine, Seretide 25/50 Evohaler.
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.
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

1. What Seretide is and what it is used for
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.
You must use Seretide every day as directed by your doctor. This will make
sure that it works properly in controlling your asthma.
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.

2. What you need to know before you use Seretide
Do not take Seretide if:
You are allergic (hypersensitive) to salmeterol xinafoate, fluticasone propionate
or to the other ingredient norflurane (HFA 134a).

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

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.

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 puffs 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
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.

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

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.

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.

9. Afterwards, rinse your mouth with water and

Driving and using machines

10. After use always replace the mouthpiece

Seretide is not likely to affect your ability to drive or use machines.

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.

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.

Adults and adolescents aged 12 years and over
 Seretide Evohaler 25/50 - 2 puffs twice a day
 Seretide Evohaler 25/125 - 2 puffs twice a day
 Seretide Evohaler 25/250 - 2 puffs twice a day
Children 4 to 12 years of age
 Seretide Evohaler 25/50 - 2 puffs twice a day
 Seretide is not recommended for use in children below 4 years of age.

spit it out and/or brush your teeth. This may help to
stop you getting thrush and becoming hoarse.

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 use correct inhalation technique, as described above.

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.
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.
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.

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.

 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 fastacting ‘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
swallowing.

Frequency not known, but may also occur:

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.

 Depression or aggression. These effects are more likely to occur in children.

If you forget to use Seretide

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.

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.
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).
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.

Reporting of side effects

5. How to store Seretide
 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 your Seretide above 25°C.
 Do not store Seretide in a cold place, as your medicine may not work as well.
 Do not use after the expiry date printed on the carton and the canister label.
The expiry date refers to the last day of that month
 The metal canister contains a pressurized liquid. Do not puncture, break or
burn it even when apparently empty.
Medicines should not be disposed of via waste water or household waste. Ask
your pharmacist how to dispose of medicines no longer required. These
measures will help to protect the environment.

6. Contents of the pack and other information
What Seretide contains
 Each metered actuation contains 25 micrograms of the active ingredient
salmeterol (as the xinafoate) together with either 125 or 250 micrograms of
the active ingredient fluticasone propionate.
 The other ingredient is norflurane (HFA 134a).

What Seretide looks like and the contents of the pack
 Seretide 25/125 Evohaler is a pressurised metered dose inhaler with a metal
canister covered with a purple plastic cover and mouthpiece with a light
purple dust cover.
 Seretide 25/250 Evohaler is a pressurised metered dose inhaler with a metal
canister covered with a dark purple plastic cover and mouthpiece with a
lighter purple dust cover.
 The device is packed in cartons containing one Evohaler.
 Each canister provides 120 puffs or metered doses of a pressurised
inhalation suspension.

Manufacturer
This product is manufactured by Glaxo Wellcome Production, Zone Industrielle
N°2, 23 Rue Lavoisier, 27000 Evreux, France. Procured from within the EU
and repackaged by Mediwin Limited, Product Licence Holder: Mediport Limited
13 Martello Enterprise Centre, Courtwick Lane, Littlehampton, BN17 7PA,
United Kingdom.
POM
PL No: 18980/0360 Seretide 25/125 Evohaler
PL No: 18980/0361 Seretide 25/250 Evohaler
SERETIDE, EVOHALER, HALERAID AND VOLUMATIC ARE
TRADEMARKS OF THE GLAXOSMITHKLINE GROUP OF COMPANIES.
AEROCHAMBER PLUS IS A TRADEMARK OF TRUDELL MEDICAL
INTERNATIONAL.
Date of leaflet preparation: 24/06/2015

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.

PIL_0360_0361_S0013

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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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