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ALIFLUS 125 EVOHALER

Active substance(s): FLUTICASONE PROPIONATE / SALMETEROL XINAFOATE

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PACKAGE LEAFLET: INFORMATION FOR THE USER
SERETIDE® 125 EVOHALER®
(salmeterol xinafoate / fluticasone propionate)
This product is available in the above name and strength but will be
referred to as Seretide throughout the remainder of this leaflet.
This product is available in multiple strengths and all strengths will
be referred to 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.
What is 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
fastacting reliever’ (‘rescue’) inhaler, such as salbutamol. You
should always have your fast-acting ‘rescue’ inhaler with you.
2.

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.

What you need to know before you use Seretide

Do not take Seretide:
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 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, 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
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.
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.
Driving and using machines
Seretide is not likely to affect your ability to drive or use machines.
3.

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.

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.

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 mouth piece 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.
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.
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.

+ Expand Transcript

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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