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SERETIDE EVOHALER 125

Active substance: SALMETEROL

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6. CONTENTS OF THE PACK AND OTHER INFORMATION

776 LEAFLET Seretide Evo 20141215

PACKAGE LEAFLET: INFORMATION FOR THE USER

What Seretide Evohaler contains




SERETIDE EVOHALER 125
SERETIDE CFC-FREE INHALER 125

Each metered actuation or puff of Seretide Evohaler 125
provides 125 micrograms of the active ingredient fluticasone
propionate and 25 micrograms of the active ingredient
salmeterol (as the xinafoate)

SERETIDE EVOHALER 250
SERETIDE CFC-FREE INHALER 250
(salmeterol xinafoate/ fluticasone propionate)

Each metered actuation or puff of Seretide Evohaler 250
provides 250 micrograms of the active ingredient fluticasone
propionate and 25 micrograms of the active ingredient
salmeterol (as the xinafoate).

Your medicine is known by the above names but will be referred to
as Seretide throughout the following patient information leaflet.



It also contains a CFC free propellant HFA 134a (1,1,1,2tetrafluoroethane).

Please note that information regarding other strengths of Seretide
Evohaler is also present in the below leaflet.



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:

Each inhaler provides 120 metered actuations (puffs).

What Seretide Evohaler looks like and contents of the pack




Seretide Evohaler 125 consists of a pressurised metered-dose
inhaler with a purple plastic device and a counter and a lighter
purple cap.
Seretide Evohaler 250 consists of a pressurised metered-dose
inhaler with a purple plastic device and a counter and a lighter
purple cap.

Procured from within the EU and repackaged by the Product
Licence holder: Chemilines Ltd, Chemilines House, Alperton Lane,
Wembley, HA0 1DX.



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.



Glaxo Wellcome Production, Zone Industrielle 2, 23 rue
Lavoisier, F-27000 Evreux, France



Glaxo Wellcome S.A., Avenida Extremadura 3, E-09400 Aranda
de Duero, Burgos, Spain.

What Seretide is and what it is used for

2

This product is manufactured by either of the below manufacturers-



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
In this leaflet:
1

Manufacturer

ß-blockers (such as atenolol, propranolol and sotalol).
ß blockers are mostly used for high blood pressure or other
heart conditions.

Read all of this leaflet carefully before you start taking this
medicine because it contains important information for you.



The medicine is contained in a pressurised can, with a mouth
piece and an ‘actuator’. The can has a counter attached to
show you how many puffs of medicine you have left.
Product Licence holder



What you need to know before you use Seretide

3

How to use Seretide

4

Possible side effects

5

How to store Seretide

6

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.

Contents of the pack and other information

Driving and using machines
Seretide is not likely to affect your ability to drive or use machines.
3. HOW TO USE SERETIDE

1. WHAT SERETIDE IS AND WHAT IT IS USED FOR
PL No. 08747/0776 Seretide Evohaler 125
Seretide CFC-Free Inhaler 125

Always use this medicine exactly as your doctor or pharmacist has
told you. Check with your doctor or pharmacist if you are not sure.

Seretide contains two medicines, salmeterol and fluticasone
propionate:



PL No. 08747/0777 Seretide Evohaler 250
Seretide CFC-Free Inhaler 250

POM



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.

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

Fluticasone propionate is a corticosteroid which reduces
swelling and irritation in the lungs.



Seretide should be inhaled through the mouth into the lungs.

Leaflet revision date: 15 December 2014
Seretide, Evohaler, Haleraid, and Volumatic are registered trade
marks of GlaxoSmithKline group of companies.
776 LEAFLET Seretide Evo 20141215



The doctor has prescribed this medicine to help prevent breathing
problems such as asthma.

Adults and adolescents aged 12 years and over

You must use Seretide every day as directed by your doctor. This
will make sure that it works properly in controlling your asthma.



Seretide Evohaler 25/50 - 2 puffs twice a day



Seretide Evohaler 25/125 - 2 puffs twice a day

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.



Seretide Evohaler 25/250 - 2 puffs twice a day

2. WHAT YOU NEED TO KNOW BEFORE YOU USE SERETIDE

Your symptoms may become well controlled using Seretide twice a
day. If so, your doctor may decide to reduce your dose to once
daily. The dose may change to:

Do not take Seretide if:
You are allergic (hypersensitive) to salmeterol, fluticasone
propionate or to the other ingredient norflurane (HFA 134a).

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.

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

If you have ever had any of these conditions, tell your doctor before
you use Seretide.

once at night - if you have night-time symptoms


Warnings and precautions



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 in as slowly as possible just before
using your inhaler.
1 Stand or sit upright when using your inhaler.



Feeling shaky (tremor) and fast or uneven heart beat
(palpitations) - these are usually harmless and get less as
treatment continues.

Tiredness and loss of appetite, feeling sick



Chest pain.

Sickness and diarrhoea





Feeling worried (this effect mainly occurs in children).

Weight loss





Disturbed sleep.

Headache or drowsiness





Allergic skin rash.

Low levels of sugar in your blood



Low blood pressure and seizures (fits)

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.

These side effects may include any of the following:


Stomach pain




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.

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 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.

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).

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:

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



Slowing of growth in children and adolescents



Thinning of the bones

4. POSSIBLE SIDE EFFECTS



Glaucoma

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.



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.

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.

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).

Cleaning your inhaler

Other side effects are listed below:

To stop your inhaler blocking, it is important to clean it at least once
a week.

Very Common (affects more than 1 person in 10)


Headache - this usually gets better as treatment continues.

Reporting of side effects

To clean your inhaler:



Increased number of colds have been reported in patients with
COPD.

If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible side effects not listed in this leaflet.

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.



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.

Frequency not known, but may also occur:


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.



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.

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.

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

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.
5. HOW TO STORE SERETIDE

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
being hoarse.

KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.



Do not store above 25°C.



Do not store Seretide Evohaler in a cold place, as your
medicine may not work as well.

The following side effects have also been reported in patients with
Chronic Obstructive Pulmonary Disease (COPD):





Do not use after the expiry date printed on the carton label or
canister.

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.



Clean your inhaler on a weekly basis as described in the
section “Cleaning your inhaler”.





Throat irritation. Rinsing your mouth out with water and spitting
it out immediately after taking each puff may help.

The metal canister is pressurised. Do not puncture, break or
burn it even when apparently empty.





Bruising and fractures.



If your doctor tells you to stop using the inhaler, please take it
back to the pharmacist for safe disposal. Only keep the inhaler
if your doctor tells you to.

Inflammation of sinuses (a feeling of tension or fullness in the
nose, cheeks and behind the eyes, sometimes with a throbbing
ache).

Do not take a double dose to make up for a missed dose. Just take
your next dose at the usual time.



A reduction in the amount of potassium in the blood (you may
get an uneven heartbeat, muscle weakness, cramp).

If you stop using Seretide

5 Place the mouthpiece in your mouth between
your teeth. Close your lips around it. Do not bite.



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.

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 a 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.



Aching, swollen joints and muscle pain



Muscle cramps.

If you forget to use 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 problem 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.



Cataract (cloudy lens in the eye).



Very fast heartbeat (tachycardia).

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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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