SERETIDE EVOHALER 125

Active substance: SALMETEROL

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776 LEAFLET Seretide Evo 20121123

Adults and adolescents aged 12 years and over

PACKAGE LEAFLET: INFORMATION FOR THE USER



Seretide Evohaler 25/50 - 2 puffs twice a day

SERETIDE EVOHALER 125
SERETIDE CFC-FREE INHALER 125
SERETIDE EVOHALER 250
SERETIDE CFC-FREE INHALER 250
(salmeterol xinafoate/ fluticasone propionate)



Seretide Evohaler 25/125 - 2 puffs twice a day



Seretide Evohaler 25/250 - 2 puffs twice a day

Your medicine is known by the above names but will be referred to
as Seretide throughout the following patient information leaflet.
Please note that information regarding other strength Seretide
Evohaler 50 is also present in the below leaflet.
Read all of this leaflet carefully before you start taking this
medicine.


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. Do not pass it on to
others. It may harm them, even if their symptoms are the same
as yours.



If any of the side effects gets serious, or if you notice any side
effects not listed in this leaflet, please tell your doctor or
pharmacist.

In this leaflet:
1

What Seretide is and what it is used for

2

Before you use Seretide

3

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 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:


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 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

How to use Seretide

4

How to store Seretide

6

Further information

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.

Possible side effects

5



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.

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.

Testing your inhaler

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. It does not work once you are breathless or wheezy. If that
happens you need to use a fast acting ‘reliever’ medication,
such as salbutamol.
2. BEFORE YOU USE SERETIDE
Do not take Seretide if:
You are allergic (hypersensitive) to salmeterol, fluticasone
propionate or to the other ingredient norflurane (HFA 134a).
Take special care with Seretide
Your doctor will supervise your treatment more closely if you have
medical conditions such as:


heart disease, including an irregular or fast heartbeat



overactive thyroid gland



low potassium in your blood



1 Stand or sit upright when using your inhaler.

diabetes mellitus (Seretide may increase your blood sugar)



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

high blood pressure



Using your inhaler

Tuberculosis (TB) now, or in the past.

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 objects.

If you have ever had any of these conditions, tell your doctor before
you use Seretide.
Taking other medicines
Please 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:


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



Antiviral and antifungal medicines (such as ritonavir,
ketoconazole and itraconazole). 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.

3 Shake the inhaler 4 or 5
4 Hold the inhaler upright with
times to ensure that
your thumb on the base,
any loose objects are removed
below the mouthpiece.
and that the contents of the
Breathe out as far as is
inhaler are evenly mixed.
comfortable.



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.

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

6 Breathe in through your mouth.
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.

Pregnancy and breast-feeding
If you are pregnant, planning to get pregnant, or breast-feeding, talk
to your doctor before taking Seretide.
Your doctor will assess whether you can take Seretide during this
time.
Driving and using machines

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.

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


Use your Seretide every day, until your doctor advises you to
stop.



Always use Seretide exactly as your doctor has told you. Don’t
exceed the recommended dose. Check with your doctor or
pharmacist if you’re not sure.

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. This may
help to stop you getting thrush and being 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.

Uncommon (affects less than 1 person in 100)

If you or your child find it difficult to use the Evohaler, either the
Volumatic™ or Aerochamber Plus™ spacer device may be used.
Before starting to use a spacer device for the first time or if you
need to change your make of spacer device, talk to your doctor,
nurse or pharmacist. 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.



Very fast heartbeat (tachycardia).



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



Muscle cramps.



Feeling worried (this effect mainly occurs in children).



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

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:

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



slowing of growth in children and adolescents

To clean your inhaler:



thinning of the bones



Remove the mouthpiece cover.



cataract and glaucoma



Do not remove the metal canister from the plastic casing at any
time.



weight gain



rounded (moon shaped) face (Cushing’s Syndrome).



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.

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.


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.

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 headache, muscle
weakness and aching joints.

Disturbed sleep and behavioural changes, such as being
unusually active and irritable (these effects mainly occur in
children).



Uneven heartbeat or heart gives an extra beat (arrhythmias).
Tell your doctor, but do not stop taking Seretide unless they tell
you to stop.



Rash.

Do not put the metal canister in water.

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.

Frequency not known, but may also occur:


If you forget to use Seretide
If you forget to use your inhaler, take your next dose when it is due.
Do not take a double dose to replace the one you forgot.

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

If any of the side effects become serious, or if you notice any side
effects not listed in this leaflet, please tell your doctor or pharmacist.

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.

5. HOW TO STORE SERETIDE EVOHALER


KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.

Do not stop or suddenly reduce your dose of Seretide. This could
make your breathing problem worse and very rarely side effects
could occur.



Do not store above 25°C.



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



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



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



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.M

These include:


Stomach pain



Tiredness and loss of appetite



Sickness and diarrhoea



Weight loss



Headache or drowsiness



Low levels of potassium in your blood



Low blood pressure and seizures.

Very rarely, if you get an infection or at times of extreme stress
(such as after a serious accident or if you have surgery), you may
get similar side effects.

ATION
6. FURTHER INFORMATION
What Seretide Evohaler contains


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)



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).



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



Each inhaler provides 120 metered actuations (puffs).

To prevent these symptoms occurring, your doctor may prescribe
extra corticosteroids (like prednisolone).
If you have any further questions on using your inhaler, ask your
doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Seretide 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 after using Seretide. You may be very wheezy and
cough. You may also notice itching and swelling (usually of the
face, lips, tongue or throat). If you get these effects or if they
happen suddenly after using Seretide, 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:

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.



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.

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. Rinsing your mouth
out with water and spitting it out immediately after taking each
puff may help. Your doctor may prescribe an antifungal
medication to treat the thrush.
Aching, swollen joints and muscle pain.

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.

Product Licence holder
Procured from within the EU and repackaged by the Product
Licence holder: Chemilines Ltd, Chemilines House, Alperton Lane,
Wembley, HA0 1DX.
Manufacturer
This product is manufactured by Glaxo Wellcome S.A., Avda
Extremuda, 3 09400 Aranda de Duero, Burgos, Spain.
POM

PL No. 08747/0776 Seretide Evohaler 125
Seretide CFC-Free Inhaler 125
PL No. 08747/0777 Seretide Evohaler 250
Seretide CFC-Free Inhaler 250
rd



Bruising and fractures.

Leaflet revision date: 23 November 2012



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

Seretide, Evohaler, Haleraid, and Volumatic are registered trade
marks of GlaxoSmithKline group of companies.



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

776 LEAFLET Seretide Evo 20121123

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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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