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SEREVENT EVOHALER 25 MICROGRAM PER ACTUATION PRESSURISED INHALATION SUSPENSION

Active substance(s): SALMETEROL

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Patient Information Leaflet

Serevent™ Evohaler™ 25 microgram per
actuation pressurised inhalation suspension
(salmeterol xinafoate)
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.
The name of your medicine is Serevent Evohaler 25 mircrogram per
actuation pressurised inhalation suspension but will be referred to as
Serevent Evohaler throughout the remainder of the leaflet.
In this leaflet:
1. What Serevent Evohaler is and what it is used for
2. Before you use Serevent Evohaler
3. How to use Serevent Evohaler
4. Possible side effects
5. How to store Serevent Evohaler
6. Contents of the pack and other information
1. What Serevent Evohaler is and what it is used for
• Serevent Evohaler contains the medicine salmeterol. It is a ‘longacting bronchodilator’. It helps the airways in the lungs to stay open.
This makes it easier for air to get in and out. The effects are usually
felt within 10 to 20 minutes and last for 12 hours or more.
• The doctor has prescribed it to help prevent breathing problems.
These could be caused by asthma. Taking Serevent Evohaler
regularly will help prevent asthma attacks. This also includes asthma
brought on by exercise or at night.
• Taking Serevent Evohaler regularly will also help prevent breathing
problems caused by other chest illnesses such as Chronic Obstructive
Pulmonary Disease (COPD).
• Serevent Evohaler helps to stop breathlessness and wheezing coming
on. It does not work once you are breathless or wheezy. If that
happens you need to use a fast acting ‘reliever’ medicine, such as
salbutamol.
• Serevent Evohaler is supplied to you in an inhaler. You breathe the
medicine directly into your lungs.
• Serevent Evohaler contains norflurane. This is less harmful to the
environment than older inhalers. Older inhalers may taste differently to
Serevent Evohaler. This will make no difference to how your medicine
works.
If you are being treated for asthma, you should always be given
both a Serevent and a steroid inhaler to use together.
2. What you need to know before you use Serevent Evohaler
Do not take Serevent Evohaler if:
you are allergic (hypersensitive) to salmeterol or to the other ingredient
norflurane (HFA 134a).
Take special care with Serevent Evohaler
• 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, do not increase your number of puffs
of Serevent. Your chest condition may be getting worse and you could
become seriously ill. See your doctor as you may need a change in
asthma treatment.
• Once your asthma is well controlled your doctor may consider it
appropriate to gradually reduce the dose of Serevent.
• If you have been prescribed Serevent for your asthma, continue to use
any other asthma medication you are already taking. These could
include a steroid inhaler or steroid tablets. Continue taking the same
doses as before, unless your doctor tells you otherwise. Do this even if
you feel much better. Do not stop taking your steroid inhaler (or
any steroid tablets) when you start using Serevent.
• Your doctor may want to check your health regularly if you have an
overactive thyroid gland, diabetes mellitus (Serevent may increase
your blood sugar) or heart disease, including an irregular or fast
heartbeat.
Other medicines and Serevent
• Tell your doctor if you are taking or have recently taken any other
medicines. This includes those for asthma or any other medicines
obtained without a prescription. This is because Serevent may not be
suitable to be taken with other medicines.
• Inform your doctor before using Serevent if you are currently being
treated for any fungal infections with medicines containing
ketoconazole or itraconazole, or if you are being treated for HIV with
ritonavir. These medicines may increase the risk of you experiencing
side effects with Serevent, including irregular heart beats, or may
make side effects worse.
• Beta-Blockers should be avoided when taking Serevent, unless your
doctor tells you to take them. Beta-blockers, including atenolol,
propranolol and sotalol, are mostly used for high blood pressure or
other heart conditions. Tell your doctor if you are taking beta-blockers
or have recently been prescribed beta-blockers as they may reduce or
abolish the effects of salmeterol.

• Serevent can reduce the amount of potassium in your blood. If this
happens you may notice an uneven heartbeat, muscle weakness or
cramp. This is more likely to happen if you take Serevent with some
medicines used to treat high blood pressure (diuretics) and other
medicines used to treat breathing problems such as theophylline or
steroids. Your doctor may ask for you to have blood tests to check the
amount of potassium in your blood. If you have any concerns discuss
them with your doctor.
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
The possible side effects associated with Serevent are unlikely to affect
your ability to drive or use machines.
3. How to use Serevent 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.
• If you are being treated for asthma, you should always be given
both a Serevent and a steroid inhaler to use together.
• Use Serevent every day, until your doctor advises you to stop.
• You will start to feel your medicine working within the first day of use.
Serevent is for inhalation by mouth only.
Adults and adolescents aged 12 years and older with Asthma
• The usual starting dose is 2 puffs twice a day.
• For people with more severe asthma, your doctor may increase your
dose to 4 puffs twice a day.
Children with Asthma
• In children aged 4 to 12 the usual dose is 2 puffs twice a day.
• Serevent is not recommended for use in children below 4 years of age.
Adults with Chronic Obstructive Pulmonary Disease (COPD)
including bronchitis and emphysema
• The usual starting dose is 2 puffs twice a day.
• Not applicable for children and adolescents.
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 inhaler properly or as prescribed, may mean that the medicine will not
help your asthma or COPD as it should.
The medicine is contained in a pressurised canister in a plastic casing
with a mouthpiece.
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. If you have
not used the inhaler for a week or more, release one puff 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.
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.
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. Just after
starting to breathe in, press 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. After use always replace the mouthpiece cover immediately to keep
out dust. Replace the cover by firmly pushing and snapping the cap into
position.
Practice in front of a mirror for the first few times. If you see a ‘mist’
coming from the top of your inhaler or the sides of your mouth you should
start again.
If you or your child find it difficult to use Serevent Evohaler, it may be
used with other devices to make its use easier e.g. a Haleraid™ or
Volumatic™ spacer device. Serevent is also available in an alternative
device. Talk to your doctor, nurse or pharmacist for further advice.
Cleaning your inhaler
To stop your inhaler blocking up, 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.
Do not put the metal canister in water.
If you use more Serevent 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
and/or dizzy. You may also have a headache, muscle weakness and
aching joints.

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.
5. How to store Serevent 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 above 30°C. Protect from heat.
• The metal canister contains a pressurised liquid. Do not puncture,
break or burn it even if you think it is empty.
• Do not use Serevent after the expiry date which is stated on the label
and carton. The expiry date refers to the last day of the month. If your
inhaler shows signs of deterioration or fails to work properly please
seek the advice of a pharmacist.
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.
6. Further Information
WHAT SEREVENT EVOHALER CONTAINS
Serevent Evohaler is a pressurised metered-dose inhaler with a metal
canister covered with dark green plastic body and a lighter green dust
cover. Serevent Evohaler delivers your medicine directly into your lungs
where it is needed. Each metered actuation of pressurised suspension
for inhalation provides 25 micrograms of the active ingredient salmeterol
(as salmeterol xinafoate). It also contains CFC-free propellant Norflurane
(HFA134a).
Serevent Evohaler is a new CFC-free inhaler
Serevent Evohaler is for oral inhalation only
Each canister contains 120 metered actuations.
PL 20774/0951 Serevent Evohaler 25 microgram per actuation
pressurised inhalation suspension.

If you forget to use Serevent Evohaler
Do not take a double dose to make up for a missed dose. Just take your
next dose at the usual time.
If you have any further questions on the use of this medicine, ask your
doctor or pharmacist.
4. Possible side effects
Like all medicines, Serevent can cause side effects, although not
everybody gets them. To reduce the chances of side effects, your doctor
will prescribe the lowest dose of Serevent to control your asthma or
COPD. These are the side effects reported by people taking Serevent.
Allergic reactions: you may notice your breathing suddenly gets
worse after using Serevent.
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 they happen suddenly after using Serevent, tell your doctor
straight away. Allergic reactions to Serevent are very rare (they affect
less than 1 person in 10,000).
Other side effects are listed below:
Common (affects less than 1 person in 10):
• Muscle cramps
• Feeling shaky; fast or uneven heartbeat (palpitations), headache,
shaking hands (tremor). Tremors are more likely if you are taking more
than two puffs twice daily. These side effects do not last long and
happen less as treatment with Serevent continues.
Uncommon (affects less than 1 person in 100):
• Rash
• Very fast heart rate (tachycardia). This is more likely to happen if you
are taking more than two puffs twice daily.
• Feeling nervous.
Rare (affects less than 1 person in 1,000):
• Feeling dizzy
• Being unable to sleep or finding sleep difficult
• A reduction in the amount of potassium in your blood (you may get an
uneven heartbeat, muscle weakness, cramp).
Very rare (affects less than 1 person in 10,000):
• Breathing difficulties or wheezing that gets worse straight after
taking Serevent. If this happens stop using your Serevent
Evohaler. Use your fast-acting ‘reliever’ inhaler to help your breathing
and tell your doctor straight away.
• Uneven heartbeat or your heart gives an extra beat (arrhythmias). If
this happens do not stop using Serevent but tell your doctor.
• 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.
• Sore mouth or throat
• Feeling sick (nausea)
• Aching, swollen joints or chest pain.

POM
This medicine is manufactured by Glaxo Wellcome Production Zone
Industrielle n°2-23 rue Lavoisier – 27000 Evreux - France and is
procured from within the EU by the Product Licence holder: Quadrant
Pharmaceuticals Ltd, and repackaged by Maxearn Ltd, Lynstock House,
Lynstock Way, Lostock, Bolton BL6 4SA.
th

Leaflet date 24 July 2014
Evohaler and Serevent are trademarks of the GlaxoSmithKline group of
companies
PP4/0951/V3

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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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