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SEREVENT EVOHALER 25 MICROGRAMS PER ACTUATION PRESSURISED INHALER SUSPENSION

Active substance(s): SALMETEROL

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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.

6. CONTENTS OF THE PACK AND OTHER
INFORMATION
What this medicine contains:
The active substance in salmeterol (as xinafoate)
Each puff provides 25 micrograms of the active
ingredient salmeterol.
There are 120 puffs in each canister.
The other ingredient is norflurane (HFA 134a).

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.

Manufacturer and Licence Holder
This medicine is manufactured by Glaxo Wellcome
Production, Zone Industrielle No.2, 23 Rue
Lavoisier, Evreux, F-27000, France and is
procured from within the EU and repackaged by
the Product Licence Holder: Lexon (UK) Limited,
Unit 18, Oxleasow Road, East Moons Moat,
Redditch, Worcestershire, B98 0RE.

5 HOW TO STORE SEREVENT
Keep out of the sight and reach of children.
Do not store above 30°C.
If the inhaler gets cold, take the metal canister
out of the plastic case and warm it IN YOUR
HANDS for a few minutes before use. NEVER
use anything else to warm it up.
• WARNING the canister contains a pressurised
liquid. Do not expose to temperatures higher
than 50°C. Do not pierce the canister.
• 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.
• Keep the pressurised canister away from heat &
light.
• Do not Freeze





What Serevent Evohaler looks like and
contents of the pack
Aerosol metered dose inhaler (actuator) with a
green plastic body and light green removable dust
cap. The green plastic body or dust cap has no
markings. A pressurised aluminium alloy container,
sealed with a metering valve containing the
inhalation suspension is fitted into the plastic
actuator.

POM

PL 15184/1015

Leaflet revision date: 14/05/14

Blind or partially sighted?
Is this leaflet hard to see or read?
Phone Lexon (UK) Limited,
Tel: 01527 505414 for help.

PATIENT INFORMATION LEAFLET
®

Ref: 1015/140514/1/F

®

SEREVENT EVOHALER
25 micrograms per actuation pressurised inhalation suspension
(salmeterol xinafoate)
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 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 Serevent Evohaler is and what it is used
for
2 What you need to know 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 ‘long-acting 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 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.
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 product, 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:

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 HaleraidTM or
VolumaticTM 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.

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).
Ref: 1015/140514/1/B

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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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