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SALMETEROL EVOHALER 25 MICROGRAMS

Active substance(s): SALMETEROL

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PACKAGE LEAFLET: INFORMATION FOR THE USER
SEREVENT® EVOHALER® 25 MICROGRAMS/
SALMETEROL EVOHALER® 25 MICROGRAMS
(salmeterol xinafoate)
This product is available as the above name but will be referred to
as Serevent Evohaler 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 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.

 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

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 ‘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.

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 two
puffs into the air. If you have not used the
inhaler for a week or more, also 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.
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.

 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 betablockers as they may reduce or abolish the effects of salmeterol.

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.
9.

Wait about half a minute between taking each puff of medicine
and then repeat steps 3 to 7.
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.

 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
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 direct sunlight.
 Do not freeze.
 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 Evohaler after the expiry date which is stated
on the label and carton. The expiry date refers to the last day of
the month.
 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
 Each actuation contains 25 micrograms
salmeterol (as the xinafoate) as an inhalation suspension.
 There are 120 puffs in each canister.
 The other ingredient is norflurane (HFA 134a).
What Serevent Evohaler looks like and contents of the pack
Pressurised inhalation, suspension. White to off-white suspension for
inhalation in a pressurised metered dose inhaler contained in a green
plastic body and a light green removable cap
This product is manufactured by:
Glaxo Wellcome Production, Rue Lavoisier 23, 27000 Evreux,
France.
Procured from within the EU, by the, Product Licence holder:
G Pharma Ltd, Dakota Avenue, Salford M50 2PU.
PL 16369/1217

POM

Leaflet Revision Date: 09/02/2015
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, this medicine 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

Serevent, Evohaler, Haleraid and Volumatic are trademarks of the
GlaxoSmithKline group of companies.

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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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