Serevent Inhaler 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.

In this leaflet:
1 What Serevent Evohaler is and what it is used for
2 What you need to know before you use SereventEvohaler
3 How to use Serevent Evohaler
4 Possible side effects
5 How to store Serevent Evohaler
6 Contents of the pack and other information

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.

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 bein g 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.

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 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. 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.
10. 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.

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.

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

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.

How to store Serevent Evohaler

Keep this medicine 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.

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.

Do not throw away medicines via wastewater or household waste. Ask your pharmacist how to
throw away medicines you no longer use. These measures will help protect the environment.

Contents of the pack and other information

What Serevent Evohaler contains

Each puff provides 25 micrograms of the active ingredient salmeterol.

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. The pressurised canister contains a white to off white suspension for inhalation.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Glaxo Wellcome UK Ltd
980 Great West Road
Brentford
Middlesex
TW8 9GS

Manufacturer
Glaxo Wellcome Production
Zone Industrielle No.2
23 Rue Lavoisier
27000 Evreux
France

This medicinal product is authorised in the Member States of the EEA
under the following names: *

Austria Serevent Evohaler
Belgium Serevent Evohaler
Denmark Serevent
Estonia Serevent
Hungary Serevent Evohaler
Iceland Serevent
Ireland Serevent Evohaler
Lithuania Serevent
Luxembourg Serevent Evohaler
Malta Serevent Evohaler
Netherlands Serevent 25 Inhalator CFK vrij, suspensie 25 microgram /dosis
Norway Serevent
Poland Serevent
Slovak Republic Serevent Inhaler N
Slovenia Serevent 25 μg/vpih inhalacijska suspenzija pod tlakom
Sweden Serevent Evohaler
United Kingdom Serevent Evohaler

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0800 198 5000 (UK Only)
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Product name Serevent Evohaler 25 micrograms per actuation
Reference number 10949/0369
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This leaflet was last revised in 11/2019 .
Evohaler, Serevent, Haleraid and Volumatic are registered trademarks of the GlaxoSmithKline
group of companies
© 2019 GlaxoSmithKline group of companies

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