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SALMETEROL 25 MICROGRAM EVOHALER

Active substance(s): SALMETEROL / SALMETEROL XINAFOATE MICRONISED / SALMETEROL / SALMETEROL XINAFOATE / SALMETEROL XINAFOATE MICRONISED / SALMETEROL / SALMETEROL XINAFOATE / SALMETEROL XINAFOATE MICRONISED

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Pregnancy and breast-feeding

PACKAGE LEAFLET: INFORMATION FOR THE USER

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.

Serevent™ 25 Microgram Evohaler™ /
Salmeterol 25 Microgram Evohaler™
(salmeterol xinafoate)

Driving and using machines

The possible side effects associated with Serevent Evohaler are unlikely to affect your ability to
drive or use machines.

Your medicine is available using the names Serevent 25 Micrograms Evohaler / Salmeterol 25
Micrograms Evohaler, but will be referred to as Serevent Evohaler throughout this leaflet.

3.

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
1.
2.
3.
4.
5.
6.
1.







Adults and adolescents aged 12 years and older with Asthma




this leaflet:
What Serevent Evohaler is and what it is used for
What you need to know before you use Serevent Evohaler
How to use Serevent Evohaler
Possible side effects
How to store Serevent Evohaler
Contents of the pack and other information

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 Evohaler is not recommended for use in children below 4 years of age.

Adults with Chronic Obstructive Pulmonary Disease (COPD) including bronchitis
and emphysema



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.

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.

If you are being treated for asthma, you should always be given both a Serevent
Evohaler and a steroid inhaler to use together.

2.

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
Evohaler and a steroid inhaler to use together.
• Use Serevent Evohaler every day, until your doctor advises you to stop.
• You will start to feel your medicine working within the first day of use.
Serevent Evohaler is for inhalation by mouth only.

WHAT YOU NEED TO KNOW BEFORE YOU USE SEREVENT EVOHALER

Do not take Serevent Evohaler if:

Using your inhaler

Take special care with Serevent Evohaler

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.

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

You are allergic (hypersensitive) to salmeterol or to the other ingredient norflurane (HFA 134a).







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 Evohaler. 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 Evohaler.
If you have been prescribed Serevent Evohaler 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 Evohaler.
Your doctor may want to check your health regularly if you have an overactive thyroid
gland, diabetes mellitus (Serevent Evohaler may increase your blood sugar) or heart
disease, including an irregular or fast heartbeat.

Other medicines and Serevent Evohaler








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 Evohaler may not be suitable to be taken with other medicines.
Inform your doctor before using Serevent Evohaler 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 Evohaler, including irregular heartbeats, or may make side effects
worse.
Beta-blockers should be avoided when taking Serevent Evohaler, 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 betablockers or have recently been prescribed beta-blockers as they may reduce or abolish the
effects of salmeterol.
Serevent Evohaler 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 Evohaler 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.

Page 1 of 2

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.

Very rare (affects less than 1 person in 10,000):




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.

Breathing difficulties or wheezing that gets worse straight after taking Serevent
Evohaler. 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 Evohaler 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.

5.

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

6.

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





Each actuation contains 25 micrograms of salmeterol (as the xinafoate).
Serevent Evohaler also contains CFC-free propellant: norflurane (HFA 134a).

What Serevent Evohaler looks like and contents of the pack

Serevent Evohaler is a pressurised metered dose inhaler comprising a green plastic body with a light
green removable cap and a metal canister.
The canister provides 120 metered actuations of a pressurised inhalation suspension.

Do not put the metal canister in water.

Manufacturer

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.

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
Evohaler to control your asthma or COPD. These are the side effects reported by people taking
Serevent Evohaler.
Allergic reactions: you may notice your breathing suddenly gets worse after using
Serevent Evohaler. 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 Evohaler, tell your doctor straight away. Allergic reactions to
Serevent Evohaler 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 Evohaler 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

Manufactured by:
Glaxo Wellcome Production, Rue Lavoisier 23, 27000 Evreux, France.
Procured from within the EU and repackaged by:
Doncaster Pharmaceuticals Group Ltd., Kirk Sandall, Doncaster, DN3 1QR.
Product Licence holder:
BR Lewis Pharmaceuticals Ltd., Kirk Sandall, Doncaster, DN3 1QR.
PL No: 08929/0529

POM

Leaflet revision and issue date (Ref.) 15.03.17
Serevent™, Evohaler™, Volumatic™ and Haleraid™ are trademarks of the GlaxoSmithKline group of
companies.

Blind or partially sighted?
Is this leaflet hard to see or read?
Call 01302 365000 (Regulatory)
Please be ready to give the following
information:
Product name:
Serevent 25 Microgram Evohaler
Reference No: 08929/0529

Rare (affects less than 1 person in 1,000):




CONTENTS OF THE PACK AND OTHER INFORMATION

What Serevent Evohaler contains

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.

If you use more Serevent Evohaler than you should

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.
Protect from frost and direct sunlight. Do not expose to temperatures higher than 50ºC.
The metal canister is pressurised. Do not pierce. Do not puncture, break or burn, even when
apparently 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.
If your inhaler fails to work properly you should ask your doctor or pharmacist for advice.
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.
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.

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)
Page 2 of 2

Expand Transcript

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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