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SEREVENT ACCUHALER 50 MICROGRAM

Active substance(s): SALMETEROL XINAFOATE

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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 one
puff twice daily
• Feeling nervous

6. CONTENTS OF THE PACK AND OTHER
INFORMATION
What Serevent Accuhaler contains
• The active substance is 50 micrograms
salmeterol (as the xinafoate).
• The other ingredient is lactose monohydrate

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)

What Serevent Accuhaler looks like and
contents of the pack
• The Serevent Accuhaler is a green, circular
device in a moulded plastic containing a foil
strip with 60 regularly spaced blisters. There is
a counter on the top of the Accuhaler indicating
how many doses are left.
• Each dose is pre-dispensed.
• The device is packed in carton which hold one
Accuhaler containing 60 inhalations

PATIENT INFORMATION LEAFLET
®

SEREVENT ACCUHALER

Ref: 1498/191214/1/F

®

50 microgram per dose inhalation powder
(salmeterol xinafoate)
Counter

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
Accuhaler. 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.
5. HOW TO STORE SEREVENT ACCUHALER
• Keep out of the sight and reach of children.
• Do not store above 30ºC.
• Store in the orginal package.
• Do not use after the expiry date printed on the
carton or accuhaler label.
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.

Manufacturer and Licence Holder
This medicine is manufactured by Glaxo Wellcome
Production, Evreux, 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.

POM

PL 15184/1498

Serevent and Accuhaler are registered trademarks
of the GlaxoSmithKline Group of Companies.
Leaflet revision date: 19/12/2014

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

Outer Case

Full Empty
60
0

Thumbgrip

Mouthpiece

Lever

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 Accuhaler is and what it is used
for
2. What you need to know before you use
Serevent Accuhaler
3. How to use Serevent Accuhaler
4. Possible side effects
5. How to store Serevent Accuhaler
6. Contents of the pack and other information

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

1. WHAT SEREVENT ACCUHALER IS AND
WHAT IT IS USED FOR
• Serevent Accuhaler 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 Accuhaler regularly
will help prevent asthma attacks. This also
includes asthma brought on by exercise or at
night.





Taking Serevent Accuhaler regularly will also
help prevent breathing problems caused by
other chest illnesses such as Chronic
Obstructive Pulmonary Disease (COPD).
Serevent Accuhaler 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 is supplied to you in an inhaler called
the Accuhaler. You breathe the medicine
directly into your lungs.

2. WHAT YOU NEED TO KNOW BEFORE YOU
USE SEREVENT ACCUHALER
Do not take Serevent Accuhaler if:
you are allergic (hypersensitive) to salmeterol
xinafoate, or to the other ingredient lactose.
Take special care with Serevent Accuhaler
• If you are using Serevent for asthma your
doctor will want to regularly check your
symptoms.
• 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 you 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 presssure (diuretics – water tablets)
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 ACCUHALER
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 1 puff twice a day.
• For people with more severe asthma, your
doctor may increase your dose to 2 puffs twice
a day.
Children with Asthma
In children aged 4 to 12 the usual dose is 1 puff
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 1 puff 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
Serevent Accuhaler properly or as prescribed
may mean that it will not help your asthma or
COPD as it should.
The Serevent Accuhaler device holds blisters
containing Serevent as a powder.
There is a counter on top of the Serevent
Accuhaler which tells you how many doses are
left. It counts down to 0. The numbers 5 to 0 will
appear in red to warn you when there are only a
few doses left. Once the counter shows 0,
your inhaler is empty.

Using your inhaler
1. To open your Serevent
Accuhaler, hold the outer
case in one hand and
put the thumb of your
other hand on the
thumbgrip. Push your
thumb away from you
as far as it will go. You will hear a click. This will
open a small hole in the mouthpiece.
2. Hold your Serevent
Accuhaler with the
mouthpiece towards you.
You can hold it in either
your right or left hand.
Slide the lever away
from you as far as it will
go. You will hear a click.
This places a dose of your medicine in the
mouthpiece.
Every time the lever is pushed back a blister is
opened inside and the powder made ready for you
to inhale. Do not play with the lever as this opens
the blisters and wastes medicine.
3. Hold the Serevent Accuhaler away from your
mouth, breathe out as far as is comfortable.
Do not breathe into your Serevent Accuhaler.
4. Put the mouthpiece to
your lips; breathe in
steadily and deeply
through the Serevent
Accuhaler, not through
your nose. Remove the
Serevent Accuhaler from
your mouth.
Hold your breath for
about 10 seconds or for as long as is
comfortable.
Breathe out slowly.
5. Afterwards rinse your mouth with water and spit
it out. This may help to stop you getting thrush
and being hoarse.
6. To close the Serevent
Accuhaler, slide the
thumbgrip back towards
you, as far as it will go.
You will hear a click.
The lever will return to its
original position and is
reset.

Your Serevent Accuhaler is now ready for you to
use again.
Cleaning your inhaler
Wipe the mouthpiece of the Serevent Accuhaler
with a dry tissue to clean it.
If you use more Serevent 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
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 one puff twice daily. These
side effects do not last long and happen less as
treatment with Serevent continues




Ref: 1498/191214/1/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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