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SEREVENT 50 MICROGRAM DISKHALER

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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 blister 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 one
blister twice daily
• Feeling nervous.




What Serevent Diskhaler looks like and
contents of the pack
The diskhaler has a two tone green diskhaler
device and 15 disks with four regularly spaced
double foil blisters.
Available in packs of one diskhaler & 14 disks x 4
blisters or 15 disks x 4 blisters.
Manufacturer and Licence Holder
This Diskhaler and Disks are manufactured by
Glaxo Wellcome GmbH & Co., Industriestrasse
32-36, D-23843, Bad Oldsloe, Germany and are
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.

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).

If you have any questions or are not sure about
anything, ask your doctor or pharmacist. They will
have additional information about this medicine
and will be able to advise you.

The following side effects have been reported
when using Serevent, but it is not known
how often they occur:
• Breathing difficulties or wheezing that gets
worse straight after taking Serevent. If this
happens stop using your Serevent Diskhaler.
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
• Sore mouth or throat
• High blood sugar
• Feeling sick (nausea)
• Aching, swollen joints or chest pain.
If any of the side effects gets serious, or if you
notice any side effects not listed in this leaflet,
please tell your doctor, nurse or pharmacist.

Serevent and Diskhaler are registered trademarks
of Glaxo Group Limited.





5, HOW TO STORE SEREVENT DISKHALER





Keep out of the sight and reach of children.
Do not store above 25ºC.
Do not puncture the blisters until you are ready to
inhale a dose.

POM

PL 15184/0369 - Serevent Diskhaler

Leaflet revision date: 22/03/13

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

PATIENT INFORMATION LEAFLET
®

SEREVENT DISKHALER
(salmeterol xinafoate)
Read all of this leaflet carefully before you
start taking this medicine.
• 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. Do
not pass it on to others. It may harm them, even
if their symptoms are the same as yours.
• If any of the side effects gets serious, or if you
notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.
In this leaflet:
1, What Serevent Diskhaler is and what it is used
for
2, Before you use Serevent Diskhaler
3, How to use Serevent Diskhaler
4, Possible side effects
5, How to store Serevent Diskhaler
6, Further information
1, WHAT SEREVENT DISKHALER IS AND
WHAT IT IS USED FOR












If your medicine becomes discoloured or shows
any other signs of deterioration, consult your
pharmacist who will tell you what to do.
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.
Do not use this medicine after the expiry date
shown on the Serevent label or carton label.
6, FURTHER INFORMATION
What Serevent Diskhaler contains
Each disk contains powder for inhalation providing
50 micrograms of salmeterol (as xinafoate).
Inactive ingredients: Lactose.
Available in packs of one diskhaler & 14 disks x 4
blisters or 15 disks x 4 blisters.

Ref: 0369/220313/1/F

®



Serevent Diskhaler consists of Rotadisks and
an inhaler called a Diskhaler. Rotadisks have
foil blisters containing the medicine salmeterol.
Refill packs are also available which contain
only the Rotadisks and not the Diskhaler.
Serevent 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 Diskhaler regularly will help
prevent asthma attacks.
This also includes asthma brought on by
exercise or at night.
Taking Serevent Diskhaler regularly will also
help prevent breathing problems caused by
other chest illnesses such as Chronic
Obstructive Pulmonary Disease (COPD).
Serevent Diskhaler 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 a Diskhaler. You
breathe the medicine directly into your lungs.

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






blisters 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.

Taking other medicines
• Please 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.
• Please 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. Please
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.

2, BEFORE YOU USE SEREVENT DISKHALER
Do not take Serevent Diskhaler if:
you are allergic (hypersensitive) to salmeterol
xinafoate, or to the other ingredient lactose
monohydrate.
Take special care with Serevent Diskhaler
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



Pregnancy and breast-feeding
If you are pregnant, planning to get pregnant or
breast-feeding, talk to your doctor before taking
Serevent. Your doctor will assess whether you can
take Serevent during this time.
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 DISKHALER

Loading a disk into the Diskhaler



1, Take off the mouthpiece cover and check inside
and outside to make sure that the mouthpiece
is clean, and that there are no foreign objects.



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. Serevent is for inhalation
by mouth only.

Using this medicine
The medicine in Serevent Diskhaler should be
inhaled using a special kind of inhaler called a
Diskhaler.
• Make sure that you have one and can use it
properly.
• Instructions on how to use the Diskhaler are
given as a step-by-step guide below.
• If you are not sure how to use the Diskhaler, ask
your nurse, pharmacist or doctor to go through
the instructions with you.
• You will start to feel your medicine working
within the first day of use and it is very
important that you use it regularly.
Adults and adolescents aged 12 years and
older with Asthma
• The usual starting dose is 1 blister twice a day.
• For people with more severe asthma, your
doctor may increase your dose to 2 blisters
twice a day.

6, Continue until the number ‘4’ appears in the
small window. The disk is now ready for use. As
you use each dose the number of doses
remaining is shown in the window.

2, Hold the corners of the white tray and pull out
gently until you can see all the plastic ridges on
the sides of the tray.

Opening the blister to release a dose
7, Keep the Diskhaler level. Lift up the back
of the lid as far as it will go and until it is fully
upright. The lid must be raised until fully upright
to pierce both the top and bottom of the
blister. This will need firm pressure.

3, Put your finger and thumb on the ridges,
squeeze inwards and gently pull the tray out of
the body of the Diskhaler.

14, There is a brush in the small space under the
lid at the rear of the Diskhaler body.
a) Remove the tray from the Diskhaler body.
b) Brush away any powder left behind on the
parts of the Diskhaler.
c) Replace the tray and mouthpiece cover.

4, Place a disk on the wheel so that the numbers
face upwards and then slide the tray back into
the Diskhaler.

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.
Then close the lid.
The Diskhaler is now ready for use.

Inhaling your medicine
8, Breathe out as far as is comfortable.
Getting ready for the first dose
The Diskhaler has a number of parts:
a green outer body with a hinged lid and
piercing needle
• a cleaning brush which fits into a space at the
rear of the body
• a mouthpiece cover
• a white wheel on which the disk is placed. The
wheel is fitted to –
• a white sliding tray with mouthpiece

Cleaning your diskhaler

Serevent disks should only be used in a
Serevent Diskhaler.

Do not try to lift the lid until the white sliding tray is
pushed fully in or is completely removed e.g. when
cleaning the Diskhaler.



13, Each disk has four blisters. As you use up
each blister, numbers will count backwards i.e.
‘4’, ‘3’, ‘2’, ‘1’. When the number ‘4’ reappears,
the disk is empty and should be replaced. To
take out the old disk and put in the new one,
repeat steps 2 to 4.

You may need to replace your Diskhaler after
about three months of use.

Children with Asthma
In children aged 4 to 12 the usual dose is 1
blister twice a day.
• Serevent is not recommended for use in children
below 4 years of age.

Using your Diskhaler

12, Turn the disk to the next number “3” by gently
pulling out the tray and pushing it in once.
Do not open the blister until you are ready to
take the next dose.
When you need to take another dose repeat
steps 7 to 12.
Always wipe the mouthpiece with a tissue and
replace the cover after use.
Replacing the disk when it is empty



Adults with Chronic Obstructive Pulmonary
Disease (COPD) including bronchitis and
emphysema
• The usual starting dose is 1 blister twice a day.
• Not applicable for children and adolescents.

Getting ready for the next dose

5, Hold the corners of the tray as shown in the
picture and slide the tray out and in. This will
rotate the disk.

9, Keep the Diskhaler level and raise it to your
mouth. Place the mouthpiece between your
teeth and close your lips firmly around it but do
not bite it. Do not cover the small air holes on
either side of the mouthpiece.

10, Suck in through your mouth as quickly and as
deeply as you can.

If you forget to use Serevent
If you forget to use your Serevent Diskhaler, take
your next dose when it is due. Do not take a
double dose to replace the one you forgot.
If you stop using Serevent Diskhaler
Do not stop treatment even if you feel better
unless told to do so by your doctor. 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).

11, Hold your breath and remove the Diskhaler
from your mouth. Continue to hold your breath
for a few seconds or as long as is comfortable.
Ref: 0369/220313/1/B

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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