SEREVENT DISKHALER

Active substance: SALMETEROL XINAFOATE

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2
Serevent
K

10000000110824

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GSK-FRA-Evreux-FREVR

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United Kingdom-GBR

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TYPE SIZE: 8/8.5
HORIZONTAL SCALE: 85%
PHARMA CODE

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

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).
Other side effects are listed below:

Common (affects less than 1 person in 10):

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.

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).

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.

5 How to store Serevent Diskhaler
• Keep out of the reach and sight of children.
• Do not store above 25°C.
• Do not puncture the blister on the Rotadisk® until you are ready to inhale a dose.
• Do not use after the expiry date which is stated on the Rotadisk and carton (EXP).The expiry date refers
to the last day of that month.
• If you are told to stop using this medicine return any unused Rotadisks to your pharmacist to be destroyed.
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 Diskhaler contains

• The active substance is salmeterol xinafoate.
• The other ingredient is lactose (which contains milk proteins).

What Serevent Diskhaler looks like and contents of the pack

• The Rotadisk contains powder with 4 foil blisters around its edge.
• Each blister contains 50 micrograms salmeterol xinafoate and lactose which acts as a ‘carrier’.
• Each dose is pre-dispensed.
• The Rotadisk protects the powder for inhalation from the effects of the atmosphere.
• The devices are packed in cartons which hold:
One Diskhaler and 15 Rotadisks each with 4 blisters, a total of 60 inhalations.
• The refill packs hold:
15 Rotadisks each with 4 blisters, a total of 60 inhalations.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:
Glaxo Wellcome UK Ltd
Stockley Park West
Uxbridge
Middlesex UB11 1BT
Manufacturer:
Glaxo Wellcome Production
Zone Industrielle N°.2
23 Rue Lavoisier
27000 Evreux
France

Other formats

To listen to or request a copy of this leaflet in Braille, large print or audio please call, free of charge:

0800 198 5000 (UK Only)

Please be ready to give the following information:
Product name
Serevent Diskhaler
Reference number
10949/0069
This is a service provided by the Royal National Institute of Blind People.
Leaflet date: February 2013
Serevent, Diskhaler, Rotadisk and Rotadisks are registered trademarks of the
GlaxoSmithKline group of companies
© 2013 GlaxoSmithKline group of companies

Serevent ® Diskhaler®

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

PHARMA CODE

• 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.

Package Leaflet: Information for the User
50 microgram per dose inhalation powder
salmeterol xinafoate

1 What Serevent Diskhaler is and what it is used for
• 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.

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 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.

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
• 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.
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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.
• nstructions on how to use the Diskhaler are given as a step-by-step
I
guide below.
• f you are not sure how to use the Diskhaler, ask your nurse, pharmacist
I
or doctor to go through the instructions with you.
• ou will start to feel your medicine working within the first day
Y
of use and it is very important that you use it regularly.

Getting ready for the first dose

5

Hold the corners of the tray as shown in
the picture and slide the tray out and in.
T
his will rotate the disk.

6

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



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.

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.

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.



window

Using your Diskhaler

cover

lid

body

Opening the blister to release a dose

brush

needle

7

tray with wheel
mouthpiece



Serevent
disk

Keep the Diskhaler level. Lift up the back
of the lid as far as it will go and
u
ntil 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.

lift rear
edge of lid

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

needle

Loading a disk into the Diskhaler

1


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




lid fully
raised

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

Inhaling your medicine

2


8
9

Hold the corners of the white tray and
pull out gently until you can see all the
p
lastic ridges on the sides of the tray.



Breathe out as far as is comfortable.

air hole

Keep the Diskhaler level and raise it to
your mouth. Place the mouthpiece
b
etween 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.

plastic
ridges

3


10
11

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

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

Getting ready for the next dose

12



wheel

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

4


13

Place a disk on the wheel so that the
numbers face upwards and then slide the
t
ray back into the Diskhaler.



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
o
ld disk and put in the new one, repeat steps 2 to 4.

Cleaning your diskhaler

14





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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.
You may need to replace your Diskhaler after about three months of use.
Serevent disks should only be used in a Serevent Diskhaler.
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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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