SEREVENT DISKHALER

Active substance: SALMETEROL XINAFOATE

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Reason for update: Type IAin - A&H to GSK logo change
MHRA Approval Date: 05 March 2014
Text Date: 10 March 2014
PIL Text Issue and Draft No.: PIL Issue 7, draft 1
SPC Issue and Draft No.: SmPC Issue 7, draft 1

Package leaflet: Information for the user

Serevent® Diskhaler®
50 microgram per dose inhalation powder
salmeterol xinafoate
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 Diskhaler is and what it is used for
2
What you need to know before you use Serevent Diskhaler
3
How to use Serevent Diskhaler
4
Possible side effects
5
How to store Serevent Diskhaler
6
Contents of the pack and other information

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.

Reason for update: Type IAin - A&H to GSK logo change
MHRA Approval Date: 05 March 2014
Text Date: 10 March 2014
PIL Text Issue and Draft No.: PIL Issue 7, draft 1
SPC Issue and Draft No.: SmPC Issue 7, draft 1

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

2 What you need to know 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.

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.

Reason for update: Type IAin - A&H to GSK logo change
MHRA Approval Date: 05 March 2014
Text Date: 10 March 2014
PIL Text Issue and Draft No.: PIL Issue 7, draft 1
SPC Issue and Draft No.: SmPC Issue 7, draft 1



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 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 Diskhaler
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.

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.
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.

Reason for update: Type IAin - A&H to GSK logo change
MHRA Approval Date: 05 March 2014
Text Date: 10 March 2014
PIL Text Issue and Draft No.: PIL Issue 7, draft 1
SPC Issue and Draft No.: SmPC Issue 7, draft 1

Using your Diskhaler
lid
cover
needle

body
brush

Tray with wheel
mouthpiece

Serevent disk

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

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.

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.

3

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

Reason for update: Type IAin - A&H to GSK logo change
MHRA Approval Date: 05 March 2014
Text Date: 10 March 2014
PIL Text Issue and Draft No.: PIL Issue 7, draft 1
SPC Issue and Draft No.: SmPC Issue 7, draft 1

4

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

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.
This will rotate the disk.

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.

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.

Reason for update: Type IAin - A&H to GSK logo change
MHRA Approval Date: 05 March 2014
Text Date: 10 March 2014
PIL Text Issue and Draft No.: PIL Issue 7, draft 1
SPC Issue and Draft No.: SmPC Issue 7, draft 1

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
8

Breathe out as far as is comfortable.

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.
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.
GETTING READY FOR THE NEXT DOSE
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

Reason for update: Type IAin - A&H to GSK logo change
MHRA Approval Date: 05 March 2014
Text Date: 10 March 2014
PIL Text Issue and Draft No.: PIL Issue 7, draft 1
SPC Issue and Draft No.: SmPC Issue 7, draft 1

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.

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

Reason for update: Type IAin - A&H to GSK logo change
MHRA Approval Date: 05 March 2014
Text Date: 10 March 2014
PIL Text Issue and Draft No.: PIL Issue 7, draft 1
SPC Issue and Draft No.: SmPC Issue 7, draft 1



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.
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 Diskhaler. Use your fastacting ‘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 Diskhaler






Keep this medicine out of the sight and reach 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.

Do not throw away any 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.

Reason for update: Type IAin - A&H to GSK logo change
MHRA Approval Date: 05 March 2014
Text Date: 10 March 2014
PIL Text Issue and Draft No.: PIL Issue 7, draft 1
SPC Issue and Draft No.: SmPC Issue 7, draft 1

6

Contents of the pack and other 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 No.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
Reference number

Serevent Diskhaler
10949/0069

This is a service provided by the Royal National Institute of Blind People.
This leaflet was last revised in 03/2014.
Serevent, Diskhaler, Rotadisk and Rotadisks are registered trademarks of the
GlaxoSmithKline group of companies

Reason for update: Type IAin - A&H to GSK logo change
MHRA Approval Date: 05 March 2014
Text Date: 10 March 2014
PIL Text Issue and Draft No.: PIL Issue 7, draft 1
SPC Issue and Draft No.: SmPC Issue 7, draft 1

© 2014 GlaxoSmithKline group of companies

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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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