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SALMETEROL 50MICROGRAMS ACCUHALER

Active substance(s): SALMETEROL XINAFOATE

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PATIENT INFORMATION LEAFLET

0106, 0122
15.08.14[15]

Serevent® Accuhaler® 50 micrograms
Salmeterol 50 micrograms Accuhaler®
(salmeterol xinafoate)

This medicine is available using any of the above names but will be
referred to as Serevent Accuhaler throughout this leaflet.
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
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.

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 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 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

 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.
 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 heartbeats, 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 betablockers 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 pressure (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.

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).

3 Hold the Serevent Accuhaler away from your mouth, breathe out as far
as is comfortable. Do not breathe into your Serevent Accuhaler.

Other side effects are listed below:

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.

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.

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.
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
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.

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. Contents of the pack and other information
What Serevent Accuhaler contains
 Each blister contains 50 micrograms of the active ingredient salmeterol
(as salmeterol xinafoate)
 The other ingredient is lactose (which contains milk proteins).
What Serevent Accuhaler looks like and contents of the pack

 Serevent Accuhaler is a two tone green, circular device in moulded






plastic containing white powder and with a dose counter indicating
number of doses remaining.
The Serevent Accuhaler contains a foil strip. The foil protects the
powder for inhalation from the effects of the atmosphere.
Each dose is pre-dispensed.
The device has a counter which tells you the number of blisters
remaining. It counts down from 60 to 0. To show when the last five
blisters have been reached, the numbers appear in red. When the
counter shows 0, your inhaler is empty and should be disposed of.
The devices are packed in cartons which hold one Accuhaler containing
60 inhalations

Manufacturer and Product Licence holder
This product is manufactured by Glaxo Wellcome Production, Z.I. No 2 27000 Evreux, France and is procured from the EU by Product Licence
holder Star Pharmaceuticals Ltd., 5 Sandridge Close, Harrow, Middlesex
HA1 1XD. Repackaged by Servipharm Ltd.



Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. 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.
 Store in a dry place below 30oC.
 Do not use Serevent after the expiry date which is stated on the label
and carton.

POM

PL 20636/0106, PL 20636/0122

Leaflet revision and issue date (Ref) 15.08.14[15]
Accuhaler and Serevent are trademarks of the Glaxo Wellcome 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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