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Assessed against Uk PIL dated September 2009

(salmeterol xinafoate)

• If you have been prescribed Serevent® Accuhaler® 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® Accuhaler® may
increase your blood sugar) or heart disease, including an irregular or
fast heartbeat.


By addisonf at 11:36 am, Jun 03, 2010




Taking other medicines
• Please tell your doctor if you are taking or have recently taken any
other medicines. This includes medicines for asthma or any other
medicines obtained without a prescription. This is because Serevent®
Accuhaler® may not be suitable to be taken with some other medicines.
• Please inform your doctor before using Serevent® Accuhaler® 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® Accuhaler® including irregular
heart beats, or may make side effects worse.
• Beta-blockers should be avoided when taking Serevent® Accuhaler®,
unless your doctor tells you to. Beta-blockers, include 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® Accuhaler 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®
Accuhaler®, with 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.

Read all of this leaflet carefully before you start taking this medicine.
• Keep this leaflet you may wish 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® Accuhaler® is and what it is used for
2. Before you use Serevent® Accuhaler®
3. How to use Serevent® Accuhaler®
4. Possible side effects
5. How to store Serevent® Accuhaler®
6. Further information
• Serevent® Accuhaler® contains the medicine salmeterol. It is a ‘longacting 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
• 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® Accuhaler® and a steroid inhaler to use together.

Pregnancy and breast-feeding
If you are pregnant, planning to get pregnant, or breast feeding, talk to
your doctor before taking Serevent® Accuhaler®. Your doctor will assess
whether you can take Serevent® Accuhaler® during this time.
Driving and using machines
The possible side effects associated with Serevent® Accuhaler® are
unlikely to affect your ability to drive or use machines.
Important information about some of the ingredients of Serevent®
Serevent® Accuhaler® contains lactose. If you have been told by your
doctor that you have an intolerance to some sugars, contact your doctor
before taking this medicinal product.

you are allergic (hypersensitive) to salmeterol xinafoate, or to the other
ingredient lactose.

• If you are being treated for asthma, you should always be given
both a Serevent® Accuhaler® and a steroid inhaler to use together.
• Use Serevent® Accuhaler® every day, until your doctor advises you to
• You will start to feel your medicine working within the first day of use.
Serevent® Accuhaler® is for inhalation by mouth only.

Take special care with Serevent® Accuhaler®

Adults and adolescents aged 12 years and over with Asthma

• If you are using Serevent® Accuhaler® 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® Accuhaler®. 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.

• 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.

Do not take Serevent® Accuhaler® if:


Children with Asthma
• In children aged 4 to 12 the usual dose is 1 puff twice a day.
• Serevent® Accuhaler® is not recommended for use in children below 4
years of age.
(Continued overleaf)


If you use more Serevent® Accuhaler® than you should

Adults with Chronic Obstructive Pulmonary Disease (COPD)
including bronchitis and emphysema

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.

• The usual starting dose is 1 puff twice a day.
• Not applicable for children and adolescents.
Instructions for use

If you forget to use Serevent® Accuhaler®

• 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.

If you forget to use your Serevent® Accuhaler®, take your next dose when
it is due. Do not take a double dose to replace the one you forgot.
If you have any further questions on the use of this product, ask your
doctor or pharmacist.
Like all medicines, Serevent® Accuhaler® can cause side effects, although
not everybody gets them. To reduce the chance of side effects, your
doctor will prescribe the lowest dose of Serevent® Accuhaler® to control
your asthma or COPD. These are the side effects reported by people
taking Serevent® Accuhaler®.
Allergic reactions: you may notice your breathing suddenly gets
worse after using Serevent® Accuhaler®. 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 if they happen suddenly after
using Serevent® Accuhaler®, tell your doctor straight away. Allergic
reactions to Serevent® Accuhaler® are very rare (they affect less than 1
person in 10,000).
Other side effects are listed below:

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
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 and the powder made
ready for you to inhale. Do not play with
the lever because this opens the blisters
and wastes medicine.

Common (affects less than 1 person in 10):

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.
What Serevent® Accuhaler® contains
Each blister contains 50 micrograms salmeterol (as the xinafoate) as the
active ingredient, and lactose which acts as the ‘carrier.’
What Serevent® Accuhaler® looks like and the contents of the pack
It is two tone green, circular device in a moulded plastic containing a foil
strip of 60 blisters containing a white inhalation powder and with a dose
counter indicating the number of doses remaining.
Serevent® Accuhaler® contains a foil strip with 60 blisters. The foil protects
the powder for inhalation from the atmosphere.
Who manufactured your medicine
Manufactured by Glaxo Wellcome Production, 23 Rue Lavoisier, 27000
Evreux, France. Procured from within the EU and repackaged by Product
Licence holder: Beachcourse Limited, 20 Alliance Court, Alliance Road,
London W3 0RB.
PL 16378/0503


Revision date: 1 March 2010
Leaflet Reference: SER A I/UT
Serevent® and Accuhaler® are trademarks of the GlaxoSmithKline group
of companies

• 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® Accuhaler® 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.

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

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).

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
Hold your breath for about 10 seconds, or for
as long as is comfortable.
Breathe out slowly.

The following side effects have been reported when using Serevent
Accuhaler, but it is not known how often they occur:
• Breathing difficulties or wheezing that get worse straight after
taking Serevent® Accuhaler®. 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 heart gives an extra beat (arrhythmias). If this
happens do not stop using Serevent® Accuhaler® 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. 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
automatically returns to its original position
and is reset.
Your Serevent® Accuhaler® is now ready for
you to use again.

• Keep out of the reach and sight of children
• Do not store above 30ºC. Store in the original package.
• Do not take this medicine after the expiry date which is stated on the
carton label.
• If your doctor stops your treatment, return any unused medicine to your
pharmacist for safe disposal. Only keep this medicine, if your doctor
tells you to.
• If your inhaler is not working properly or shows visible signs of
deterioration, you should seek the advice of your pharmacist who will
tell you what to do.

Cleaning your inhaler
Wipe the mouthpiece of the Serevent® Accuhaler® with a dry tissue to
clean it.



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Source: Medicines and Healthcare Products Regulatory Agency

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