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SALMETEROL ACCUHALER 50 MICROGRAM

Active substance(s): SALMETEROL XINAFOATE

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Package Leaflet: Information for the User

Salmeterol Accuhaler
50microgram
(salmeterol xinafoate)
Outer case

Counter
Full Empty
60

0

Thumbgrip
Mouthpiece
Lever

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.
The name of your medicine is Salmeterol
Accuhaler 50microgram but will be referred to as
Salmeterol Accuhaler or Salmeterol throughout
this leaflet.

In this leaflet:
1
2
3
4
5
6

What Salmeterol Accuhaler is and what it is
used for
What you need to know before you use
Salmeterol Accuhaler
How to use Salmeterol Accuhaler
Possible side effects
How to store Salmeterol Accuhaler
Contents of the pack and other information

1

What Salmeterol Accuhaler is and
what it is used for

Salmeterol Accuhaler contains the medicine
salmetrol. 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 Salmeterol Accuhaler
regularly will help prevent asthma attacks.
This also includes asthma brought on by
exercise or at night.
Taking Salmeterol Accuhaler regularly will also
help prevent breathing problems caused by
other chest illnesses such as Chronic
Obstructive Pulmonary Disease (COPD).
Salmeterol 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.
Salmeterol 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 Salmeterol and a
steroid inhaler to use together.

2

What you need to know before you
use Salmeterol Accuhaler

Do not take Salmeterol Accuhaler if:
you are allergic (hypersensitive) to salmeterol
xinafoate, or to the other ingredient lactose.

Take special care with Salmeterol Accuhaler
If you are using Salmeterol 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 Salmeterol. 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 Salmeterol.
If you have been prescribed Salmeterol 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 Salmeterol.
Your doctor may want to check your health
regularly if you have an overactive thyroid
gland, diabetes mellitus (Salmeterol may
increase your blood sugar) or heart disease,
including an irregular or fast heartbeat.

Other medicines and Salmeterol
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 Salmeterol may not be
suitable to be taken with other medicines.

Inform your doctor before using Salmeterol 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 Salmeterol,
including irregular heart beats, or may make
side effects worse.
Beta-blockers should be avoided when taking
Salmeterol, 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 betablockers as they may reduce or abolish the
effects of salmeterol.
Salmeterol 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 Salmeterol 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
Salmeterol are unlikely to affect your ability to
drive or use machines.

3

There is a counter on top of the Salmeterol
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.

How to use Salmeterol 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 Salmeterol
and a steroid inhaler to use together.
Use Salmeterol every day, until your doctor
advises you to stop.
You will start to feel your medicine working
within the first day of use.
Salmeterol 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.
Salmeterol 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 Salmeterol Accuhaler properly or as
prescribed may mean that it will not help your
asthma or COPD as it should.
The Salmeterol Accuhaler device holds
blisters containing Salmeterol as a powder.

Using your inhaler
To open your Salmeterol

1 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.
Hold your Salmeterol
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.

2

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

If you forget to use Salmeterol
Put the mouthpiece to your lips; breathe in
steadily and deeply
through the Salmeterol
Accuhaler, not through your
nose. Remove the Salmeterol
Accuhaler from your mouth.
Hold your breath for about 10
seconds or for as long as is
comfortable.
Breathe out slowly.

4

Afterwards rinse your mouth with water and
s
spit it out. This may help to stop you getting
thrush and being hoarse.

5

To close the Salmeterol 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.

6

Your Salmeterol Accuhaler is now ready for you to
use again.

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

If you use more Salmeterol 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.

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 Salmeterol to control
your asthma or COPD. These are the side effects
reported by people taking Salmeterol.
Allergic reactions: you may notice your
breathing suddenly gets worse after using
Salmeterol. 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
Salmeterol, tell your doctor straight away.
Allergic reactions to Salmeterol 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
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 Salmeterol 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 Salmeterol. If
this happens stop using your Salmeterol
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 Salmeterol 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,
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 Salmeterol Accuhaler

KEEP OUT OF THE SIGHT AND REACH OF
CHILDREN.
Do not store above 30 C. Store in the original
package.
Do not use after the date shown as ‘Exp’ on the
carton and Accuhaler
If your medicine shows any signs of deterioration
or discolouration, you should seek the advice of
your pharmacist.
IMPORTANT - REMEMBER: This medicine is for
your use only. It can only be prescribed by a
doctor. NEVER give it to anyone else even if their
symptoms are the same as yours as it may harm
them.

6

Contents of the pack and other
information

What Salmeterol Accuhaler contains
Each blister, which protects the medicine from the
effects of the atmosphere, contains 50 micrograms
of the active ingredient salmeterol (as the
xinafoate). It also contains lactose monohydrate
as the inactive ingredient which acts as the carrier.
Warning: If you have been told by your doctor that
you have an intolerance to some sugars, contact
your doctor before taking this medicinal product.
What Salmeterol Accuhaler looks like and
contents of the pack
Your medicine comes as a two-tone green circular
device in moulded plastic containing a foil strip
with regularly spaced blisters containing white
inhalation powder, and with a dose counter
indicating the number of doses remaining.
Each Accuhaler has 60 doses .

Manufactured by: Glaxo Wellcome Productions,
23 rue Lavoisier, 27000 Evreux, France.
Procured from within the EU and repackaged
by the Product Licence holder: B&S Healthcare,
Unit 4, Bradfield Road, Ruislip, Middlesex,
HA4 0NU, UK.
Salmeterol Accuhaler 50microgram
PL: 18799/0901
Leaflet date: 28.04.2015

POM

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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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