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INASPIR ACCUHALER 50MICROGRAMS

Active substance(s): SALMETEROL XINAFOATE

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Product:
Colours:
PLPI:
Item Code:
Dimensions:
Proof:

Salmeterol Accuhaler
Black
17211/0394
SAL2005S/H
420mm x 297mm
1

The name of your medicine is either Inaspir/Salmeterol
Accuhaler 50 micrograms, but will be referred to as
Salmeterol Accuhaler throughout the 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 Salmeterol Accuhaler is and what it is used for
2 What you need to know before you use Salmeterol
Accuhaler
3 How to use Salmeterol Accuhaler
4 Possible side effects
5 How to store Salmeterol Accuhaler
6 Contents of the pack and other information
1 What Salmeterol Accuhaler is and what it is used for
Salmeterol 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
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 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
Salmeterol 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.
Once your asthma is well controlled your doctor may
consider it appropriate to gradually reduce the dose of
Salmeterol Accuhaler.
If you have been prescribed Salmeterol 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
Salmeterol Accuhaler.

Your doctor may want to check your health regularly if you
have an overactive thyroid gland, diabetes mellitus
(Salmeterol Accuhaler 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 Accuhaler may not be suitable
to be taken with other medicines.
Inform your doctor before using Salmeterol
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 Salmeterol Accuhaler,
including irregular heart beats, or may make side-effects
worse.
Beta-blockers should be avoided when taking Salmeterol
Accuhaler, unless your doctor tells you to take them. Betablockers, 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.
Salmeterol 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 Salmeterol Accuhaler 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
Accuhaler are unlikely to affect your ability to drive or use
machines.
3 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 Accuhaler every day, until your doctor
advises you to stop.
You will start to feel your medicine working within the first
day of use.
Salmeterol Accuhaler 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 Accuhaler 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.

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.
Using your inhaler
open your Salmeterol
1 To
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.

Cleaning your inhaler
the mouthpiece to your
4 Put
lips; breathe in steadily

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

and deeply through the Salmeterol
Accuhaler, not through your nose.

If you use more Salmeterol Accuhaler than you should

Remove the Salmeterol Accuhaler
from your mouth.
Hold your breath for about
10 seconds or for as long as is
comfortable.
Breathe out slowly.

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

your Salmeterol Accuhaler
2 Hold
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.

close the Salmeterol
6 To
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 Salmeterol Accuhaler is now
ready for you to use again.

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.

3

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

Product:
Colours:
PLPI:
Item Code:
Dimensions:
Proof:

Salmeterol Accuhaler
Black
17211/0394
SAL2005S/H
400mm x 297mm
1

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 Salmeterol Accuhaler
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 Accuhaler to control your asthma or
COPD. These are the side effects reported by people taking
Salmeterol Accuhaler.
Allergic reactions: you may notice your breathing
suddenly gets worse after using Salmeterol 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 they happen suddenly after
using Salmeterol Accuhaler, tell your doctor straight away.
Allergic reactions to Salmeterol Accuhaler 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 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
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 Accuhaler. 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
Accuhaler 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 Salmeterol Accuhaler
Keep out of the sight and reach of children.
Do not store above 30°C. Store in a dry place to protect
from moisture.

Do not use Salmeterol Accuhaler after the expiry date
which is stated on the label and carton.
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 Salmeterol Accuhaler contains
Each blister contains 50 micrograms of the active
ingredient salmeterol (as xinafoate).
The inactive ingredient is lactose (which acts as a carrier).
What Salmeterol Accuhaler looks like and contents of
the pack
Salmeterol Accuhaler is a two-tone green plastic inhaler
device containing a foil strip with 60 blisters.
The blisters protect the powder for inhalation from the
effects of the atmosphere. The Accuhaler has a counter,
which tells you the number of blisters remaining. It counts
down from 60 to 0. When the first blisters have been
reached the numbers will appear in red. When the counter
shows ‘0’ the Accuhaler is empty, and should be disposed
of. Pack size: 1 accuhaler containing 60 blisters.
Manufacturer:
This product is manufactured by Glaxo Wellcome Production,
23 Rue Lavoisier, 27000 Evreux, France and procured from
within the EU by the Product Licence Holder Polyfarma Ltd
and repackaged by Kent Pharmaceuticals both at Repton
Road, Measham, DE12 7DT, UK.
POM

Salmeterol Accuhaler
®

PL No: 17211/0394

Accuhaler is a trademark of the Glaxo Group of
companies.
Leaflet revision and issue date: 16.04.2014

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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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