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SALMETEROL CFC-FREE 25 MICROGRAMS PER ACTUATION PRESSURISED INHALATION SUSPENSION

Active substance(s): SALMETEROL XINAFOATE

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Sandoz Ltd

Page 1

Salmeterol CFC-free 25 micrograms per actuation
pressurised inhalation, suspension

11/09/2014

Package leaflet: Information for the user
Salmeterol CFC-free 25 micrograms per actuation pressurised inhalation, suspension
salmeterol (as xinafoate)
The name of this medicine is Salmeterol CFC-free 25 micrograms per actuation pressurised
inhalation, suspension which will be referred to as Salmeterol Inhaler throughout this leaflet.

Read all of this leaflet carefully before you start using 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, pharmacist or nurse.

This medicine has been prescribed for you only. Do not pass it on to others. It may harm them,


even if their symptoms and signs of illness are the same as yours.
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any
possible side effects not listed in this leaflet. See section 4.

What is in this leaflet
What Salmeterol Inhaler is and what it is used for
1.
2.
What you need to know before you use Salmeterol Inhaler
3.
How to use Salmeterol Inhaler
Possible side effects
4.
5.
How to store Salmeterol Inhaler
6.
Contents of the pack and other information

1.

What Salmeterol Inhaler is and what it is used for

Salmeterol Inhaler is indicated for use in adults 18 years of age and older only.
Salmeterol Inhaler is NOT indicated for use in children 12 years of age and younger or

adolescents 13 to 17 years of age.






Salmeterol Inhaler contains the active substance 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 Salmeterol Inhaler to help prevent breathing problems.
These could be caused by asthma. Taking Salmeterol Inhaler regularly will help prevent
asthma attacks. This also includes asthma brought on by exercise or at night.
Taking Salmeterol Inhaler regularly will also help prevent breathing problems caused by
other chest illnesses such as Chronic Obstructive Pulmonary Disease (COPD).
Salmeterol Inhaler helps to stop breathlessness and wheezing coming on. It does not
work once you are breathless or wheezy, it should not be used to relieve a sudden attack

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Salmeterol CFC-free 25 micrograms per actuation
pressurised inhalation, suspension




11/09/2014

of breathlessness or wheezing. If this happens you need to use a fast-acting ‘reliever’ or
‘rescue’ inhaler, such as salbutamol. You should always have your fast-acting 'rescue'
inhaler with you.
Salmeterol Inhaler is supplied to you in an inhaler. You should breathe the medicine in
through your mouth directly into your lungs.
Salmeterol Inhaler contains norflurane and does not contain any chlorofluorocarbons
(CFCs). Norflurane-containing inhalers are less harmful to the environment than older
CFC-containing inhalers. Salmeterol Inhaler may taste differently to older CFCcontaining Inhalers. This will make no difference to how your medicine works.

If you are being treated for asthma, you should always be given both a Salmeterol
Inhaler and a steroid inhaler to use together. Both inhalers must be used regularly.
2.

What you need to know before you use Salmeterol Inhaler

Do not use Salmeterol Inhaler:

if you are allergic to salmeterol or any of the other ingredients of this medicine (listed in
section 6).

If you are allergic to peanut or soya, do not use Salmeterol Inhaler as it contains soya lecithin.
Warnings and precautions
Talk to your doctor or pharmacist before using Salmeterol Inhaler:

If your asthma or breathing gets worse tell your doctor straightaway. 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 Inhaler. Your chest condition may be getting worse and you could become seriously
ill. See your doctor straightaway 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 Inhaler.

If you have been prescribed Salmeterol Inhaler for your asthma, continue to use any other
asthma medication you are already taking, including your steroid inhaler and any 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 using your steroid inhaler (or taking any
steroid tablets) when you start using Salmeterol Inhaler.

Your doctor may want to check your health regularly if you have an overactive thyroid gland,
heart disease including an irregular or fast heartbeat, high blood pressure, low blood potassium
or diabetes mellitus (as salmeterol may increase your blood sugar). If you have diabetes your
doctor may want to monitor your blood sugar more frequently than usual and may need to
adjust the treatment you take for your diabetes.
Other medicines and Salmeterol Inhaler

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines.
This includes those for asthma, including any inhalers or any other medicines obtained without
a prescription. This is because Salmeterol Inhaler may not be suitable to be taken with other
medicines.

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Please inform your doctor before using Salmeterol Inhaler if you are currently being treated for
any fungal infections with medicines containing ketoconazole or itraconazole, with antibiotics
such as telithromycin or erythromycin 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 heartbeats, or may make side effects worse.
Beta blockers should be avoided when taking Salmeterol Inhaler, 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 beta
blockers or have recently been prescribed beta blockers as they may reduce or abolish the
effects of salmeterol.
Salmeterol Inhaler can reduce the amount of potassium in your blood. If this happens you may
notice an irregular heartbeat, muscle weakness or cramp. This is more likely to happen if you
use Salmeterol Inhaler with some medicines used to treat high blood pressure (diuretics also
known as ‘water tablets’) and other medicines also used to treat asthma and 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 from time to time. If you have any concerns discuss them
with your doctor or nurse.
The concurrent use of other β2 agonists similar to salmeterol (bronchodilators used to treat
asthma and other pulmonary problems) and Salmeterol Inhaler may increase the effects and
particularly side effects of the medicines. Please inform your doctor before using these
medicines concurrently.

Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask
your doctor for advice before using this medicine. Your doctor will assess whether you can use
Salmeterol Inhaler during this time.
Driving and using machines
The possible side effects associated with Salmeterol Inhaler are unlikely to affect your ability to drive
or use machines.

3.

How to use Salmeterol Inhaler

Always use this medicine exactly as your doctor, nurse or pharmacist has told you. Check with your
doctor, nurse or pharmacist if you are not sure.
If you are being treated for asthma, you should always have both a Salmeterol Inhaler and a
steroid inhaler to use together.





Use Salmeterol Inhaler every day, until your doctor advises you to stop. Do not take more than
the recommended dose.
Do not stop taking Salmeterol Inhaler or reduce the dose of Salmeterol Inhaler without talking
to your doctor first.
Salmeterol Inhaler should be inhaled through the mouth into the lungs.
You will start to feel your medicine working within the first day of use.

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pressurised inhalation, suspension



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It is important that you follow your doctor’s instructions on how often to use your inhaler and
how many puffs to take.

The recommended dose is:
Adults (18 years of age and older) with asthma

The usual starting dose is 2 puffs twice a day.

If you have more severe asthma, your doctor may increase your dose to 4 puffs twice a day.
Children and adolescents with asthma
The safety and efficacy of Salmeterol Inhaler have not been demonstrated in children and adolescents.
Therefore, Salmeterol Inhaler should not be used in children 12 years of age and younger or in
adolsecents aged between 13 and 17 years.
Adults with Chronic Obstructive Pulmonary Disease (COPD) including bronchitis and
emphysema

The usual starting dose is 2 puffs twice a day.
Not for use in children and adolescents below 18 years of age.
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 inhaler properly or as prescribed may mean that the
medicine will not help your asthma or COPD as it should.
The medicine is contained in a pressurised canister in a plastic casing with a mouthpiece.
Testing your inhaler
When you use the inhaler for the first time you should test if it works properly.
1.
Remove the mouthpiece cover by gently pressing the sides with your thumb and index finger.
2.
Shake the inhaler, point the mouthpiece away from you and press the canister twice to release
two puffs into the air. If you have not used the inhaler for a week or more or if you have
cleaned the inhaler, you should release one puff into the air.
Using your inhaler
Do not rush the process of inhalation.
1.
2.

You should either stand up or sit upright when using the inhaler.
Remove the mouthpiece cover. Check the mouthpiece inside and outside to see that it is clean
(figure 1).
fig.1

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Shake the inhaler well before use (figure 2) to ensure that any loose objects are removed and
that the contents of the Inhaler are evenly mixed.
fig.2

4.
5.

Hold the inhaler upright with your thumb on the base, below the mouthpiece.
Breathe out as far as is comfortable (figure 3).
fig.3

6.

Place the mouthpiece in your mouth between your teeth and close your lips around it but do not
bite it (figure 4).
fig.4

7.

8.

Just after starting to breathe in as slowly as you can through your mouth, press down on top of
the inhaler to release a puff into your mouth while still breathing in steadily and deeply (figure
4).
While holding your breath, take the inhaler from your mouth and take your finger from the top
of the inhaler. Continue holding your breath for as long as is comfortable (figure 5).
fig.5

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10.

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If you are to take a second puff, wait about half a minute before repeating steps 3 to 8.
After use always replace the mouthpiece cover to keep out dust and fluff. The mouthpiece
cover is replaced by firmly pushing and snapping it into position.

Practise in front of a mirror the first few times. If you see ‘mist’ coming from the top of your inhaler
or the sides of your mouth you should start again.
People with weak hands may find it easier to hold the inhaler with both hands. Put the two forefingers
on top of the inhaler and both thumbs on the base below the mouthpiece.
If you find it difficult to use the inhaler, a Volumatic® spacer device may help to overcome this
problem. Contact your doctor, nurse or pharmacist. If you do need to use the Volumatic® spacer
device, please refer to the instruction leaflet provided with the spacer device, which includes all the
information you need to use the spacer correctly. Your doctor, nurse or pharmacist will show you how
to use the spacer device with the inhaler and how to care for the spacer device, particularly in respect
of cleaning. If you are using a spacer device with the inhaler, do not stop using the spacer device and
do not change to an alternative spacer device without talking to your doctor first, as he/she may need
to change the dose of Salmeterol Inhaler.
Always talk to your doctor before making any changes to your asthma treatment.
If the inhaler gets very cold, take the metal canister out of the plastic case and warm it in your hands
for a few minutes. Never use anything else to warm it up. After warming up the inhaler, spray one
puff in the air before use.
Cleaning your inhaler
To stop your inhaler blocking up, it is important to clean it at least once a week.
To clean your inhaler:

Remove the mouthpiece cover.

Do not remove the metal canister from the plastic casing at any time.

Wipe the inside and outside of the mouthpiece and the plastic casing with a dry cloth or tissue.

Release one puff into the air before next using the inhaler to test the inhaler.

Replace the mouthpiece cover.
Do not put the metal canister in water.
If you use more Salmeterol Inhaler 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 Salmeterol Inhaler
If you forget to use your inhaler, take your next dose when it is due. Do not take a double dose to
make up for a forgotten dose.
If you have any further questions on the use of this product, ask your doctor, pharmacist or nurse.

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4.

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Possible side effects

Like all medicines, Salmeterol Inhaler 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 Inhaler
to control your asthma or COPD.
The side effects listed below have been reported following use of salmeterol.
Allergic reactions: you may notice your breathing suddenly gets worse after using Salmeterol
Inhaler. You may experience:

Wheezing, shortness of breath or coughing

Rash (hives), itching and swelling (usually of the face, lips, tongue or throat)

The feeling that your heart is beating very fast or you feel faint and light headed (which may
lead to collapse or loss of consciousness)
If you get these effects or they happen suddenly after using Salmeterol Inhaler, stop using the
inhaler and tell your doctor straightaway. Allergic reactions to salmeterol are very rare (they may
affect up to 1 in 10,000 people).
Other side effects are:
Common, may affect up to 1 in 10 people

Muscle cramps

Feeling shaky; fast or irregular heartbeat (palpitations), headache, shaking hands (tremor).
Tremors are more likely if you are taking more than two puffs twice daily. These side effects
do not last long and happen less as treatment with Salmeterol Inhaler continues.
Uncommon, may affect up to1 in 100 people

Rash

Very fast heart rate (tachycardia). This is more likely to happen if you are taking more than two
puffs twice daily.

Feeling nervous.
Rare, may affect up to 1 in 1,000 people

Feeling dizzy

Being unable to sleep (insomnia) or finding sleep difficult

A reduction in the amount of potassium in your blood (you may get an irregular heartbeat,
muscle weakness and/or muscle cramps). Your doctor may ask you to have blood tests to check
the amount of potassium in your blood from time to time. If you have any concerns discuss
them with your doctor.
Very rare, may affect up to 1 in 10,000 people

Breathing difficulties or wheezing that gets worse straight after using Salmeterol Inhaler.
If this happens stop using your Salmeterol Inhaler immediately. Use your fast-acting
‘reliever’ inhaler to help your breathing and tell your doctor straightaway.

Irregular heartbeat or your heart gives an extra beat (arrhythmias). If this happens do not stop
using Salmeterol Inhaler but tell your doctor or nurse immediately.

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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
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: 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 Inhaler

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the label and on the carton after
{EXP}. The expiry date refers to the last day of that month.
Store below 30ºC.
Do not freeze.
This canister contains a pressurised liquid. Do not expose to temperatures higher than 50°C, protect
from direct sunlight.
Do not puncture, break or burn the canister, even when apparently empty.
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.

6.

Contents of the pack and other information

What Salmeterol Inhaler contains


The active substance is salmeterol (as xinafoate).
Each metered dose (ex-valve) contains 25 micrograms salmeterol (as xinafoate). This is
equivalent to a delivered dose (ex-actuator) of 21 micrograms salmeterol (as xinafoate).



The other ingredients are anhydrous ethanol, soya lecithin (E322) and norflurane (HFA 134a).

What Salmeterol Inhaler looks like and contents of the pack
Salmeterol Inhaler is a mid-green inhaler holding an aluminium canister with a pale green mouthpiece
cover. Each canister contains 120 actuations, each actuation containing 25 micrograms salmeterol (as
xinafoate).

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Salmeterol CFC-free 25 micrograms per actuation
pressurised inhalation, suspension

This medicine is available in boxes containing 1, 2, 3, 4 or 5 inhalers.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Sandoz Limited
Frimley Business Park,
Frimley,
Camberley,
Surrey,
GU16 7SR
United Kingdom
Manufacturer
Aeropharm GmbH
Francois-mitterrand-allee 1,
07407 Rudolstadt
Germany
This leaflet was last revised in September 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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