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AIRFLUSAL FORSPIRO 50 MICROGRAM/500 MICROGRAM PER ACTUATION INHALATION POWDER PRE-DISPENSED

Active substance(s): FLUTICASONE PROPIONATE / SALMETEROL / SALMETEROL XINAFOATE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

SZ13502LT01A

AirFluSal® Forspiro® 50 microgram/500
microgram per actuation inhalation powder,
pre-dispensed
salmeterol/fluticasone propionate
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 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.
What is in this leaflet
1. What AirFluSal Forspiro is and what it is
used for
2. What you need to know before you use
AirFluSal Forspiro
3. How to use AirFluSal Forspiro
4. Possible side effects
5. How to store AirFluSal Forspiro
6. Contents of the pack and other information

1

What AirFluSal Forspiro is and
what it is used for

The name of your medicine is AirFluSal
Forspiro. AirFluSal Forspiro is an inhaler that
contains two active ingredients, salmeterol and
fluticasone propionate. Salmeterol is a longacting bronchodilator. Bronchodilators help the
airways in the lungs to stay open. This makes it
easier for air to get in and out. The effects last
for at least 12 hours. Fluticasone propionate
is a corticosteroid which reduces swelling and
irritation in the lungs.
The doctor has prescribed this medicine to help
to prevent breathing problems associated with
chronic obstructive pulmonary disease (COPD).
AirFluSal Forspiro reduces the number of flare
ups of symptoms related to COPD.
You must use AirFluSal Forspiro every day, as
prescribed by your doctor. This will ensure that
the medicine works properly in controlling these
symptoms.
AirFluSal Forspiro helps to stop
breathlessness and wheeziness coming
on. However, AirFluSal Forspiro should
not be used to relieve a sudden attack of
breathlessness or wheezing. If this happens
you need to use a fast-acting “reliever”
(“rescue”) inhaler, such as salbutamol.
You should always have your fast-acting
“rescue” inhaler with you.
AirFluSal Forspiro is intended for use in adults
with COPD 18 years of age and older only.
Not for use in asthma.

you need to know before
2 What
you use AirFluSal Forspiro
Do not use AirFluSal Forspiro
• if you are allergic (hypersensitive) to
salmeterol, fluticasone propionate or the
other ingredient in this medicine (listed in
section 6).
Warnings and precautions
Your doctor will supervise your treatment more
closely if you have or ever had:
• heart disease, including irregular or fast
heartbeat
• overactive thyroid gland
• high blood pressure
• diabetes mellitus (AirFluSal Forspiro may
increase your blood sugar)
• low potassium in your blood
• tuberculosis (TB) now or in the past or other
lung infections
Talk to your doctor before using AirFluSal
Forspiro if any of the above applies to you.
Children and adolescents
Do not give this medicine to children and
adolescents less than 18 years of age.
AirFluSal Forspiro is intended for use in adults
18 years of age and older only.
Other medicines and AirFluSal Forspiro
Tell your doctor or pharmacist if you are taking,
have recently taken or might take any other
medicines, before you start using AirFluSal
Forspiro. This includes other medicines
for COPD, other inhalers or any medicines
obtained without a prescription. This is because
AirFluSal Forspiro may not be suitable to be
taken with some other medicines.
In particular tell your doctor if you are taking
any of the following:
• Beta-blockers (such as atenolol,
propranolol, sotalol). Beta blockers are
mostly used for high blood pressure and
heart conditions.
• Medicines to treat infections caused
by viruses and fungi (such as ritonavir,
ketoconazole, itraconazole and
erythromycin). Some of these medicines
may increase the amount of fluticasone
propionate or salmeterol in your body, which
can increase your risk of experiencing side
effects, including irregular heartbeats, or may
make side effects worse.
• Corticosteroids (taken by mouth or by
injection). If you have used these medicines
recently, this might increase the risk of
AirFluSal Forspiro affecting the function of
your adrenal gland.
• Diuretics, also known as ‘water tablets’ used
to treat high blood pressure.
• Other bronchodilators (such as salbutamol).
• Xanthine medicines. These are often used to
treat asthma.

Inhalation use.









Use AirFluSal Forspiro every day, until your
doctor advises you to stop.
Do not take more than the recommended dose.
Do not stop taking AirFluSal Forspiro or
reduce the dose of AirFluSal Forspiro without
talking to your doctor first.
AirFluSal Forspiro should be inhaled through
the mouth into the lungs.

Adults
The recommended dose is:
One inhalation twice a day
It is very important to follow your doctor’s
instructions on how many inhalations to take
and how often to take your medicine.
Use in children and adolescents
This medicine is not for use in children and
adolescents less than 18 years of age.
Method of use
If your breathing gets worse or is not well
controlled even if AirFluSal Forspiro is used
regularly as prescribed by your doctor, tell your
doctor straight away. You may feel more wheezy,
your chest feels tight more often or you may need
more of your fast-acting ‘reliever’ medicine.
If any of these happen, you should continue
to take AirFluSal Forspiro but do not increase
the number of inhalations you take. Your chest
condition could be getting worse and you could
become seriously ill. See your doctor straight
away as you may need additional treatment.
Instructions for use
Your doctor, nurse or pharmacist should show
you how to use your inhaler. They should check
on how you use it from time to time. If you do
not use the inhaler properly or as prescribed,
the medicine might not help your COPD and
your symptoms as it should.
The inhaler contains 60 doses of powder
medication in a coiled strip of foil. It has a dose
counter which shows you how many doses you
have remaining counting down from 60 to 0.
When you have reached the last 10 doses the
numbers will be on a red background.
The inhaler is not refillable – please dispose of
the inhaler when it is empty and replace it with
a new one.
Protective cap
Side
chamber:
The foil strip
collects here
for removal.
Dose counter:
When you
open the
protective cap
you can check
how many
doses are left.

White lever:
Only use this
lever when
you are
ready to take
a dose.

Air inlets:
Either side
of the
mouthpiece

Before using the inhaler
• Open the transparent side chamber door.
• Remove the foil strip from the side chamber
by carefully tearing away the full length of
strip against the ‘teeth’ of the side chamber as
shown below. Do not pull or tug on the strip.

• Close the side chamber door and dispose of
the used strip.
Important:
As you use the inhaler the side chamber
will gradually fill up with used strip. The foil
strips with black bars don’t contain
medication. Eventually the numbered
sections of the strip will appear in the side
chamber.
Do not let more than 3 sections of foil
strip build up in the side chamber as they
may cause the inhaler to jam. Tear the strip
away carefully as shown above, and dispose
of it safely.
Using the inhaler
Hold the inhaler in your hands as seen in the
pictures.
1. Open

Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think
you may be pregnant or are planning to have a
baby, ask your doctor for advice before taking
this medicine. Your doctor will assess whether
you can take this medicine or not.
Driving and using machines
AirFluSal Forspiro is unlikely to affect your
ability to drive or use machines.
AirFluSal Forspiro contains lactose
AirFluSal Forspiro contains 11.95 mg lactose in
each dose.
The amount of lactose in this medicine does
not normally cause problems in people who are
lactose intolerant.
If you have been told by your doctor that you
have an intolerance to some sugars, contact
your doctor before taking this medicine.






Open the protective cap downwards to
reveal the mouthpiece.
Check the dose counter to see how many
doses are left.

2. Prepare the dose

3 How to use AirFluSal Forspiro
Always use this medicine exactly as your
doctor has told you. Check with your doctor,
pharmacist or nurse if you are not sure.

• Lift up the edge of the white lever. Make
sure the side chamber is closed.
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Remember: Only operate the white lever
when you are ready to inhale a dose of your
medication. If you play with the white lever,
you will waste doses.








Open: Move the white lever fully over
as far as it will go and until it clicks. This
action moves a new dose into position with
the number at the top.

• Close: Afterwards close the white lever
fully so that it clicks back into its original
position. The inhaler is now ready for
immediate use.
3. Inhale
• Away from the inhaler mouthpiece, breathe
out as much as is comfortable. Never
breathe directly into the inhaler as this
could affect the dose.
• Hold the inhaler level with the protective cap
pointing downwards.
• Close your lips firmly around the mouthpiece.
• Breathe in steadily and deeply through the
inhaler, not through your nose.
Do not block
the air inlets

• Remove the inhaler from your mouth and
hold your breath for 5-10 seconds or as
long as you can without causing discomfort.
• Afterwards, breathe out slowly, but not into
the inhaler.
• Close the protective cap over the mouthpiece.
• Rinse your mouth with water and spit it out.
This may help to prevent you from getting
fungal infections in the mouth and becoming
hoarse.
Cleaning
• Wipe the outside of the mouthpiece with a
clean, dry tissue if necessary.
• Do not attempt to take the inhaler apart to
clean it or for any other purpose.
• Do not use water or wet wipes to clean the
inhaler parts as dampness can affect the
dose.
• Never insert a pin or other sharp objects into
the mouthpiece, or any other part, as this
could damage the inhaler.
If you use more AirFluSal Forspiro 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, pharmacist
or nurse. You may notice your heart beating
faster than usual and you may feel shaky. You
may also have dizziness, a headache, muscle
weakness and aching joints.
If you have used larger doses for a long
period of time, you should talk to your doctor,
pharmacist or nurse for advice. This is because
larger doses of this medicine may reduce the
amount of steroid hormones produced by your
adrenal gland.
If you forget to use AirFluSal Forspiro
If you forget to use your inhaler, take your next
inhalation when it is due. Do not take a double
inhalation to make up for a forgotten one.
If you stop using AirFluSal Forspiro
It is very important you use the inhaler every
day, as the doctor recommended.
Keep taking your medicine until your doctor
tells you to stop. Do not stop or suddenly
reduce your dose of AirFluSal Forspiro.
This can make your breathing worse. Very
rarely, if you suddenly stop using your inhaler
or suddenly reduce the dose, this can cause
you to have problems with your adrenal gland
(adrenal insufficiency) and you may experience
side effects. These may include any of the
following:








stomach pain
tiredness and loss of appetite, feeling sick
sickness and diarrhoea
weight loss
headache or drowsiness
low levels of sugar in your blood
low blood pressure and seizures (fits)

When your body is under stress such as from
fever, trauma (such as a car accident), infection
or surgery, adrenal insufficiency can get worse
and you may have any of the side effects listed
above. To prevent these symptoms occurring,
your doctor may prescribe extra corticosteroids
in tablet form (such as prednisolone).
If you do get any of the side effects listed
above, or any other side effects, talk to your
doctor or pharmacist straight away.
If you have any further questions on the use
of this medicine or device, ask your doctor,
pharmacist or nurse.

4 Possible side effects
Like all medicines, this medicine can cause side
effects, although not everybody gets them.
Allergic reactions: you may notice your
breathing suddenly gets worse immediately
after using AirFluSal Forspiro. You may
be very wheezy and cough or be short of
breath. You may also notice itching, a rash
(hives) and swelling (usually of the face, lips,
tongue, or throat), or you may suddenly feel
your heart beating very fast or you feel faint
and light headed (which may lead to collapse
or loss of consciousness). If you get any of
these effects or if they happen suddenly
after using AirFluSal Forspiro, stop using
AirFluSal Forspiro and tell your doctor
straight away. Allergic reactions to AirFluSal
Forspiro are uncommon (they may affect up to
1 in 100 people).

• Increased number of colds has been reported.
Common, may affect up to 1 in 10 people
• Thrush (sore, creamy-yellow, raised patches)
in the mouth and throat. Also sore tongue,
hoarse voice and throat irritation. Rinsing
your mouth out with water and spitting it out
immediately and/or brushing your teeth after
taking each dose of your medicine may help.
Your doctor may prescribe you an anti-fungal
medication to treat the thrush.
• Aching, swollen joints and muscle pain
• Muscle cramps
• Pneumonia and bronchitis (lung infection)
Tell your doctor if you notice any of the
following symptoms:
- increase in the liquid/phlegm which you
cough up from your lungs (sputum)
- change in sputum colour
- fever
- chills
- increased cough
- increased breathing problems
• Bruising and fractures
• Inflammation of sinuses (a feeling of tension
or fullness in the nose, cheeks and behind
the eyes, sometimes with a throbbing ache).
• A reduction of the amount of potassium in
the blood (you may get uneven heartbeats,
muscle weakness, cramp).
Uncommon, may affect up to 1 in 100 people
• Increase 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.
• Cloudy lens in the eye (cataract)
• Very fast heartbeat (tachycardia)
• Feeling shaky (tremor) with fast or uneven
heartbeat (palpitation).
These are usually harmless and occur less
as treatment continues.
• Chest pain
• Feeling worried
This effect mainly occurs in children.
• Disturbed sleep
• Allergic skin rash
Rare, may affect up to 1 in 1,000 people
• Breathing difficulties or wheezing which
worsen immediately after using AirFluSal
Forspiro.
If this happens stop using AirFluSal
Forspiro. Use your fast-acting ‘reliever’
inhaler to help your breathing and tell your
doctor immediately.
• AirFluSal Forspiro may affect the normal
production of steroid hormones in the body,
particularly if you have taken high doses for
long periods of time.
The effects include:
- Slowing of growth in children and
adolescents
- Thinning of the bones
- Increased eye pressure (glaucoma)
- Weight gain
- Rounded, moon shaped face (Cushing’s
Syndrome).
Your doctor will check you regularly for any of
the above side effects and will make sure you
are taking the lowest dose of salmeterol/
fluticasone propionate to control your disease.
• Behavioural changes, such as being
unusually active and irritable
These effects mainly occur in children.
• Uneven heartbeats or heart gives an extra
beat (arrhythmias).
Tell your doctor, but do not stop using AirFluSal
Forspiro unless the doctor tells you to stop.
• Fungal infection in the oesophagus (gullet),
which might cause difficulties in swallowing.
Frequency not known, but may also occur
• Depression or aggression
These effects mainly occur in children.
Reporting of side effects
If you get any side effects, talk to your doctor,
pharmacist or nurse. This includes any 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 AirFluSal Forspiro
Keep this medicine out of the sight and reach
of children.
Do not store above 25°C.
Do not use this medicine after the expiry date
which is stated on the label and carton after
EXP. The expiry date refers to the last day of
that month.
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.

of the pack and other
6 Contents
information
What AirFluSal Forspiro contains
AirFluSal® Forspiro® 50 microgram/500
microgram per actuation inhalation powder,
pre-dispensed:
• The active substances are salmeterol and
fluticasone. Each metered dose of AirFluSal
Forspiro provides 50 micrograms of
salmeterol (as salmeterol xinafoate) and
500 micrograms of fluticasone propionate.
Corresponding with a delivered dose of:
• 45 micrograms of salmeterol (as salmeterol
xinafoate) and 465 micrograms of fluticasone

propionate
• The other ingredient is lactose monohydrate.
What AirFluSal Forspiro looks like and
contents of the pack
• In the purple plastic dry-powder inhalation
device, 60 doses of powder blend are
contained in an aluminium blister.
• Each dose is pre-dispensed.
• Pack sizes:
1, 2, 3, 4, 5, 6 or 10 devices containing 60
doses
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, UK
Manufacturer
Aeropharm GmbH, Francois-Mitterrand-Allee 1,
07407 Rudolstadt, Germany
This leaflet was last revised in 10/2015.

Other side effects are listed below:
Very Common, may affect more than 1 in 10
people
• Headache
This usually gets better as treatment continues.

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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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