Skip to Content

AIRFLUSAL MDI 25 MICROGRAM/250 MICROGRAM PER ACTUATION PRESSURISED INHALATION SUSPENSION

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

View full screen / Print PDF » Download PDF ⇩

PDF Transcript

Package leaflet: Information for the user

SZ13504LT01A

AirFluSal® MDI 25 microgram/125 microgram per actuation pressurised inhalation,
suspension
AirFluSal® MDI 25 microgram/250 microgram per actuation pressurised inhalation,
suspension
salmeterol (as salmeterol xinafoate) / 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 MDI is and what it is used for
2. What you need to know before you use AirFluSal MDI
3. How to use AirFluSal MDI
4. Possible side effects
5. How to store AirFluSal MDI
6. Contents of the pack and other information

1

What AirFluSal MDI is and what it is used for

AirFluSal MDI is indicated for use in adults with asthma 18 years of age and older only.

AirFluSal MDI contains two medicines, salmeterol and fluticasone propionate:
• Salmeterol is a long-acting 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.
AirFluSal MDI is not recommended for use in children 12 years of age and younger or
adolescents 13 to 17 years of age.

The doctor has prescribed this medicine to help prevent breathing problems such as
asthma.
You must use AirFluSal MDI every day as directed by your doctor. This will make sure that
it works properly in controlling your asthma.

AirFluSal MDI helps to stop breathlessness and wheeziness coming on. However
AirFluSal MDI 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.

2

What you need to know before you use AirFluSal MDI

Do not take AirFluSal MDI:
If you are allergic to salmeterol, fluticasone propionate or any of the other ingredients of
this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor before using AirFluSal MDI if you have:
• Heart disease, including an irregular or fast heart beat
• Overactive thyroid gland
• High blood pressure
• Diabetes mellitus (AirFluSal MDI may increase your blood sugar)
• Low potassium in your blood
• Tuberculosis (TB) now, or in the past, or other lung infections.

Other medicines and AirFluSal MDI
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any
other medicines. This includes medicines for asthma or any medicines obtained without
a prescription. This is because AirFluSal MDI may not be suitable to be taken with some
other medicines.

Tell your doctor if you are taking the following medicines, before starting to use
AirFluSal MDI:
• β blockers (such as atenolol, propranolol and sotalol). β blockers are mostly used for
high blood pressure or other heart conditions.
• Medicines to treat infections including some medicines for HIV (such as ritonavir,
cobicistat, ketoconazole, itraconazole and erythromycin). Some of these medicines may
increase the amount of fluticasone propionate or salmeterol in your body. This can
increase your risk of experiencing side effects with AirFluSal MDI, including irregular
heartbeats, or may make side effects worse. Your doctor may wish to monitor you
carefully if you are taking these medicines.
• Corticosteroids (by mouth or by injection). If you have had these medicines recently, this
might increase the risk of this medicine affecting 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.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a
baby, ask your doctor or pharmacist for advice before taking this medicine.

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, you should continue to take
AirFluSal MDI but do not increase the number of puffs you take. Your chest condition may
be getting worse and you could become seriously ill. See your doctor as you may need
additional treatment.
AirFluSal MDI is only available in two strengths, 25/125 micrograms and
25/250 micrograms. If your doctor feels that you need a lower dose of your inhaler than
is available with AirFluSal MDI, your doctor will change you to an alternative combination
product containing the same two medicines but in a lower strength. This is currently
available on the market.
Use in children
Children 12 years of age and younger:
AirFluSal MDI should not be used in the management of asthma in children 12 years of
age and younger.
The maximum authorised dose of fluticasone propionate for use in children is
100 microgram twice daily which cannot be achieved with the available strengths of
AirFluSal MDI.
There are no data available for the use of AirFluSal MDI in children 12 years of age and
younger.
Adolescents:
AirFluSal MDI should not be used by adolescents aged 13 to 17 years
Instructions for use
• Your doctor or pharmacist should show you how to use your inhaler. They should check
how you use it from time to time. Not using the AirFluSal MDI inhaler properly or as
prescribed may mean that it will not help your asthma as it should.
• The medicine is contained in a pressurised canister in a plastic casing with a
mouthpiece.
• There is an indicator in front of the inhaler which tells you how many doses are left. As
you use the inhaler the dose indicator will typically rotate during every five to seven
puffs towards next decreasing number. The dose indicator will show the approximate
number of puffs remaining in the inhaler.
• Take care not to drop the inhaler as this may cause the indicator to count down.
Testing your inhaler
1. When using your inhaler for the first time, test that it is working. Remove the mouthpiece
cover by gently squeezing the sides with your thumb and forefinger and pull apart.
2. To make sure that it works, shake it well, point the mouthpiece away from you and
press the canister to release 4 puffs into the air, shaking the inhaler before releasing
each puff. The indicator displays the number 120, the number of puffs contained in the
inhaler. If you have not used your inhaler for a week or more, release two puffs of
medicine into the air.
Using your inhaler
It is important to start to breathe as slowly as possible just before using your inhaler.
1. Stand or sit upright when using your inhaler.
2. Remove the mouthpiece cover (as described
in step 1 of Testing your inhaler). Check inside
and outside to make sure that the mouthpiece
is clean and free of loose objects (Figure A).

Figure A
3. Shake the inhaler 4 or 5 times to ensure that
any loose objects are removed and that the
contents of the inhaler are evenly mixed
(Figure B).

Driving and using machines
AirFluSal MDI is not likely to affect your ability to drive or use machines.

3

How to use AirFluSal MDI

Always use this medicine exactly as your doctor or pharmacist has told you. Check with
your doctor or pharmacist if you are not sure.
• Use your AirFluSal MDI every day, until your doctor advises you to stop. Do not take
more than the recommended dose. Check with your doctor or pharmacist if you are not
sure.
• Do not stop taking AirFluSal MDI or reduce the dose of AirFluSal MDI without talking to
your doctor first.
• AirFluSal MDI should be inhaled through the mouth into the lungs.
The recommended dose is:
Adults aged 18 years and over
• AirFluSal MDI 25/125 - 2 puffs twice a day
• AirFluSal MDI 25/250 - 2 puffs twice a day
It is very important to follow your doctor’s instructions on how many puffs to take and how
often to take your medicine.
If you are using AirFluSal MDI 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

Figure B
4. Hold the inhaler upright with your thumb on
the base, below the mouthpiece. Breathe out
as far as is comfortable (Figure C).

Figure C
5. Place the mouthpiece in your mouth between
your teeth. Close your lips around it. Do not
bite (Figure D).

Figure D

6. Breathe in through your mouth slowly and deeply. Just after starting to breathe in, press
firmly down on the top of the canister to release a puff of medicine. Do this while still
breathing in steadily and deeply (Figure D).
Continued on the next page >>

7. Hold your breath, take the inhaler from your
mouth and your finger from the top of the
inhaler. Continue holding your breath for a few
seconds, or as long as is comfortable (Figure E).

Figure E
8. Between taking each puff of medicine, wait about half a minute and then repeat steps
3 to 7.
9. Afterwards, rinse your mouth with water and spit it out, and/or brush your teeth. This
may help to stop you getting thrush and becoming hoarse.
10. After use always replace the mouthpiece cover straight away to keep out dust. When the
mouthpiece cover is fitted correctly it will ‘click’ into position. If it does not ‘click’ into place,
turn the mouthpiece cover the other way round and try again. Do not use too much force.
Do not rush steps 4, 5, 6 and 7. It is important that you breathe in as slowly as possible
just before using your inhaler. You should use your inhaler whilst standing in front of a
mirror for 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 from step 3.

If you find it difficult to use the inhaler, either your doctor or other healthcare provider
may recommend using a spacer device such as the Volumatic® or AeroChamber Plus®
(depending on National Guidance) with your inhaler. Your doctor, pharmacist or other
healthcare provider should show you how to use the spacer device with your inhaler and
how to wash and care for your spacer device and will answer any questions you may have.
Patients should continue to use the same make of spacer device, either the Volumatic
spacer device or the AeroChamber Plus spacer device, as switching between spacer
devices can result in changes in the dose delivered to the lungs.

It is important that if you are using a spacer device with your inhaler that you do not stop
using it without talking to your doctor first. It is also important that you do not change
the type of spacer device that you use without talking to your doctor. If you stop using a
spacer device or change the type of spacer device that you use your doctor may need to
change the dose of medicine required to control your asthma.
Always talk to your doctor before making any changes to your asthma treatment.

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 bottom below the mouthpiece.

You should get a replacement when the indicator shows the number ‘40’ and the colour on
the dose indicator will change from green to red. Stop using the Inhaler when the indicator
shows ‘0’ as any puffs left in the device may not be enough to give you a full dose. Never
try to alter the numbers on the indicator or detach the indicator from the actuator. The
indicator cannot be reset and is permanently attached to the actuator.
Cleaning your inhaler
To stop your inhaler blocking, 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.
• Replace the mouthpiece cover. It will ‘click’ into place when fitted correctly. If it does not
‘click’ into place, turn the mouthpiece cover the other way round and try again. Do not
use too much force.
Do not put the metal canister in water.

If you use more AirFluSal MDI 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. 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
or pharmacist for advice. This is because larger doses of AirFluSal MDI may reduce the
amount of steroid hormones produced by the adrenal gland.

If you forget to use AirFluSal MDI
Do not take a double dose to make up for a forgotten dose. Just take your next dose at the
usual time.
If you stop using AirFluSal MDI
It is very important that you take your AirFluSal MDI every day as directed. Keep taking
it until your doctor tells you to stop. Do not stop or suddenly reduce your dose of
AirFluSal MDI. This could make your breathing worse.
In addition, if you suddenly stop taking AirFluSal MDI or reduce your dose of AirFluSal
MDI this may (very rarely) cause you to have problems with your adrenal gland (adrenal
insufficiency) which sometimes causes side effects.
These side effects 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.
If you get any side effects, talk to your doctor or pharmacist. To prevent these symptoms
occurring, your doctor may prescribe extra corticosteroids in tablet form (such as
prednisolone).
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 chance of side effects, your doctor will prescribe the lowest dose of
AirFluSal MDI to control your asthma.

Allergic reactions: you may notice your breathing suddenly gets worse immediately
after using AirFluSal MDI. 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 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 any
of these effects or if they happen suddenly after using AirFluSal MDI, stop using
AirFluSal MDI and tell your doctor straight away. Allergic reactions to AirFluSal MDI are
uncommon (they affect less than 1 person in 100).
Other side effects are listed below:

Very Common (may affect more than 1 in 10 people)
• Headache - this usually gets better as treatment continues.
• Increased number of colds have been reported in patients with COPD.

Common (may affect up to 1 in 10 people)
• Thrush (sore, creamy-yellow, raised patches) in the mouth and throat. Also sore tongue
and 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 an anti-fungal medication to treat the thrush.
• Aching, swollen joints and muscle pain.
• Muscle cramps.
The following side effects have also been reported in patients with Chronic Obstructive
Pulmonary Disease (COPD):
• Pneumonia and bronchitis (lung infection). Tell your doctor if you notice any of the
following symptoms: increase in sputum production, change in sputum colour, fever,
chills, increased cough, increased breathing problems.
• Throat irritation. Rinsing your mouth out with water and spitting it out immediately after
taking each puff may help.
• 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 in the amount of potassium in the blood (you may get an uneven heartbeat,
muscle weakness, cramp).
Uncommon (may affect up to 1 in 100 people)
• 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.
• Cataract (cloudy lens in the eye).
• Very fast heartbeat (tachycardia) or a rapid and irregular heartbeat (atrial fibrillation).
• Feeling shaky (tremor) and fast or uneven heart beat (palpitations) - these are usually
harmless and get 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 that gets worse straight after taking AirFluSal
MDI. If this happens stop using your AirFluSal MDI inhaler. Use your fast-acting
‘reliever’ inhaler to help your breathing and tell your doctor straight away.
• AirFluSal MDI 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
- Glaucoma
- Weight gain
- Rounded (moon shaped) face (Cushing’s Syndrome)
Your doctor will check you regularly for any of these side effects and make sure you are
taking the lowest dose of AirFluSal MDI to control your asthma.
• Behavioural changes, such as being unusually active and irritable (these effects mainly
occur in children).
• Uneven heart beat or heart gives an extra beat (arrhythmias). Tell your doctor, but do
not stop taking AirFluSal MDI unless the doctor tells you to stop.
• A fungal infection in the oesophagus (gullet), which might cause difficulties in swallowing.
Frequency not known, but may also occur:
• Depression or aggression. These effects are more likely to occur in children.

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 AirFluSal MDI

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 carton after
EXP. The expiry date refers to the last day of that month.
After first opening pouch: 3 months
Store below 25°C.

Keep the container in the outer carton in order to protect from light.
Do not refrigerate or freeze.
The container contains a pressurised liquid.
The container should not be punctured, broken or burnt even when apparently empty.

As with most inhaled medicinal products in pressurised containers, the therapeutic effect
of this medicinal product may decrease when the container is cold.
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 AirFluSal MDI contains

AirFluSal MDI 25 microgram/125 microgram per actuation pressurised inhalation,
suspension
The active substances are salmeterol and fluticasone propionate. Each metered dose
provides 25 micrograms of salmeterol (as salmeterol xinafoate) and 125 micrograms of
fluticasone propionate.
The other ingredient is norflurane (HFA 134a) as propellant.

AirFluSal MDI 25 microgram/250 microgram per actuation pressurised inhalation,
suspension
The active substances are salmeterol (as salmeterol xinafoate) and fluticasone.
Each metered dose provides 25 micrograms of salmeterol (as salmeterol xinafoate) and
250 micrograms of fluticasone propionate.
The other ingredient is norflurane (HFA 134a) as propellant.

What AirFluSal MDI looks like and contents of the pack
The inhaler consists of an aluminium container with a suitable metering valve and a
polypropylene actuator with dose indicator and fitted with dust cap in a sealed pouch with
a silica gel bag.
The container contains a white homogeneous suspension.
Each container is filled to deliver 120 actuations.
Pack sizes:
1; 2; 2 (bundled package 2x1); 3; 3 (bundled package 3x1); 4; 5; 6; 10; 10 (bundled
package 10x1) x 120 actuations inhaler(s)
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
Salutas Pharma GmbH, Otto-von-Guericke-Allee 1, Sachsen-Anhalt, 39179, Barleben,
Germany
This leaflet was last revised in 02/2017.

50059328
SZ13504LT01A

draft: 44072138, 44072179
laetus code: supplier to add
mat.no.: 50059328

Artwork Proof Box
Ref: Licence application + update
Proof no.
001.1

Date prepared:
22/02/2017

Colours:
Black
Dimensions: 240 x 440 mm

Font size:
8pt
Fonts:
Helvetica

Expand Transcript

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.

Hide