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ALOFLUTE 25 MICROGRAM/250 MICROGRAM PER METERED DOSE PRESSURISED INHALATION SUSPENSION

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

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Package leaflet: Information for the user

Aloflute

25 microgram/125 microgram per
metered dose pressurised
inhalation, suspension
25 microgram/250 microgram per
metered dose pressurised
inhalation, suspension
salmeterol/fluticasone propionate
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 symptoms and 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 Aloflute is and what it is used for
2. What you need to know before you use Aloflute
3. How to use Aloflute
4. Possible side effects
5. How to store Aloflute
6. Contents of the pack and other information

1. What Aloflute is and what it is used for
Aloflute 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.
Aloflute is indicated for use in adults 18 years of
age and older only.
Aloflute is NOT indicated 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 Aloflute every day as directed by your
doctor. This will make sure that it works properly in
controlling your asthma.
Aloflute helps to stop breathlessness and
wheeziness coming on. However Aloflute
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
Aloflute
Do not take Aloflute if:
You are allergic (hypersensitive) to salmeterol,
fluticasone propionate or any of the other
ingredients of this medicine (listed in section 6).
Warnings and precautions
Your doctor will supervise your treatment more
closely if you have medical conditions such as:
• Heart disease, including an irregular or fast heart
beat
• Overactive thyroid gland
• High blood pressure
• Diabetes mellitus (Aloflute may increase your
blood sugar)
• Low potassium in your blood
• Tuberculosis (TB) now, or in the past, or other
lung infections
If you have ever had any of these conditions, tell
your doctor before you use Aloflute.
Contact your doctor if you experience blurred
vision or other visual disturbances.
Children and adolescents
This medicine should not be used in children or
adolescents under the age of 18 years.
Other medicines and Aloflute
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 Aloflute 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 Aloflute:
• 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 (such as ritonavir,
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 Aloflute, including
irregular heart beats, or may make side effects
worse.
• 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.
• Some medicines may increase the effects of
Aloflute and your doctor may wish to monitor
you carefully if you are taking these medicines
(including some medicines for HIV: ritonavir,
cobicistat).
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.

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

3. How to use Aloflute
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 Aloflute 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 Aloflute or reduce the dose of
Aloflute without talking to your doctor first.
• Aloflute should be inhaled through the mouth
into the lungs.
Adults aged 18 years and over
• Aloflute 25/125 - 2 puffs twice a day
• Aloflute 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 Aloflute 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, you should
continue to take Aloflute 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.
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
Aloflute 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 a counter on the back of the inhaler
which tells you how many doses are left. Each
time you press the canister, a puff of medicine is
released and the counter will count down by one.
• Take care not to drop the inhaler as this may
cause the counter 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 (figure 1).
2. To make sure that the inhaler works, shake it well,
point the mouthpiece away from you and press
the canister firmly to release a puff into the air.
Repeat these steps at least three times, shaking
the inhaler before releasing each puff, until the
counter reads 120. If you have not used your
inhaler for a week or more, or your inhaler gets
very cold (below 0˚C) you should 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.

2.

Component Type Leaflet
Affiliate Item Code 1195687

Vendor Job No.

N/A

1. Stand up or sit upright when using your inhaler.
2. Remove the mouthpiece cover (figure 1). Check
inside and outside to make sure that the
mouthpiece is clean and free of loose objects.
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 2).
4. Hold the inhaler upright with your thumb on the
base, below the mouthpiece. Breathe out as far
as is comfortable (figure 3).
5. Place the mouthpiece in your mouth between
your teeth. Close your lips around it. Do not bite.
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 4).
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 5).
8. Wait about half a minute between taking each
puff of medicine 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. The
mouthpiece cover will 'click' into position. 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 your inhaler, either your
doctor or other healthcare provider may recommend
using a spacer device such as the AeroChamber Plus®
with your inhaler. Your doctor, nurse, pharmacist or
other healthcare provider should show you how to
use the spacer device with your inhaler and how to
care for your spacer device and will answer any
questions you may have.
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 or nurse first.

Client Market UK

MA No.

Keyline/Drawing No.N/A

Packing Site/Printer 3M
Supplier Code TBC
Pharma Code TBC
Sign-offs

09.05.17

No. of colours
Colours

1

Page Count

1/2

Black

Proof No. 3

Previous Aff Code. 1113392
00068/0405 - 0406

5.

4.

Date:
Description Salmeterol/Fluticasone 25/125 & 25/250 mcg (Aloflute)

3.

Barcode Info N/A
Dimensions 160 x 507 mm

Non-Print
Colours

Keyline

Main Font Myriad Pro

Body Text Size 9 pt

Only the AeroChamber Plus® spacer device
should be used with Aloflute. Other spacing
devices should not be used with Aloflute and
you should not switch from one spacer device
to another. If you stop using a spacer device 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 counter shows the
number 20 (figure 6). Stop
using the inhaler when the
counter 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 counter or
detach the counter from the plastic casing.

6.

Cleaning your inhaler
To stop your inhaler blocking, it is important to
clean your inhaler at least once a week.
To clean your inhaler
• Remove the mouthpiece cover.
• Do not remove the 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. Do not use too much force.
Do not wash or put any parts of your inhaler in water.
If you use more Aloflute 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 Aloflute
may reduce the amount of steroid hormones
produced by the adrenal gland.
If you forget to use Aloflute
Do not take a double dose to make up for a missed
dose. Just take your next dose at the usual time.
If you stop using Aloflute
It is very important that you take your Aloflute
every day as directed. Keep taking it until your
doctor tells you to stop. Do not stop or suddenly
reduce your dose of Aloflute. This could make your
breathing worse.
In addition, if you suddenly stop taking Aloflute or
reduce your dose of Aloflute 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)

The following side effects have also been reported
in patients with 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 heart beat, muscle
weakness, cramp).
Uncommon (affects less than 1 person in 100)
• 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 heart beat (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 (affects less than 1 person in 1000)
• Breathing difficulties or wheezing that get
worse straight after taking Aloflute. If this
happens stop using your Aloflute inhaler. Use
your fast-acting 'reliever' inhaler to help your
breathing and tell your doctor straight away.
• Aloflute 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 Aloflute 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 Aloflute 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.
• Blurred vision.
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 Aloflute

4. Possible side effects

• Keep this medicine out of the sight and reach
of children.
• Do not use Aloflute 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 store above 25°C.
• The canister contains a pressurised liquid. Do not
expose to temperatures higher than 50°C, protect
from direct sunlight. Do not pierce or burn the
canister even when empty.
• As with most inhaled medicinal products in
pressurised canisters, the therapeutic effect of
this medicinal product may decrease when the
canister is cold.

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 Aloflute to control your asthma.

Do not throw away 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.

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 about the use of
this medicine, ask your doctor, nurse or pharmacist.

Allergic reactions: you may notice your
breathing suddenly gets worse immediately
after using Aloflute. 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
Aloflute, stop using Aloflute and tell your doctor
straight away. Allergic reactions to Aloflute are
uncommon (they affect less than 1 person in 100).
Other side effects are listed below:
Very Common (affects more than 1 person in 10)
• Headache - this usually gets better as treatment
continues.
• Increased number of colds have been reported in
patients with chronic obstructive pulmonary
disease (COPD). COPD is a long-term lung disease
that causes shortness of breath, coughing and
frequent chest infections. The term COPD
includes conditions known as chronic bronchitis
and emphysema.
Common (affects less than 1 person in 10)
• 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.

6. Contents of the pack and other information
What Aloflute contains
Each metered dose (ex valve) contains 25
micrograms of salmeterol (as salmeterol
xinafoate) and 125 or 250 micrograms of fluticasone
propionate. This is equivalent to a delivered dose
(ex actuator) of 21 micrograms of salmeterol and
110 or 220 micrograms of fluticasone propionate.
The other ingredients are the propellant, norflurane
(HFA 134a) and ethanol, anhydrous.
What Aloflute looks like and contents of the pack
• Aloflute is supplied to you in a metered dose
inhaler which delivers your medicine in a
pressurised suspension for you to inhale through
your mouth into your lungs.
• The pressurised canister contains a white to off
white suspension for inhalation.
• The canisters are fitted into a white plastic casing
incorporating a mouthpiece and fitted with
mauve or burgundy dustcaps.
• The devices are packed in cartons of 1 inhaler.
Each inhaler contains 120 metered doses.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
3M Health Care Ltd
3M House, 1 Morley Street
Loughborough, LE11 1EP UK.
Manufacturer:
3M Health Care Ltd
Derby Road, Loughborough
Leicestershire, LE11 5SF UK.
This leaflet was last revised 05/2017
AeroChamber Plus is a trademark of Trudell Medical International
3M is a trademark of 3M Company

1195687
TBC

Date:
Description Salmeterol/Fluticasone 25/125 & 25/250 mcg (Aloflute)
Component Type Leaflet
Affiliate Item Code 1195687
Previous Aff Code
MA No.

1113392
00068/0405 - 0406

Packing Site/Printer 3M
Supplier Code TBC
Pharma Code TBC
Sign-offs

Vendor Job No.

N/A

09.05.17

No. of colours
Colours

1

Page Count

2/2

Black

Proof No. 3
Client Market UK

Keyline/Drawing No.N/A
Barcode Info N/A
Dimensions 160 x 507 mm

Non-Print
Colours

Keyline

Main Font Myriad Pro

Body Text Size 9 pt

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.

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