Aloflute 25 micrograms / 125 micrograms per Metered dose pressurised inhalation suspension – patient leaflet, side effects, dosage

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.

Aloflute contains alcohol

This medicine contains 0.7 mg of alcohol (ethanol)

in each metered dose. The amount in one

metered dose of this medicine is equivalent to less than 1 ml beer or 1 ml wine. The small amount

of alcohol in this medicine will not have any

noticeable effects.

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. 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).

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 0ºC) 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. 3.

   2. 1.

   4.

   5.

   1. 1. Stand up or sit upright when using your

inhaler.

1. 2. Remove the mouthpiece cover (figure 1).

Check inside and outside to make sure that the

mouthpiece is clean and free of loose objects.

1. 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).

1. 4. Hold the inhaler upright with your thumb on

the base, below the mouthpiece. Breathe out

as far as is comfortable (figure 3).

1. 5. Place the mouthpiece in your mouth between

your teeth. Close your lips around it. Do not

bite.

1. 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).

1. 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).

1. 8. Wait about half a minute between taking each

puff of medicine and then repeat steps 3 to 7.

1. 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.

1. 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. 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

BACK

Date: Time:

26 MAY 2025 10:25

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.

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)

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.

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 Aloflute to control

your asthma.

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.

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 Website: www.mhra.gov.uk/

yellowcard or search for MHRA Yellow Card in the

Google Play or Apple App Store.

By reporting side effects you can help provide

more information on the safety of this medicine.

5. How to store Aloflute

• 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.

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.

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.

This medicine contains fluorinated greenhouse

gases.

Aloflute 25/125 mcg - Each inhaler contains

12.249 g of HFC-134a corresponding to 0.018

tonne CO² equivalent (global warming potential

GWP = 1430).

Aloflute 25/250 mcg - Each inhaler contains

12.228 g of HFC-134a corresponding to 0.017

tonne CO² equivalent (global warming potential

GWP = 1430).

Marketing Authorisation Holder and

Manufacturer

Kindeva Drug Delivery Ltd.

Derby Road

Loughborough

Leicestershire

LE11 5SF

UK

This leaflet was last revised 06/2025

AeroChamber Plus is a trademark of Trudell Medical International

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3797487

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