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SEREFLO 25 MICROGRAM/125 MICROGRAM PER ACTUATION PRESSURISED INHALATION SUSPENSION

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

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Sereflo UK PIL

Actual Size: 240 X 485 mm
Size after folding: 30 X 65 mm

Front
240 mm

PACKAGE LEAFLET: INFORMATION FOR THE USER

CP.SER.JNT.IN.CP.V1P1

SEREFLO 25MICROGRAM/125MICROGRAM PER ACTUATION PRESSURISED INHALATION, SUSPENSION
SEREFLO 25MICROGRAM/250MICROGRAM PER ACTUATION PRESSURISED INHALATION, SUSPENSION
salmeterol/fluticasone propionate
Read this leaflet carefully BEFORE you start taking this medicine because it contains important information for you.
• Keep this leaflet. You may need it to read it again.
• If you have further questions, please ask your doctor or your pharmacist.
• This medicine has been prescribed for you personally and you should not pass it on to others. It may harm them, even if their symptoms 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 Sereflo is and what it is used for
2. What you need to know before you use Sereflo
3. How to use Sereflo
4. Possible side effects
5. How to store Sereflo
6. Contents of the pack and other information

1.

WHAT SEREFLO IS AND WHAT IT IS USED FOR

Sereflo 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.
The doctor has prescribed this medicine to help prevent breathing problems such as
asthma. You must use Sereflo every day as directed by your doctor. This will make
sure that it works properly in controlling your asthma.
Sereflo helps to stop breathlessness and wheeziness coming on. However,
Sereflo 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 SEREFLO

Do not take Sereflo:
If you are allergic (hypersensitive) to salmeterol, fluticasone propionate or to the
other ingredient norflurane (HFA 134a).

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 Sereflo 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 dose indicator on the front of the inhaler. The dose indicator will show
the number of doses left in the canister through a window in the plastic actuator.
As you use the inhaler the dose indicator will typically rotate during every five to
seven puffs towards the next decreasing number. The dose indicator will show
the approximate number of puffs remaining in the inhaler.
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.
• 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 side 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 four puffs into the air.
The dose indicator will show the number ‘120’ indicating the number of puffs in the
inhaler. If you have not used your inhaler for a week or more, shake well and release
two puffs of medicine into the air.
Using your inhaler

Other medicines and Sereflo
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 Sereflo 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
Sereflo:
• 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 Sereflo, including irregular heartbeats, 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.

1. Stand or sit upright when using your inhaler.

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.

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.

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

3.

HOW TO USE SEREFLO

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 Sereflo 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 Sereflo or reduce the dose of Sereflo without talking to your
doctor first.
• Sereflo should be inhaled through the mouth into the lungs.
Adults
Sereflo is indicated for use in adults 18 years of age and older only.
• Sereflo 25microgram/125microgram - 2 puffs twice a day
• Sereflo 25microgram/250microgram - 2 puffs twice a day
Adolescents aged 13 to 17 years
Sereflo is not indicated for the management of asthma in adolescents 13 to 17
years of age. No data are available on the use of Sereflo in this age group.
Children 12 years of age and younger
Sereflo is not indicated for the management of asthma in children 12 years of
age and younger. No data are available on the use of Sereflo in this age group.
Neither of the two strengths of Sereflo can be used in the management of
asthma in children as the dose of the corticosteroid (fluticasone propionate) in
both strengths of Sereflo is too high for use in this young age group.

3

It is important to start to breathe as slowly as possible
just before using your inhaler.

2. Remove the mouthpiece cover (as shown in the first
picture). Check inside and outside to make sure that the
mouthpiece is clean and free of loose objects.

4

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.
4. Hold the inhaler upright with your thumb on the base
below the mouthpiece. Breathe out as far as is comfortable.
5. Place the mouthpiece in your mouth between your
teeth. Close your lips around it. Do not bite.

5

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.

6

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. 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.

7

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.
As with all inhalers, caregivers should ensure that patients prescribed Sereflo use
correct inhalation technique, as described above.
Spacer device
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® with your inhaler. Limited data available from a study shows that the spacer to
be washed and dried prior to use.
Your doctor, nurse, 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 correctly and will answer any questions you may have.

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’ inhaler. If any of these happen, you should
continue to take Sereflo 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
straightaway as you may need additional treatment.

However, a spacer device is recommended only for use with the Sereflo
25microgram/250microgram Inhaler (the high strength inhaler): a spacer device is
NOT recommended for use with Sereflo 25microgram/125microgram Inhaler (the
lower strength inhaler). If you need to use a spacer device with this lower strength
inhaler, you will have to change to an alternative inhaler containing the same
medicines, that is salmeterol 25microgram and fluticasone propionate
125microgram, licensed for use with a spacer device.

Your doctor will assess your asthma symptoms regularly to make sure you are
taking the correct dose of Sereflo and will reduce your dose to the lowest dose
required to control your symptoms.
However Sereflo is only available in two strengths, 25/125micrograms and
25/250micrograms. If your doctor feels that you need a lower dose of your inhaler
than is available with Sereflo, your doctor will change you to an alternative
combination product containing the same two medicines but in a lower strength.

If you have previously used an alternative product and spacing device and are
then transferred to these new fixed-dose combination inhalers with or without
a spacing device, re-titration of your dose to the lowest effective dose should
always be carried out.
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

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BRAND NAME Panel

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30 mm

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485 mm

Warnings and precautions
Talk to your doctor before using Sereflo if you have:
• Heart disease, including an irregular or fast heart beat
• Overactive thyroid gland
• High blood pressure
• Diabetes mellitus (Sereflo may increase your blood sugar)
• Low potassium in your blood
• Tuberculosis (TB) now, or in the past, or other lung infections

This is currently available on the market. It is very important to follow your doctor’s
instructions on how many puffs to take and how often to take your medicine.

Pantone
280 C

Back

240 mm

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 or nurse first. It is
also important that you do not change the type of spacer device that you use
without talking to your doctor or nurse.
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 Sereflo 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 Sereflo may reduce
the amount of steroid hormones produced by the adrenal gland.
If you forget to use Sereflo
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 Sereflo
It is very important that you take your Sereflo every day as directed. Keep taking it
until your doctor tells you to stop. Do not stop or suddenly reduce your dose
of Sereflo. This could make your breathing worse.

485 mm

In addition, if you suddenly stop taking Sereflo or reduce your dose of Sereflo 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, nurse
or pharmacist.

4.

POSSIBLE SIDE EFFECTS

• Disturbed sleep.
• Allergic skin rash.
Rare (affects less than 1 person in 1000)
• Breathing difficulties or wheezing that get worse straight after taking Sereflo.
If this happens stop using your Sereflo. Use your fast-acting ‘reliever’ inhaler to
help your breathing and tell your doctor straight away.
• Sereflo 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 Sereflo to control your asthma.
• Behavioural changes, such as being unusually active and irritable (these effects
mainly occur in children).
• Uneven heart beat or your heart gives an extra beat (arrhythmias). Tell your
doctor, but do not stop taking Sereflo unless the doctor tells you to stop.
• Thrush, a fungal infection in the oesophagus (gullet, food canal), 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 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 SEREFLO

• 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.
• 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 beneficial
effects of your medicine may decrease when the canister 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 Sereflo contains
• Each metered dose contains 25 micrograms of salmeterol (as salmeterol
xinafoate) and 125 or 250 micrograms of fluticasone propionate. The other
ingredient is propellant: norflurane (HFA 134a).
What Sereflo looks like and contents of the pack
• Aluminium canister with a suitable metering valve and a polypropylene actuator
with dust cap (pink (25microgram/125microgram) or rubine red
(25microgram/250microgram)) and with a dose indicator attached to the actuator,
in a sealed pouch containing desiccant.
• Each canister is filled to deliver 120 doses.
Pack sizes:
• 1, 2 (bundled package 2 x 1) or 3 (bundled package 3 x 1) canisters containing
120 doses
• 10 (bundled package 10 x 1) canisters containing 120 doses - hospital/pharmacy
use only

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 Sereflo to control your asthma.

Marketing Authorisation Holder:
Fannin (UK) Ltd, DCC Vital, Westminster Industrial Estate, Repton Road, Measham,
DE12 7DT, England.

Allergic reactions: you may notice your breathing suddenly gets worse
immediately after using Sereflo. You may need to use your fast-acting ‘reliever’
inhaler to help your breathing. 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 Sereflo,
stop using Sereflo and tell your doctor straight away. Allergic reactions to
Sereflo are uncommon (they affect less than 1 person in 100).

Manufacturer:
Cipla Goa, Unit II, Verna Industrial Estate, Verna, Goa-403722, India.

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).
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 medicine
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
heartbeat, 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 heartbeat (tachycardia).
• 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).

Batch Release:
Cipla (EU) Limited, 20 Balderton Street, London W1K6TL, U.K.
Cipla Europe NV, Ultbreidingstraat 80, Antwerpen, 2600 Belgium.
Kent Pharmaceuticals Limited, Crowbridge Road, Ashford, Kent, TN24 0GR, U.K.
Kent Pharmaceuticals Limited, Repton Road, Measham, DE12 7DT, U.K.
Other formats:
To listen to or request a copy of this leaflet in Braille, large print or audio please call
free of charge: 0800 198 5000 (UK Only)
Please be ready to give the following information:
Product name
Sereflo 25microgram/125microgram per actuation pressurised inhalation,
suspension
Sereflo 25microgram/250microgram per actuation pressurised inhalation,
suspension
Reference number
PL 20417/0116
PL 20417/0117
This is a service provided by the Royal National Institute of Blind People.
This leaflet was last revised in 11/2016

CP.SER.JNT.IN.CP.V1P1

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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