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ALIFLUS 500 ACCUHALER

Active substance(s): FLUTICASONE PROPIONATE MICRONISED / SALMETEROL

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Aliflus® 500 Accuhaler®/Seretide® 500 Accuhaler®
(salmeterol xinafoate and fluticasone propionate)

Outer Case

Counter
Full Empty
60

0

Thumb grip
Mouthpiece

Lever

This product is also available as 100 and 250 micrograms strength.
Your medicine is known by any of the above names but will be referred to
as Seretide Accuhaler throughout this:
Patient Information Leaflet
Read all of this leaflet carefully before you start taking this medicine.
 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. Do not pass it on to others.
It may harm them, even if their symptoms are the same as yours.
 If any of the side effects gets serious, or if you notice any side effects
not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1) What Seretide Accuhaler is and what it is used for
2) Before you use Seretide Accuhaler
3) How to use Seretide Accuhaler
4) Possible side effects
5) How to store Seretide Accuhaler
6) Further information

1) What Seretide Accuhaler is and what it is used for
Seretide Accuhaler contains two medicines, salmeterol xinafoate and
fluticasone propionate:
 Salmeterol xinafoate 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
 Chronic Obstructive Pulmonary Disease (COPD). Seretide Accuhaler,
at a dose of 50/500 micrograms, reduces the number of flare ups of
COPD symptoms.
You must use Seretide Accuhaler every day as directed by your doctor.
This will make sure that it works properly in controlling your asthma or
COPD.
Seretide Accuhaler helps to stop breathlessness and wheeziness
coming on. It does not work once you are breathless or wheezy. If that
happens you need to use a fast acting ‘reliever’ medication, such as
salbutamol.

2) Before you use Seretide Accuhaler
Do not take Seretide Accuhaler if:
you are allergic (hypersensitive) to salmeterol xinafoate, fluticasone
propionate or to the other ingredient lactose monohydrate.
Take special care with Seretide Accuhaler
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 (Seretide Accuhaler may increase your blood sugar)
 low potassium in your blood
 Tuberculosis (TB) now or in the past
If you have ever had any of these conditions, tell your doctor before you use
Seretide Accuhaler.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently
taken any other medicines. This includes medicines for asthma or any
medicines obtained without a prescription. This is because Seretide
Accuhaler 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 Seretide Accuhaler:
 Beta-blockers (such as atenolol, propranolol, sotalol). Beta-blockers are
mostly used for high blood pressure or other heart conditions.
 Antiviral and antifungal medicines (such as ritonavir, ketoconazole and
itraconazole). 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 Seretide Accuhaler, 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.

Pregnancy and breast-feeding
If you are pregnant, planning to get pregnant, or breast feeding, talk to your
doctor before taking Seretide Accuhaler. Your doctor will assess whether
you can take Seretide Accuhaler during this time.
Driving and using machines
Seretide Accuhaler is not likely to affect your ability to drive or use
machines.
Important information about some of the ingredients of Seretide
Accuhaler
Seretide Accuhaler contains up to 12.5 milligrams of lactose in each dose.
The amount of lactose in this medicine does not normally cause problems in
people who are lactose intolerant.

3) How to use Seretide Accuhaler



Use your Seretide Accuhaler every day, until your doctor advises you to
stop.
Always use Seretide Accuhaler exactly as your doctor has told you.
Don’t exceed the recommended dose. Check with your doctor or
pharmacist if you’re not sure.

For asthma
Adults and adolescents aged 12 years and over
 Seretide 50/100 Accuhaler - One inhalation twice a day
 Seretide 50/250 Accuhaler - One inhalation twice a day
 Seretide 50/500 Accuhaler - One inhalation twice a day
Children 4 to 12 years of age
 Seretide 50/100 Accuhaler - One inhalation twice a day
 Seretide Accuhaler is not recommended for use in children below 4
years of age.
For adults with Chronic Obstructive Pulmonary Disease (COPD)
 Seretide 50/500 Accuhaler - One inhalation twice a day
Your symptoms may become well controlled using Seretide Accuhaler twice
a day. If so, your doctor may decide to reduce your dose to once a day. The
dose may change to:
 once at night - if you have night-time symptoms
 once in the morning - if you have daytime symptoms.
It is very important to follow your doctor’s instructions on how many
inhalations to take and how often to take your medicine. If you are using
Seretide Accuhaler 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 Seretide Accuhaler 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
the Seretide Accuhaler properly or as prescribed may mean that it will
not help your asthma or COPD as it should.
 The Seretide Accuhaler device holds blisters containing Seretide as a
powder.
 There is a counter on top of the Seretide Accuhaler which tells you how
many doses are left. It counts down to 0. The numbers 5 to 0 will
appear in red to warn you when there are only a few doses left. Once
the counter shows 0, your inhaler is empty.
Using your inhaler

1 To open your Seretide Accuhaler, hold the
outer case in one hand and put the thumb of your
other hand on thumbgrip. Push your thumb away
from you as far as it will go. You will hear a click.
This will open a small hole in the mouthpiece.

2 Hold your Seretide Accuhaler with the
mouthpiece towards you. You can hold it in either
your right or left hand. Slide the lever away from
you as far as it will go. You will hear a click. This
places a dose of your medicine in the
mouthpiece.
Every time the lever is pulled back a blister is
opened inside and the powder made ready for
you to inhale. Do not play with the lever as this
opens the blisters and wastes medicine.

3 Hold the Seretide Accuhaler away from your mouth, breathe out as far
as is comfortable. Do not breathe into your Seretide Accuhaler.

4 Put the mouthpiece to your lips;
breathe in steadily and deeply through the
Seretide Accuhaler, not through your nose.
Remove the Seretide Accuhaler from
your mouth.
Hold your breath for about 10 seconds
or for as long as is comfortable.
Breathe out slowly.

5 Afterwards rinse your mouth with water
and spit it out. This may help to stop you getting thrush and being hoarse.

Uncommon (affects less than 1 person in 100)
 Very fast heartbeat (tachycardia).
 Feeling shaky and fast or uneven heartbeat (palpitations) – these are
usually harmless and get less as treatment continues.
 Chest pain
 Muscle cramps.
 Feeling worried, (this effect mainly occurs in children).
 Throat irritation. Rinsing your mouth out with water and spitting it out
immediately after taking each puff may help.

If you use more Seretide Accuhaler 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 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
Seretide Accuhaler may reduce the amount of steroid hormones produced
by the adrenal gland.

Rare (affects less than 1 person in 1000)
 Breathing difficulties or wheezing that get worse straight after
taking Seretide Accuhaler. If this happens stop using your Seretide
Accuhaler. Use your fast-acting ‘reliever’ inhaler to help your breathing
and tell your doctor straight away.
 Seretide Accuhaler 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 includes:
- slowing of growth in children and adolescents
- thinning of the bones
- cataract and 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 Seretide Accuhaler to control your
asthma.
 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.
 Disturbed sleep and behavioural changes, such as being unusually
active and irritable (these effects mainly occur in children).
 Uneven heartbeat or heart gives an extra beat (arrhythmias). Tell your
doctor, but do not stop taking Seretide Accuhaler unless they tell you to
stop.
 Rash.

If you forget to use Seretide Accuhaler
If you forget to use your inhaler, take your next dose when it is due.
Do not take a double dose to replace the one you forgot.

Frequency not known, but may also occur:
 Depression or aggression. These effects are more likely to occur in
children.

If you stop using Seretide Accuhaler
It is very important that you take your Seretide Accuhaler every day as
directed. Keep taking it until your doctor tells you to stop. Do not stop or
suddenly reduce your dose of Seretide Accuhaler. This could make your
breathing problem worse and very rarely side effects could occur.
These include:
 stomach pain
 tiredness and loss of appetite
 sickness and diarrhoea
 weight loss
 headache or drowsiness
 low levels of potassium in your blood
 low blood pressure and seizures.
Very rarely, if you get an infection or at times of extreme stress (such as
after a serious accident or if you have surgery), you may get similar side
effects.
To prevent these symptoms occurring, your doctor may prescribe extra
corticosteroids (like prednisolone).
If you have any further questions on using the inhaler, ask your doctor or
pharmacist.

If any of the side effects become serious, or if you notice any side effects
not listed in this leaflet, please tell your doctor or pharmacist.

6 To close the Seretide Accuhaler, slide
the thumb grip back towards you, as far as
it will go. You will hear a click. The lever
will return to its original position and is
reset.

Your Seretide Accuhaler is now ready for you to use again.
Cleaning your inhaler
Wipe the mouthpiece of the Seretide Accuhaler with a dry tissue to clean it.

4) Possible side effects
Like all medicines, Seretide Accuhaler can cause side effects, although not
everybody gets them. To reduce the chance of side effects, your doctor will
prescribe the lowest dose of Seretide Accuhaler to control your asthma or
COPD.
Allergic reactions: you may notice your breathing suddenly gets
worse after using Seretide Accuhaler. You may be very wheezy and
cough. You may also notice itching and swelling (usually of the face, lips,
tongue, or throat). If you get these effects or if they happen suddenly
after using Seretide Accuhaler, tell your doctor straight away. Allergic
reactions to Seretide 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 COPD.
Common (affects less than 1 person in 10)
 Thrush (sore, creamy-yellow, raised patches) in the mouth and throat.
Also sore tongue, throat and hoarse voice. Rinsing your mouth out with
water and spitting it out immediately after taking each puff may help.
Your doctor may prescribe antifungal medication to treat the thrush.
 Aching, swollen joints and muscle pain.
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.
 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).

5) How to store Seretide Accuhaler
 Keep out of the sight and reach of children.
 Do not store above 25°C. Store in a dry place.
 Do not use Seretide Accuhaler after the expiry date which is stated on the
label and carton. The expiry date refers to the last day of that month.
 Medicines should not be disposed of via wastewater or household waste.
Ask your pharmacist how to dispose of medicines no longer required.
These measures will help to protect the environment.
 If the Seretide Accuhaler fails to work properly or shows signs of
deterioration, you should seek the advice of your pharmacist who will tell
you what to do.

6) Further information
What Seretide Accuhaler contains
 Each actuation contains 50 micrograms of salmeterol (as the xinafoate)
and 500 micrograms of fluticasone propionate.
 The other ingredient is lactose monohydrate (which contains milk
proteins).
What Seretide Accuhaler looks like and contents of the pack
 The Seretide Accuhaler is supplied as a dark purple plastic metered dose
inhaler with a counter device and a light purple cap containing a foil strip
with 60 blisters
 Each dose is pre-dispensed.
Who makes and repackages your medicine?
PL 10383/1680
Seretide 500 Accuhaler

POM

Your medicine is manufactured by Glaxo Wellcome Operations, UK Ltd,
Ware Herts., UK Procured from within the EU and repackaged by the
Product Licence holder: Primecrown Ltd., 4/5 Northolt Trading Estate,
Belvue Road, Northolt, Middlesex, UB5 5QS.
Leaflet date: 20.02.2013
Seretide® and Accuhaler® are trademarks of the GlaxoSmithKline group of
companies.

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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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