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ALIFUS 250 ACCUHALER

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

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3.

PACKAGE LEAFLET : INFORMATION FOR THE USER
SERETIDE® 250 ACCUHALER®
(salmeterol xinafoate / fluticasone propionate)
This product is available in the above name and strength but will be
referred to as Seretide throughout the remainder of this leaflet.
This product is available in multiple strengths and all strengths will be
referred to throughout this leaflet

Outer Case

Counter
Full
Empty

60

0

Thumbgrip

Mouthpiece
Lever

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.
What is in this leaflet:
1. What Seretide is and what it is used for
2. What you need to know before you use Seretide
3. How to use Seretide
4. Possible side effects
5. How to store Seretide
6. Contents of the pack and other information
1.

What Seretide is and what it is used for

Seretide 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
 Chronic Obstructive Pulmonary Disease (COPD). Seretide
Accuhaler, at a dose of 500 micrograms, reduces the number of
flare ups of COPD symptoms.
You must use Seretide every day as directed by your doctor. This will
make sure that it works properly in controlling your asthma or COPD.
Seretide helps to stop breathlessness and wheeziness coming on.
However Seretide 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 Seretide

Do not take Seretide:
If you are allergic to salmeterol, fluticasone propionate or to the other
ingredient lactose monohydrate.
Warnings and precautions
Talk to your doctor before using Seretide if you have:
 Heart disease, including an irregular or fast heart beat
 Overactive thyroid gland
 High blood pressure
 Diabetes mellitus (Seretide may increase your blood sugar)
 Low potassium in your blood
 Tuberculosis (TB) now or in the past, or other lung infections
Other medicines and Seretide
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 Seretide
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:
 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
Seretide, 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.
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
Seretide is not likely to affect your ability to drive or use machines.
Seretide Accuhaler contains lactose
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.

How to use Seretide

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 Seretide 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 Seretide or reduce the dose of Seretide without
talking to your doctor first.
 Seretide should be inhaled through the mouth into the lungs.
For asthma
Adults and adolescents aged 12 years and over
 Seretide 100 Accuhaler - One inhalation twice a day
 Seretide 250 Accuhaler - One inhalation twice a day
 Seretide 500 Accuhaler - One inhalation twice a day
Children 4 to 12 years of age
 Seretide 100 Accuhaler - One inhalation twice a day
 Seretide is not recommended for use in children below 4 years of
age.
For adults with Chronic Obstructive Pulmonary Disease (COPD)
 Seretide 500 Accuhaler - One inhalation twice a day
Your symptoms may become well controlled using Seretide 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 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
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 Accuhaler device holds blisters containing Seretide as a
powder.
 There is a counter on top of the 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 Accuhaler, hold the outer
case in one hand and put the thumb of your
other hand on the 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 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 Accuhaler away from your mouth, breathe out as far as is
comfortable. Do not breathe into your Accuhaler.
4. Put the mouthpiece to your lips; breathe in
steadily and deeply through the Accuhaler,
not through your nose.
Remove the 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, and/or brush
your teeth. This may help to stop you getting thrush and becoming
hoarse.
6. To close the Accuhaler, slide the thumbgrip
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 Accuhaler is now ready for you to use again.
As with all inhalers, caregivers should ensure that children prescribed
Seretide Accuhaler use correct inhalation technique, as described
above.
Cleaning your inhaler
Wipe the mouthpiece of the Accuhaler with a dry tissue to clean it.
If you use more Seretide 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
Seretide may reduce the amount of steroid hormones produced by the
adrenal gland.

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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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