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ANASMA 250 CFC FREE INHALER

Active substance(s): FLUTICASONE PROPIONATE / SALMETEROL

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Seretide® 125 CFC Free Inhaler/Seretide® 125 Evohaler® / Anasma® 125 CFC Free Inhaler
Seretide® 250 CFC Free Inhaler/Seretide® 250 Evohaler® / Anasma® 250 CFC Free Inhaler
(Salmeterol xinafoate and Fluticasone propionate)
Your medicine is known by one of the above names, but will be referred to as
Seretide throughout this leaflet. Seretide is available in other strengths.
Package Leaflet: Information for the User
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.
You must use Seretide every day as directed by your doctor. This will make
sure that it works properly in controlling your asthma.
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 fastacting ‘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 norflurane (HFA 134a).
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

• once in the morning - if you have daytime symptoms.
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 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 Seretide
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 Evohaler 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.
2 To make sure that it works, shake it well,
point the mouthpiece away from you and
press the canister to release a puff into the air.
Repeat these steps, shaking the inhaler
before releasing each puff, until the counter
reads 120. If you have not used your inhaler
for a week or more, 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 Stand or sit upright when 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.
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.

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.

3) 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.
Adults and adolescents aged 12 years and over
Seretide 25/50 - 2 puffs twice a day
Seretide 25/125 - 2 puffs twice a day
Seretide 25/250 - 2 puffs twice a day
Children 4 to 12 years of age
• Seretide 25/50 – 2 puffs twice a day.
• Seretide is not recommended for use in children below 4 years of age.
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

3
4 Hold the inhaler upright with your thumb
on the base, below the mouthpiece.
Breathe out as far as is comfortable.

4
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
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.

7
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.
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 children prescribed
Seretide use correct inhalation technique, as described above.
If you or your child find it difficult to use the Evohaler, either your doctor or
other healthcare provider may recommend using a spacer device such as the
®
®
Volumatic or 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. It is also important that you do not change the type
of spacer device that you use without talking to your doctor. 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.
Older children or 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. A special device called a
®
Haleraid may also make it easier.
You should get a replacement when the counter shows the number 020. Stop
using the inhaler when the counter shows 000 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 metal canister.
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 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.
If you forget to use Seretide
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 Seretide
It is very important that you take your Seretide every day as directed. Keep
taking it until your doctor tells you to stop. Do not stop or suddenly
reduce your dose of Seretide. This could make your breathing worse.
In addition, if you suddenly stop taking Seretide or reduce your dose of
Seretide 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
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 Seretide to control your asthma.

• Aching, swollen joints and muscle pain.
• Muscle cramps.
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.
• 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).
• Disturbed sleep.
• Allergic skin rash.
Rare (affects less than 1 person in 1000)
• Breathing difficulties or wheezing that get worse straight after taking
Seretide. If this happens stop using your Seretide inhaler. Use your fastacting ‘reliever’ inhaler to help your breathing and tell your doctor straight
away.
• Seretide 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 Seretide 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 Seretide 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.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. 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 Seretide
• Keep all medicines out of the sight and reach of children.
• Straight after use, replace the mouthpiece cover firmly and click it into
position. Do not use excessive force.
• Do not store above 25°C. Protect from frost and direct sunlight.
• Do not store Seretide in a cold place, as your medicine may not work as
well.
• Do not use Seretide after the expiry date which is stated on the label and
carton.
• The metal canister contains a pressurised liquid. Don’t puncture, break or
burn even when apparently empty.
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.

6) Further information
What Seretide contains
• Seretide delivers your medicine as a pressurised suspension for inhalation
for you to inhale, which delivers your medicine directly into your lungs
where it is needed. Each puff provides 25 micrograms of the active
ingredient salmeterol (as the xinafoate) together with either, 125 or 250
micrograms of the active ingredient fluticasone propionate.
• It also contains a CFC-free propellant, Norflurane (HFA 134a).
What Seretide looks like and contents of the pack
• The medicine is contained in a pressurised can, with a mouthpiece and an
'actuator'.
• Each can provides 120 puffs.
Who makes and repackages your medicine?
PL 10383/1439
Seretide 125 CFC Free Inhaler/Seretide 125
Evohaler/Anasma 125 CFC Free Inhaler
PL 10383/1436
Seretide 250 CFC Free Inhaler/Seretide 250
Evohaler/Anasma 250 CFC Free Inhaler

Allergic reactions: you may notice your breathing suddenly gets worse
immediately after using Seretide. 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 Seretide, stop using Seretide and tell your
doctor straight away. Allergic reactions to Seretide are uncommon (they
affect less than 1 person in 100).

Seretide is manufactured by Glaxo Wellcome Production, Zone Industrielle
No.2, 23 Rue Lavoisier, 27000 Evreux, France. Procured from within the EU
and repackaged by the Product Licence Holder who is Primecrown Ltd., 4/5
Northolt Trading Estate, Belvue Road, Northolt, Middlesex, UB5 5QS.

Other side effects are listed below:

Leaflet date: 18.05.2015

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.

Evohaler, Seretide, Haleraid and Volumatic are registered trademarks of the
Glaxo SmithKline group of companies. Aerochamber Plus is a registered
trademark of Trudell Medical International.

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.

®

POM
POM

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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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