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SERETIDE 250 EVOHALER

Active substance(s): FLUTICASONE PROPIONATE / SALMETEROL

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Add/Amend 17 - To update the manufacturers details.
SERETIDE 250 EVOHALER
Adults andpreviously
adolescents
aged 12
yearsUK
andPIlover
This version replaces PIl dated 17/12/2014,
assessed
against
dated August 2014.
(salmeterol xinafoate/ fluticasone propionate)
• Seretide 50 Evohaler – 2 puffs twice a day
A Chohan. 11 March 2015
• Seretide 125 Evohaler – 2 puffs twice a day
Patient Information Leaflet
• Seretide 250 Evohaler – 2 puffs twice a day
This leaflet tells you about Seretide 250 Evohaler but will be referred to
Children 4 to 12 years of age
as Seretide throughout this leaflet. Seretide Evohaler is also available in
• Seretide 50 Evohaler – 2 puffs twice a day
other strengths.
• Seretide is not recommended for use in children below 4 years of age.
Read all of this leaflet carefully before you start taking this medicine
Your symptoms may become well controlled using Seretide twice a
because it contains important information for you.
day. If so, your doctor may decide to reduce your dose to once a day.
Keep this leaflet. You may need to read it again.
The dose may change to:
If you have any further questions, ask your doctor or pharmacist.
• once at night - if you have night-time symptoms
• once in the morning - if you have daytime symptoms.
This medicine has been prescribed for you only. Do not pass it on to
It is very important to follow your doctor’s instructions on how many
others. It may harm them, even if their symptoms and signs of illness are
puffs to take and how often to take your medicine.
the same as yours.
If you get any side effects talk to your doctor or pharmacist. This
If you are using Seretide for asthma, your doctor will want to regularly
includes any possible side effects not listed in this leaflet. See section 4.
check your symptoms. If your asthma or breathing gets worse, tell
your doctor straight away. You may find that you feel more wheezy,
In this leaflet:
your chest feels tight more often or you may need to use more of your
1. What Seretide is and what it is used for
fast- acting ‘reliever’ medicine. If any of these happen, you should
2. What you need to know before you use Seretide
continue to take Seretide but do not increase the number of puffs you
3. How to use Seretide
take. Your chest condition may be getting worse and you could
4. Possible side effects
become seriously ill. See your doctor as you may need additional
5. How to store Seretide
treatment.
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 fast
acting ‘reliever’ (‘rescue’) inhaler, such as salbutamol. You should
always have your fast-acting ‘rescue’ inhaler with you.

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 Evohaler 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.

WHAT YOU NEED TO KNOW BEFORE YOU USE SERETIDE

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.

Do not take Seretide if:
You are allergic (hypersensitive) to salmeterol, fluticasone propionate or to
the other ingredient norflurane (HFA 134a).

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

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 (Seretide 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 Seretide.

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.

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.

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.

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.

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.

2.

Other medicines and Seretide
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 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.

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 Evohaler use correct inhalation technique, as described above.
If you or your child find it difficult to use 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 missed 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
problem 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 about the use of this medicine,
ask your doctor, nurse or pharmacist.

4.





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 fast-acting ‘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.
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 SERETIDE


Straight after use, replace the mouthpiece cover firmly and click
it into position. Do not use excessive force.
• Keep out of the sight and reach of children.
• Do not store above 25°C.
• 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 after EXP. The expiry date refers to the last
day of that month.
• The metal canister contains a pressurised liquid. Do not puncture,
break or burn it even if you think it is 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.
If you notice any signs of deterioration of your medicine, return it to
your pharmacist who will tell you what to do.

POSSIBLE SIDE EFFECTS

Like all medicines, Seretide 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.
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).
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 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
Chronic Obstructive Pulmonary Disease (COPD):

6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Seretide contains:
• The active substances are 25 micrograms salmeterol (as salmeterol
xinafoate) and 250 micrograms fluticasone propionate.
• The other ingredient is norflurane (HFA 134a).
What Seretide looks like and contents of the pack
• Seretide is supplied to you in a metered dose inhaler which delivers
your medicine in a pressurised suspension for you to inhale.
• The metered dose inhaler consists of a pressurized metal canister
with a metering valve, covered with purple plastic cover and
mouthpiece with a lighter purple dust cap.
• The device is packed in cartons containing one Evohaler of 120
metered actuations.
Leaflet revision and issue date (Ref.) 11th March 2015
POM

PL No: 20507/0078

Seretide 250 Evohaler

This product is manufactured by

Glaxo Wellcome Production,
Zone Industrielle n.2,
23 Rue Lavoisier,
La madeleine,
27000 - Evreux,
France
or
Aspen Bad Oldesloe GmbH
Industriestrasse 32-36,
D-23843,
Bad Oldesloe,
Germany

or

or

Glaxo Wellcome S.A.
Avenida de Extremadura,
3 – 09400,
Aranda de Duero,
Burgos,
Spain
or
A. Menarini Manufacturing
Logistics and Services S.r.l.
Via Sette Santi,
3 – Firenze,
Italy

and is procured from within the EU and repackaged on behalf of the PL(PI) Holder: Central
Pharmaceuticals (UK) Limited, 37 Chestnut Drive, Harrow, HA3 7DL, United Kingdom.
Evohaler, Seretide, Haleraid and Volumatic are trademarks of the GlaxoSmithKline group of
companies. Aerochamber Plus is a trademark of Trudell Medical International
CPL/78/6

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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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