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SERETIDE 125 MICROGRAMS EVOHALER

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• Feeling worried (this effect mainly occurs in children).
• Disturbed sleep.
• Rash.

Package Leaflet: Information for the User

SeretideTM 125 micrograms EvohalerTM

Rare (affects less than 1 person in 1000)

fluticasone propionate & salmeterol xinafoate

• 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 heartbeat or heart gives an extra beat (arrhythmias). Tell your doctor, but do
not stop taking Seretide unless they tell you to stop.

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






• 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.
The name of your medicine is Seretide 125 micrograms Evohaler. Throughout this
leaflet it will be referred to as Seretide. Please note that the leaflet also contains
information about other strengths of the medicine, Seretide Evohaler 25/50 and Seretide
Evohaler 25/250.

In this leaflet:
1
2
3
4
5
6

What Seretide is and what it is used for
Before you use Seretide
How to use Seretide
Possible side effects
How to store Seretide
Further Information

1 What Seretide is and what it is used for

5 How to store Seretide






Read all of this leaflet carefully before you start taking this medicine.

Keep Seretide in a safe place where children cannot reach or see it
Clean your inhaler on a weekly basis as described under CLEANING.
Do not store the inhaler above 25°C.
Avoid storage in direct sunlight.
WARNING. The metal can is pressurised. Do not puncture, break or burn it even
when apparently empty.
Do not use after the date shown as 'EXP' on the carton and label.
If you are told to stop taking this medicine, RETURN ANY Seretide TO YOUR
PHARMACIST for disposal.
If your inhaler does not work properly or if your medicine shows visible signs of
deterioration, show it to a pharmacist who will advise you what to do.
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

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.

6 Further information

Seretide 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.

What Seretide Evohaler contains

2 Before you use Seretide

• The active substances are 25 micrograms of salmeterol (as the xinafoate) and 125
micrograms of the active ingredient fluticasone propionate.
• The other ingredient is a CFC-free propellant, Norflurane (HFA 134a).

Do not take Seretide if:

What Seretide Evohaler looks like and contents of the pack
• Each canister provides 120 metered actuations.
• Seretide delivers your medicine as a pressurised white to off-white suspension for
inhalation.
• Seretide Evohaler is available in a pressurised metered dose inhaler, with a
mouthpiece and an "actuator". The can has a counter attached to show you how
many puffs of medicine you have left. The number will show through a window in the
back of the plastic actuator. Each time the actuator is pressed a dose of the medicine
is released and the counter will count down by one.

Manufacturer:
Manufactured by Glaxo Wellcome Production, Zone Industrielle n. 2-23 Rue Lavoisier
27000 - Evreux, France. Procured from within the EU by Polyfarma Ltd and repackaged
by Kent Pharmaceuticals Ltd both at Repton Road, Measham, DE12 7DT, UK.

POM

Seretide 125mcg Evohaler

PL No: 17211/1036

Leaflet issue and revision date: 07.08.2013
Evohaler, Haleraid, Seretide and Volumatic are trademarks of the GlaxoSmithKline
group of companies.
Aerochamber Plus is a trademark of Trudell Medical International.

You are allergic (hypersensitive) to salmeterol, fluticasone propionate or to the other
ingredient norflurane (HFA 134a).

Take special care with Seretide
Your doctor will supervise your treatment more closely if you have medical conditions
such as:
• heart disease, including an irregular or fast heartbeat
• 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.
If you have ever had any of these conditions, tell your doctor before you use Seretide.

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 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:
• Beta-blockers (such as atenolol, propranolol and 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, 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.

Pregnancy and breast-feeding
If you are pregnant, planning to get pregnant, or breast-feeding, talk to your doctor
before taking Seretide. Your doctor will assess whether you can take Seretide during
this time.

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

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

Adults and adolescents aged 12 years and over
• Seretide Evohaler 25/50 - 2 puffs twice a day
• Seretide 125 micrograms Evohaler - 2 puffs twice a day
• Seretide Evohaler 25/250 - 2 puffs twice a day

Product: Seretide 125Mcg Evohaler
Colours: Black

PLPI: 17211/1036
Item Code: SER2021I/E

Dimensions: 297mm x 420mm
Proof: 2

Children 4 to 12 years of age
• Seretide Evohaler 25/50 – 2 puffs twice a day
• Seretide Evohaler 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 daily. 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 or your child find it difficult to use the Evohaler, either the Volumatic™ or
Aerochamber Plus™ spacer device may be used. Before starting to use a spacer
device for the first time or if you need to change your make of spacer device, talk to
your doctor, nurse or pharmacist. 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
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.

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.

Instructions for use

Do not put the metal canister in water.

• 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

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

1

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 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 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.

2

Using your inhaler
It is important to start to breathe as slowly as possible just before using your inhaler.
Stand or sit upright when
using your inhaler.

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 objects.

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 forget to use Seretide

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.

1

If you use more Seretide than you should

To prevent these symptoms occurring, your doctor may prescribe extra corticosteroids
(like prednisolone).
If you have any further questions on using your inhaler, ask your doctor or pharmacist.

4 Possible side effects

2

3

4

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

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.

3
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.

Breathe in through your mouth. 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.

Other side effects are listed below:

5

Common (affects less than 1 person in 10)

6

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

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.
This may help to stop you getting thrush and being hoarse.

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.

10

Product: Seretide 125Mcg Evohaler
Colours: Black

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.

6

8

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.

7

• 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 after taking each puff may help. Your doctor may prescribe
an antifungal 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):
• 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.
• Cloudy lens in the eye.
• Very fast heartbeat (tachycardia).
• Feeling shaky and fast or uneven heart beat (palpitations) – these are usually
harmless and get less as treatment continues.
• Chest pain.

PLPI: 17211/1036
Item Code: SER2021I/E

Dimensions: 297mm x 420mm
Proof: 2

+ 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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