SERETIDE 250 MICROGRAM EVOHALERView full screen / Print PDF » Download PDF ⇩
• 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.
• Feeling worried (this effect mainly occurs in children).
• Disturbed sleep.
Package Leaflet: Information for the User
Read all of this leaflet carefully before you start taking this medicine.
• 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
− 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
• 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.
• 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 250 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 25/125.
In this leaflet:
What Seretide is and what it is used for
Before you use Seretide
How to use Seretide
Possible side effects
How to store Seretide
1 What Seretide is and what it is used for
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.
5 How to store Seretide
• Keep your Seretide™ Inhaler in a safe place WHERE CHILDREN CANNOT SEE OR REACH
• Clean your inhaler on a weekly basis as described under CLEANING.
• Do not store the inhaler above 25°C.
• Protect from frost and direct sunlight.
• WARNING. The metal can is pressurized. Do not puncture, break or burn it even when
• Do not use after the expiry date shown as ‘EXP’ on the carton and label.
• If you are told to stop taking this medicine, RETURN ANY Seretide™ TO YOUR
PHARMACIST to be destroyed.
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
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. 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
Do not take Seretide if:
You are allergic (hypersensitive) to salmeterol, fluticasone propionate or to the other ingredient
norflurane (HFA 134a).
6 Further information
Take special care with Seretide
What Seretide Evohaler contains
• Each puff provides 25 micrograms of the active ingredient salmeterol (as the xinafoate)
together with 250 micrograms of the active ingredient fluticasone propionate.
• The other ingredient is a CFC-free propellant, Norflurane (HFA 134a).
What Seretide Evohaler looks like and contents of the pack
• Each can provides 120 puffs.
• Seretide delivers your medicine as a pressurised white to off-white suspension for
• The medicine is contained in a pressurised can, with a mouthpiece and an “actuator”. The can
has a counter attached to show 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.
This product is manufactured by Glaxo Wellcome Production, Zone Industrielle No2, 23 Rue
Lavoisier, 27000 Evreux, France and procured from within the EU by the Product Licence
Holder Polyfarma Ltd and repackaged by Kent Pharmaceuticals Ltd both at Repton Road,
Measham, DE12 7DT, UK.
Seretide 250 micrograms Evohaler
250 microgram EvohalerTM
salmeterol xinafoate & fluticasone propionate
Rare (affects less than 1 person in 1000)
PL No: 17211/1025
Leaflet issue and revision date: 07.08.2013
Seretide™ and Evohaler™ are trademarks of the GlaxoSmithKline group of companies.
Aerochamber Plus is a trademark of Trudell Medical International.
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
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 Evohaler 25/125 - 2 puffs twice a day
• Seretide 250 micrograms Evohaler - 2 puffs twice a day
Product: Seretide 250Mcg Evohaler
Item Code: SER2022I/E
Dimensions: 297mm x 420mm
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
Children 4 to 12 years of age
• Seretide Evohaler 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 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 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 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.
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.
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
• 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
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 a headache, muscle weakness and
If you forget to use Seretide
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.
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.
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.
Cleaning 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.
Testing your inhaler
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.
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.
• 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
If you have any further questions on using your inhaler, ask your doctor or pharmacist.
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.
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.
Hold the inhaler upright with your thumb on the base,
below the mouthpiece. Breathe out as far as is comfortable.
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.
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)
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.
Wait about half a minute between taking each puff of
medicine and then repeat steps 3 to 7.
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.
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).
Other side effects are listed below:
4 Possible side effects
• 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 monitoring and possibly adjustment of your usual diabetic treatment
may be required.
Product: Seretide 250Mcg Evohaler
Item Code: SER2022I/E
Dimensions: 297mm x 420mm
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.