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SALMETEROL 50 MICROGRAM ACCUHALER
Active substance(s): SALMETEROL / SALMETEROL XINAFOATE / SALMETEROL / SALMETEROL XINAFOATE / SALMETEROL / SALMETEROL XINAFOATE
SEREVENT™ 50 MICROGRAM ACCUHALER™/
SALMETEROL 50 MICROGRAM ACCUHALER™
PATIENT INFORMATION LEAFLET
Your medicine is available using either of the above names, but will be referred to as Serevent
Accuhaler throughout this leaflet.
Beta-blockers should be avoided when taking Serevent Accuhaler, unless your doctor tells you to
take them. Beta-blockers, including atenolol, propranolol and sotalol, are mostly used for high
blood pressure or other heart conditions. Tell your doctor if you are taking beta-blockers or have
recently been prescribed beta-blockers as they may reduce or abolish the effects of salmeterol.
Serevent Accuhaler can reduce the amount of potassium in your blood. If this happens you may
notice an uneven heartbeat, muscle weakness or cramp. This is more likely to happen if you take
Serevent Accuhaler with some medicines used to treat high blood pressure (diuretics – water
tablets) and other medicines used to treat breathing problems such as theophylline or steroids.
Your doctor may ask for you to have blood tests to check the amount of potassium in your blood.
If you have any concerns discuss them with your doctor.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, 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
The possible side effects associated with Serevent Accuhaler are unlikely to affect your ability to drive
or use machines.
This medicine contains lactose. If you have been told by your doctor that you have an intolerance to
some sugars, contact your doctor before taking this product.
If you are being treated for asthma, you should always be given both a Serevent
Accuhaler and a steroid inhaler to use together.
Use Serevent Accuhaler every day, until your doctor advises you to stop.
You will start to feel your medicine working within the first day of use.
Serevent Accuhaler is for inhalation by mouth only.
What Serevent Accuhaler is and what it is used for
What you need to know before you use Serevent Accuhaler
How to use Serevent Accuhaler
Possible side effects
How to store Serevent Accuhaler
Contents of the pack and other information
Adults and adolescents aged 12 years and older with Asthma
The usual starting dose is 1 puff twice a day.
For people with more severe asthma, your doctor may increase your dose to 2 puffs twice a day.
Children with Asthma
In children aged 4 to 12 the usual dose is 1 puff twice a day.
Serevent Accuhaler is not recommended for use in children below 4 years of age.
Adults with Chronic Obstructive Pulmonary Disease (COPD) including bronchitis
WHAT SEREVENT ACCUHALER IS AND WHAT IT IS USED FOR
Serevent Accuhaler contains the medicine salmeterol. It is a “long-acting bronchodilator”. It helps
the airways in the lungs to stay open. This makes it easier for air to get in and out. The effects are
usually felt within 10 to 20 minutes and last for 12 hours or more.
The doctor has prescribed it to help prevent breathing problems. These could be caused by
asthma. Taking Serevent Accuhaler regularly will help prevent asthma attacks. This also includes
asthma brought on by exercise or at night.
Taking Serevent Accuhaler regularly will also help prevent breathing problems caused by other
chest illnesses such as Chronic Obstructive Pulmonary Disease (COPD).
Serevent Accuhaler helps to stop breathlessness and wheezing coming on. It does not work once
you are breathless or wheezy. If that happens, you need to use a fast-acting “reliever” medicine,
such as salbutamol.
Serevent Accuhaler is supplied to you in an inhaler called the Accuhaler. You breathe the medicine
directly into your lungs.
If you are being treated for asthma, you should always be given both a Serevent Accuhaler
and a steroid inhaler to use together.
HOW TO USE SEREVENT ACCUHALER
Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or
pharmacist if you are not sure.
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 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.
The usual starting dose is 1 puff twice a day.
Not applicable for children and adolescents.
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 Serevent Accuhaler properly or as prescribed may
mean that it will not help your asthma or COPD as it should.
The Serevent Accuhaler device holds blisters containing Serevent Accuhaler as a powder.
There is a counter on top of the Serevent 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
To open your Serevent 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.
Hold your Serevent 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 pushed 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.
Hold the Serevent Accuhaler away from your mouth, breathe out as far as is comfortable.
Do not breathe into your Serevent Accuhaler.
Put the mouthpiece to your lips; breathe in steadily and deeply
through the Serevent Accuhaler, not through your nose. Remove
the Serevent Accuhaler from your mouth. Hold your breath for
about 10 seconds or for as long as is comfortable. Breathe out
WHAT YOU NEED TO KNOW BEFORE YOU USE SEREVENT
Do not take Serevent Accuhaler if:
You are allergic (hypersensitive) to salmeterol xinafoate, or to the other ingredient lactose.
Take special care with Serevent Accuhaler
If you are using Serevent Accuhaler for asthma your doctor will want to regularly check
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, do not increase your number of puffs of
Serevent Accuhaler. Your chest condition may be getting worse and you could become seriously ill.
See your doctor as you may need a change in asthma treatment.
Once your asthma is well controlled your doctor may consider it appropriate to gradually reduce
the dose of Serevent Accuhaler.
If you have been prescribed Serevent Accuhaler for your asthma, continue to use any other
asthma medication you are already taking. These could include a steroid inhaler or steroid tablets.
Continue taking the same doses as before, unless your doctor tells you otherwise. Do this even if
you feel much better. Do not stop taking your steroid inhaler (or any steroid tablets) when
you start using Serevent Accuhaler.
Your doctor may want to check your health regularly if you have an overactive thyroid gland,
diabetes mellitus (Serevent Accuhaler may increase your blood sugar) or heart disease, including
an irregular or fast heartbeat.
Other medicines and Serevent Accuhaler
Tell your doctor if you are taking or have recently taken any other medicines. This includes those
for asthma or any other medicines obtained without a prescription. This is because Serevent
Accuhaler may not be suitable to be taken with other medicines.
Inform your doctor before using Serevent Accuhaler if you are currently being treated for any
fungal infections with medicines containing ketoconazole or itraconazole, or if you are being
treated for HIV with ritonavir. These medicines may increase the risk of you experiencing side
effects with Serevent Accuhaler, including irregular heart beats, or may make side-effects worse.
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Afterwards rinse your mouth with water and spit it out. This may help to stop you getting thrush
and being hoarse.
To close the Serevent 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.
CONTENTS OF THE PACK AND OTHER INFORMATION
What Serevent Accuhaler contains
Each blister contains: 72.5 micrograms of salmeterol xinafoate (equivalent to 50 micrograms
salmeterol), and lactose, which acts as a ‘carrier’.
What Serevent Accuhaler looks like and contents of the pack
Serevent Accuhaler is a plastic inhaler device containing a foil strip with 60 blisters.
The blister protects the powder for inhalation from the effects of the atmosphere.
The device has a counter which tells you the number of blisters remaining. It counts down from 60 to
0. To show when the last five blisters have been reached, the numbers will appear in red. When the
counter shows 0, your inhaler is empty and should be disposed of.
Serevent Accuhaler is available in packs with one Accuhaler containing 60 inhalations.
Your Serevent Accuhaler is now ready for you to use again.
Cleaning your inhaler
Wipe the mouthpiece of the Serevent Accuhaler with a dry tissue to clean it.
If you use more Serevent Accuhaler 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 and/or dizzy. You may also have a headache, muscle weakness and aching
If you forget to use Serevent Accuhaler
Do not take a double dose to make up for a missed dose. Just take your next dose at the usual time.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side effects, although not everybody gets them. To reduce
the chances of side effects, your doctor will prescribe the lowest dose of Serevent Accuhaler to control
your asthma or COPD. These are the side effects reported by people taking Serevent Accuhaler.
Allergic reactions: you may notice your breathing suddenly gets worse after using Serevent
Accuhaler. 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 they happen suddenly after using Serevent
Accuhaler, tell your doctor straight away. Allergic reactions to Serevent Accuhaler are very rare
(they affect less than 1 person in 10,000). Other side effects are listed below:
Manufactured by: Glaxo Operations UK Ltd., Ware, Great Britain.
Procured from within the EU and repackaged by: Doncaster Pharmaceuticals Group Ltd., Kirk Sandall,
Doncaster, DN3 1QR.
Product Licence holder: Doncaster Pharmaceuticals Group Ltd., Kirk Sandall, Doncaster, DN3 1QR.
PL No: 04423/0535
To listen to or request a copy of this leaflet in Braille, large print or audio please call 01302 365000
and ask for the Regulatory Department.
Please be ready to give the following information:
SEREVENT 50 MICROGRAM ACCUHALER/
SALMETEROL 50 MICROGRAM ACCUHALER
Serevent™ and Accuhaler™ are both trademarks of the GlaxoSmithKline group of companies.
Leaflet revision and issue date (Ref): 01.10.14
Common (affects less than 1 person in 10):
Feeling shaky; fast or uneven heartbeat (palpitations), headache, shaking hands (tremor).
Tremors are more likely if you are taking more than one puff twice daily. These side effects do not
last long and happen less as treatment with Serevent Accuhaler continues
Uncommon (affects less than 1 person in 100):
Very fast heart rate (tachycardia). This is more likely to happen if you are taking more than one
puff twice daily
Rare (affects less than 1 person in 1,000):
Being unable to sleep or finding sleep difficult
A reduction in the amount of potassium in your blood (you may get an uneven heartbeat,
muscle weakness, cramp)
Very rare (affects less than 1 person in 10,000):
Breathing difficulties or wheezing that gets worse straight after taking Serevent
Accuhaler. If this happens stop using your Serevent Accuhaler. Use your fast-acting ‘reliever’
inhaler to help your breathing and tell your doctor straight away
Uneven heartbeat or your heart gives an extra beat (arrhythmias). If this happens do not stop
using Serevent Accuhaler but tell your doctor
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
Sore mouth or throat
Feeling sick (nausea)
Aching, swollen joints, or chest pain
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:
By reporting side effects you can help provide more information on the safety of this medicine.
HOW TO STORE SEREVENT ACCUHALER
KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.
Do not store above 30°C. Store in the original package to protect from moisture.
Do not use Serevent Accuhaler after the date shown as 'Exp' on the carton and the device.
If you are told to stop taking this medicine, RETURN ANY SEREVENT ACCUHALER TO YOUR
PHARMACIST TO BE DESTROYED.
If your inhaler fails to work properly or you notice any other signs of deterioration, you should ask
your doctor or pharmacist for advice.
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.
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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.