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SALMETEROL 50MICROGRAMS ACCUHALER

Active substance(s): SALMETEROL XINAFOATE / SALMETEROL XINAFOATE / SALMETEROL XINAFOATE

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PACKAGE LEAFLET: INFORMATION FOR THE USER
SEREVENT® ACCUHALER® / SALMETEROL 50MICROGRAMS ACCUHALER®
(salmeterol xinafoate)
This medicine is available as either of the above names but will be referred to as Serevent Accuhaler throughout
the following leaflet.
Counter
Empty
Full
Outer Case

0

60

Thumbgrip

Mouthpiece
Lever
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.
In this leaflet:
1. What Serevent Accuhaler is and what it is used for
2. What you need to know before you use Serevent Accuhaler
3. How to use Serevent Accuhaler
4. Possible side effects
5. How to store Serevent Accuhaler
6. Contents of the pack and other information
1. 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 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 and a steroid inhaler to
use together.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE SEREVENT ACCUHALER
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 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, do not increase your number of puffs of Serevent. 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.
• If you have been prescribed Serevent 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.
• Your doctor may want to check your health regularly if you have an overactive thyroid gland, diabetes mellitus
(Serevent may increase your blood sugar) or heart disease, including an irregular or fast heartbeat.
Other medicines and Serevent
• 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 may not be suitable to be taken
with other medicines.
• Inform your doctor before using Serevent 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, including irregular heart beats,
or may make side-effects worse.
• Beta-blockers should be avoided when taking Serevent, unless your doctor tells you to take them. Betablockers, 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 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 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, If you are
pregnant, planning to get pregnant or breast-feeding, talk to your doctor before taking Serevent. Your doctor will
assess whether you can take Serevent during this time.
Driving and using machines
The possible side effects associated with Serevent are unlikely to affect your ability to drive or use machines.
3. 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.
• If you are being treated for asthma, you should always be given both a Serevent and a steroid inhaler to
use together.
• Use Serevent every day, until your doctor advises you to stop.
• You will start to feel your medicine working within the first day of use.
Serevent is for inhalation by mouth only.
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 is not recommended for use in children below 4 years of age.
Adults with Chronic Obstructive Pulmonary Disease (COPD) including bronchitis and emphysema
• 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 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
4 Put the mouthpiece to
your lips; breathe in
steadily and deeply
through the Serevent
Accuhaler, not through
your nose.

1 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.

Remove the Serevent
Accuhaler from your
mouth.
Hold your breath for
about 10 seconds or for
as long as is
comfortable.

2 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.

Breathe out slowly.
5 Afterwards rinse your mouth with water and spit
it out. This may help to stop you getting thrush
and being hoarse.
6 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.

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.
3 Hold the Serevent Accuhaler away from your
mouth, breathe out as far as is comfortable. Do
not breathe into your Serevent Accuhaler.

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 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 joints.
If you forget to use Serevent
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.
4. 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 to control your asthma or COPD. These are
the side effects reported by people taking Serevent.
Allergic reactions: you may notice your breathing suddenly gets worse after using Serevent. 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, tell your doctor straight away. Allergic reactions
to Serevent are very rare (they affect less than 1 person in 10,000).
Other side effects are listed below:
Common (affects less than 1 person in 10):
• Muscle cramps
• 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 continues.
Uncommon (affects less than 1 person in 100):
• Rash
• Very fast heart rate (tachycardia). This is more likely to happen if you are taking more than one puff twice daily
• Feeling nervous.
Rare (affects less than 1 person in 1,000):
• Feeling dizzy
• 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. 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
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, 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 SEREVENT ACCUHALER
Do not store above 30°C. Store in the original package.
Keep out of the sight and reach of children.
Do not use after the expiry date printed on the carton or Accuhaler label.
If your doctor tells you to stop using the Accuhaler, please take it back to the pharmacist for safe disposal. Only
keep the Accuhaler if your doctor tells you to.
• If your Accuhaler fails to work properly or you notice any other signs of deterioration, you should seek the
advice of your pharmacist.
• 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 Serevent Accuhaler contains
• Each blister contains powder for inhalation providing 50 micrograms of salmeterol (as xinafoate).
• The other ingredient is lactose monohydrate (which contains milk proteins).
What Serevent Accuhaler looks like and contents of the pack
• Serevent Accuhaler is a two-tone green/turquoise colour, circular device in moulded dose counter indicating the
number of doses remaining. Each blister contains white powder.
• The Serevent Accuhaler contains a foil strip. The foil protects the powder for inhalation from the effects of the
atmosphere.
• Each dose is pre-dispensed.
• The devices are packed in cartons which hold one Accuhaler containing 60 inhalations.
Serevent Accuhaler is manufactured by Glaxo Wellcome Production, 23 Rue Lavoisier, Evreux, F-27000, France
and is procured from within the EU by the Product Licence holder: Pharma-XL Ltd, Unit 6 Colonial Way, Watford,
Herts WD24 4PR. Repackaged by O.P.D Laboratories Ltd, Watford, Herts WD24 4PR.
PL 29510/0010

POM

Leaflet revision date (ref): 18.03.2014
Serevent and Accuhaler are Trade Marks of GlaxoSmithKline Group of Companies.
To request a copy of this leaflet in Braille, large print or audio please call 01923 332 796.

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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