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SALMETEROL 50 MICROGRAMS DRY POWDER INHALER

Active substance(s): SALMETEROL / SALMETEROL XINAFOATE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Other medicines and Serevent Accuhaler

Serevent® 50 micrograms Accuhaler®
Salmeterol 50 micrograms Dry Powder Inhaler
(salmeterol xinafoate)
This product is available using any of the above names but will be referred to as
Serevent Accuhaler throughout the following leaflet.
Full
Outer Case

Counter
Empty

60

0
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

 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.
 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.
3. How to use Serevent Accuhaler

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.

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 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.

 Taking Serevent Accuhaler regularly will also help prevent breathing problems
caused by other chest illnesses such as Chronic Obstructive Pulmonary
Disease (COPD).

Adults and adolescents aged 12 years and older with Asthma

 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.

 For people with more severe asthma, your doctor may increase your dose to 2
puffs twice a day.

 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 Accuhaler and a steroid inhaler to use together.

 The usual starting dose is 1 puff 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.

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.

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.

Take special care with Serevent Accuhaler
 If you are using Serevent Accuhaler 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 Accuhaler. Your
chest condition may be getting worse and you could become seriously ill. See
you 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.

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

Rare (affects less than 1 person in 1,000):

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.

 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):

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.
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.
4 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 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.

 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, 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. Store in a dry place.

Your Serevent Accuhaler is now ready for you to use
again.

 Keep out of the sight and reach of children.

Cleaning your inhaler

 Do not use after the expiry date printed on the carton or Accuhaler label.

Wipe the mouthpiece of the Serevent Accuhaler with a dry tissue to clean it.

 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 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 joints.
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 your Accuhaler fails to work properly or you notice any other signs of
deterioration, you should seek the advice of your pharmacist.
 Do not throw away medicines via wastewater or household waste. Ask your
pharmacist how to throw away any medicines you no longer use. These
measures will help protect the environment.
6. Contents of the pack and other information
What Serevent Accuhaler contains

If you have any further questions on the use of this medicine, ask your doctor or
pharmacist.

 Each blister contains 50 micrograms of salmeterol (as the xinafoate) powder
for inhalation

4. Possible side effects
 The other ingredient is lactose.
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).

What Serevent Accuhaler looks like and contents of the pack
 Serevent Accuhaler is a two-tone green, circular moulded plastic device
containing a foil strip with 60 regularly spaced blisters each containing white
inhalation powder and a dose counter indicating the number of doses
remaining.
 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.

Other side effects are listed below:
Common (affects less than 1 person in 10):

 The devices are packed in cartons which hold one Accuhaler containing 60
inhalations.

 Muscle cramps

POM

 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.

This product is manufactured by GlaxoSmithKline Slovakia s.r.o., Bratislava,
Slovakia. Procured from within the EU and repackaged by the Product Licence
holder: OPD Laboratories Ltd, Unit 6 Colonial Way, Watford, Herts WD24 4PR.

Uncommon (affects less than 1 person in 100):

Leaflet revision date (ref): 09.02.2015.
Serevent and Accuhaler are Trade Marks of GlaxoSmithKline Group of
Companies.

 Rash
 Very fast heart rate (tachycardia). This is more likely to happen if you are
taking more than one puff twice daily
 Feeling nervous.

PL No: 15814/1125

To request a copy of this leaflet in Braille, large print or audio please call 01923
332 796.

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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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