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SEREVENT 25 EVOHALER

Active substance(s): SALMETEROL

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Package Leaflet: Information for the User

Serevent® 25 Evohaler®
(salmeterol xinafoate)
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.
• Your medicine is called Serevent 25 Evohaler but will be referred to as
Serevent Evohaler throughout this leaflet.
In this leaflet:
1. What Serevent Evohaler is and what it is used for
2. What you need to know before you use Serevent Evohaler
3. How to use Serevent Evohaler
4. Possible side effects
5. How to store Serevent Evohaler
6. Contents of the pack and other information
1. What Serevent Evohaler is and what it is used for
• Serevent Evohaler 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 Evohaler regularly
will help prevent asthma attacks. This also includes asthma brought on
by exercise or at night.
• Taking Serevent Evohaler regularly will also help prevent breathing
problems caused by other chest illnesses such as Chronic Obstructive
Pulmonary Disease (COPD).
• Serevent Evohaler 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 Evohaler is supplied to you in an inhaler. You breathe the
medicine directly into your lungs.
• Serevent Evohaler contains norflurane. This is less harmful to the
environment than older inhalers. Older inhalers may taste differently to
Serevent Evohaler. This will make no difference to how your medicine
works.
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 Evohaler
Do not take Serevent Evohaler if:
you are allergic (hypersensitive) to salmeterol or to the other ingredient
norflurane (HFA 134a).
Take special care with Serevent Evohaler
• 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. 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 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) 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 are unlikely to affect
your ability to drive or use machines.

3. How to use Serevent Evohaler
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 2 puffs twice a day.
• For people with more severe asthma, your doctor may increase your
dose to 4 puffs twice a day.
Children with Asthma
• In children aged 4 to 12 the usual dose is 2 puffs 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 2 puffs 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 inhaler properly or as prescribed, may mean that the medicine will not
help your asthma or COPD as it should.
The medicine is contained in a pressurised canister in a plastic casing
with a mouthpiece.
Testing your inhaler

1 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.

2 To make sure that it works, shake it well, point the mouthpiece
away from you and press the canister to release two puffs into the air.
If you have not used the inhaler for a week or more, also release two
puffs of medicine into the air.
Using your inhaler
It is important to start to breathe in as slowly as possible just before
using your inhaler.

1 Stand or sit upright when using your
inhaler.

2 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.

3 Shake the inhaler 4 or 5 times to ensure

3

that any loose objects are removed and that
the contents of the inhaler are evenly mixed.

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.

4

6 Breathe in through your mouth. Just after
starting to breathe in, press down on the top
of the canister to release a puff of medicine.
Do this while still breathing in steadily and
deeply.

7 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.

5

8 Wait about half a minute between taking
each puff of medicine and then repeat steps
3 to 7.

9 After use always replace the mouthpiece
cover immediately to keep out dust. Replace
the cover by firmly pushing and snapping the
cap into position.
Practice in front of a mirror for the first few
times. If you see a ‘mist’ coming from the top
of your inhaler or the sides of your mouth
you should start again
If you or your child find it difficult to use
Serevent Evohaler, it may be used with other
devices to make its use easier e.g. a
Haleraid® or Volumatic® spacer device.
Serevent is also available in an alternative
device. Talk to your doctor, nurse or
pharmacist for further advice.

6

7

Cleaning your inhaler
To stop your inhaler blocking up, 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.
Do not put the metal canister in water.

Product Licence Holder and Manufacturer
Product Licence Holder
The product licence holder is CST Pharma Ltd, Westgate Business Park,
Unit 5-7, Tintagel Way, Aldridge, Walsall WS9 8ER
Manufacturer
This medicine is manufactured by Glaxo Wellcome Production, Zone
Industrielle 2, 23 Rue Lavoisier, Evreux, France.
It is procured from within the EU by the product licence holder CST
Pharma Ltd, Westgate Business Park, Unit 5-7 Tintagel Way, Aldridge,
Walsall WS9 8ER

If you use more Serevent Evohaler 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.

Repackaged by XXXXXXXXXXXXXXXXXXXXXXXXXXXX

If you forget to use Serevent Evohaler
Do not take a double dose to make up for a missed dose. Just take your
next dose at the usual time.

Leaflet dated 14th January 2015
Leaflet coded XXXXXXXXXXXXXXXXXXXXXX

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 two puffs 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 two puffs 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
Evohaler. 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 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:
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 Evohaler
• Keep out of the sight and reach of children.
• Straight after use, replace the mouthpiece cover firmly and click it into
position. Do not use excessive force.
• Do not store above 30oC.
• Protect from heat and direct sunlight.
• Do not freeze.
• The metal canister contains a pressurised liquid. Do not puncture,
break or burn it even if you think it is empty.
• Do not use Serevent after the expiry date which is stated on the label
and carton. The expiry date refers to the last day of the month.
• 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.
• If your medicine shows any sign of deterioration, return it to your
pharmacist.
6. Contents of the pack and other information
What Serevent Evohaler contains
• Each puff provides 25 micrograms of the active ingredient salmeterol.
• There are 120 puffs in each canister.
• The other ingredient is norflurane (HFA 134a).
What Serevent Evohaler looks like and contents of the pack
Pressurised metered dose inhaler comprising of a green plastic body with
a light green removable cap and a metal canister. The pressurised
canister contains a white to off white suspension for inhalation.

PL:18773/0188

POM

Evohaler, Serevent, Haleraid and Volumatic are trademarks of the
GlaxoSmithKline group of companies

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