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SEREVENT 25 MICROGRAMS CFC FREE INHALER

Active substance(s): SALMETEROL

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Serevent® 25 micrograms CFC Free Inhaler
Serevent® 25 micrograms Evohaler
(salmeterol xinafoate)

Your medicine is known by one of the above names but will be referred to
as Serevent Evohaler throughout this:
Patient Information Leaflet
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 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.



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 Evohaler 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 Evohaler 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.



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.

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.



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.

Adults with Chronic Obstructive Pulmonary Disease
including bronchitis and emphysema
 The usual starting dose is 2 puffs twice a day.
 Not applicable for children and adolescents.

If you are being treated for asthma, you should always be given both
a Serevent Evohaler 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 Evohaler. 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.

(COPD)

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.



Once your asthma is well controlled your doctor may consider it
appropriate to gradually reduce the dose of Serevent Evohaler



If you have been prescribed Serevent Evohaler 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.

Using your inhaler
It is important to start to breathe in as slowly as possible just before using
your inhaler.

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.

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.



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 heartbeats, or may make
side effects worse.

1 Stand or sit upright when using your inhaler.

3 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.

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.

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.

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.
Cleaning your inhaler
To stop your inhaler blocking up, it is important to clean it at least once a
week.

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 Evohaler. 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 all medicines 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 30°C.
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 Evohaler after the expiry date which is stated on
the carton and canister label. 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 doctor tells you to stop using the inhaler, please take it back to the
pharmacist for safe disposal.

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.

Only keep the inhaler if your doctor tells you to.

Do not put the metal canister in water.

What Serevent Evohaler contains
 Each metered actuation contains 25 micrograms salmeterol (as the
xinafoate)
 There are 120 metered actuations in each canister.
 The other ingredient is norflurane (HFA 134a).

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.
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.
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 Evohaler, 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.

If your inhaler fails to work properly you should ask your doctor or
pharmacist for advice.

6) Contents of the pack and other information

What Serevent Evohaler looks like and contents of the pack
White to off white suspension sealed in a canister in a green actuator with
a light green cap.
Who makes and repackages your medicine?
PL 10383/1767

Serevent micrograms CFC Free Inhaler/
Serevent 25 micrograms Evohaler

POM

Your medicine is manufactured by GlaxoSmithKline Pharmaceuticals S.A.
UI. Grunwaldzka 189, 60-322 Poznan, Poland and Glaxo Wellcome
Production, Zone Industrielle 2, Rue Lavoisier 23, 2700 Evreux, France.
Procured from within the EU and repackaged by the Product Licence
holder: Primecrown Ltd., 4/5 Northolt Trading Estate, Belvue Road,
Northolt, Middlesex, UB5 5QS.
Leaflet date: 23.09.2014
Evohaler®, Serevent®, Haleraid® and Volumatic® are trademarks of the
GlaxoSmithKline Group of Companies.

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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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