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SALMETEROL 25 MICROGRAMS PER ACTUATION PRESSURISED INHALATION SUSPENSION

Active substance(s): SALMETEROL

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PACKAGE LEAFLET: INFORMATION FOR THE USER

SEREVENT® EVOHALER® / SALMETEROL 25 micrograms PER ACTUATION,
PRESSURISED INHALATION SUSPENSION
(salmeterol xinafoate)
This medicine is known by any of the above names but will be referred to as Serevent Evohaler throughout this
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.
• 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 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.
• 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 Evohaler.
• Your doctor may want to check your health regularly if you have an overactive thyroid gland, diabetes mellitus
(Serevent Evohaler 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 Evohaler may not be suitable to
be taken with other medicines.
• Inform your doctor before using Serevent Evohaler 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 Evohaler, including irregular
heartbeats, or may make side effects worse.
• Beta-Blockers should be avoided when taking Serevent Evohaler, 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 Evohaler 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 Evohaler 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 Evohaler 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 Evohaler 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 Evohaler 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 a puff into the air. If you have not used
the inhaler for a week or more, release one puff of medicine into the air.

Using yo
our inhalerr
It is important to start to breath
he in as slow
wly as posssible just be
efore using your inhale
er.
1 Stand or
o sit uprigh
ht when using your inh
haler.
2 Removve the mo
outhpiece cover (as shown in the first
picture). Check insside and outside
o
to make
m
sure
e that the
mouthpie
ece is clean
n and free of
o objects.
3 Shake the inhale
er 4 or 5 times to ensure that any
a
loose
objects are
a removed
d and that the conten
nts of the in
nhaler are
evenly mixed.
4 Hold the inhaler upright with your thumb
b on the ba
ase, below
the mouth
hpiece. Bre
eathe out ass far as is comfortable
c
e.
5 Place the
t
mouthp
piece in yo
our mouth between yo
our teeth.
Close you
ur lips arou
und it. Do no
ot bite.
6 Breath
he in throu
ugh your mouth. Ju
ust after starting to
breathe in, press do
own on the top of the canister to release a
puff of medicine.
m
Do
o this while
e still breatthing in ste
eadily and
deeply.
7. Hold your
y
breath
h, take the inhaler from
m your mouth and yo
our finger frrom the top
p of
the inhaler. Contin
nue holding
g your bre
eath for a few seco
onds, or a
as long ass is
comfortab
ble.
8 Wait ab
bout half a minute
m
betw
ween taking
g each puff of medicine
e and then repeat step
ps 3
to 7.
9 After use
u
alwayss replace the mouth
hpiece cove
er immedia
ately to ke
eep out du
ust.
Replace the
t cover by
b firmly pusshing and snapping
s
th
he cap into position.
Practice in
i front of a mirror for the first few
w times. If you
y see a ‘m
mist’ comin
ng from the top
of your in
nhaler or the
e sides of your
y
mouth you should
d start again
n
If you or your child find it diffiicult to use
e Serevent Evohaler, it may be used with other devic
ces to makke its use
easier e.g
g. a Halera
aidTM or VolumaticTM sp
pacer devicce. Sereven
nt Evohalerr is also ava
ailable in an alternativve device.
Talk to yo
our doctor, nurse or ph
harmacist for
f further advice.
a
Cleaning
g your inha
aler
To stop your
y
inhalerr blocking up,
u it is impo
ortant to cle
ean it at lea
ast once a w
week.
To clean your inhale
er:
• Remo
ove the mou
uthpiece co
over.
• Do no
ot remove th
he metal ca
anister from
m the plasticc casing at any time.
• Wipe the inside and
a outside
e of the mou
uthpiece an
nd the plasttic casing w
with a dry clloth or tissu
ue.
• Repla
ace the mou
uthpiece co
over.
Do not pu
ut the meta
al canister in
n water.
If you us
se more Se
erevent Evo
ohaler than
n you shou
uld
It is impo
ortant to usse the inhaler as instrructed. If yo
ou acciden
ntally take a larger do
ose than recommende
ed, talk to
your doctor or pharrmacist. Yo
ou may nottice your he
eart beating faster than usual and
a
that yo
ou feel shakky and/or
dizzy. Yo
ou may also
o have a he
eadache, muscle weakkness and aching
a
jointts.
If you forrget to use
e Serevent Evohaler
Do not ta
ake a double
e dose to make
m
up forr a missed dose.
d
Just take your n
next dose at the usual time.
If you havve any furth
her questions on the use
u of this medicine,
m
ask your docctor or pharrmacist.
4. POSSIIBLE SIDE EFFECTS
S
Like all medicines,
m
t
this
medicin
ne can causse side effe
ects, although not everybody getss them. To reduce the
e chances
of side efffects, yourr doctor willl prescribe
e the lowestt dose of Serevent
S
Evvohaler to control you
ur asthma o
or COPD.
These are
e the side effects
e
repo
orted by people taking
g Serevent Evohaler.
E
Allergic reactions: you may notice you
ur breathin
ng suddenlly gets wo
orse after using
u
Serev
vent Evohaler. You
may be very
v
wheezzy and cou
ugh. You may
m also no
otice itching and swe
elling (usua
ally of the face,
f
lips, ttongue or
throat). Iff you get th
hese effectss or they ha
appen sudd
denly after using Sere
event Evohaler, tell yo
our doctorr straight
away. Alllergic reacttions to Serrevent Evoh
haler are ve
ery rare (the
ey affect lesss than 1 person
p
in 10
0,000).
Other sid
de effects are listed be
elow:
Common
n (affects less than 1 person in
n 10):
• Muscle cramps
ng shaky; fa
ast or unevven heartbeat (palpita
ations), hea
adache, shaking hand
ds (tremor). Tremors are more
• Feelin
likely if you are taking
t
more
e than two puffs twice
e daily. The
ese side efffects do no
ot last long and happe
en less as
ment with Se
erevent Evo
ohaler conttinues.
treatm
Uncomm
mon (affectts less than
n 1 person
n in 100):
• Rash
f
heart ra
ate (tachyca
ardia). Thiss is more likkely to happ
pen if you a
are taking more
m
than tw
wo puffs tw
wice daily.
• Very fast
• Feelin
ng nervous.
Rare (afffects less than
t
1 pers
son in 1,00
00):
• Feelin
ng dizzy
• Being unable to sleep
s
or finding sleep difficult
uction in the
e amount of potassium in your blood
d (you may get an unevven heartbe
eat, muscle weakness,
w
ccramp).
• A redu
Very rare
e (affects less than 1 person in
n 10,000):
• Breathing diffic
culties or wheezing
w
th
hat gets worse
w
straig
ght after ta
aking Serevent Evohaler. If thiss happens
u
yourr Serevent Evohaler. Use your fast-acting
f
‘reliever’ inhaler to he
elp your bre
eathing and tell your
stop using
docto
or straight away.
• Uneve
en heartbea
at or your heart
h
givess an extra beat
b
(arrhytthmias). If this happens do not stop
s
using Serevent
Evoha
aler but tell your docto
or.
• Increa
ases in the amount of sugar (gluccose) in you
ur blood (hyperglycae
emia). If you
u have diab
betes, more
e frequent
blood sugar mon
nitoring and possibly adjustment of
o your usual diabetic treatment may
m be req
quired.
m
or th
hroat
• Sore mouth
• Feelin
ng sick (nau
usea)
• Aching
g, swollen joints
j
or chest pain.
Reporting of side effects
e
e
talk to
t your docctor, pharma
acist or nursse. This includes any possible
p
side effects no
ot listed in
If you gett any side effects,
this leafle
et. You can also report side effectss directly via
a the Yellow
w Card Sche
eme at: ww
ww.mhra.gov
v.uk/yellowccard.
By reporting side effe
ects you ca
an help provvide more in
nformation on
o the safetty of this me
edicine.
5. HOW TO
T STORE
E SEREVEN
NT EVOHA
ALER
• Keep out of the sight
s
and re
each of children.
e, replace th
he mouthpiiece cover firmly
f
and click
c
it into position. Do
o not use excessive
e
fo
orce.
• Straight after use
ot store abo
ove 30°C.
• Do no
• The metal
m
canistter containss a pressuriised liquid. Do not pun
ncture, brea
ak or burn itt even if you think it is empty.
• Do no
ot use Sere
event Evoh
haler after the
t
expiry date
d
which is stated o
on the labe
el and carton. The exxpiry date
refers to the last day of the month.
• If you
ur inhaler fails
f
to wo
ork properlyy or showss any sign
ns of deterrioration yo
ou should ask your doctor or
pharm
macist for ad
dvice.
• Mediccines should
d not be disposed of via
v wastew
water or hou
usehold wa
aste. Ask yo
our pharma
acist how to
o dispose
of med
dicines no longer requ
uired. These
e measuress will help to
t protect th
he environm
ment.
6. CONTENTS OF THE
T
PACK
K AND OTH
HER INFOR
RMATION
What Serrevent Evo
ohaler conttains
• Each puff
p provide
es 25 micrograms of th
he active ing
gredient salmeterol.
• There are 120 pu
uffs in each canister.
• The otther ingredient is norflu
urane (HFA
A 134a).
What Serrevent Evo
ohaler looks
s like and contents
c
o the pack
of
Pressurissed inhalatio
on, suspenssion. White to off white suspension
n sealed in an aluminiu
um canisterr in a green actuator.
PL No: 15
5814/0860
P
POM
This prod
duct is manufactured by
b Glaxo We
ellcome Pro
oduction, Evvreux, Fran
nce and is procured
p
fro
om within th
he EU and
repackaged by the Product
P
Lice
ence holderr: OPD Labo
oratories Ltd
d., Unit 6 Colonial Wayy, Watford, Herts WD24 4PR.
Leaflet re
evision and Issue date
e (Ref.): 17.04.2015.
Sereventt and Evoha
aler are trad
demarks off the GlaxoS
SmithKline group of co
ompanies.
To request a copy of
o this leafle
et in Braille, large printt or audio please call 0
01923 332 796.
7

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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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