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RESPOCORT 50 MCG/ACTUATION PRESSURISED INHALATION SOLUTION AUTOHALER

Active substance(s): BECLOMETASONE DIPROPIONATE

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Package leaflet: Information for the user
Respocort™ 50 or 100 micrograms/actuation pressurised inhalation solution
Autohaler™
Beclometasone Dipropionate
Read all of this leaflet carefully before you start using 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, pharmacist or nurse. This includes any possible side
effects not listed in this leaflet. See section 4.
What is in this leaflet
1.
2.
3.
4.
5.
6.

What Respocort Autohaler is and what it is used for
What you need to know before you use Respocort Autohaler
How to use Respocort Autohaler
Possible side effects
How to store Respocort Autohaler
Contents of pack and other information

1. What Respocort Autohaler is and what it is used for
Respocort Autohaler contains an active ingredient called beclometasone dipropionate.
Beclometasone dipropionate is one of a group of medicines known as corticosteroids, which can be
used to treat asthma and prevent the symptoms of asthma in patients who require regular treatment.

How your medicine works
 Beclometasone dipropionate pressurised inhalation solution works deep in your lungs to make
breathing easier by reducing the inflammation, swelling and irritation in the airways. This type of
medicine is known as a ‘preventer’. It needs to be taken regularly every day, even if you have no
symptoms.
 This inhaler will not give immediate relief of wheezing or breathlessness during a sudden asthma
attack. You will need to use a ‘reliever’ inhaler which contains a different medicine. You should
still continue to use this inhaler.
2.

What you need to know before you use Respocort Autohaler

DO NOT use Respocort Autohaler if you:
 are allergic to beclometasone dipropionate or any of the other ingredients of this medicine
(listed in section 6)

Warnings and precautions
Talk to your doctor before you start to take this medicine if:
 you are suffering from tuberculosis (TB) now or have you suffered from it in the past
 You are allergic to other similar inhalers
Important points to remember while you are using this medicine:
 your doctor may prescribe this inhaler to replace steroid tablets, which may mean that for a
short time you have to take both medicines. It is important to follow your doctor’s advice.
Whilst you are reducing the number of steroid tablets that you take you may feel generally
unwell even though you can breathe as well as normal or better. If you have other allergies you
may find that stopping your steroid tablets makes them worse. If this happens keep using your
inhaler and tell your doctor.


there may be times when you need to take steroid tablets as well as using your inhaler, for
example if you have worsening asthma attacks, you get a chest infection or you need an
operation. Your doctor may give you a small supply of steroid tablets to be taken in these
situations; if he does you will be given full instructions on how and when to take them. Contact
your doctor immediately if you think that you need to take steroid tablets, even if you have your
own supply.



you should have been given a steroid card with this inhaler, if you have not, please ask your
pharmacist for one. Make sure you carry your steroid card with you at all times until your
doctor decides that it is no longer necessary.



visit your doctor regularly for a review of your condition.



if you have to go into hospital, remember to take all your inhalers and other medicines with
you.

Other medicines and Respocort Autohaler
 Please tell your doctor or pharmacist if you are taking any other medicines and/or inhalers
either prescribed by a doctor or bought from a pharmacy.
Pregnancy and breast-feeding
 If you are pregnant, trying to become pregnant or breast feeding a child, ask your doctor for
advice before taking this medicine.
3.

How to use Respocort Autohaler

Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or
pharmacist if you are not sure. .
This inhaler has a softer feel and a different taste than CFC inhalers you may have used before. There
are two strengths of the Respocort Autohaler device available and your doctor will have chosen the
strength which best suits your condition. The label should remind you how many puffs to take and how
often. Do not take more puffs than your doctor has told you to. It is important that you take your dose
as stated on the pharmacist’s label or as advised by your doctor. You should not increase or decrease

your dose without seeking medical advice. If you are unsure ask your doctor or pharmacist for advice.
This inhaler is an extrafine pressurised inhalation solution which results in more of each dose being
delivered to your lungs. Your doctor may, therefore, prescribe a lower dose of this inhaler than your
previous CFC beclometasone dipropionate inhaler. Even when your doctor has prescribed a lower dose
you may find that the number of puffs you are asked to take from this inhaler is the same as from your
previous CFC beclometasone dipropionate inhaler; this is because this inhaler may be a lower strength
product (which means that each puff of this new inhaler contains less beclometasone dipropionate than
your old CFC beclometasone dipropionate inhaler).

The recommended dose is:
Respocort 50 Autohaler device
Adults, elderly and children over 12 years
The starting dose for mild asthma is one puff twice a day. This may be increased up to two puffs twice
a day.
The starting dose for moderate asthma is two puffs twice a day. This may be increased up to four puffs
twice a day.
For more severe asthma the usual dose is up to eight puffs twice a day.
Your doctor may prescribe up to a total of sixteen puffs per day.
Children under 12 years
No dosage recommendations are available.
Respocort 100 Autohaler device
Adults, elderly and children over 12 years
The starting dose for mild to moderate asthma is one puff twice a day. This may be increased to two
puffs twice a day.
For more severe asthma the usual dose is up to four puffs twice a day.
Your doctor may prescribe up to a total of eight puffs per day.
Children under 12 years
No dosage recommendations are available.
In some circumstances your doctor may prescribe more than the usual number of puffs.
This inhaler must be used regularly, even when you feel well. You must not stop using your inhaler
unless your doctor tells you to.
If you forget to use your inhaler
If you forget to use this inhaler at your usual time, take your recommended number of puffs as soon as
you remember, then continue to take regularly.
If you think your usual treatment is not working, for example your symptoms are not getting better, or
are getting worse, or you need to use more puffs from your reliever inhaler, or if your reliever inhaler
does not seem to be working as well as usual, or your peak flow falls, please tell your doctor. Your
asthma may be getting worse.

IIf you use more
m
mediciine than you
u should
IIf you accidentally take more puffs than
t
recomm
mended, pleaase tell your doctor.
A
Ask your do
octor for a prrescription fo
or a replacem
ment inhalerr before this one is emptyy.
B
Before usin
ng this inhaler:
B
Before use:
IIf this is a new
n device or
o if you hav
ve not used it for 2 weeeks or moree, it must be tested befoore use
b
by releasing
g 2 puffs intto the air in the following way:

1. Take the cover
c
off fro
om the mouth
hpiece, by pulling
p
downn on the lip aat the back (ffig. 1).
22. Point the mouthpiece away from you
y so that the
t puffs of m
medicine wiill go into the air. Push thhe lever
uup so that it stays up (fig
g. 2).
3. Then, to release
r
a pufff, push the dose
d
release slide on the bottom of thhe device in the directionn
iindicated by
y the arrow on
o it (fig. 3).
44. To releasee the second
d puff you neeed to return the lever to its down poosition (fig. 44) and follow
w steps
2 and 3 agaiin.
A
After releasiing the secon
nd puff, retu
urn the lever to its down position, to be ready to take a puff oof your
m
medicine.
D
DO NOT USE
U THE DO
OSE RELE
EASE SLIDE
E TO TAKE
E YOUR M
MEDICINE, THE
A
AUTOHALE
ER DEVICE WILL AU
UTOMATICALLY RE
ELEASE A DOSE WH
HEN YOU B
BEGIN
TO BREAT
THE IN FRO
OM THE MOUTHPIE
M
ECE.
T
The instructtions for takiing a puff aree given belo
ow.
H
How to use your Respo
ocort Autohaler™ devicce
c
off fro
om the mouth
hpiece, by pulling
p
downn on the lip aat the back.
1. Take the cover
22. Hold yourr Autohaler device uprig
ght as shown
n. Push the leever up so thhat it stays uup. Continue to hold
yyour device upright, mak
king sure thaat your hand
d is not blockking the air vvent (markedd by X in figg. 2) at
tthe bottom of
o the devicee.
3. Breathe out
o as far as is
i comfortab
ble and then immediately
i
y place the m
mouthpiece inn your moutth and
cclose your liips around itt.
44. Breathe in
n slowly and
d deeply thro
ough the mou
uthpiece. Doo not stop brreathing in w
when you heaar the
slight click and
a feel the puff in yourr mouth as it is importantt that you caarry on breatthing in afterr the
ppuff is released.
5. Hold yourr breath for 10 seconds and
a then breathe out slow
wly.
6. The leverr must be low
wered to the down position after eachh puff. If youur doctor haas prescribedd more
tthan one pufff, repeat steeps 2 - 6. Aftter use, replaace the coverr on the mouuthpiece.

H
How to tell when your Respocort Autohaler
A
deevice is emp
pty
W
When the deevice is com
mpletely emptty you will not
n feel or heear any proppellant beingg discharged..
Cleaning in
nstructions
F
For normal hygiene,
h
the mouthpiecee of your Auttohaler deviice should bee cleaned weeekly with a clean,
ddry tissue orr cloth.
D
DO NOT WASH
W
OR PU
UT ANY PA
ART OF YO
OUR INHAL
LER IN WAT
TER.
44. Possiblee side effectss
L
Like all med
dicines, Resp
pocort Autoh
haler can cau
use side effeects, althoughh not everyoone gets them
m.
T
The followin
ng side-effeccts may occu
ur when takiing any inhalled medicinee containingg beclometassone
ddipropionatee:H
Hoarseness, a sore moutth or thrush (white spotss in mouth annd throat). T
These are less likely if yoou rinse
yyour mouth out with waater after usin
ng your inhaaler. If you gget thrush tallk to your dooctor who maay
rrecommend a medicine to treat you.
A sore and inflamed
i
thro
oat (pharyng
gitis), coughiing or increaased symptooms of asthm
ma.
F
Feeling of siickness or alltered taste after
a
inhaling
g this mediciine.
H
Headaches, dizziness (vertigo), trem
mbling or shaaking.
H
Hypersensitivity (allergiic) reactionss such as rash
hes, itching, redness andd swelling off the lips, moouth,
tthroat and ey
yes may occcur. If you ex
xperience an
ny of these efffects you shhould see yoour doctor ass soon as
ppossible.
Treatment with
T
w Respoco
ort Autohalerr devices maay affect thee normal prodduction of corticosteroidds in the
bbody. If you
u become unw
well, particu
ularly with ab
bdominal paain, weaknesss or vomitinng, you shouuld see
yyour doctor.. This is espeecially important if you have
h
been exxposed to otther illness, ssurgery or innfection.
A
At high dosees, taken forr prolonged periods,
p
bone thinning, cclouding of tthe lens of thhe eye (catarract)
rresulting in blurred
b
visio
on, or loss off vision due to abnormallly high presssure in the eeye may occur.
Children or adolescents who are usin
ng the inhaleer for a proloonged periodd may grow more slowlyy. Your
ddoctor may therefore
t
wiish to monito
or the heightt of a child reeceiving proolonged treattment with
R
Respocort Autohaler
A
dev
vices.
F
Frequency not
n known, but
b may also occur:
Sleeping pro
oblems, deprression or feeling worrieed, restless, nnervous, oveer-excited orr irritable. Thhese
effects are more
m
like to occur
o
in chilldren.
IImportant: if immediattely after tak
king a puff off this inhalerr you feel whheezy or tighht chested do not
ttake any mo
ore puffs. Use your reliev
ver inhaler to
o help your bbreathing annd contact yoour doctor sttraight
away.
R
Reporting off side effects

If you get 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 Respocort Autohaler
Keep this medicine out of sight and reach of children.
You can use your inhaler at temperatures as low as -10°C.
Do not store your inhaler above 25°C. Avoid storage in direct sunlight or heat. Protect from frost.
The canister is pressurised and should not be punctured or burnt even if it seems empty.
Do not use this inhaler after the date (shown as ‘EXP’) on the carton and label.
If your doctor decides to stop treatment, return the inhaler to your doctor or pharmacist for safe
disposal.
CAUTION: Do not push a drying cloth or anything else into any part of the Autohaler device since it
may cause damage to its operating parts.
Do not take the Autohaler device apart.
6.
Contents of pack and other information
What Respocort Autohaler contains:
 The active ingredient is beclometasone dipropionate.
 The other ingredients are propellant HFA-134a and ethanol.
 The name of your medicine is Respocort 50 micrograms/actuation pressurised inhalation
solution Autohaler or Respocort 100 micrograms/actuation pressurised inhalation solution
Autohaler device depending on which strength your doctor has prescribed for you. These are its
brand names, its common name is beclometasone dipropionate pressurised inhalation solution.
What Respocort Autohaler looks like and contents of the packs
 The Respocort Autohaler is a breath-actuated device with a pressurised canister fitted with a
metering valve.
 The Respocort 50 Autohaler device delivers 50 micrograms of beclometasone dipropionate per
puff (actuation).
 The Respocort 100 Autohaler device delivers 100 micrograms of beclometasone dipropionate
per puff (actuation).
 Your inhaler contains 100 or 200 puffs.
Chlorofluorocarbons (CFCs) have been shown to damage the ozone layer in the atmosphere. Your
Respocort Autohaler device does not contain CFCs, instead the inhaler contains a hydrofluoroalkane
(called propellant HFA-134a or Norflurane) as an inactive ingredient. Hydrofluoroalkanes have been
developed as a replacement for CFCs because they do not damage the ozone layer.
Marketing Authorisation Holder and Manufacturer
The marketing authorisation holder is
3M Health Care Limited
Loughborough LE11 1EP

England
3M, Respocort and Autohaler are trade marks of 3M
Who produces your medication
Respocort Autohaler devices are made by the product licence holder; 3M Health Care Limited,
Loughborough, Leicestershire LE11 1EP England.

This leaflet was last revised in November 2015.
For further information about asthma, contact the National Asthma Campaign, the independent UK
charity working to conquer asthma:
National Asthma Campaign, Providence House, Providence Place, London N1 0NT.
Asthma Helpline: 0345 010203 (Open Monday to Friday, 9am to 7pm. All calls charged at local rates.).
Or visit the National Asthma Campaign’s web site - http://www.asthma.org.uk
C03739

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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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