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RESPOCORT 100 MCG/ACTUATION PRESSURISED INHALATION SOLUTION

Active substance(s): BECLOMETASONE DIPROPIONATE

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Package leaflet: Information for the user
Respocort™50 or 100 micrograms/actuation pressurised inhalation
solution
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 pressurised inhalation solution is and what it is used for
What you need to know before you use Respocort pressurised inhalation solution
How to use Respocort pressurised inhalation solution
Possible side effects
How to store Respocort pressurised inhalation solution
Contents of pack and other information

1. What Respocort pressurised inhalation solution is and what it is used for
Respocort pressurised inhalation solution 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 pressurised inhalation solution
DO NOT use Respocort pressurised inhalation solution 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 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.



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



visit your doctor regularly for a review of your condition.

Other medicines and Respocort pressurised inhalation solution
 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 pressurised inhalation solution
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 Respocort pressurised inhalation solution 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 pressurised inhalation solution
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 pressurised inhalation solution
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 mustt be used reg
gularly, even
n when you ffeel well. Yoou must not stop using
your inhaler unless your docttor tells you to.
If you
u forget to use
u your inh
haler
If you
u forget to use
u this inhaller at your ussual time, takke your recoommended nnumber of
puffs as soon as you
y rememb
ber, then conttinue to takee regularly.
If you
u think yourr usual treatm
ment is not working,
w
for example youur symptoms are not
gettin
ng better, or are getting worse,
w
or you need to usse more pufffs from your reliever
inhaler, or if yourr reliever inh
haler does no
ot seem to b e working as well as usuual, or your
peak flow falls, please
p
tell yo
our doctor. Your
Y
asthma may be gettting worse.
u use more medicine th
han you sho
ould
If you
If you
u accidentallly take moree puffs than recommende
r
ed, please teell your doctoor.
Ask your
y
doctor for
f a prescription for a replacement inhaler befoore this one iis empty.
ur inhaler:
Beforre using you
Beforre use:
If thiis is a new in
nhaler or iff you have not
n used you
ur inhaler foor two week
ks or more, iit
mustt be tested before
b
use by
y removing the mouthp
piece cover and pressin
ng down on
the canister insid
de the inhaller. Release 2 puffs intoo the air, aw
way from yoou.
How to use yourr inhaler
1. Taake the coverr off the mou
uthpiece.
2. Breathe out as far as is com
mfortable an
nd then immeediately placce the mouthhpiece in youur
moutth and close your lips aro
ound it.
3. Staart to breathee in slowly and
a deeply th
hrough yourr mouth and press down on the
canister inside the inhaler as shown. Thiss releases onne puff of meedicine. It is important
that you
y carry on breathing in
n after the pu
uff is releaseed.
4. Ho
old your breaath for 10 seconds, then breathe out slowly. If yoour doctor has prescribed
more than one pu
uff repeat steeps 2 to 4 agaain. After usse, replace thhe cover on tthe
moutthpiece.

Somee people find it difficultt to press th
heir inhaler and breath
he in at the ssame time.
A spaacer device helps
h
to overrcome this problem.
p
Thee spacer thatt fits Respocoort
pressurised inhalaation solutio
on is called th
he AeroChaamber® spaccer device. Iff you use thee
AeroChamber® spacer
s
devicce please folllow the instrructions provvided with itt. Your

doctor, nurse or pharmacist will be able to advise you about the AeroChamber® device.
Alternatively your doctor may wish to prescribe the Respocort Autohaler™ device which
automatically releases a puff of medication as you breathe in.
How to tell when your Respocort pressurised inhalation solution is empty
When the canister is completely empty you will not feel or hear any propellant being
discharged.
Cleaning instructions
For normal hygiene, the mouthpiece of your inhaler should be cleaned weekly with a
clean, dry tissue or cloth.
DO NOT WASH OR PUT ANY PART OF YOUR INHALER IN WATER.

4. Possible side effects
Like all medicines, Respocort pressurised inhalation solution can cause side effects,
although not everyone gets them.
The following side-effects may occur when taking any inhaled medicine containing
beclometasone dipropionate:
Hoarseness, a sore mouth or thrush (white spots in mouth and throat). These are less
likely if you rinse your mouth out with water after using your inhaler. If you get thrush
talk to your doctor who may recommend a medicine to treat you.
A sore and inflamed throat (pharyngitis),coughing or increased symptoms of asthma.
Feeling of sickness or altered taste after inhaling this medicine.
Headaches, dizziness (vertigo), trembling or shaking.
Hypersensitivity (allergic) reactions such as rashes, itching, redness and swelling of the
lips, mouth, throat and eyes may occur. If you experience any of these effects you should
see your doctor as soon as possible.
Treatment with Respocort pressurised inhalation solution may affect the normal
production of corticosteroids in the body. If you become unwell, particularly with
abdominal pain, weakness or vomiting, you should see your doctor. This is especially
important if you have been exposed to other illness, surgery or infection.
At high doses, taken for prolonged periods, bone thinning, clouding of the lens of the eye
(cataract) resulting in blurred vision, or loss of vision due to abnormally high pressure in
the eye may occur.
Children or adolescents who are using the inhaler for a prolonged period may grow more
slowly. Your doctor may therefore wish to monitor the height of a child receiving
prolonged treatment with Respocort pressurised inhalation solution.
Frequency not known, but may also occur:
Sleeping problems, depression or feeling worried, restless, nervous, over-excited or
irritable. These effects are more like to occur in children.
Important: if immediately after taking a puff of this inhaler you feel wheezy or tight
chested do not take any more puffs. Use your reliever inhaler to help your breathing and
contact your doctor straight away.
Reporting of 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 pressurised inhalation solution
Storing your medication
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.
6.

Contents of pack and other information

What Respocort pressurised inhalation solution 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 or Respocort 100 micrograms/actuation pressurised inhalation
solution 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 Inhaler looks like and contents of the packs
 The Respocort pressurised inhalation solution is a pressurised canister fitted with
a metering valve.
 Respocort 50 pressurised inhalation solution delivers 50 micrograms of
beclometasone dipropionate per puff (actuation).
 Respocort 100 pressurised inhalation solution 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 pressurised inhalation solution 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
Who produces your medication
Respocort pressurised inhalation solution is made by the product licence holder; 3M
Health Care Limited, Loughborough, Leicestershire LE11 1EP England
This leaflet was last revised in November 2015.
3M, Autohaler, and Respocort are trade marks of 3M
Aerochamber is a registered trade mark of Trudell Medical
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
C03740

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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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