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QVAR 100MICROGRAMS AEROSOL INHALER

Active substance(s): BECLOMETASONE DIPROPIONATE

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Package Leaflet: Information for the User

Qvar® 100 micrograms Aerosol Inhaler
(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.
 Your medicine is called Qvar 100 micrograms Aerosol Inhaler, but will
be referred to as Qvar Aerosol throughout this leaflet. Please note that
the leaflet also contains information about other strengths of the
medicine, Qvar 50 micrograms Aerosol Inhaler.
What is in this leaflet
1. What Qvar Aerosol is and what it is used for
2. What you need to know before you use Qvar Aerosol
3. How to use Qvar Aerosol
4. Possible side effects
5. How to store Qvar Aerosol
6. Contents of pack and other information

 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 Qvar Aerosol
 Please tell your doctor or pharmacist if you are taking or have recently
taken any other medicines, including any medicines bought without a
prescription.
In particular tell your doctor if you are taking:
 Disulfiram
 Metronidazole.
Pregnancy and breast-feeding
 If you are pregnant, planning to become pregnant or are breastfeeding, ask your doctor for advice before taking this medicine.
Driving and using machines
 Qvar Aerosol is not known to affect your ability to drive or operate
machinery.
Important information about some of the ingredients of Qvar
 Qvar contains a small amount of alcohol.

1. What Qvar Aerosol is and what it is used for
3. How to use Qvar Aerosol
Qvar Aerosol contains beclometasone dipropionate, which is one of a
group of medicines known as corticosteroids.
Qvar Aerosol is used to prevent the symptoms of mild, moderate, or
severe asthma, in patients who require regular treatment.
How your medicine works
 Qvar Aerosol 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 Qvar Aerosol
DO NOT use Qvar Aerosol if you:
 are allergic to beclometasone dipropionate or any of the other
ingredients of this medicine (listed in section 6).
 are allergic to other similar inhalers.
 are suffering from a sudden attack of breathlessness. It will not help.
Use a quick-acting ‘reliever’ inhaler for this purpose and carry it with
you at all times.
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 must avoid alcohol for any reason.
 your asthma seems to be getting worse. Perhaps you are more
wheezy and short of breath than usual, your ‘reliever’ inhaler seems to
be less effective, you require more puffs from your ‘reliever’ inhaler
than usual, or you do not seem to be getting better. Your doctor may
need to increase the dose of your steroid inhaler or give you a course
of steroid tablets, or change your treatment altogether. If you have an
infection in your chest your doctor may prescribe a course of
antibiotics.
 when transferring from steroid tablets to an inhaler you find that, even
if your chest is getting better, you feel generally unwell, you develop a
rash, eczema or a runny nose and sneezing (rhinitis). Do not stop
treatment with your inhaler unless your doctor tells you to.
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.
 If you have been treated for a long time with high doses of inhaled
steroid, you may require a course of steroid tablets or possibly a
steroid injection in times of stress. For example, during admission to
hospital after a serious accident, before an operation, during an acute
attack of asthma or if you have a chest infection or other serious
illness. Your doctor will decide if you need any extra steroid treatment
and will also advise you as to how long you need to take the course of
steroid tablets and how you should reduce these as you get better.
 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.

There are two strengths of Qvar Aerosol available and your doctor will
have chosen the strength which best suits your condition.
Remember that it is important to use this medicine exactly as your doctor
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 other inhalers you
may have used before. This inhaler is an extra fine aerosol 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 previously
used 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 inhaler; this is because this inhaler may be a lower
strength product (which means that each puff of this inhaler contains less
beclometasone dipropionate than your old inhaler).
DO NOT take more puffs than your doctor has told you to. In some
circumstances, your doctor may prescribe more than the usual number of
puffs. The usual number of puffs to take is:
Qvar 50 Aerosol
Adults (including the elderly) and children over 12 years
 Mild Asthma
The starting dose is one puff twice a day. This may be increased up to
two puffs twice a day.
 Moderate Asthma
The starting dose is two puffs twice a day. This may be increased up to
four puffs twice a day.
 Severe Asthma
The starting dose is four puffs twice a day. This may be increased up
to eight puffs twice a day.
The maximum dose is a total of sixteen puffs a day.
Qvar 100 Aerosol
Adults (including the elderly) and children over 12 years
 Mild to Moderate Asthma
The starting dose is one puff twice a day. This may be increased to
two puffs twice a day.
 Severe Asthma
The starting dose is two puffs twice a day. This may be increased up to
four puffs twice a day.
The maximum dose is a total of eight puffs a day.
Children under 12 years
Qvar Aerosol is not recommended for use in children under 12 years.
What to do if you think your treatment is not working
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.
If you use more Qvar Aerosol than you should
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 accidentally take more puffs than recommended, please tell your
doctor.
If you forget to use Qvar Aerosol
If you forget to use this inhaler at your usual time, take your
recommended number of puffs as soon as you remember unless it is
nearly time to use your inhaler again. DO NOT take a double dose to
make up for a forgotten dose. Then continue to use your inhaler regularly
at the correct time, as prescribed by your doctor.

If you stop using Qvar Aerosol
This inhaler must be used regularly, even when you feel well. You must
not stop using your inhaler unless your doctor tells you to.
Ask your doctor for a prescription for a replacement inhaler before this
one is empty.
If your doctor decides to stop treatment, return the inhaler to your doctor
or pharmacist for safe disposal.
Using your Qvar Aerosol inhaler
Before Use
 If this is a new inhaler or if you have not used your inhaler for two
weeks or more, it must be tested before use by removing the
mouthpiece cover and pressing down on the canister inside the
inhaler. Release 2 puffs into the air, away from you.
How to use your inhaler
1. Take the cover off the mouthpiece.

The following side effects may also occur in patients taking
beclometasone dipropionate. If you experience any of these effects,
keep using your inhaler but see your doctor if they last for a while or
they are worrying you:
 hoarseness
 a sore mouth or thrush (white spots in your mouth and throat). These
are less likely if you rinse your mouth out with water after using your
inhaler. If you get thrush your doctor may recommend a medicine to
treat you
 feeling sick
 headache
 feeling dizzy or faint
 tremor
 change in taste
 increase in wheezing, shortness of breath and cough
 sleeping problems, depression or feeling worried, restless, nervous,
over-excited or irritable. These effects are more likely to occur in
children (Frequency not known).
At high doses, taken for prolonged periods the following side effects have
been reported:
 bone thinning
 clouding of the lens of the eye (cataract) resulting in blurred vision
 loss of vision due to abnormally high pressure in the eye may occur.

2. Breathe out as far as is comfortable and
then immediately place the mouthpiece
in your mouth and close your lips
around it.

3. Start to breathe in slowly and deeply
through your mouth and press down on
the canister inside the inhaler as shown.
This releases one puff of medicine. It is
important that you carry on breathing in
after the puff is released.

4. Hold your breath for 10 seconds, then
breathe out slowly. If your doctor has
prescribed more than one puff repeat
steps 2 to 4 again. After use, replace
the cover on the mouthpiece.

 Some people find it difficult to press their inhaler and breathe in
at the same time. A spacer device helps to overcome this problem.
The spacer that fits Qvar Aerosol is called the AeroChamber Plus®
spacer device. If you use the AeroChamber Plus® spacer device,
please follow the instructions provided with it. Your doctor, nurse or
pharmacist will be able to advise you about the AeroChamber Plus®
device.
Alternatively your doctor may wish to prescribe the Qvar® Autohaler®
device which automatically releases a puff of medication as you
breathe in.
How to tell when your Qvar Aerosol device 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. You should also rinse your mouth
with water after using your inhaler.
Do not wash or put any part of your inhaler in water
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.
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 immediately.
Stop using your inhaler and tell your doctor immediately or go to the
casualty department at your nearest hospital if the following happens:
 an allergic reaction (swelling of the lips, face or neck leading to severe
difficulty in breathing; skin rash or hives).
This is a very serious but rare side effect. You may need urgent medical
attention or hospitalisation.
Treatment with Qvar Aerosol may affect the normal production of
corticosteroids in the body. Keep using your inhaler but see your
doctor as soon as possible if you become unwell, particularly with any
of the following:
 abdominal pain
 weakness
 vomiting.
This is especially important if you have been exposed to other stress
such as other illness, surgery, or infection.

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 Qvar Aerosol.
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 Qvar Aerosol
 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 25oC.
 The metal canister is pressurised, it should not be broken, punctured
or burnt even when apparently empty.
 Protect from frost.
 Keep pressurised container away from heat and light.
 You can use your inhaler at temperatures as low as -10oC.
 The canister contains a pressurised liquid.
 Do not use Qvar Aerosol inhaler after the expiry date which is stated
on the label and carton.
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 pack and other information
What Qvar Aerosol contains
 The active ingredient is beclometasone dipropionate.
 Each actuation contains 100 micrograms beclometasone dipropionate
Ph Eur. as the active ingredients.
 Also contains norflurane (HFA 134a) and Ethanol.
What Qvar Aerosol looks like and contents of the pack
 Qvar Aerosol Inhaler is a colourless solution in a pressurised
aluminium canister fitted with a metering valve and actuator, with a
dark red body and grey cap.
 Your Inhaler contains 200 doses.
 The Qvar Aerosol Inhaler is packed in cartons containing one inhaler
with 200 doses.
Manufactured by
3M Health Care Limited, 1 Morley Street, Loughborough, Great Britain.
Procured from within the EU by the Product Licence holder:
MPT Pharma Ltd, Westgate Business Park, Unit 5-7 Tintagel Way,
Aldridge, Walsall WS9 8ER, UK.
POM
Repackaged by: xxxxxxxxxxxxxxxxxxxxxxxxxxxxxx
PL: 33532/0342
For further information about asthma, contact Asthma UK, the
independent UK charity working to conquer asthma:
Asthma UK, Summit House, 70 Wilson Street, London, EC2A 2DB.
Asthma Helpline: 0845 7 010203
(Open Monday to Friday, 9am to 5pm, calls charged at local rates).
Leaflet dated 28th January 2016
Leaflet coded XXXXXXXXX
Qvar® is a registered trademark of xxxxxxxxxxxxxxxxxxxxxxxxxxxxxx
AeroChamber Plus® is a registered trademark of xxxxxxxxxxxxxxxxxxxxx
xxxxxxxxxxxxx
Autohaler® is a trademark of xxxxxxxxxxxxxxxxxxxx

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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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