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BECLOMETASONE DIPROPIONATE 100 MICROGRAMS AEROSOL

Active substance(s): BECLOMETASONE DIPROPIONATE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Qvar™ 100 Aerosol /
Beclometasone Dipropionate 100 micrograms Aerosol
(beclometasone dipropionate)
This medicine is available as the above name but will be referred to as Qvar
Aerosol throughout the following leaflet. Please note that the leaflet also contains
information about other strength (Qvar™ 50 Aerosol).
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. 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
1. What Qvar Aerosol is and what it is used for
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.
 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 breast-feeding, 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.
3. How to use Qvar Aerosol
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.

This is especially important if you have been exposed to other stress such as
other illness, surgery, or infection.
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, overexcited 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.

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.
 Do not store above 25°C.
 Avoid storage in direct sunlight and heat. Protect from frost. You can use your
inhaler at temperatures as low as -10°C.
 Do not use after the expiry date stated on the carton and blister. The expiry
date refers to the last day of that month.
 Caution: Pressurised canister. Do not puncture. Do not burn, even when
empty.
 Medicines should not be disposed via wastewater or household waste. If your
doctor decides to stop treatment, return the inhaler to your doctor or
pharmacist for safe disposal. These measures will help to protect the
environment.
6. Contents of pack and other information
Your Qvar aerosol 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.
What Qvar Aerosol contains:
The active ingredient is beclometasone dipropionate.
Each actuation delivers 100 micrograms of active ingredient beclometasone
dipropionate into the mouthpiece.
The other ingredients are HFA-134a (norflurane) and ethanol.

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

What Qvar Aerosol looks like and contents of the pack:
 Qvar Aerosol is a pressurised canister closed with a metering valve.
 Your inhaler contains 200 actuations.

If you have any further questions on the use of this medicine, ask your doctor or
pharmacist.

Qvar Aerosol is manufactured by 3M Health Care Limited, 1 Morley Street,
Loughborough, UK.
Procured from within the EU and repackaged by the Product Licence Holder:
O.P.D. Laboratories Ltd., Unit 6 Colonial Way, Watford, Herts WD24 4PR.

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.

POM

PL No: 15814/1091

Leaflet revision and issue date (Ref.) 13.01.16.
Qvar™ is a registered trademark of IVAX International GmbH.
AeroChamber Plus is a registered trade mark of Trudell Medical International.
Autohaler is a trade mark of 3M and used under licence.
To request a copy of this leaflet in Braille, large print or audio please call 01923 332
796.
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).

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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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