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QVAR 100 AEROSOL

Active substance(s): BECLOMETASONE DIPROPIONATE

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231-30-87772- QVAR A/S AEROSOL 200 DOSE IVAX <3M

1

24 June 2015

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

REG0061990

Package leaflet: Information for the user

87772-F

Read all of this
leaflet carefully
before you start
using this medicine
because it contains
important
information for you.

TBC

1. What Qvar Aerosol is and
what it is used for

50 & 100 Aerosol
Beclometasone Dipropionate

TEVA UK Ref:

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.

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

Version 2.4

Approved

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.

Page 1 of 3

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

1. Take the cover off the
mouthpiece.
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.

REG0061990

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.

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4. Possible side effects
Like all medicines, this medicine can cause side
effects, although not everybody gets them.

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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.

Version 2.4

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, 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.
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 this medicine out of the sight and reach of
children.
Do not store above 25°C. Avoid storage in direct
sunlight or heat. Protect from frost. You can use your
inhaler at temperatures as low as -10˚C.

Approved

Do not use this medicine after the expiry date that is
stated on the outer packaging after EXP. The expiry
date refers to the last day of that month.
The canister is pressurised and should not be
punctured or burnt even if it seems empty.
Do not throw any medicines 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.
The Qvar 50 Aerosol delivers 50 micrograms of
beclometasone dipropionate per puff.
The Qvar 100 Aerosol delivers 100 micrograms of
beclometasone dipropionate per puff.
The other ingredients are HFA-134a (norflurane)
and ethanol.
What Qvar Aerosol looks like and contents of the
pack:
Qvar Aerosol is a pressurised canister closed with
a metering valve.
Your inhaler contains 100 or 200 puffs.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
The marketing authorisation holder is Teva UK
Limited, Brampton Road, Hampden Park, Eastbourne,
East Sussex, BN22 9AG, UK
The manufacturer is 3M Health Care Limited,
Loughborough, Leicestershire LE11 1EP, England.
AeroChamber Plus is a registered trade mark of
Trudell Medical International.
Autohaler is a trade mark of 3M and used under
licence.
This leaflet was last revised: May 2015
PL 00289/1371-72

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).

Page 2 of 3

50 & 100 Aerosol
Beclometasone Dipropionate

How to use your inhaler

How to tell when your Qvar
Aerosol device is empty

24 June 2015

Package leaflet: Information for the user

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.

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.

1

TBC

Version:

231-30-87772- QVAR A/S AEROSOL 200 DOSE IVAX <3M

87772-F

TEVA UK Ref:

THIS IS A REPRESENTATION OF AN ELECTRONIC RECORD THAT WAS SIGNED ELECTRONICALLY AND THIS
PAGE IS THE MANIFESTATION OF THE ELECTRONIC SIGNATURE

Teva Pharmaceuticals Europe B.V
1.3.2
mockup-pil-uk-pl-00289-1371-1372-qvar-aerosol-50mcg-100mcg-per-actuatio
n-beclomethasone-dipropionate

APPROVALS
Signed by

Meaning of Signature

Regulatory Affairs Approval

REG0061990

Server Date
29-Jun-2015 03:42:03 PM

Version 2.4

Approved

Page 3 of 3

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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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