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QVAR 100MICROGRAMS AUTOHALER

Active substance(s): BECLOMETASONE DIPROPIONATE

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What is in this leaflet

Package leaflet: Information for the user

If you have any
further questions,
ask your doctor or
pharmacist.

(beclometasone dipropionate)

Qvar® 100micrograms Autohaler®

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.

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 or pharmacist.
This includes any
possible side effects
not listed in this
leaflet. See section 4.

The name of your medicine is Qvar 100micrograms

The name of your medicine is Qvar 100micrograms
Autohaler but it will be referred as Qvar Autohaler
throughout in this leaflet. Please note that the leaflet also
contains information about other strengths Qvar
50micrograms Autohaler.

1. What Qvar Autohaler is and what it is used for
2. What you need to know before you use Qvar
Autohaler
3. How to use Qvar Autohaler
4. Possible side effects
5. How to store Qvar Autohaler
6. Contents of pack and other information

1. What Qvar Autohaler is and what it
is used for
Qvar Autohaler contains beclometasone dipropionate,
which is one of a group of medicines known as
corticosteroids.
Qvar Autohaler is used to prevent the symptoms of mild,
moderate, or severe asthma in patients who require
regular treatment.
How your medicine works
Qvar Autohaler 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. Before you use Qvar Autohaler
DO NOT use Qvar Autohaler if you:
are allergic (hypersensitive) to beclometasone
dipropionate or any of the other ingredients of this
medicine (listed in section 6).
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 use this
medicine if:
you are suffering from tuberculosis (TB) now or have
suffered from it in the past
you are allergic to other similar inhalers.
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 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.
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 Autohaler
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 Autohaler is not known to affect your ability to
drive or operate machinery.

Important information about some of the
ingredients of Qvar:
Qvar Autohaler contains a small amount of alcohol.

3. How to use Qvar Autohaler
There are two strengths of the Qvar Autohaler device
available and your doctor will have chosen the strength
which best suits your condition.
Remember that it is important to take this medicine as
your doctor has told you. The label should remind you
how many puffs to take and how often. 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, because it is
an extra fine aerosol which results in more of each dose
being delivered to your lungs. Your doctor may prescribe
a lower dose of this inhaler than your previously used
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
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 dipropionate 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. You
should check with your doctor or pharmacist if you are
not sure. The usual number of puffs to take is.

Qvar 50 Autohaler device
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 Autohaler device
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 Autohaler 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 of your Qvar Autohaler
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 Autohaler
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 Autohaler
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 Autohaler Device
Before using your inhaler, please read this leaflet
carefully and follow the instructions. If you are not sure
how to use the inhaler device, ask your doctor or a
pharmacist.

Before use:
If this is a new device or if you have not used it for 2
weeks or more, it must be tested before use by releasing
2 puffs into the air in the following way:
1. Take the cover off from
the mouthpiece, by pulling
down on the lip at the back
(fig. 1).
2. Point the mouthpiece
away from you so that the
puffs of medicine will go into
the air. Push the lever up so
that it stays up (fig. 2).
3. Then, to release a puff,
push the dose release slide
on the bottom of the device
in the direction indicated by
the arrow on it (fig. 3).
4. To release the second
puff you need to return the
lever to its down position (fig. 4) and follow steps 2
and 3 again. After releasing the second puff, return
the lever to its down position, to be ready to take a
puff of your medicine.

How to use your Qvar Autohaler device
Do not use the dose
release slide to take your
medicine; the Autohaler
device will automatically
release a dose when you
begin to breathe in from
the mouthpiece.
the instructions for taking a puff
are given below.
1. Take the cover off from
the mouthpiece, by pulling
down on the lip at the back.
2. Hold your Autohaler
device upright as shown.
Push the lever up so that it
stays up. Continue to hold
your device upright, making
sure that your hand is not
blocking the air vent
(marked by X in fig. 2) at
the bottom of the device.

3. Breathe out as far as is
comfortable, then
immediately place the
mouthpiece in your
mouth, and close your
lips around it.
4. Breathe in slowly and
deeply through the
mouthpiece. Do not stop
breathing in when you
hear
the slight click and
feel the puff in your mouth
as it is important that you
carry on breathing in after
the puff is released.
5. Hold your breath for 10
seconds and then breathe
out slowly.
6. The lever must be
lowered to the down
position after each puff. If
your doctor has
prescribed
more than one puff,
repeat
steps 2 - 6. After use,
replace the cover on the
mouthpiece.

How to tell when your Qvar Autohaler
device is
empty
When
the device is completely empty you will not feel or
hear any propellant being discharged.

Cleaning instructions
For normal hygiene, the mouthpiece of your Autohaler
device should be cleaned weekly with a clean, dry tissue
or cloth. You should also rinse your mouth with water
after using your inhaler.
Caution:
Do not wash or put any part of your inhaler in water
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.
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 Autohaler devices 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.
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

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 Autohaler.
Reporting of side effects
If you get any 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 Autohaler
Keep out of the sight and reach of children.
Do not take your Qvar Autohaler after the expiry date
which is stated on the Carton and Canister label after
‘Exp’. The date refers to the last day of that month.
Do not store above 25°C.
Do not freeze.
Keep pressurised container away from heat and light.
Pressurised canister. Do not pierce or burn container
even when empty.
Do not spray against flames or red-hot objects.
If your medicine become discoloured or show any signs
of deterioration, you should seek the advice of your
pharmacist.
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.

6. Contents of pack and other
information
What Qvar 100micrograms Autohaler contains
The active ingredient is beclometasone dipropionate.
Each metered actuation contains 100micrograms
beclometasone dipropionate.
The other ingredients are propellant norflurane and
ethanol 99.4% V/V (alcohol).
What Qvar Autohaler looks like and contents of the
pack:
A pressurised aluminium canister enclosed in a grey and
part transparent, part brick red body with a grey
mouthpiece
There are 200 actuation in each canister.

Manufactured by: 3M Health Care Ltd, 1 Morley Street,
Loughborough, UK.
Procured from within the EU and repackaged by the
Product Licence holder: B&S Healthcare, Unit 4,
Bradfield Road, Ruislip, Middlesex, HA4 0NU, UK.
®

Qvar 100micrograms Autohaler®
PL 18799/2234
Leaflet date: 14.03.2016

POM

Qvar and Autohaler are registered trademark of Teva
Group of companies.
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: 08457010203
(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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