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QVAR 50 AUTOHALER

Active substance(s): BECLOMETASONE DIPROPIONATE / BECLOMETASONE DIPROPIONATE / BECLOMETASONE DIPROPIONATE

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ZINC Ref:

EAS746 LEA QVAR A/S AUTOHALER 200 DOSE IVAX <3M
Dim’s Changed?:
Length:
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No
315 mm
180 mm
N/A
N/A

What is in this leaflet
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

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

REG0059705

3100008114
EAS746

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

Package leaflet: Information for the user

50 & 100 Autohaler ®
Beclometasone Dipropionate

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. What you need to know
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 taking 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.


••


Version 5.6

Approved

2

Version:

Colours Used:

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

29 April 2017
PANTONE® 2768 C
PANTONE® 492 C

Template

PANTONE® GREEN C

Some medicines may increase the effects of Qvar
Autohaler and your doctor may wish to monitor you
carefully if you are taking these medicines (including
some medicines for HIV: ritonavir, cobicistat).

Pregnancy, breast-feeding and
fertility

are pregnant, planning to become pregnant or
• Ifareyoubreast-feeding,
ask your doctor for advice before
taking this medicine.

Driving and using machines

Asthma
• Severe
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 Asthma
The Qvar 100 Autohaler device is not suitable for
the starting dose. It is suitable for an increased dose
of one puff twice a day.
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.
Use in children under 12 years
Qvar Autohaler is not recommended for use in children
under 12 years.



Autohaler is not known to affect your ability to

• Qvar
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 Autohaler
Always take this medicine exactly as your doctor or
pharmacist has told you. Check with your doctor or
pharmacist if you are not sure.
There are two strengths of the Qvar Autohaler device
available and your doctor will have chosen the strength
which best suits your condition.
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.

tell your doctor or pharmacist if you are taking
• Please

or have recently taken any other medicines, including
any medicines obtained without a prescription.
In particular tell your doctor if you are taking:

•• Disulfiram
Metronidazole

Page 1 of 3

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.

EAS746 LEA QVAR A/S AUTOHALER 200 DOSE IVAX <3M

If your doctor decides to stop treatment, return the
inhaler to your doctor or pharmacist for safe disposal.
If you have any further questions on the use of this
medicine, ask your doctor or pharmacist.

Using your Qvar Autohaler
Device

3.

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.
4.

Before use

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

6.

4

5

6
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.

••


1

4. Possible side effects

2

REG0059705

X

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

Version 5.6

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.
In addition, the following side effects have been
reported for high doses, taken for prolonged periods:
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
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
difficulty in swallowing accompanied by earache and
swollen glands, sore throat (pharyngitis)
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
difficulty in breathing, increase in wheezing,
shortness of breath and cough (bronchospasm)
sleeping problems, depression or feeling worried, restless,
nervous, over-excited or irritable. These effects are
more likely to occur in children (Frequency not known).
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 or
pharmacist. This includes any possible side effects not



••

••

••

••
••
••


Approved

PANTONE® 2768 C
PANTONE® 492 C
Template

PANTONE® GREEN C

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 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.
The canister is pressurised and should not be punctured
or burnt even if it seems empty.
Do not use this medicine after the expiry date that is
stated on the outer packaging (shown as 'EXP'). The
expiry date refers to the last day of that month.
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 Autohaler device 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 Autohaler contains:
The active ingredient is beclometasone dipropionate.
The Qvar 50 Autohaler device delivers 50
micrograms of beclometasone dipropionate per puff.
The Qvar 100 Autohaler device delivers 100
micrograms of beclometasone dipropionate per puff.
The other ingredients are propellant HFA-134a and
ethanol.
What Qvar Autohaler looks like and contents of the
pack:
The Qvar Autohaler is a pressurised canister with a
metering valve.
The Qvar Autohaler contains 100 or 200 puffs.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Qvar Autohaler devices are made by 3M Health Care
Limited, Loughborough, Leicestershire LE11 1EP
England. Autohaler is a trademark of 3M and used
under licence
The marketing authorisation holder is Teva UK Limited,
Brampton Road, Hampden Park, Eastbourne, East
Sussex, BN22 9AG, UK
This leaflet was last revised in June 2017
PL 00289/1373-74






Page 2 of 3

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.).
Autohaler is a trademark of 3M
and used under licence

50 & 100 Autohaler®
Beclometasone Dipropionate

How to use your Qvar Autohaler
device

5.

3

Colours Used:

29 April 2017

Package leaflet: Information for the user

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 1
2
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).
3
4. To release the second puff
4
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.

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.
Breathe out as far as is
comfortable, then
immediately place the
mouthpiece in your mouth,
and close your lips around
it.
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.
Hold your breath for
10 seconds and then
breathe out slowly.
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.

No
315 mm
180 mm
N/A
N/A

2

3100008114

Dim’s Changed?:
Length:
Width:
Depth:
Foil Width:

Version:

EAS746

ZINC Ref:

Expand Transcript

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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