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QVAR 50 AUTOHALER

Active substance(s): BECLOMETASONE DIPROPIONATE

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231-30-87777-H LEA QVAR A/S AUTOHALER 200 DOSE IVAX Fr3M

1

25 June 2015

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

REG0059705

Package leaflet: Information for the user

• 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.

87777-H

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

TBC

1. What QVAR Autohaler is
and what it is used for

50 & 100 Autohaler ®
Beclometasone Dipropionate

TEVA UK Ref:

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


••


Version 2.4

Approved

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
tell your doctor or pharmacist if you are taking
• Please
or have recently taken any other medicines, including

Asthma
In particular tell your doctor if you are taking:
• Severe
The starting dose is four puffs twice a day. This may
•• Disulfiram
Metronidazole
be increased up to eight puffs twice a day.
The maximum dose is a total of sixteen puffs a day.
Pregnancy and breast-feeding
are pregnant, planning to become pregnant or
Qvar 100 Autohaler device
• Ifareyoubreast-feeding,
ask your doctor for advice before
taking this medicine.

Driving and using machines

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.


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
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.




any medicines bought without a prescription.

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.

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:

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

REG0059705



4

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.

••


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

2

X

Version 2.4

••
••
••

••


Approved

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: May 2015
PL 00289/1373-74






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

Page 2 of 3

Package leaflet: Information for the user

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.
1
Push the lever up so that it
2
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 3
4
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.

3

Reporting of side effects
If you get any side effects, talk to your doctor or
pharmacist. 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.

50 & 100 Autohaler®
Beclometasone Dipropionate

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:

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.

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.

TBC

Using your Qvar
Autohaler Device

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.

87777-H

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.

Expand view ⇕

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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