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QVAR 100 MICROGRAMS AUTOHALER

Active substance(s): BECLOMETASONE DIPROPIONATE

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Previously assessed against UK PIL dated May 2015 To amend the layout of the diagrams
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 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.

5. HOW TO STORE QVAR AUTOHALER






KEEP OUT OF THE SIGHT AND REACH OF
CHILDREN.
Do not store above 30°C.
Keep Press. container away from heat and light.
Do not pierce or burn canister even when
empty.

Do not use this medicine after the expiry date
shown on the carton label.
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. Only keep this medicine, if your
doctor tells you to.
If your medicine shows any other signs of
deterioration, consult your pharmacist (chemist)
who will tell you what to do.

6. CONTENTS OF PACK AND OTHER
INFORMATION
Qvar Autohaler is a grey and dark-red multi-dose
autohaler device enclosing a pressured canister
and fitted with a metering valve and autohaler
actuator.
Qvar Autohaler comes in 200 doses.
What is in your medicine
Each metered actuation contains 100 micrograms
of beclometasone dipropionate as the active
ingredient.
Qvar Autohaler also has the following inactive
ingredients: HFA-134a and ethanol.
HFA-134a is a propellant which has been
developed to replace chlorofluorocarbons (CFC’s).
Qvar Autohaler does not contain any CFC
propellants.

Who manufactured you medicine?
Qvar Autohaler is manufactured by 3M Health
Care Limited, 3M House, 1 Morley Street,
Loughborough, Leicestershire, LE11 1EP, United
Kingdom and are procured from within the EU and
repackaged by the Product Licence Holder: Lexon
(UK) Limited, Unit 18, Oxleasow Road, East
Moons Moat, Redditch, Worcestershire, B98 0RE.

POM

PL Number: 15184/1010

Qvar and Autohaler are registered trademarks of
Teva Pharmaceuticals International GmbH.
Leaflet revision date: 08/02/16
For further information about, asthma, contact
Asthma UK, the independent 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.).

Blind or partially sighted?
Is this leaflet hard to see or read?
Phone Lexon (UK) Limited,
Tel: 01527 505414 for help.

MOCK-UP

By rajeevkumarj at

PATIENT INFORMATION LEAFLET

Ref: 1010/080216/F/1

®

Qvar 100 micrograms Autohaler
beclometasone dipropionate
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 or
pharmacist. This includes any possible side
effects not listed in this leaflet. See section 4.
Your medicine is called Qvar 100 micrograms
Autohaler but will be referred to as Qvar Autohaler
thoughout this leaflet.
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 the 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. 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.



• 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

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.

• 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.

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

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.

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).
Ref: 1010/080216/B/1

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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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