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QVAR EASI-BREATHE 50 MICROGRAMS PER ACTUATION INHALER

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

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Package leaflet: Information for the user

Beclometasone Dipropionate

Qvar® Easi-Breathe® 50 micrograms per actuation Inhaler
Qvar® Easi-Breathe® 100 micrograms per actuation Inhaler

EAS1061a

PE3485

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.

What is in this leaflet

Warnings and precautions

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

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 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.

1. What Qvar Easi-Breathe Inhaler is and
what it is used for
Qvar Easi-Breathe Inhaler contains beclometasone
dipropionate, which belongs to a group of medicines
known as corticosteroids.
Qvar Easi-Breathe Inhaler is used to prevent the
symptoms of mild, moderate, or severe asthma in
patients who require regular treatment.
How your medicine works

Qvar Easi-Breathe Inhaler 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.
you 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

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.


2. What you need to know before you
use Qvar Easi-Breathe Inhaler
Do not use Qvar Easi-Breathe Inhaler if you:

are allergic (hypersensitive) to beclometasone
dipropionate or any of the other ingredients of this
medicine (listed in section 6)

are allergic to other similar inhalers.

REG0059786

Version 3.6

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.

Approved



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

Disulfiram

Metronidazole
Some medicines may increase the effects of QVAR
Easi-breathe 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
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 Easi-Breathe Inhaler 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.

FP code: FA1420/FA1421

Artwork Co-ordinator:

Job No.: 406452

Date: 19/07/2017

Perigord Premedia Job No: 304049

Component: Leaflet

Template: LF15.2

Pharmacode: 1620

Dimensions (mm): 369 x 160mm

Software Used: Adobe Indesign CS6



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.

SAP CODE: PE3485

Product Name: QVAR HFA E/B 50MCG & 100MCG 200 TUK

N/A



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.

Page 1 of 3

TEVA Pharmaceuticals Ireland, IDA Industrial Park, Cork Road, Waterford, Ireland.

Barcode



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3. How to use Qvar Easi-Breathe Inhaler
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 Easi-Breathe 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.
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
previously 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. You
should check with your doctor or pharmacist if you are
not sure. The usual number of puffs to take is as follows:
Qvar Easi-Breathe 50 micrograms Inhaler
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 Easi-Breathe 100 micrograms Inhaler
Adults (including the elderly) and children over 12 years

Mild Asthma
The Qvar 100 Easi-Breathe 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 Easi-Breathe Inhaler 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 Easi-Breathe Inhaler 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 immediately.
If you forget to use Qvar Easi-Breathe Inhaler
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.

Do not wash or put any part of your inhaler in water.

1

If the following happens, stop using your inhaler and
tell your doctor immediately or go to the casualty
department at your nearest hospital:

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.

3. Take the inhaler out of your 3
mouth and hold your breath
for 10 seconds or as long as
you comfortably can. Then
breathe out slowly.

Top

4. After you have used your inhaler, hold it upright
and close the cap immediately.

Cap

5. If you need to take more than one puff, close the
cap, wait about one minute and then start again
from step 1.

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.
REG0059786

Version 3.6

TEVA Pharmaceuticals Ireland,
IDA Industrial Park, Cork Road, Waterford, Ireland.
406452



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.

Open

JOB NO:

4. Possible side effects



DRAFT:

DATE:
05

Treatment with Qvar Easi-Breathe inhalers may affect
the normal production of corticosteroids in the body.
If you become unwell, particularly with any of the
following you should see your doctor:

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 have been reported in
patients taking beclometasone dipropionate:

hoarseness

difficulty in swallowing accompanied by earache
and swollen glands, sore throat (pharyngitis)

a sore mouth or thrush (white spots in mouth and
throat). These are less likely if you rinse your mouth
out with water after using your inhaler. If you get

Approved

19/07/2017






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 Easi-Breathe inhalers.
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 Easi-Breathe
Inhaler
Keep this medicine out of the sight and reach of
children.
Do not store above 25°C. Avoid storage in direct sunlight
or heat. You can use your inhaler at temperatures as low
as -10˚C. However, protect from frost.
The canister contains a pressurised liquid. Do not
expose to temperatures higher than 50ºC. Do not
pierce the canister.
Do not use Qvar Easi-Breathe Inhaler after the expiry
date that is stated on the outer packaging after 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

Page 2 of 3

PAGE NO:
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2 OF 2

thrush, talk to your doctor who 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).

pharmacist for safe disposal. These measures will help
to protect the environment.

6. Contents of pack and other
information
Your Qvar Easi-Breathe 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 Easi-Breathe Inhaler contains:

The active ingredient is beclometasone dipropionate.
The Qvar Easi-Breathe 50 micrograms Inhaler
contains 50 micrograms of beclometasone
dipropionate per puff.
The Qvar Easi-Breathe 100 micrograms Inhaler
contains 100 micrograms of beclometasone
dipropionate per puff.

The other ingredients are propellant HFA-134a
(norflurane) and ethanol anhydrous.
What Qvar Easi-Breathe Inhaler looks like and
contents of the pack:

Qvar Easi-Breathe is a pressurised inhalation solution

Your inhaler contains 100 or 200 puffs.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Qvar Easi-Breathe Inhalers are made by IVAX
Pharmaceuticals Ireland, Waterford, Ireland.
The marketing authorisation holder is Teva UK Limited,
Brampton Road, Hampden Park, Eastbourne, East
Sussex, BN22 9AG, UK.
This leaflet was last revised: June 2017
PL 00289/1375-76
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).

Qvar® Easi-Breathe® 50 micrograms per actuation Inhaler
Qvar® Easi-Breathe® 100 micrograms per actuation Inhaler

2. Breathe out normally as far 2
as you comfortably can. Then
hold the mouthpiece firmly
between your lips. Hold the
inhaler upright and make
sure that your hand is not
blocking the air holes.
Breathe in slowly and deeply
through the mouthpiece.
Don’t stop breathing when
the inhaler puffs the dose
into your mouth. Carry on
until you have taken a deep
breath.

How to tell when your Qvar Easi-Breathe Inhaler is
empty

PE3485



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

Air Holes

SAP:

If you have any further questions on the use of this
medicine, ask your doctor or pharmacist.

Beclometasone Dipropionate

Closed

1. Hold the inhaler upright
and open it by folding down
the cap which fits over the
mouthpiece.

Package leaflet: Information for the user

If you stop using Qvar Easi-Breathe Inhaler
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 Easi-Breathe Inhaler
Qvar Easi-Breathe CFC-Free Inhaler is designed to make
it easier for you to use.
It is a breath-operated inhaler. This means it only
releases a dose when you breathe in.
Before Use
Before using your inhaler, please read this leaflet
carefully and follow the instructions.

Test spray the inhaler by firing two shots into the
air before you use it for the first time, or if you have
not used it for a period of two weeks or more.

To test spray your inhaler, unscrew the top of it so you
can see the metal can inside. Open the cap and spray
the aerosol by pressing the can with your finger or
thumb. Close the cap and put the top back on.
Opening
To open the inhaler, fold down the cap which fits over
the mouthpiece.

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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