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BECONASE AQUEOUS NASAL SPRAY

Active substance(s): BECLOMETHASONE DIPROPIONATE

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Design 1:
Total Colours & Varnishes: 1

Harmony AMS
Artwork Information Panel
AMS Document Number:
DFT-00158-1922090
Manufacturing Site(s):
GSK_Aranda_SPAIN
Brand:
BECONASE
Sub Brand:
N/A
Variant:
N/A
Approving Market(s):
United Kingdom-GBR

Technical Drawing (Do NOT include version number):
02-01-XX-273-02
Material Spec. (Do NOT include version number):
N/A
Body Text Size:
8.0pt
Smallest Text Size:
8.0pt
Leading:
9.0pt
Horizontal Scale:
100%
Microtext:
N
Additional Info (1):
N/A
Additional Info (2):
N/A
Additional Info (3):
N/A
Artwork copyright is the property of the GSK Group
of Companies. All suppliers providing a service to GSK for
printed components of any description must ensure that
they have a licence for all fonts / software used in
conjunction with GSK artwork.
The distribution and use of fonts / software without a licence
constitutes an intellectual property infringement. GSK will
not accept any liability for the breach of third party
intellectual property rights by printed component suppliers.
The GSK certification / audit process requires suppliers to
declare that they do not use unlicensed fonts / software and
may require the supplier to produce evidence of such
licence to GSK.

175 mm Measuring Bar

Print Process:
Offset - Lithography

If an e-banner DOES NOT appear on the top of this document, THEN this document has NOT been printed from the Harmony system.

BLACK

DRAFT REGULATORY – for text and graphics regulatory submission
Package Leaflet: Information for the user

Total Special Finishes: 0

Aqueous Nasal Spray
Colour Standard Reference:
N/A
Material Type:
N/A

N/A

AIP_Template_V_INDD - 04_2017 - Harmony - Version 2

IMPORTANT
GSK LOC is responsible to
approve the change
documentation, artwork brief
and final artwork, ensuring
that it is accurate, consistent
and complete.
GSK SDC is responsible for site
technical requirements and
pre-press suitability.
GSK Market is responsible
to advise SDC when changes
required impact the following:

Formulation
Tablet embossing
Storage conditions
Shelf Life

AIP_Template_V_INDD - 04_2017 - Harmony - Version 2

NOTE TO MARKET

Local approvers must ensure that trade mark and
copyright statements included in the brief
comply with guidance provided by
Legal: Global Trade Marks.

IMAGE RESOLUTION
GSK is aware that the resolution of the colour
or greyscale image is less than 300 dpi,
which is acceptable for printing.

beclometasone dipropionate
50 micrograms

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 of the side effects, talk to your doctor or
pharmacist. This includes any possible side effects not
listed in the leaflet. See section 4.
What is in this leaflet:
1. What Beconase is and what it is used for
2. What you need to know before you use Beconase
3. How to use Beconase
4. Possible side effects
5. How to store Beconase
6. Contents of the pack and other information

1 What Beconase is and what it is used for
Beconase Aqueous Nasal Spray (called ‘Beconase’ in
this leaflet) contains a medicine called beclometasone
dipropionate. This belongs to a group of medicines called
steroids (also called ‘cortico-steroids’).
• steroids work by reducing inflammation
• they reduce swelling and irritation in your nose
• this helps to relieve itching, sneezing and your blocked or
runny nose.
Beconase is used to prevent and treat:
• Inflammation in the lining of your nose (rhinitis) due to
seasonal allergies, such as Hayfever.
• Inflammation in the lining of your nose (rhinitis) due to
year round (perennial) allergies, such as animal allergies.

2 What you need to know before you use Beconase
Do not use Beconase if:
• you are allergic to beclometasone dipropionate or any of
the other ingredients of this medicine (listed in section 6).
Contact your doctor if you experience blurred vision or other
visual disturbances.
Other medicines and Beconase
Please tell your doctor if you are taking or have recently
taken any other medicines, including medicines obtained
without a prescription. This includes herbal medicines.
Some medicines may increase the effects of Beconase and
your doctor may wish to monitor you carefully if you are
taking these medicines (including some medicines for HIV:
ritonavir, cobicistat).
Check with your doctor or pharmacist before using your
medicine if:
• you have had steroids for a long time, either as an
injection or by your mouth.
• you have ever had an operation on your nose
• you have an infection in your nose
If you are unsure if the above apply to you, talk to your
doctor or pharmacist before using Beconase.
Beconase with food and drink
You can use Beconase at any time of day, with or without food.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be
pregnant or are planning to have a baby, ask your doctor or
pharmacist for advice before taking this medicine.

Driving and using machines
Beconase is not likely to affect you being able to drive or use
any tools or machines.
Beconase contains benzalkonium chloride
Beconase contains benzalkonium chloride which may cause
problems with your breathing (bronchospasm).

3 How to use Beconase
Always use this medicine exactly as your doctor has told
you. Check with your doctor or pharmacist if you are not
sure.
• 
Do not use in children under 6 years old
• 
It takes a few days for this medicine to work. So
keep using it, even though you may not feel better
straight away.
• You should use the spray every day.
How much to use - adults and children (aged 6 and over)
• The usual starting dose is 2 sprays into each nostril twice
a day.
• The most you would use in over 24 hours is normally
8 sprays (4 sprays per nostril).
• As you become better, your doctor may ask you to use a
lower dose - one spray into each nostril twice a day.
• If your symptoms then get worse, your dose may be
increased back to the starting dose.
• Do not use a larger dose or use your nasal spray more
often than your doctor tells you.
If you use high doses of Beconase
There are times when your doctor may need to adjust the
dose of the steroid you are given or the way in which you
take it. These times are:
• times of extreme stress
• during admission to hospital after a serious accident,
injury or illness
• before and after a surgical operation.
If you think that any of these apply to you whilst using
Beconase, speak to your doctor or pharmacist.

Preparing your spray
Each spray has a dust cap which protects the nozzle
and keeps it clean. Remember to take this off before
using the spray.
A new spray (or one that has not been used for a few
days), may not work first time. You need to ‘prime’ the
spray by pumping the spray a few times until a fine
mist is produced.
1. Hold the bottle as
shown and make
sure it is pointed
away from you
2. Put your forefinger
and middle finger
on the collar either
side of the nozzle
and put your thumb
underneath the
bottle
3. Keep your thumb
still, and press down
with your fingers to
pump the spray.
• If the spray does not work and you think it may be
blocked, you will need to clean it. Please see the
section over the page, Cleaning your spray.
• Never try to unblock or enlarge the tiny spray hole
with a pin or other sharp object. This will damage
the way the spray works.

Please turn
over the page
DFT-00158-1922090

PHARMA CODE N° 0000

2

2

Design 1:
Total Colours & Varnishes: 1

Harmony AMS
Artwork Information Panel
AMS Document Number:
DFT-00158-1922090
Manufacturing Site(s):
GSK_Aranda_SPAIN
Brand:
BECONASE
Sub Brand:
N/A
Variant:
N/A
Approving Market(s):
United Kingdom-GBR

Technical Drawing (Do NOT include version number):
02-01-XX-273-02
Material Spec. (Do NOT include version number):
N/A
Body Text Size:
8.0pt
Smallest Text Size:
8.0pt
Leading:
9.0pt
Horizontal Scale:
100%
Microtext:
N
Additional Info (1):
N/A
Additional Info (2):
N/A
Additional Info (3):
N/A
Artwork copyright is the property of the GSK Group
of Companies. All suppliers providing a service to GSK for
printed components of any description must ensure that
they have a licence for all fonts / software used in
conjunction with GSK artwork.
The distribution and use of fonts / software without a licence
constitutes an intellectual property infringement. GSK will
not accept any liability for the breach of third party
intellectual property rights by printed component suppliers.
The GSK certification / audit process requires suppliers to
declare that they do not use unlicensed fonts / software and
may require the supplier to produce evidence of such
licence to GSK.

175 mm Measuring Bar

Print Process:
Offset - Lithography

If an e-banner DOES NOT appear on the top of this document, THEN this document has NOT been printed from the Harmony system.

BLACK

Total Special Finishes: 0

Colour Standard Reference:
N/A
Material Type:
N/A

N/A

AIP_Template_V_INDD - 04_2017 - Harmony - Version 2

IMPORTANT
GSK LOC is responsible to
approve the change
documentation, artwork brief
and final artwork, ensuring
that it is accurate, consistent
and complete.
GSK SDC is responsible for site
technical requirements and
pre-press suitability.
GSK Market is responsible
to advise SDC when changes
required impact the following:

Formulation
Tablet embossing
Storage conditions
Shelf Life

AIP_Template_V_INDD - 04_2017 - Harmony - Version 2

NOTE TO MARKET

Local approvers must ensure that trade mark and
copyright statements included in the brief
comply with guidance provided by
Legal: Global Trade Marks.

IMAGE RESOLUTION
GSK is aware that the resolution of the colour
or greyscale image is less than 300 dpi,
which is acceptable for printing.

DRAFT REGULATORY – for text and graphics regulatory submission

Using your spray
1 Shake the bottle and take off the dust cap.
2 Blow your nose gently.
3 Close one nostril
with your finger as
shown, and put the
nozzle in the other
nostril. Tilt your head
forward slightly
and keep the bottle
upright. Hold the
bottle as shown.
4 Start to breathe in
slowly through your
nose. While you are
breathing in press
down firmly on the
collar with your
fingers. A spray of fine mist will go into your nostril.
5 Breathe out through your mouth.
6 Repeat step 4 to use a second spray in the same
nostril.
7 Remove the nozzle from this nostril and breathe out
through your mouth.
8 Repeat steps 3 to 6 for your other nostril.
9 After using your spray, wipe the nozzle carefully
with a clean tissue or handkerchief, and replace the
dust cap.

Cleaning your spray
Clean your spray at least once a week, or more often
if it gets blocked.
1 Take the dust cap off.
2 Pull upwards on the
white collar to remove
Collar
the nozzle.
3 Soak the nozzle and
dust cap in warm water
for a few minutes.
4 Then rinse under a
running tap.
5 Shake off the excess
water and let them dry
in a warm place.
6 Put the nozzle back on
the spray.
7 ‘Prime’ the bottle as described in the section above,
Preparing your spray
If you forget to use Beconase
If you miss a dose, just use the next dose when it is due.
If you use more Beconase than you should
Tell your doctor if you use more than you were told to.
It is important that you take your dose as stated on the
pharmacist’s label or as advised by your doctor. You should
use only as much as your doctor recommends; using more or
less may make your symptoms worse.
If you stop taking Beconase
Do not stop treatment even if you feel better, unless your
doctor tells you to stop. If you do stop, the symptoms may
come back.
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. The following side effects
may happen with this medicine:
Allergic reactions: get a doctor’s help straight away
A small number of people get allergic reactions to Beconase,
which can develop into a more serious, even life-threatening
problem if not treated. Symptoms include;
• becoming very wheezy or having difficulty with breathing
• swelling around the face or throat

PHARMA CODE N° 0000

If this happens, tell your doctor straight away – you
may need urgent medical treatment.
Immediately after you use your spray
• You may sneeze a little, but this soon stops.
• Very occasionally you may find you get an unpleasant
taste or smell.
Tell your doctor as soon as possible if you notice any
of the following side effects:
Common (may affect up to 1 in 10 people)
• A dry or painful nose or throat.
• Bad nose bleeds.
• Mild allergic reactions including skin rashes or redness,
itching or weals like nettle rash or hives.
Very rare (may affect up to 1 in 10,000 people)
• Damage to your nose
• Cloudy lens in the eye (cataract)
• Increased pressure in the eye (glaucoma)
Very rarely, the normal production of steroids in your body
may be affected. This is more likely to happen if you use
high doses for a long time. Your doctor will help stop this
happening by making sure you use the lowest dose of steroid
which controls your symptoms. In children this side effect can
rarely cause them to grow more slowly than others. Children
who receive this treatment for a long period of time will
have their height checked regularly by their doctor.
Not Known: frequency cannot be estimated from the
available data
• Blurred vision (see Section 2 – Do not use Beconase if)
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
the leaflet. You can also report any side effects directly via
the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard
or search for MHRA Yellow Card in the Google Play or Apple
App Store.
By reporting side effects you can provide more information
on the safety of this medicine.

5 How to store Beconase
Keep this medicine out of the sight and reach of children.
• Protect from frost and light.
• Do not store above 30°C (86°F).
• Do not use this medicine after the expiry date which is
stated on the label and carton after ‘EXP’. The expiry date
refers to the last day of that month.

• Stop using this bottle three months after you first opened it.
• If you are told to stop taking this medicine return any
unused spray to your pharmacist to be destroyed.
Do not throw away any medicines via wastewater or
household waste. Ask your pharmacist how to throw away
medicines you no longer use. These measures will help
protect the environment.

6 Contents of the pack and other Information
What Beconase Aqueous Nasal Spray contains
• The active substance is beclometasone dipropionate
• The other ingredients are microcrystalline cellulose,
sodium carboxymethylcellulose, dextrose, polysorbate 80,
purified water and the preservatives benzalkonium chloride
and phenylethylalcohol. These other ingredients are needed
to make a stable suspension which will not go off.
What Beconase Aqueous Nasal Spray looks like and
contents of the pack
Each bottle delivers 200 sprays. Each spray contains
50 micrograms of beclometasone dipropionate.
Marketing Authorisation Holder
Glaxo Wellcome UK Ltd
Stockley Park West
Uxbridge
Middlesex
UB11 1BT
Manufacturer
Glaxo Wellcome SA
Aranda de Duero
Burgos
Spain
Other formats:
To listen to or request a copy of this leaflet in Braille, large
print or audio please call, free of charge:

0800 198 5000 (UK Only)
Please be ready to give the following information:
Product name
Beconase Aqueous Nasal Spray
Reference number 10949/0104
This is a service provided by the Royal National Institute of
Blind People.
This leaflet was last revised in 12/2017
Trade marks are owned by or licensed to the GSK group of
companies.
© 2017 GSK group of companies or its licensor.
DFT-00158-1922090

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