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ULTRA CHLORASEPTIC PAIN RELIEF THROAT SPRAY 0.71% OROMUCOSAL SPRAY

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Patient Leaflet: Information for User

Ultra Chloraseptic® Pain Relief Throat Spray
0.71% w/v Oromucosal Spray
Please read this leaflet carefully before you
start using your medicine, as it contains
important information for you.
• Keep this leaflet.You may need to read it again.
• Ask your pharmacist if you need more
information or advice.
• If a side effect occurs and it seems serious to
you, or if you notice a side effect not listed in this
leaflet, tell your doctor or pharmacist.

In this leaflet:
1. What Ultra Chloraseptic® Throat Spray is and
what it is used for
2. Before you use Ultra Chloraseptic® Throat Spray
3. How to use Ultra Chloraseptic® Throat Spray
4. Possible side effects
5. How to store your medicine
6. Further information

1. What Ultra Chloraseptic® Throat
Spray is and what it is used for

3. How to use Ultra Chloraseptic®
Throat Spray

Ultra Chloraseptic® Pain Relief Throat Spray
0.71% w/v Oromucosal Spray is used to relieve sore
throat pain and will be referred to as Ultra
Chloraseptic® Throat Spray throughout this leaflet.
The product contains the active ingredient
benzocaine which belongs to the group of medicines
called local anaesthetics. It has a fast action and
works by numbing the pain of a sore throat. The
product comes in the form of a spray. It has a swivel
head applicator to help deliver the local anaesthetic
direct to the throat.

Ultra Chloraseptic® Throat Spray is for use by adults
and teenagers, and in children aged from 6 years when
supervised by an adult.
The product is designed so that the medication can
be sprayed directly to the back of the throat.
The following instructions will help you to
get the best results from your spray:
• Remove the cap from the bottle, and rotate the
spray head around by half a circle so that the
nozzle extends beyond the bottle
(see diagram below).

2. Before you use Ultra Chloraseptic®
Throat Spray
DO NOT use this spray if
• you have difficulty in breathing, noisy breathing or
severe difficulty in swallowing. Talk to your
pharmacist or doctor if this applies to you
• you know you are allergic to benzocaine or any of
the other ingredients (see Section 6, Further
Information).
• you have been told that you have a rare blood
condition called methaemoglobinaemia.
• you are pregnant or breast-feeding
DO NOT use this medicine for children under 6
years of age.
This medicine contains a small quantity of alcohol
(less than 0.006 units per spray) to dissolve the other
ingredients. Contains propylene glycol - this may
cause skin irritation.
If your sore throat is severe or prolonged, or
accompanied by fever, headache, or feeling sick,
consult a doctor.

Nozzle in stored position

Nozzle ready for use

• If this is a new bottle, or you have not used it since
your last sore throat, activate the pump by
spraying 3 times away from your face into a
sink. This will also help you to get a feel
for the pump action.
• Hold the bottle in your hand with your index
(first) finger on the pump, ready to spray.
• When you are ready, open the mouth a little and
point the spray nozzle towards the back of
your throat. The nozzle should be just inside your
mouth (see diagram below). This will help the spray
get to its target at the back of the throat.
Continued overleaf

3. How to use (CONTINUED)
• H
 old your breath and then press the
pump to spray. Do not exceed the dosage
on the labelling.

Press pump
here to
spray

• It may be easier the first few times to stand in front
of the mirror whilst spraying the product.
Spray Dosage:
DO NOT spray into the eyes. If you accidentally spray
into your eyes, rinse them thoroughly
under water.
For Adults and Teenagers:
• Hold breath and spray 3 times to the back of your
throat.
• Repeat every 2-3 hours if required.
• Do not use more than 8 times a day.
For Children 6-12 years:
• Use only under adult supervision.
• Do not use in a child who is unable to hold their
breath whilst spraying.
• Hold breath and spray once to the back of the
throat.
• Repeat every 2-3 hours if required.
• Do not use more than 8 times a day.
DO NOT use for more than 3 days in a row. If
symptoms do not improve, consult your pharmacist
or doctor.
You should experience temporary numbness in your
throat after using the spray. This indicates that the
product is working. Avoid eating or drinking as
long as the numbness lasts.
If you spray more than you should, and you feel
drowsy, you must contact a doctor immediately.

4. Possible side effects
Allergic reactions have been reported occasionally
with benzocaine. Although very unlikely, if your
breathing is affected after using the spray, or if your
face or mouth become swollen, stop using the spray
and seek immediate medical advice.
Methaemoglobinaemia (a very rare blood condition)
has been reported with benzocaine use.

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 this
leaflet.You can also report side effects directly via the
Yellow Card Scheme:
Website: 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 your medicine
Keep out of the sight and reach of children.
Do not use the spray after the Expiry date which is
shown on the top of the carton and on the base of
the spray bottle.

6. Further information
What Ultra Chloraseptic® Pain Relief Throat
Spray 0.71% w/v Oromucosal Spray contains
The spray contains Benzocaine 0.71% w/v (1mg per
spray) as the active ingredient. It also contains:
ethanol, macrogol 300, propylene glycol, glycerol,
cetylpyridinium chloride, saccharin sodium, sodium
dihydrogen phosphate dihydrate, sodium hydroxide,
flavouring (levomenthol) and purified water.
What Ultra Chloraseptic® Pain Relief Throat
Spray 0.71% w/v Oromucosal Spray looks like
and contents of pack
The spray is a clear colourless to straw coloured
solution, presented in a glass bottle with a spray
nozzle under a plastic cap. Each bottle contains 15ml.
The nozzle is used to target the spray to the back of
the throat.
The marketing authorisation for Ultra Chloraseptic®
Pain Relief Throat Spray 0.71% w/v Oromucosal Spray
is held by: Prestige Brands (UK) Ltd, 46 High Street,
Yatton, Somerset, BS49 4HJ, UK.
The product is manufactured at: Wagener & Co
GmbH, Poststrasse 24, 49525 Lengerich, Germany.
000000000
Version 6
This leaflet is dated January 2016.
© Prestige Brands (UK) Limited 2016
® Chloraseptic is a registered trademark.

To get this leaflet in large print, Braille or
as an audio CD, call the RNIB Medicine
Leaflet line on 0800 198 5000 and
quote PL 18259-0005.

Patient Leaflet: Information for User

Ultra Chloraseptic® Pain Relief Throat Spray
0.71% w/v Oromucosal Spray (Benzocaine)
Please read this leaflet carefully before you
start using your medicine, as it contains
important information for you.
• Keep this leaflet.You may need to read it again.
• Ask your pharmacist if you need more
information or advice.
• If a side effect occurs and it seems serious to
you, or if you notice a side effect not listed in this
leaflet, tell your doctor or pharmacist.

In this leaflet:
1. What Ultra Chloraseptic® Throat Spray is and
what it is used for
2. Before you use Ultra Chloraseptic® Throat Spray
3. How to use Ultra Chloraseptic® Throat Spray
4. Possible side effects
5. How to store your medicine
6. Further information

1. What Ultra Chloraseptic® Throat
Spray is and what it is used for

3. How to use Ultra Chloraseptic®
Throat Spray

Ultra Chloraseptic® Pain Relief Throat Spray
0.71% w/v Oromucosal Spray is used to relieve sore
throat pain and will be referred to as Ultra
Chloraseptic® Throat Spray throughout this leaflet.
The product contains the active ingredient
benzocaine which belongs to the group of medicines
called local anaesthetics. It has a fast action and
works by numbing the pain of a sore throat. The
product comes in the form of a spray. It has a swivel
head applicator to help deliver the local anaesthetic
direct to the throat.

Ultra Chloraseptic® Throat Spray is for use by adults
and teenagers, and in children aged from 6 years when
supervised by an adult.
The product is designed so that the medication can
be sprayed directly to the back of the throat.
The following instructions will help you to
get the best results from your spray:
• Remove the cap from the bottle, and rotate the
spray head around by half a circle so that the
nozzle extends beyond the bottle
(see diagram below).

2. Before you use Ultra Chloraseptic®
Throat Spray
DO NOT use this spray if
• you have difficulty in breathing, noisy breathing or
severe difficulty in swallowing. Talk to your
pharmacist or doctor if this applies to you
• you know you are allergic to benzocaine or any of
the other ingredients (see Section 6, Further
Information).
• you have been told that you have a rare blood
condition called methaemoglobinaemia.
• you are pregnant or breast-feeding
DO NOT use this medicine for children under 6
years of age.
This medicine contains a small quantity of alcohol
(less than 0.006 units per spray) to dissolve the other
ingredients. Contains propylene glycol - this may
cause skin irritation.
If your sore throat is severe or prolonged, or
accompanied by fever, headache, or feeling sick,
consult a doctor.

Nozzle in stored position

Nozzle ready for use

• If this is a new bottle, or you have not used it since
your last sore throat, activate the pump by
spraying 3 times away from your face into a
sink. This will also help you to get a feel
for the pump action.
• Hold the bottle in your hand with your index
(first) finger on the pump, ready to spray.
• When you are ready, open the mouth a little and
point the spray nozzle towards the back of
your throat. The nozzle should be just inside your
mouth (see diagram below). This will help the spray
get to its target at the back of the throat.
Continued overleaf

3. How to use (CONTINUED)
• H
 old your breath and then press the
pump to spray. Do not exceed the dosage
on the labelling.

Press pump
here to
spray

• It may be easier the first few times to stand in front
of the mirror whilst spraying the product.
Spray Dosage:
DO NOT spray into the eyes. If you accidentally spray
into your eyes, rinse them thoroughly
under water.
For Adults and Teenagers:
• Hold breath and spray 3 times to the back of your
throat.
• Repeat every 2-3 hours if required.
• Do not use more than 8 times a day.
For Children 6-12 years:
• Use only under adult supervision.
• Do not use in a child who is unable to hold their
breath whilst spraying.
• Hold breath and spray once to the back of the
throat.
• Repeat every 2-3 hours if required.
• Do not use more than 8 times a day.
DO NOT use for more than 3 days in a row. If
symptoms do not improve, consult your pharmacist
or doctor.
You should experience temporary numbness in your
throat after using the spray. This indicates that the
product is working. Avoid eating or drinking as
long as the numbness lasts.
If you spray more than you should, and you feel
drowsy, you must contact a doctor immediately.

4. Possible side effects
Allergic reactions have been reported occasionally
with benzocaine. Although very unlikely, if your
breathing is affected after using the spray, or if your
face or mouth become swollen, stop using the spray
and seek immediate medical advice.
Methaemoglobinaemia (a very rare blood condition)
has been reported with benzocaine use.

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 this leaflet.You
can also report side effects directly via the Yellow
Card Scheme:
Website: 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 your medicine
Keep out of the sight and reach of children.
Do not use the spray after the Expiry date which is
shown on the top of the carton and on the base of
the spray bottle.

6. Further information
What Ultra Chloraseptic® Pain Relief Throat
Spray 0.71% w/v Oromucosal Spray contains
The spray contains Benzocaine 0.71% w/v (1mg per
spray) as the active ingredient. It also contains:
ethanol, macrogol 300, propylene glycol, glycerol,
cetylpyridinium chloride, saccharin sodium, sodium
dihydrogen phosphate dihydrate, sodium hydroxide,
flavouring (levomenthol) and purified water.
What Ultra Chloraseptic® Pain Relief Throat
Spray 0.71% w/v Oromucosal Spray looks like
and contents of pack
The spray is a clear colourless to straw coloured
solution, presented in a glass bottle with a spray
nozzle under a plastic cap. Each bottle contains 15ml.
The nozzle is used to target the spray to the back of
the throat.
The marketing authorisation for Ultra Chloraseptic®
Pain Relief Throat Spray 0.71% w/v Oromucosal Spray
is held by: Prestige Brands (UK) Ltd, 46 High Street,
Yatton, Somerset, BS49 4HJ, UK.
The product is manufactured at: Pharmasol Limited,
North Way, Walworth Industrial Estate,
Andover, Hampshire, SP10 5AZ.
MPxxxxx
Version 6
This leaflet is dated January 2016.
© Prestige Brands (UK) Limited 2016
® Chloraseptic is a registered trademark.

To get this leaflet in large print, Braille or
as an audio CD, call the RNIB Medicine
Leaflet line on 0800 198 5000 and
quote PL 18259-0005.

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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