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CHILDRENS CHLORASEPTIC SORE THROAT SPRAY 0.71%W/V OROMUCOSAL SPRAY

Active substance(s): BENZOCAINE

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Patient Leaflet: Information for User

Children’s Chloraseptic® Sore Throat Spray
0.71% w/v Oromucosal Spray (Benzocaine)
Please read this leaflet carefully before
you start using this medicine on a child,
as it contains important information.
• 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 Children’s Chloraseptic® Throat Spray is
and what it is used for
2. Before you use Children’s Chloraseptic® Throat
Spray
3. How to use Children’s Chloraseptic® Throat Spray
4. Possible side effects
5. How to store your medicine
6. Further information

1. What Children’s Chloraseptic®
Sore Throat Spray is and what
it is used for

3. How to use Children’s
Chloraseptic® Throat Spray

Children’s Chloraseptic® Sore Throat Spray 0.71% w/v
Oromucosal Spray is used to relieve sore throat pain
and will be referred to as Children’s 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.

2. Before you use Children’s
Chloraseptic® Throat Spray
DO NOT use this spray if the child
• has difficulty in breathing, noisy breathing or
severe difficulty in swallowing. Talk to your
pharmacist or doctor if this applies
• is allergic to benzocaine or any of the other
ingredients (see Section 6, Further Information)
• has a rare blood condition called
methaemoglobinaemia
DO NOT use this medicine for children under 6 years
of age.
Adults and teenagers:
DO NOT use this spray if you are pregnant or breastfeeding.
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 the sore throat is severe or prolonged, or
accompanied by fever, headache, or feeling sick,
consult a doctor.

Children’s Chloraseptic® Throat Spray is for use 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).

Nozzle in stored position Nozzle ready for use

• If this is a new bottle, or you have not used it since
the 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 ready, open the mouth a little and point
the spray nozzle towards the back of the throat.
The nozzle should be just inside the 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)
• E
 nsure the child holds their breath and
then press the pump to spray. Do not
exceed the dosage on the labelling.

Press pump
to spray

Spray Dosage:
DO NOT spray into the eyes. If you accidentally
spray into the eyes, rinse them thoroughly
under water.
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.
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.
DO NOT use for more than 3 days in a row. If
symptoms do not improve, consult your pharmacist or
doctor.
The child should experience temporary numbness in
their 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 the child feels
drowsy, you must contact a doctor immediately.

4. Possible side effects
Allergic reactions have been reported occasionally
with benzocaine. Although very unlikely, if the child’s
breathing is affected after using the spray, or if their
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 the child gets 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 Children’s Chloraseptic® Sore 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,
flavourings (levomenthol, blackcurrant) and purified
water.
What Children’s Chloraseptic® Sore 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 Children’s
Chloraseptic® Sore 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.
XXXXXXXXX NUCKidsV1
This leaflet is dated April 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 18259/0006.

Artwork reference guide
file name NUC Childrens pil V1 01.04.16 draft
product

NEW Children’s Ultra Chloraseptic

item

PIL

status

Draft

version

NUCBLKV1

date

01.04.16

contacts

Prestige Brands - Sally Walton 01308 488097
Tin Racer Design - Steve Foote 01993 844404

colours

Black only

145mm x 200mm

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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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