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AAA SORE THROAT SPRAY 1.5 MG OROMUCOSAL SPRAY

Active substance(s): BENZOCAINE

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Package leaflet: Information for the user

AAA SORE THROAT SPRAY
1.5mg OROMUCOSAL SPRAY
Benzocaine

Read all of this leaflet carefully before you start
using this medicine because it contains important
information for you.
Always use this medicine exactly as described in this
leaflet or as your doctor or pharmacist has told you.
This medicine is available without prescription.
Keep this leaflet. You may need to read it again
Ask your pharmacist if you need more information
or advice
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
You must talk to a doctor if you do not feel better or
if you feel worse after 3 days.
What is in this leaflet
1. What AAA Sore Throat Spray is and what it is
used for
2. What you need to know before you use AAA
Sore Throat Spray
3. How to use AAA Sore Throat Spray
4. Possible side effects
5. How to store AAA Sore Throat Spray
6. Contents of the pack and other information

1. What AAA Sore Throat Spray is and what it
is used for
AAA Sore Throat Spray 1.5mg Oromucosal Spray
(hereinafter referred to as AAA Sore Throat Spray)
contains benzocaine, which is a local anaesthetic.
This means that it relieves pain by acting on the
surface area treated.
The spray is used to relieve the pain of sore throats
and minor mouth infections.

2. What you need to know before you use
AAA Sore Throat Spray
Do not use AAA Sore Throat 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
if you are allergic to benzocaine or any of the other
ingredients (listed in section 6)
if you have a rare blood condition called
methaemoglobinaemia
if you are pregnant or breast-feeding.
Do not use this medicine for children under 6 years
of age.

Warnings and precautions
Talk to your doctor or pharmacist before using AAA
Sore Throat Spray:
if your sore throat is severe or prolonged, or
accompanied by fever, headache, or feeling sick.
Do not use this medicine for more than three days in
a row.
Do not spray into eyes.
Pregnancy and breast-feeding
This product is not recommended for use during
pregnancy or breast feeding.
Ask your doctor or pharmacist for advice before
taking any medicines.
Driving and using machines
There are no known effects of this medicine on your
ability to drive or use machinery.
AAA Sore Throat Spray contains ethanol
This spray contains small amounts of ethanol
(alcohol), less than 100mg per metered dose.

3. How to use AAA Sore Throat Spray
Always use this medicine exactly as described in this
leaflet or as your doctor or pharmacist has told you.
Check with your doctor or pharmacist if you are not sure.
The recommended dose is:
Adults, including the elderly, and teenagers:
Spray two doses to the affected part of the mouth or
throat when necessary. The dose can be repeated
every two or three hours, but adults must not have more
than sixteen doses in any twenty-four hour period.
(continued overleaf)

Children aged 6 to 12 years: Spray one dose to
the affected area when necessary. The dose can be
repeated every two to three hours, but children should
not have more than eight doses in any twenty-four
hour period.
Do not use this medicine for children under 6 years
of age.
Do not spray into the eyes. If you accidentally spray
into your eyes, rinse them thoroughly with water.
Please follow the handling instructions below:
raise nozzle from vertical to horizontal position
hold spray in the hand with index finger on the
button
with head upright insert nozzle well into the mouth
on pressing the button a measured dose will be
delivered.
Before use it may be necessary to press the plunger
3 times to activate spray. If necessary this process
can be repeated.
Do not use the spray near a naked flame.
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 use more AAA Sore Throat Spray than
you should
If you spray more than you should, and you feel
drowsy, you must contact a doctor immediately.

4. Possible side effects
Like all medicines AAA Sore Throat Spray can cause
side effects, although not everybody gets them.
If you experience any of the following allergic
reactions stop using the spray and and seek
immediate medical advice:
if your breathing is affected after using the spray
if your face or mouth become swollen
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 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 help provide more
information on the safety of this medicine.

5. How to store AAA Sore Throat Spray
Keep out of the sight and reach of children.
Store in a cool place and keep away from naked
flames.
Do not use the spray after the expiry date which is
printed on the pack.
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.

6. Contents of the pack and other information
What AAA Sore Throat Spray contains
Each dose of AAA Sore Throat Spray contains the
active benzocaine 1.5%w/v (1.5mg). It also contains
cetylpyridinium chloride, glycerin, ethanol, clove bud
oil, peppermint, menthol, saccharin sodium 450,
cremophor RH40 (polyethoxylated castor oil) and
purified water.
What AAA Sore Throat Spray looks like and
contents of the pack
This product is available in a white aluminium can with
a folding arm activator and cap.
Each can contains approximately sixty doses of liquid
spray.
Marketing Authorisation Holder
Manx Pharma Ltd, Taylor Group House,
Wedgnock Lane, Warwick, CV34 5YA, United Kingdom.
Manufacturer
Pharmasol Ltd, North Way, Walworth Industrial Estate,
Andover, Hampshire, SP10 5AZ, United Kingdom.
Other formats
To request a copy of this leaflet in Braille, large print or
audio, please call 01926 482511.
This leaflet was last revised in January 2018

WIP URN: 050118-AA01-PIL-19

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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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