AAA SORE THROAT SPRAY 1.5 MG OROMUCOSAL SPRAY

Active substance: BENZOCAINE

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PATIENT INFORMATION LEAFLET - INFORMATION FOR THE USER

AAA SORE THROAT SPRAY
1.5mg OROMUCOSAL SPRAY
Benzocaine

Read all of this leaflet carefully because it contains
important information for you.
This medicine is available without prescription.
However, you still need to take AAA Sore Throat Spray
carefully to get the best results from it.
Keep this leaflet. You may need to read it again.
Ask your pharmacist if you need more information
or advice.
You must contact a doctor if your symptoms worsen
or do not improve.
If any of the side effects get serious, or if you notice
any side effect not listed in this leaflet, please tell
your doctor or pharmacist.
In this leaflet
1. What AAA Sore Throat Spray is and what it is
used for
2. 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. Further 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. Before you use AAA Sore Throat Spray
Do not take AAA Sore Throat Spray if you have had:
an allergic (hypersensitive) reaction such as rash,
itching or wheezing to benzocaine or any of the
other ingredients of AAA Sore Throat Spray (see
section 6 for other ingredients)
a rare blood condition called
methaemoglobinaemia.
Take special care and please tell your doctor if you
have or have had:
a headache or fever (raised temperature)
sore throat or mouth symptoms for more than a few
days, or if the throat is so sore that you cannot
swallow.

Please tell your doctor or pharmacist if you have or
have had:
asthma
an allergic reaction to any other local anaesthetic
an allergic reaction to a sunscreen product.
Do not use the medicine for more than seven days in a
row. If the problem does not improve, or you need to
take more doses than the number recommended in
section 3, you should see your doctor.
Care should be taken to avoid getting the spray into
your eyes or airways (do not breathe it in).
Children under 6 years of age should not use this
spray.
Taking other medicines
Please tell your doctor or pharmacist if you are taking
or have recently taken any other medicines, including
medicines obtained without prescription.
sulphonamide antibiotics such as co-trimoxazole
for an infection.
Pregnancy and breast-feeding
You should not use the spray during pregnancy.
Ask your doctor or pharmacist for advice before taking
any medicines.
Driving and operating machinery
There are no known effects of this medicine on your
ability to drive or use machinery.
Important information about some of the
ingredients in this product
This spray contains small amounts of ethanol (alcohol),
less than 100mg per metered dose.

3. How to use AAA Sore Throat Spray
Always take AAA Sore Throat Spray exactly as your
doctor has told you. You should check with your doctor
or pharmacist if you are not sure.
The usual doses are:
Adults, including the elderly: 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)

Client:
APPROVED
ARTWORK URN:
Job:
Size:
Cutter Guide:
Dragon Ref Date:
BOH Approval Date:
Saved as:
Proof No:
Folder:
Barcode No:
File Location:
Prints:

Manx Pharma Limited
AA01-PIL-14-221111
AAA Sore Throat Spray PIL - Page 1
210 x 148mm
Not applicable
23 November 2011
13995/14 AAA PIL P1.ai
14
Manx 13995
Not applicable
Mac Pocket Drive
1 Colour - Black

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.
The medicine is not recommended for use by children
younger than 6 years.
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
2-3 times to activate spray.
Do not use the spray near a naked flame.

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 speak to your doctor
immediately:
severe rash, itching, swelling of the face, lips or
mouth
shortness of breath or difficulty breathing
irregular heartbeats, low blood pressure (lightheaded feeling when standing).
Methaemoglobinaemia (a very rare blood condition)
has been reported with benzocaine use.
If any of the side effects get serious or you notice
any side effects not listed please tell your doctor or
pharmacist.

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. Further 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.
This leaflet was last revised in November 2011

5. How to store AAA Sore Throat Spray
Keep out of the reach and sight 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 in the packet.

MP00807
URN: AA01-PIL-14-221111

Client:
APPROVED
ARTWORK URN:
Job:
Size:
Cutter Guide:
Dragon Ref Date:
BOH Approval Date:
Saved as:
Proof No:
Folder:
Barcode No:
File Location:
Prints:

Manx Pharma Limited
AA01-PIL-14-221111
AAA Sore Throat Spray PIL - Page 2
210 x 148mm
Not applicable
23 November 2011
13995/14 AAA PIL P2.ai
14
Manx 13995
Not applicable
Mac Pocket Drive
1 Colour - Black

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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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