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.

I 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.

I 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)

WIP URN	v/	240315-AA01-PIL-15
APPROVED URN	N/A
Job		AAA Sore Throat Spray PIL - Side 1
Size		210 x 148mm
Date		24 March 2015
BOH Approval Date
Saved as		13995/15 AAA PIL S1.ai M1
Prints		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.

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. 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 in the packet.

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. 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 March 2015

MANX

Pharma

WIP URN: 240315-AA01-PIL-15

WIP URN	x/	240315-AA01-PIL-15
APPROVED URN	N/A
Job		AAA Sore Throat Spray PIL - Side 2
Size		210 x 148mm
Date		24 March 2015
BOH Approval Date
Saved as		13995/15 AAA PIL S2.ai M1

Prints

1 Colour - Black