AAA Sore Throat Spray

1. Name Of The Medicinal Product

AAA Sore Throat Spray

2. Qualitative And Quantitative Composition

Benzocaine 1.5mg

3. Pharmaceutical Form

Aerosol spray with metered dose

4. Clinical Particulars

4.1 Therapeutic Indications

Symptomatic temporary relief of pain associated with sore throat pain and minor infections

4.2 Posology And Method Of Administration

Adults (including elderly):

Spray two metered doses every two to three hours if required (not more than sixteen doses in every 24 hours) or as directed by the physician.

Children:

Children 6 – 12 years: One metered dose every two to three hours if required (not more than eight doses in every 24 hours) or as directed by the physician.

Not suitable for children under 6 years.

Route of administration

Topical application to the mucosa of the mouth and throat by means of a metered dose aerosol.

Product should not be administered for more than 7 consecutive days.

Can be shaken before use.

4.3 Contraindications

Known hypersensitivity to benzocaine or any of the excipients

Methaemoglobinaemia

4.4 Special Warnings And Precautions For Use

This preparation should not be administered to children under 6 years or used for more than seven consecutive days unless directed by a physician.

If the sore throat is severe, persistent or accompanied by fever or headache, a physician should be consulted before the use of this product. Avoid spraying into the eyes.

Caution should be exercised in the use of this product if there have been previous allergic reactions with other local anaesthetics or sunscreen products.

Avoid inhalation of the product.

To be used with caution in patients with asthma.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Benzocaine is an ester which on hydrolysis produces p-aminobenzoic acid, so it should not be used in patients being treated with sulphonamides.

4.6 Pregnancy And Lactation

There is no evidence, at present, of hazard from benzocaine in pregnancy. However, only very limited data is available. Therefore it should not be used in pregnancy unless considered essential by a physician.

4.7 Effects On Ability To Drive And Use Machines

None

4.8 Undesirable Effects

Hypersensitivity reactions to benzocaine have been reported.

Methaemoglobinaemia may occur in patients receiving high doses or repeated applications of benzocaine-containing products.

4.9 Overdose

There have been no reports of overdosage with AAA Spray. Systemic effects are unlikely.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Benzocaine is a surface anaesthetic of the ester type. It has found frequent use as lozenges or solution to treat pain arising from various throat and mouth conditions.

5.2 Pharmacokinetic Properties

Benzocaine is sparingly soluble in water with toxicity about a tenth that of cocaine. It is not readily absorbed from mucus membranes. It is an ester which on hydrolysis produced p-aminobenzoic acid.

5.3 Preclinical Safety Data

None stated

6. Pharmaceutical Particulars

6.1 List Of Excipients

Cetylpyridinium chloride

Glycerin

Ethanol

Clove bud oil

Menthol crystals

Sodium saccharin 450

Peppermint cremophor

Water

6.2 Incompatibilities

None

6.3 Shelf Life

24 months

6.4 Special Precautions For Storage

Keep away from a naked flame. Store in a cool place

6.5 Nature And Contents Of Container

White aluminium can with 100ml pumps, white high density polypropylene folding arm activator and white high density polyethylene cap.

6.6 Special Precautions For Disposal And Other Handling

7. Marketing Authorisation Holder

Manx Pharma Ltd

Taylor Group House

Wedgnock Lane

Warwick

CV34 5YA

United Kingdom

8. Marketing Authorisation Number(S)

PL 15833/0001

9. Date Of First Authorisation/Renewal Of The Authorisation

1 September 1997

10. Date Of Revision Of The Text

January 2010