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Manx Healthcare
Taylor Group House, Wedgnock Lane, Warwick, Warwickshire, CV34 5YA Telephone: +44 (0)1926 482 511 Fax: +44 (0)1926 498 711 Need to contact this company?

Summary of Product Characteristics last updated on the eMC: 25/09/2008

SPC	AAA Sore Throat Spray

Table of Contents

1. NAME OF THE MEDICINAL PRODUCT
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
3. PHARMACEUTICAL FORM
4. CLINICAL PARTICULARS
4.1 Therapeutic indications
4.2 Posology and method of administration
4.3 Contraindications
4.4 Special warnings and precautions for use
4.5 Interaction with other medicinal products and other forms of interaction
4.6 Pregnancy and lactation
4.7 Effects on ability to drive and use machines
4.8 Undesirable effects
4.9 Overdose
5. PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
5.2 Pharmacokinetic properties
5.3 Preclinical safety data
6. PHARMACEUTICAL PARTICULARS
6.1 List of excipients
6.2 Incompatibilities
6.3 Shelf life
6.4 Special precautions for storage
6.5 Nature and contents of container
6.6 Special precautions for disposal and other handling
7. MARKETING AUTHORISATION HOLDER
8. MARKETING AUTHORISATION NUMBER(S)
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
10. DATE OF REVISION OF THE TEXT

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1. NAME OF THE MEDICINAL PRODUCT

AAA Sore Throat Spray

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2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Benzocaine 1.5mg

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3. PHARMACEUTICAL FORM

Aerosol spray with metered dose

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4. CLINICAL PARTICULARS

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4.1 Therapeutic indications

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

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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.

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4.3 Contraindications

Known hypersensitivity to benzocaine

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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.

Avoid inhalation of the product.

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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.

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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.

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4.7 Effects on ability to drive and use machines

None

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4.8 Undesirable effects

Hypersensitivity reactions to benzocaine have been reported.

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4.9 Overdose

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

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5. PHARMACOLOGICAL PROPERTIES

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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.

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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.

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5.3 Preclinical safety data

None stated

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6. PHARMACEUTICAL PARTICULARS

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6.1 List of excipients

Cetylpyridinium chloride

Glycerin

Ethanol

Clove bud oil

Menthol crystals