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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

Go to top of the page1. NAME OF THE MEDICINAL PRODUCT
AAA Sore Throat Spray



Go to top of the page2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Benzocaine 1.5mg



Go to top of the page3. PHARMACEUTICAL FORM
Aerosol spray with metered dose



Go to top of the page4. CLINICAL PARTICULARS

Go to top of the page4.1 Therapeutic indications
Symptomatic temporary relief of pain associated with sore throat pain and minor infections



Go to top of the page4.2 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.



Go to top of the page4.3 Contraindications
Known hypersensitivity to benzocaine



Go to top of the page4.4 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.



Go to top of the page4.5 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.



Go to top of the page4.6 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.



Go to top of the page4.7 Effects on ability to drive and use machines
None



Go to top of the page4.8 Undesirable effects
Hypersensitivity reactions to benzocaine have been reported.



Go to top of the page4.9 Overdose
There have been no reports of overdosage with AAA Spray. Systemic effects are unlikely.



Go to top of the page5. PHARMACOLOGICAL PROPERTIES

Go to top of the page5.1 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.


Go to top of the page5.2 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.



Go to top of the page5.3 Preclinical safety data
None stated



Go to top of the page6. PHARMACEUTICAL PARTICULARS

Go to top of the page6.1 List of excipients
Cetylpyridinium chloride

Glycerin

Ethanol

Clove bud oil

Menthol crystals

Sodium saccharin 450

Peppermint cremophor

Water



Go to top of the page6.2 Incompatibilities
None



Go to top of the page6.3 Shelf life
24 months



Go to top of the page6.4 Special precautions for storage
Keep away from a naked flame. Store in a cool place



Go to top of the page6.5 Nature and contents of container
White aluminium can with 100ml pumps, white high density polypropylene folding arm activator and white high density polyethylene cap.



Go to top of the page6.6 Special precautions for disposal and other handling



Go to top of the page7. MARKETING AUTHORISATION HOLDER
Manx Pharma Ltd

Taylor Group House

Wedgnock Lane

Warwick

CV34 5YA

United Kingdom



Go to top of the page8. MARKETING AUTHORISATION NUMBER(S)
PL 15833/0001



Go to top of the page9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
1 September 1997



Go to top of the page10. DATE OF REVISION OF THE TEXT
March 2008

原文：http://emc.medicines.org.uk/medi ... +Sore+Throat+Spray/