SUMMARY OF PRODUCT CHARACTERISTICS

1    NAME OF THE MEDICINAL PRODUCT

MHL Benzocaine Sore Throat Spray 1.5 mg Oromucosal Spray

2    QUALITATIVE AND QUANTITATIVE    COMPOSITION

Benzocaine 1.5 mg per actuation.

For full list of excipients, see section 6.1

3    PHARMACEUTICAL FORM

Oromucosal spray, solution (Oromucosal spray)

4    CLINICAL PARTICULARS

4.1    Therapeutic indications

Symptomatic temporary relief of pain associated with sore throat pain and minor mouth 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 aged 6 and over:

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. The container should be shaken before use.

Fig. 1

Resting position (cannot be activated)

Before use it may be necessary to press the plunger 2-3 times to activate spray.

4.3 Contraindications

Known hypersensitivity to benzocaine. Methaemoglobinaemia

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 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.

Undesirable effects

Hypersensitivity reactions to benzocaine have been reported.

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

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard

4.9 Overdose

There have been no reports of overdosage with MHL Benzocaine Sore Throat Spray. Systemic effects are unlikely.

5 PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

ATC Code: R02AD01

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 produces p-aminobenzoic acid.

5.3 Preclinical safety data

None stated.

6.1 List of excipients

Cetylpyridinium chloride

glycerine

ethanol

clove bud oil

menthol crystals

sodium saccharin 450

peppermint

Cremophor RH40

water

6.2 Incompatibilities

None.

6.3 Shelf life

24 months.

6.4 Special precautions for storage

Do not store above 25 °C

6.5 Nature and contents of container

folding arm activator and white high density polyethylene cap.

Pack size: not less than 7.3 g (approximately 60 metered doses).

6.6 Special precautions for disposal

To help protect the environment, do not dispose of this medicine via wastewater or household waste. Ask a pharmacist for advice on disposal.

7    MARKETING AUTHORISATION HOLDER

Manx Pharma Limited Taylor Group House Wedgnock Lane Warwick CV34 5YA United Kingdom

8    MARKETING AUTHORISATION NUMBER(S)

15833/0059

9    DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

10/10/2012

10    DATE OF REVISION OF THE TEXT

09/06/2015