Throatzone Sore Throat Spray

Cherry Flavour Ultra Chloraseptic Anaesthetic Throat Spray

Benzocaine          0.71 % w/v

For full list of excipients, see 6.1

Oromucosal Spray

Direct application to throat by spraying.

Clear, colourless to straw coloured liquid

Symptomatic relief of sore throat pain.

Posology

Adults and children 13 years and over: Administer 3 sprays (3mg) to the back of the throat. Repeat every 2-3 hours up to a maximum of 8 doses per day.

Children 6-12 years: Use only under adult supervision. Administer 1 spray (1mg) to the back of the throat. Repeat every 2-3 hours up to a maximum of 8 doses per day

This product is contraindicated in children under 6 years.

Method of administration: oromucosal

Hold breath and spray to the back of the throat.

Do not use in a child who is unable to hold their breath whilst spraying.

Before first use, or after prolonged storage, activate the pump by spraying 3 times away from the face into the sink.

Children under 6 years.

Epiglottitis

Known hypersensitivity to benzocaine or any of the other ingredients.

Methaemoglobinaemia

Do not administer to children under 6 years.

Do not use for more than 3 consecutive days.

Do not spray into eyes.

If sore throat is severe or persistent, or accompanied by fever, headache or nausea consult your doctor.

You should experience temporary numbness in your throat after using the spray. This indicates that the product is working. Avoid eating or drinking as long as the numbness lasts.

Labelling will include the following information:

Do not use if you have any difficulty in breathing, noisy breathing or severe difficulty in swallowing.

Do not use if you have been told that you have a rare blood condition called methaemoglobinaemia.

Contains propylene glycol which may cause skin irritation.

None known

Animal studies are insufficient with respect to effects on pregnancy and lactation. The potential risk for humans is unknown. Therefore Ultra Chloraseptic spray is not recommended during pregnancy or breast-feeding.

None expected

Allergic reactions have been reported very occasionally with benzocaine. There have been occasional reports of temporary breathing difficulty, face or mouth swelling.

Methaemoglobinaemia has been reported with benzocaine use.

Pronounced reversible anaesthesia would be observed. No systemic adverse effects are expected due to the poor systemic absorption and low administered dose of benzocaine.

Treatment of overdose

N/A

ATC code: R02AD01

Benzocaine is a local anaesthetic of the ester type. The mode of action is a reversible inhibition of the flux of sodium and potassium ions through the axonal membranes of peripheral pain receptors. As a consequence, the depolarisation and propagation of nerve impulses are inhibited.

The onset of action of benzocaine on mucous membranes is rapid due to the spray delivery of the anaesthetic direct to the site of action, rapid absorption, and the surface analgesic effect. The local anaesthesia induced by benzocaine is temporary but Ultra Chloraseptic spray has not been tested for duration of action.

Benzocaine is absorbed into the mucosal membranes. After systemic absorption, which is negligible, the drug is thought to be metabolised to ethanol and aminobenzoic acid by plasma esterases. Aminobenzoic acid is excreted unchanged or conjugated with glycerine to amoniohippuric acid in the liver, the metabolites and unchanged benzocaine are excreted in the urine.

No animal data are available on Ultra Chloraseptic spray. Non-clinical studies on benzocaine showed local irritation and sensation, and methaemoglobinaemia at high doses in some species.

Ethanol

Macrogol 300

Propylene glycol

Glycerol

Cetylpyridinium chloride

Levomenthol

Saccharin sodium

Cherry Flavouring

Creamfeel flavouring

Sodium dihydrogen phosphate dihydrate

Sodium hydroxide

Purified water

None known.

No data held

36 months

This medicinal product does not require any special storage conditions

Uncoloured, clear or textured Type III glass bottle, containing 15ml of product with a polypropylene/low density polyethylene pump and polypropylene cap.

Or

Amber, clear Type III glass bottle, containing 15ml of product with a polypropylene/polyethylene pump.

None

Prestige Brands (UK) Limited

Beechwood, 3 Scotlands Drive, Farnham Common

Slough, Berkshire, SL2 3ES

United Kingdom

PL 18259/0002

11/12/2008

24^th October 2010

Not applicable

Not applicable

Recent History:

24^th October 2010 – 16 – User Test. Sections 4.4, 6.2.

5^th May 2010 – 0028 - Type IB Az Group – Sections 2, 3, 4.2, 5.1, 6.4

30^th Dec 2009 – 0024 - Type IB 29a textured bottle – Section 6.5