ULTRA CHLORASEPTIC ANAESTHETIC THROAT SPRAY - summary of medicine characteristics

1 NAME OF THE MEDICINAL PRODUCT

Ultra Chloraseptic Anaesthetic Throat Spray

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Benzocaine 0.71 % w/v

For full list of excipients, see 6.1

3 PHARMACEUTICAL FORM

4.1.   Therapeutic Indications

4.3 Contraindications

Children under 6 years.

Epiglottitis.

Known hypersensitivity to benzocaine or any of the excipients listed in section 6.1.

Methaemoglobi­naemia.

4.4 Special warnings and precautions for use

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.

4.5 Interaction with other medicinal products and other forms of interaction

No interaction studies have been performed.

4.6 Fertility, pregnancy and lactation

Pregnancy

Animal studies are insufficient with respect to effects on pregnancy. The potential risk for humans is unknown. Therefore, Ultra Chloraseptic spray is not recommended during pregnancy.

Breast-feeding

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

Fertility

The specific effect of benzocaine therapy on human fertility is unknown.

4.7 Effects on ability to drive and use machines

Ultra Chloraseptic spray has no expected effect on the ability to drive and use machines.

4.8 Undesirable effects

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.

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: Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

4.9 Overdose

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

5 PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

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.

5.2 Pharmacokinetic properties

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 glycine to aminohippuric acid in the liver, the metabolites and unchanged benzocaine are excreted in the urine.

5.3 Preclinical safety data

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

6. PHARMACEUTICAL PARTICULARS

6.1. List of Excipients

Ethanol

Macrogol 300

Propylene glycol

Glycerol

Cetylpyridinium chloride

Levomenthol

Saccharin Sodium

Sodium dihydrogen phosphate dihydrate

Sodium hydroxide

Purified water.

6.2 Incompatibilities

None known.

6.3. Shelf-Life

36 months.

6.4 Special precautions for storage

This medicinal product does not require any special storage conditions.

6.5 Nature and contents of container

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.

6.6. Instruction for Use, Handling and Disposal

None.

7 MARKETING AUTHORISATION HOLDER

Prestige Brands (UK) Ltd

5–7 London Road

St. Albans

AL1 1LA,

United Kingdom

8. MARKETING AUTHORISATION NUMBER(S)

PL 18259/0001

9. DATE OF FIRST AUTHORISATION / RENEWAL OF AUTHORISATION

07 July 2000