SUMMARY OF PRODUCT CHARACTERISTICS

1 NAME OF THE MEDICINAL PRODUCT

Dequaspray

Strepsils Sore Throat 2.0 % w/v Spray

2    QUALITATIVE AND QUANTITATIVE COMPOSITION

Lidocaine hydrochloride 2.0 % w/v (Lignocaine hydrochloride)

3    PHARMACEUTICAL FORM

Oromucosal Spray

4    CLINICAL PARTICULARS

4.1    Therapeutic indications

For the symptomatic relief of severe sore throats

4.2 Posology and method of administration

Adults and children over 12 years: Three sprays.

Aim nozzle at back of throat and spray on to the affected area. Repeat the dose every three hours as needed up to a maximum of six times in 24 hours.

Children under 12 years: Should not be given to children less than 12 years of age.

Elderly: There is no need for dose reduction in the elderly.

4.3 Contraindications

Hypersensitivity to any of the ingredients. Patients suffering from asthma or bronchospasm. Children under 12 years.

4.4 Special warnings and precautions for use

Do not use if you are sensitive to any of the ingredients.

Avoid contact with the eyes.

Children under 12 years of age should not be given this medicine.

Do not inhale whilst using the spray.

Do not exceed the stated dose.

Keep all medicines out of the reach of children.

Seek medical advice if symptoms persist or are accompanied by high fever, headache,

nausea or vomiting.

Seek medical advice before using this product if you are pregnant, breast feeding or receiving any medical treatment.

Strepsils Pain Relief Spray may cause numbness of the tongue and therefore care should be taken in eating and drinking hot foods.

4.5 Interaction with other medicinal products and other forms of interaction

No clinically significant interactions are known.

4.6 Pregnancy and lactation

The safety of the medicinal product for use in human pregnancy has not been established. Experimental animal studies are insufficient to assess the safety with respect to the development of the embryo or foetus, the course of gestation and peri-and post-natal development. The product is, therefore, not recommended during pregnancy and lactation except under medical supervision.

4.7 Effects on ability to drive and use machines

No adverse effects are known.

4.8 Undesirable effects

Occasional hypersensitivity reactions.

4.9 Overdose

Symptoms of overdose include yawning, restlessness, excitement, nervousness, dizziness, nystagmus, tinnitus, blurred vision, nausea, vomiting, muscle twitching, tremors and convulsions. Excitation may be transient and followed by depression with drowsiness, respiratory failure and coma. There may be simultaneous effects on the cardiovascular system with myocardial depression and peripheral vasodilatation, resulting in hypotension, arrhythmias and cardiac arrest. May also cause methaemoglobinaemia.

Treatment consists essentially of maintaining the circulation and respiration and controlling convulsions. The circulation may be maintained with infusions of plasma or suitable electrolyte solutions. Convulsions may be controlled by the intravenous administration of diazepam. If necessary, suxamethonium together with endotracheal intubation and artificial respiration may be used if convulsions persist. Methaemoglobinaemia may be treated by intravenous administration of 1-4 mg/kg methylthioninium chloride injection.

5 PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Pharmacotherapeutic group: Throat

Preparations; Anaesthetics, Local; ATC Code: R02AD02

Lidocaine is a local anaesthetic of the amide type, acting to produce reversible loss of sensation by preventing or diminishing the generation and transmission of sensory nerve impulses near the site of application. Depolarisation of the neuronal membrane and ion exchange are reversibly inhibited. It provides an anaesthetic effect by blocking neuronal transmission.

5.2 Pharmacokinetic properties

Lidocaine is readily absorbed from mucous membranes. The plasma elimination half-life is about two hours.

Lidocaine undergoes significant first pass metabolism in the liver and is rapidly de-ethylated to the active metabolite monoethylglycinexylidide and then hydrolysed to various metabolites including glycinexylidide. Less than 10% is excreted unchanged by the kidneys. The metabolites are also excreted in the urine.

5.3 Preclinical safety data

Not applicable.

6    PHARMACEUTICAL PARTICULARS

6.1    List of excipients

Sorbitol Levomenthol Peppermint Flavour Aniseed Flavour Sodium Citrate Saccharin Alcohol

Carmoisine Edicol (E122)

Water

6.2 Incompatibilities

Not applicable.

6.3 Shelf life

24 months.

6.4 Special precautions for storage

None.

6.5    Nature and contents of container

A clear, glass bottle fitted with metering valve spray pump with an extended polypropylene nozzle containing 20ml or 30ml or product.

6.6    Special precautions for disposal

On first use or after prolonged storage, spray 3 times away from face into a sink.

7 MARKETING AUTHORISATION HOLDER

Reckitt Benckiser Healthcare (UK) Limited

Dansom Lane

Hull

HU8 7DS United Kingdom

8 MARKETING AUTHORISATION NUMBER(S)

PL 00063/0403

9    DATE OF FIRST AUTHORISATION/RENEWAL OF THE

AUTHORISATION

22/08/1996

10 DATE OF REVISION OF THE TEXT

15/06/2016