SUMMARY OF PRODUCT CHARACTERISTICS

1    NAME OF THE MEDICINAL PRODUCT

Dequacaine.

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Each lozenge contains 0.25mg dequalinium chloride BP and 10.0mg benzocaine BP.

3 PHARMACEUTICAL FORM

Lozenge.

4 CLINICAL PARTICULARS

4.1 Therapeutic indications

For the relief of severe sore throats.

4.2 Posology and method of administration

Adults and Children over 12 years: One lozenge to be sucked slowly every two hours as required. Not more than 8 lozenges to be taken in any 24 hours.

Children under 12 years: Not suitable.

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

4.3 Contraindications

Patients hypersensitive to any of the ingredients or to para-aminobenzoic acid and its derivatives.

Patients with low plasma cholinesterase concentrations.

4.4 Special warnings and precautions for use

Dequacaine should be used with caution in patients with myasthenia gravis.

The label states:

Warning: Do not exceed the stated dose.

Keep all medicines out of the reach of children.

If symptoms persist consult your doctor.

4.5 Interaction with other medicinal products and other forms of interaction

Dequacaine is contraindicated in those patients taking anticholinesterases. Benzocaine is metabolised to para-aminobenzoic acid and Dequacaine may therefore antagonise the effects of sulphonamides.

4.6 Pregnancy and lactation

The safety of Dequacaine during pregnancy and lactation has not been established. As local anaesthetics can cross the placenta, it is recommended that this product is not taken during pregnancy. No information in the use of this product in lactation is available and it is recommended that Dequacaine is not taken whilst breast-feeding.

4.7 Effects on ability to drive and use machines

No adverse effects known.

4.8 Undesirable effects

Dequacaine may occasionally cause hypersensitivity reactions. Methaemoglobinaemia has occasionally been reported following the use of benzocaine.

4.9 Overdose

Symptoms of overage including 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 vasodilation, resulting in hypotension, arrythmias and cardiac arrest. May also cause methaemoglobinaemia.

Treatment consists of 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

Benzocaine is a local anaesthetic of the ester type. Dequalinium chloride is a quaternary ammonium antiseptic active against many gram-positive and gramnegative bacterial, yeasts and fungi.

5.2 Pharmacokinetic properties

Benzocaine is readily absorbed through mucous membranes and is hydrolysed by esterases in the plasma and to a lesser extent in the liver.

5.3 Preclinical safety data

There are no preclinical safety data of relevance to the consumer.

6    PHARMACEUTICAL PARTICULARS

6.1    List of excipients

Sodium saccharin, levomenthol or racementhol, racemic camphor, sorbitol, peppermint oil, benzyl alcohol, liquid sugar, liquid glucose, invert syrup.

6.2 Incompatibilities

None.

6.3 Shelf life

2 years.

Special precautions for storage

Do not store above 30°C.

6.5 Nature and contents of container

PVC/PVDC blister strips sealed with aluminium foil enclosed in cardboard cartons to give a pack of 24 lozenges.

6.6 Special precautions for disposal

None.

7    MARKETING AUTHORISATION HOLDER

Reckitt Benckiser Healthcare (UK) Limited

Dansom Lane

Hull

HU8 7DS United Kingdom

8    MARKETING AUTHORISATION NUMBER(S)

PL 00063/0401

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

9.4.1991

10 DATE OF REVISION OF THE TEXT

01/08/2008