Reckitt Benckiser Ireland Limited

Dequacaine Lozenges

Benzocaine 10 mg

Dequalinium chloride 0.25 mg

Each lozenge contains 0.25 mg dequalinium chloride and 10 mg benzocaine

Excipients: Sorbitol (E420), Sugar base (consisting of glucose and sucrose) 2.6g/lozenge

For full list of excipients, see section 6.1

Lozenge.

Round, yellow lozenge.

For the relief of severe sore throats and for the relief of pain and discomfort in the oral cavity associated with superficial infection of the oropharynx or with dental procedures.

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 elderly.

Patients sensitive 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 before use

Speak to your doctor before use if you are pregnant, breast feeding, taking any medicines (especially sulphonamides) or suffer from Myasthenia Gravis.

The label states:

Warning: Do not exceed the stated dose. Keep all medicines out of the reach of the children. If symptoms persist or are accompanied by fever, headache, nausea or vomiting consult your doctor.

Dequacaine is contraindicated in those patients taking anticholinesterases.

Benzocaine is metabolised to para-aminobenzoic acid and Dequacaine may therefore antagonise the effects of sulphonamides.

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

No adverse effects known.

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

Symptoms of overdosage including yawning, restlessness, excitement, nervousness, dizziness, nystagmus, tinnitus, blurred vision, nausea, vormitting, 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 hypertension, arrhythmias and cardiac arrest. May also cause methaemoglobinaemia.

Treatment consist 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 with the infusions of plasma or suitable electrolyte solution. 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 persists.

Metahemoglobinaemia may be treated by intravenous administraion of 1-4 mg/kg methylene blue injection.

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

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

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

Saccharin sodium

Levomenthol or racemic menthol

Racemic camphor

Peppermint oil

Benzyl alcohol

Liquid sugar

Liquid glucose

Invert syrup

Not applicable.

2 years.

This medicinal product does not require any special storage conditions.

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

No special requirements.

Reckitt Benckiser Ireland Ltd

7 Riverwalk

Citywest Business Campus

Dublin 24

Ireland

PA 979/35/1

Date of first authorisation: 26^th August 1991

Date of last renewal: 26^th August 2006

February 2009