Reckitt Benckiser Ireland Limited

Dequadin 0.25mg Lozenges

Each lozenge contains 0.25 mg Dequalinium chloride.

Excipient: Sunset yellow (E100) 0.4 mg per lozenge.

Sucrose 998.925 mg

Liquid Glucose BPC 63 50 mg

For full list of excipients, see section 6.1.

Lozenge

Round, pale orange lozenges.

For the local therapy of most of the common infections of the mouth and oropharynx including: vincents angina, pharyngitis, sore throats, tonsillitis, stomatitis, aphthous ulcers, thrush, glossitis.

For oral administration.

Adults and children over 10 years:

One lozenge to be sucked every 2 to 3 hours, up to a maximum of eight in one day.

Elderly:

There is no need for dosage reduction in elderly.

Hypersensitivity to any of the ingredients.

The label states:

Keep all medicines out of the reach of children.

If symptoms persist, consult your doctor.

Warning: Do not exceed the stated dose.

4.5

No clinically significant drug interactions known.

The safety of Dequadin during pregnancy and lactation has not been established, but it is considered a hazard.

No adverse effects known.

Occasional hypersensitivity reactions and soreness of the tongue are possible.

Overdosage should not present a problem other than gastrointestinal discomfort. Treatment should be symptomatic.

Dequalinium chloride is a quaternary ammonium antiseptic active against many gram-positive and gram-negative bacteria, yeasts and fungi.

Not available.

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

Sucrose

Citric acid monohydrate

Liquid glucose

Saccharin sodium

Racemic camphor

Magnesium stearate

Gelatine

Sunset yellow (E110)

Lime flavour

Peppermint oil

Not applicable

3 years.

Do not store above 25°C

PVC/PVDC blister strips sealed with aluminium foil enclosed in cardboard cartons to give packs of 20 or 40 lozenges.

No special requirements

Reckitt Benckiser Ireland Ltd

7 Riverwalk

Citywest Business Campus

Dublin 24

Ireland

PA 979/35/1

26^th August 1991/ 26^th August 1996

February 2009