This information is intended for use by health professionals
SUGAR FREE PASTILLES
Benzalkonium Chloride Solution 1.11 mg per pastille; Compound Benzoin Tincture 8.06 mg per pastille (0.75% v/w).
For excipients, see section List of Excipients.
For the relief of mouth ulcers and sore gums.
Adults, the elderly and children of 3 years and above: Dissolve one pastille in the mouth at 2 hourly intervals.
Do not take more than 8 pastilles per day.
Hypersensitivity to benzalkonium chloride, benzoin or any of the other ingredients.
Contains sorbitol. Patients with rare hereditary problems of fructose intolerence should not take this medicine.
There is no or inadequate evidence of the safety of the active ingredients in this medicine in human pregnancy. The potential risk for humans is unknown. In the absence of sufficient data, the use during pregnancy is not recommended.
It is not known whether the active ingredients of this product are excreted in human breast milk. In the absence of sufficient data, the use during lactation is not recommended.
Studies on the effects on fertility have not been investigated.
Sensitivity to benzalkonium chloride may occur in some people.
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 at: www.mhra.gov.uk/yellowcard
Symptoms of overdose are unlikely unless the recommended dosage is grossly exceeded, when nausea and vomiting may be seen. Treat by discontinuation, giving milk and egg whites and observation.
Benzalkonium chloride is an antiseptic detergent.
Benzoin tincture is included as a mild antiseptic and a mucosal protective.
The product is used by being allowed to dissolve in the mouth, and its action is therefore dependent on local distribution in the buccal cavity and contact with the affected areas.
None specific to the product.
Sorbitol liquid, non-crystallising; Acacia; Peppermint Oil; Simethicone Antifoam (water, polydimethyl siloxane and silica mix, polyoxyethylene 20 sorbitan monostearate, glyceryl monostearate, sodium carboxymethyl cellulose, methyl-4-hydroxybenzoate, propyl-4-hydroxybenzoate, hydrogen chloride); Vegetable oil; Carnauba wax; Water.
Do not store above 25°C. Store in the original package in order to protect from moisture.
24 pastilles, blister packed and contained in a printed carton.
Ernest Jackson & Co Ltd
Devon EX17 3AP, UK.
11 October 1989 / 1 May 2008.