SUMMARY OF PRODUCT CHARACTERISTICS

1    NAME OF THE MEDICINAL PRODUCT

Superdrug Mouth Ulcer Pastilles Iglu Sugar Free Pastilles Boots Mouth Ulcer Pastilles

2    QUALITATIVE AND QUANTITATIVE    COMPOSITION

Benzalkonium Chloride Solution    1.11 mg per pastille

Compound Benzoin Tincture    8.06 mg per pastille (0.75% v/w)

3    PHARMACEUTICAL FORM

Pastille

4    CLINICAL PARTICULARS

4.1    Therapeutic indications

For the relief of mouth ulcers and sore gums

4.2    Posology and method of administration

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.

4.3    Contraindications

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.

4.4    Special warnings and precautions for use

None

4.5    Interaction with other medicinal products and other forms of interaction

None known

4.6    Fertility, pregnancy and lactation

Pregnancy

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.

Lactation

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. Fertility

Studies on the effects on fertility have not been investigated.

4.7    Effects on ability to drive and use machines

None known

4.8    Undesirable effects

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.

4.9    Overdose

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.

5    PHARMACOLOGICAL PROPERTIES

5.1    Pharmacodynamic properties

Benzalkonium chloride is an antiseptic detergent.

Benzoin tincture is included as a mild antiseptic and a mucosal protective.

5.2    Pharmacokinetic properties

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.

5.3 Preclinical safety data

None specific to the product

Pharmaceutical Particulars

6.1. List of Excipients

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

6.2 Incompatibilities

None known

6.3.    Shelf Life

24 months

6.4.    Special Precautions for Storage

Do not store above 25°C. Store in the original package in order to protect from moisture.

6.5    Nature and contents of container

24 pastilles, blister packed and contained in a printed carton 45 pastilles contained in a laminate bag integral with a printed carton.

6.6    Special precautions for disposal

None specific to packs

7    MARKETING AUTHORISATION HOLDER

Ernest Jackson & Co Ltd

High Street

Crediton

Devon EX17 3AP, UK

MARKETING AUTHORISATION NUMBER(S)

PL 0094/5016R

DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

11/10/1989 / 19/05/1995

DATE OF REVISION OF THE TEXT

19/12/2014