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THE BOOTS COMPANY PLC
1 Thane Road West, Beeston, Nottingham, NG2 3AA Telephone: +44 (0)1159 595 165 Fax: +44 (0)1159 592 565 Before you contact this company: often several companies will market medicines with the same active ingredient. Please check that this is the correct company before contacting them. Why?

Summary of Product Characteristics last updated on the eMC: 04/05/2011

SPC	Boots Sore Mouth Pastilles

Table of Contents

1. NAME OF THE MEDICINAL PRODUCT
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
3. PHARMACEUTICAL FORM
4. CLINICAL PARTICULARS
4.1 Therapeutic indications
4.2 Posology and method of administration
4.3 Contraindications
4.4 Special warnings and precautions for use
4.5 Interaction with other medicinal products and other forms of interaction
4.6 Pregnancy and lactation
4.7 Effects on ability to drive and use machines
4.8 Undesirable effects
4.9 Overdose
5. PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
5.2 Pharmacokinetic properties
5.3 Preclinical safety data
6. PHARMACEUTICAL PARTICULARS
6.1 List of excipients
6.2 Incompatibilities
6.3 Shelf life
6.4 Special precautions for storage
6.5 Nature and contents of container
6.6 Special precautions for disposal and other handling
7. MARKETING AUTHORISATION HOLDER
8. MARKETING AUTHORISATION NUMBER(S)
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
10. DATE OF REVISION OF THE TEXT

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1. NAME OF THE MEDICINAL PRODUCT

Boots Sore Mouth Pastilles

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2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Active ingredient

2.4 - Dichlorobenzyl alcohol

1.29

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3. PHARMACEUTICAL FORM

Deep orange-coloured, pleasantly flavoured, concave-convex, well glazed pastille with corrugations on the upper convex surface.

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4. CLINICAL PARTICULARS

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4.1 Therapeutic indications

For the symptomatic relief of sore mouths.

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4.2 Posology and method of administration

Adults and children over 3 years: Allow a pastille to dissolve slowly in the mouth every two or three hours during the day, keeping the pastille near the painful area.

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

For oral administration.

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4.3 Contraindications

Hypersensitivity to any of the ingredients.

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4.4 Special warnings and precautions for use

Not recommended for children under 3 years.

Keep all medicines out of the reach of children.

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4.5 Interaction with other medicinal products and other forms of interaction

No clinically significant interactions known.

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4.6 Pregnancy and lactation

The safety of this product during pregnancy and lactation has not been established but is not considered to constitute a hazard during these periods.

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4.7 Effects on ability to drive and use machines

No adverse effects known.

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4.8 Undesirable effects

Occasional hypersensitivity reactions and soreness of the tongue

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4.9 Overdose

No specific symptoms associated with overdosage, other than nausea, vomiting, diarrhoea and soreness of the tongue. Treatment, if required, should be symptomatic.

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5. PHARMACOLOGICAL PROPERTIES

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5.1 Pharmacodynamic properties

Dichlorobenzyl alcohol has antiseptic properties.

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5.2 Pharmacokinetic properties

No data available.

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5.3 Preclinical safety data

There are no preclinical data of relevance to the prescriber which are additional to that already included.

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