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BOOTS SORE MOUTH PASTILLES

Active substance(s): 2 4-DICHLOROBENZYL ALCOHOL / 2 4-DICHLOROBENZYL ALCOHOL / 2 4-DICHLOROBENZYL ALCOHOL

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SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
Boots Sore Mouth Pastilles

2

QUALITATIVE AND QUANTITATIVE COMPOSITION
Active ingredient 2.4 - Dichlorobenzyl alcohol mg 1.29

3

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

4
4.1

CLINICAL PARTICULARS
Therapeutic indications For the symptomatic relief of sore mouths.

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.

4.3.

Contra-indications Hypersensitivity to any of the ingredients.

4.4.

Special Warnings and Precautions for Use Not recommended for children under 3 years. Keep all medicines out of the reach of children.

4.5

Interaction with other medicinal products and other forms of interaction No clinically significant interactions known.

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.

4.7.

Effects on Ability to Drive and Use Machines No adverse effects known.

4.8.

Undesirable Effects Occasional hypersensitivity reactions and soreness of the tongue.

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.

5
5.1

PHARMACOLOGICAL PROPERTIES
Pharmacodynamic properties

Dichlorobenzyl alcohol has antiseptic properties.

5.2.

Pharmacokinetic Properties No data available.

5.3.

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

6
6.1

PHARMACEUTICAL PARTICULARS
List of excipients Silicone antifoam 1510 Glycerin Annatto WSA acid stab liquid biocon Purity gum 40 Nat Starch and chemical Maltitol liquid Potable water Adipic acid Myrrh tincture Levomenthol natural Clove leaf oil Sweet orange oil special IFF Capol 3073B

6.2.

Incompatibilities Not applicable.

6.3

Shelf life
18 months

6.4.

Special Precautions for Storage Store in a dry place below 25C.

6.5.

Nature and Contents of Container Clear cellulose film coated with nitrocellulose and heat-sealed to form a bag. Each bag is packed in a cardboard carton. Pack size: 30g

6.6

Special precautions for disposal None.

7

MARKETING AUTHORISATION HOLDER
The Boots Company PLC 1 Thane Road West Nottingham NG2 3AA

8

MARKETING AUTHORISATION NUMBER(S)
PL 00014/5370R

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
23 January 1990

10

DATE OF REVISION OF THE TEXT
25/08/2012

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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