This information is intended for use by health professionals

1. Name of the medicinal product

Sore Mouth Gel or Boots Mouth Ulcer Gel

2. Qualitative and quantitative composition

Active ingredients

Lidocaine base

Cetylpyridinium chloride

Quantity % w/w

0.6

0.02

3. Pharmaceutical form

Oromucosal Gel

4. Clinical particulars
4.1 Therapeutic indications

For the rapid relief of pain caused by minor recurrent aphthous mouth ulcers.

4.2 Posology and method of administration

For topical application to the mouth and gums.

Adults and children

A small quantity of gel to be applied to the sore area with a clean finger every three hours as necessary.

Babies

Not suitable.

4.3 Contraindications

Patients hypersensitive to any of the ingredients.

4.4 Special warnings and precautions for use

Keep all medicines out of the reach of children.

If symptoms persist for more than seven days consult your doctor or dentist.

Not suitable for treatment of teething in children.

4.5 Interaction with other medicinal products and other forms of interaction

No clinically significant drug 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.

4.7 Effects on ability to drive and use machines

No adverse effects known.

4.8 Undesirable effects

Hypersensitivity reactions due to lidocaine have been reported rarely and to cetylpyridinium chloride occasionally.

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

Overdosage with this product is unlikely to constitute a hazard and therefore symptomatic treatment only is necessary.

5. Pharmacological properties
5.1 Pharmacodynamic properties

Lidocaine is a local anaesthetic of the amide type. Cetylpyridinium chloride is a cationic antiseptic.

5.2 Pharmacokinetic properties

Lidocaine is rapidly absorbed from mucous membranes. The plasma elimination half life is about two hours.

Lidocaine undergoes significant first pass metabolism in the liver and is rapidly de-ethylated to the active metabolite monoethylglycinexylidide and then hydrolysed to various metabolites including glycinexylidide. Less than 10% is excreted unchanged by the kidneys. The metabolites are also excreted in the urine.

5.3 Preclinical safety data

Not applicable.

6. Pharmaceutical particulars
6.1 List of excipients

Refined sugar

Cetomacrogol 1000

Hypromellose

Alcohol 96%

Eucalyptol

Levomenthol synthetic or natural

Star anise oil

Purified water

6.2 Incompatibilities

None stated.

6.3 Shelf life

36 months.

6.4 Special precautions for storage

Store below 25°C.

6.5 Nature and contents of container

A collapsible aluminium tube, internally lacquered with a polyamide/polyimide lacquer system with a membrane seal fitted with a wadless polythene cap or polypropylene cap.

Pack size: 15 gm.

6.6 Special precautions for disposal and other handling

None stated.

7. Marketing authorisation holder

The Boots Company PLC

1 Thane Road West

Nottingham NG2 3AA

8. Marketing authorisation number(s)

PL 00014/0150

9. Date of first authorisation/renewal of the authorisation

Date of First Authorisation:

Date of Last Renewal:

25 June 1974

16 April 2004

10. Date of revision of the text

11 August 2018