Home | About the eMC | Help | Mobile

eMC - trusted, up to date and comprehensive information about medicines

Search medicine/company name only

Search full document

Medicine name A-Z | Active ingredient A-Z | Pharmaceutical company A-Z | Latest medicine updates | Yellow card report

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: 24/11/2010

SPC	Boots Sore Mouth Gel

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

Go to top of the page

1. NAME OF THE MEDICINAL PRODUCT

Sore Mouth Gel or Boots Mouth Ulcer Gel

Go to top of the page

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Active ingredients	Quantity % w/w
Lidocaine base	0.6
Cetylpyridinium chloride	0.02

Go to top of the page

3. PHARMACEUTICAL FORM

Oromucosal Gel

Go to top of the page

4. CLINICAL PARTICULARS

Go to top of the page

4.1 Therapeutic indications

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

Go to top of the page

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.

Go to top of the page

4.3 Contraindications

Patients hypersensitive to any of the ingredients.

Go to top of the page

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.

This product is not suitable for the treatment of teething troubles in babies.

Go to top of the page

4.5 Interaction with other medicinal products and other forms of interaction

No clinically significant drug interactions known.

Go to top of the page

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.

Go to top of the page

4.7 Effects on ability to drive and use machines

No adverse effects known.

Go to top of the page

4.8 Undesirable effects

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

Go to top of the page

4.9 Overdose

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

Go to top of the page

5. PHARMACOLOGICAL PROPERTIES

Go to top of the page

5.1 Pharmacodynamic properties

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

Go to top of the page

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.

Go to top of the page

5.3 Preclinical safety data

Not applicable.

Go to top of the page

6. PHARMACEUTICAL PARTICULARS

Go to top of the page

6.1 List of excipients

Refined sugar

Cetomacrogol 1000

Hypromellose

Alcohol 96%

Eucalyptol

Levomenthol synthetic or natural

Star anise oil

Purified water

Go to top of the page

6.2 Incompatibilities

None stated.

Go to top of the page

6.3 Shelf life

36 months.

Go to top of the page

6.4 Special precautions for storage

Store below 25°C.

Go to top of the page

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.

Go to top of the page

6.6 Special precautions for disposal and other handling

None stated.

Go to top of the page

7. MARKETING AUTHORISATION HOLDER

The Boots Company PLC

1 Thane Road West

Nottingham NG2 3AA

Go to top of the page

8. MARKETING AUTHORISATION NUMBER(S)

PL 00014/0150