Boots Mouth Ulcer Gel
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Sore Mouth Gel or Boots Mouth Ulcer Gel
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Active ingredients Quantity % w/w
Lidocaine base 0.6
Cetylpyridinium chloride 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. This product is not suitable for the treatment of teething troubles in babies.
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.
Overdose
4.9
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 monoethyiglycinexylidide 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 polyporpylene cap.
Pack size: 15 gm.
6.6 Special precautions for disposal
None stated.
7 MARKETING AUTHORISATION HOLDER
The Boots Company PLC 1 Thane Road West Nottingham NG2 3AA
MARKETING AUTHORISATION NUMBER(S)
PL 00014/0150
9
10
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
25/06/1974 / 16/04/2002
DATE OF REVISION OF THE TEXT
12/02/2015