Boots Teething Gel 3 Months Plus
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Boots Teething Gel 3 Months Plus
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Active ingredient Quantity
0.6% w/w 0.02% w/w
Lignocaine Hydrochloride Ph Eur Cetylpyridinium Chloride Ph Eur
3. PHARMACEUTICAL FORM
Gel
4. CLINICAL PARTICULARS
4.1 Therapeutic indications
For the relief of teething troubles.
4.2 Posology and method of administration
Children over 3 months:
Apply a small quantity of gel to the sore area. Repeat the application every three hours if necessary.
For topical application to mouth and gums.
4.3 Contraindications
Hypersensitivity to any of the ingredients.
4.4 Special warnings and precautions for use
Keep all medicines out of the reach of children.
4.5 Interactions with other medicinal products and other forms of interaction
There are no clinically significant interactions.
4.6 Pregnancy and lactation
The safety of this medicine during pregnancy and lactation has not been established, but use during these periods 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 lignocaine 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 medicine is unlikely to constitute a hazard and therefore symptomatic treatment only is necessary.
5.1 Pharmacodynamic properties
Lignocaine is a local anaesthetic of the amide type. Cetylpyridinium Chloride is a cationic antiseptic.
5.2 Pharmacokinetic properties
Lignocaine is readily absorbed from mucous membranes. The plasma elimination half life is about two hours. Lignocaine is bound to plasma proteins, including a-1 acid glycoprotein. Extent of binding is between 60 and 80%.
Lignocaine 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
None stated.
6. PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Methocel E4 Premium Glycerin
Sodium saccharin crystals Citric acid monohydrate Sorbic acid Sodium citrate
Salt pure vacuum dried extra analysis Spearmint Naefco flay Firmench Purified water
6.2 Incompatibilities
None stated.
6.3 Shelf life
36 months.
6.4 Special precautions for storage
Do not store above 30°C
6.5 Nature and contents of container
An internally lacquered collapsible aluminium tube with a membrane seal and either a polyethylene or polypropylene white wadless screw cap with a piercer device.
Pack sizes: 13/15 gm
6.6 Instruction for use, handling and disposal
None.
7 MARKETING AUTHORISATION HOLDER
The Boots Company PLC 1 Thane Road West Nottingham NG2 3AA
8. MARKETING AUTHORISATION NUMBER
PL 00014/0392
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
10/10/2005
10
DATE OF REVISION OF THE TEXT
04/06/2015