Boots teething

Overdose

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

Shelf life

36 months.

Contraindications

Hypersensitivity to any of the ingredients.

Incompatibilities

None stated.

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 flav Firmench

Purified water

Pharmaceutical form

Gel

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.

Preclinical safety data

None stated.

Therapeutic indications

For the relief of teething troubles.

Pharmacodynamic properties

Lignocaine is a local anaesthetic of the amide type. Cetylpyridinium Chloride is a cationic antiseptic.

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 α-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 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.

Date of revision of the text

4 June 2015

Name of the medicinal product

Boots Teething Gel 3 Months Plus

Marketing authorisation holder

The Boots Company PLC

1 Thane Road West

Nottingham NG2 3AA

Special precautions for storage

Do not store above 30°C

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

Marketing authorisation number(s)

PL 00014/0392

Qualitative and quantitative composition

Active ingredient

Quantity

Lignocaine Hydrochloride Ph Eur

0.6% w/w

Cetylpyridinium Chloride Ph Eur

0.02% w/w

Special warnings and precautions for use

Keep all medicines out of the reach of children.

Effects on ability to drive and use machines

No adverse effects known.

Dosage (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.

Special precautions for disposal and other handling

None.

Date of first authorisation/renewal of the authorisation

12 March 1990 / 15 May 2000