Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2021 Publisher: Reckitt Benckiser Healthcare (UK) Ltd, Slough, SL1 4AQ
Hypersensitivity to benzocaine or to any of the excipients listed in section 6.1 or paraaminobenzoic acid (PABA), parabens or paraphenylenediamine or to commercial hair dyes as there is cross-sensitivity between these products.
A history of allergy to local anaesthetics such as procaine, butacaine or any other ‘caine’ anaesthetics.
In patients who have a history of or are suspected to have methaemoglobinaemia (see section 4.8).
Do not use with sulphonamides (see section 4.5).
Do not use with cholinesterase inhibitors (see section 4.5).
Do not apply to large areas of skin, eczematous, sunburnt, infected or broken skin.
Local anaesthetics should not be used in patients with complete heart block.
Not for use on extensive body area or on the mouth or eyes or under conditions in which significant inhalation is likely.
This medicine contains fragrance with citronellol, benzyl benzoate, geraniol, benzyl alcohol, citral, cinnamal, alcohol, linalool and d-limonene that may cause allergic reactions.
Benzyl benzoate and benzyl alcohol may cause local irritation.
Lanacane contains sulphonated castor oil which may cause skin reactions.
Sulphonamides: Benzocaine is metabolised to para-aminobenzoic acid and may antagonise the effects of sulphonamides.
Cholinesterase Inhibitors: Cholinesterase inhibitors inhibit the metabolism of benzocaine.
Do not use in pregnancy or during breast feeding without first consulting a doctor.
There are limited amounts of data from the use of benzocaine in pregnant women.
There is insufficient information on the excretion of benzocaine metabolites in human milk.
No known effects.
None.
Adverse events which have been associated with benzocaine are given below, listed by system organ class and frequency. Frequencies are defined as: very common (≥1/10), common (≥1/100 and <1/10), uncommon (≥1/1000 and <1/100), rare (≥1/10,000 and <1/1000), very rare (<1/10,000) and not known (cannot be estimated from the available data). Within each frequency grouping, adverse events are presented in order of decreasing seriousness.
| System Organ Class | Frequency | Adverse Event |
|---|---|---|
| Blood and Lymphatic System Disorders | Not known | Methaemoglobinaemia |
| Immune System Disorders | Not known | Hypersensitivity reactions, dermatitis allergic |
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.
None known.
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