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of everyone affected by epilepsy

Epilepsy charity successful in changing bonjela warning

6 July, 2006

The charity
Epilepsy Action has been successful in having the warning removed that
people with epilepsy could not use the mouth ulcer and teething gel Bonjela.

A
caller to the organisation's epilepsy helpline asked why people with
the condition weren't able to use the gel.  Advice and information
officer Diane Wallace contacted manufacturer Reckitt Benckiser and the UK Medicines and Healthcare products Regulatory Agency (MHRA).

The
MHRA said the warning on the label and packaging leaflet for Bonjela
was required under the 2003 European Union Excipients guidelines
because of the ethanol (alcohol) content in the product.  However, the
MHRA reviewed the warning and decided it only should apply where a
product is swallowed or injected into a vein or muscle, and not to
products such as Bonjela which are applied to an area of the body.

The MHRA have now written to Reckitt Benckiser and asked them to revise
the packaging. Reckitt Benckiser will be submitting the amended
packaging to the MHRA Patient Information Quality Unit for assessment and approval.

It will take several months for the new packaging to be printed and to appear on the shelves.