The Pharmaceutical Journal
Vol 272 No 7286 p177
14 February 2004

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MHRA
  Updating overdose sections of selected summaries of product characteristics (PDF 140K)
  Generic overdose sections for selected summaries of product characteristics (PDF 120K)

Overdose advice updates required

Anxiety over inappropriate and out-of-date advice in the summaries of product characteristics of some medicines has prompted the MHRA to issue guidance to manufacturers.

The Medicines and Healthcare products Regulatory Agency has produced standard suggested SPC entries for the 10 drugs about which the National Poisons Information Service most frequently received inquiries during 2002. Guidance on three further drugs has also been drawn up because of the complexity of their overdose management.

Companies have been told that they should apply for SPC variations in line with the recommendations within six months.

The drugs concerned are aminophylline/theophylline, amitriptyline, citalopram, codeine, co-proxamol, diazepam/ temazepam, fluoxetine, ibuprofen, lithium, paroxetine, salicylates/aspirin, and zopiclone.

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