Freedom of Information request (FOI 22/919)
Published 17 January 2024
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FOI 22/919
21st September 2022
Dear
Thank you for your email dated 22nd August 2022.
| The MHRA has not undertaken an analysis of the potential risk to patients from the sale of the combined ibuprofen and codeine painkiller Nurofen Plus in large pack sizes (24- and 32-tablet packs). Nurofen Plus contains 12.8mg codeine and 200mg ibuprofen and therefore may only be sold without prescription under the supervision of a pharmacist. In 2009, the Commission for Human Medicines (CHM) recommended that pack sizes containing codeine larger than 32 tablets are only available by prescription Microsoft Word - Codeine and addiction FINAL.doc (publishing.service.gov.uk). Codeine is an opioid and with a potential risk of addiction. As Nurofen Plus is a combined product, there is a risk that overuse will lead to addiction with increased potential for side effects associated with the overuse of ibuprofen. In 2019, the Commission for Human Medicines recommended that the labels of all opioids should have the prominent warning “Can cause addiction, contains opioid” on the front face of the package. This warning has been implemented in all packs of Nurofen Plus. In addition, based on evidence of addiction and dependence, the CHM gave provisional advice that the availability of codeine without a prescription may present a direct danger to public health. [CHM 18 April 2019 - Final Summary Minutes.pdf | Powered by Box](https://app.box.com/s/jv487awvqzzsrdql0o34h9gg350ceyd4/file/480539561228). The Agency is currently examining potential risk minimisation measures to address CHM advice, taking into account all benefits and risks. |
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