Freedom of Information request (FOI 22/936)
Published 17 January 2024
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19th October 2022
FOI 22/936
Dear
Thank you for your email and we apologise for delay in response.
On 31st August 2022 we received your request under the Freedom of Information Act “Please could you provide the Merrell Patient Information Leaflets for Debendox, which contained Doxylamine, Dicyclomine and Pyridoxine and the other Debendox PIL which contained only Doxylamine and Pyridoxine.”
We have not identified in our records a copy of patient information leaflets for Debendox in either the triple (doxylamine, dicyclomine and pyridoxine) combination or the dual (doxylamine and pyridoxine) combination. Merrell Dow Pharmaceuticals voluntarily ceased production of Debendox in 1983. It became mandatory for Patient Information Leaflets to be provided with medicines in 1999 (unless the required information could be accommodated on the outer packaging) and before this provision of leaflet was voluntary. It is possible that a PIL may not have been in place at the time Debendox was available.
As you may be aware, doxylamine succinate 10mg, pyridoxine hydrochloride 10mg is currently authorised as the combination product Xonvea (PL 44081/0006) for the treatment of nausea and vomiting of pregnancy in women who do not respond to conservative management (i.e. changes in diet or other non-medicine treatments). The PIL for Xonvea is attached.
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Yours sincerely MHRA Customer Experience Centre