'Generic' overdose sections

The 'generic' overdose sections for the following drugs are available:

Aminophylline/theophylline
Amitriptyline   
Citalopram 
Codeine 
Co-proxamol 
Diazepam/temazepam 
Fluoxetine
Ibuprofen
Lithium
Paroxetine
Salicylates/aspirin 
Zoplicone

MAHs for products containing the above substances are invited to submit variations with the updated overdose sections of the SPCs.

For all paracetamol products, the minimum SPC requirements have also been updated within the overdose section. MAHs are requested to update their SPCs accordingly. Paracetamol SPC overdose section

Type of variation
These will, in the first instance be Type II standard variations and the usual fee will apply. However, should substantial amounts of data be submitted for assessment, a complex variation fee may become applicable in accordance with the Fee Regulations. 

Time frame
We shall expect to receive variations over the next six months.

Complex regulatory situations
We appreciate that the regulatory situation with some of the listed products is complex as there may be on-going action at a European level on other safety related issues. However, this should in no way prevent MAHs from reviewing their advice on overdose management and MAHs should then consider the most appropriate means of achieving the SPC update. The Agency will be happy to advise in individual situations.

Other marketing authorisations
This article draws attention to those medicinal products most frequently associated with overdose. However, MAHs are also advised to ensure that the overdose section of all SPCs is up-to-date at the time of renewal.

Contacts for further information 
For further information on this part of our site please contact Dr Nigel Baber, telephone 020 7084 2270, or e-mail info@mhra.gsi.gov.uk