GovWire

MDR number

MDR 146-02/23

Company name

Thornton & Ross Ltd

Product name

Methadone 1mg/mL Oral Solution BP - Sugar Free, PL 00240/0044

SNOMED Code

5196111000001108

Active Pharmaceutical Ingredient: methadone hydrochloride

Product name

Methadone Mixture 1mg/mL, PL 00240/0039

SNOMED Code

337711000001108

Active Pharmaceutical Ingredient: methadone hydrochloride

Brief description of the problem

Thornton & Ross Ltd has informed the MHRA that specific batches of Methadone 1mg/mL Oral Solution BP Sugar Free have been packaged with the incorrect Product Information Leaflet (PIL). The incorrect PIL is missing important safety information. Please see Appendix 1 (Page 4-6 of the Class 4 Medicines Defect Notification) for full details of the missing information including the text in the current (erroneous) version of the leaflet packaged within the affected batches and the subsequent correct PIL text.

The batches listed as not yet distributed have also been packaged with the incorrect PIL and this affects both Methadone 1mg/mL Oral Solution BP Sugar Free and Methadone Mixture 1mg/mL. The MHRA, in discussion with the Department of Health and Social Care, considers these products critical for patients, therefore these batches will not be repackaged and continue to be distributed. They are therefore included in the notification.

Advice for healthcare professionals

There is no risk to product quality as a result of this issue and the affected batches on the market are not being recalled. Supervised consumption of methadone means that it is usually administered in the presence of a healthcare professional, who can advise the patient on important safety information and precautions.

For dispensing of products from all affected batches, healthcare professionals are advised to discuss the missing information with patients and provide a copy of the updated PIL, where appropriate. The missing information in the PIL provides additional safety information related to dependency, addiction, and withdrawal reactions; potential effects on hormones; safety information about pregnancy and breastfeeding; and potential interactions with other medicines. Links to the correct PILs are provided below:

Methadone 1mg/mL Oral Solution BP - Sugar Free: https://www.medicines.org.uk/emc/product/4905/pil

Methadone Mixture 1mg/mL: https://www.medicines.org.uk/emc/product/4907/pil

Advice for patients

The Patient Information Leaflet (PIL) included in the pack with the above batches of these medicines does not contain the most up to date safety information. We have asked healthcare professionals to discuss the latest safety information with patients who are receiving medicines from these batches. Patients can also read the updated sections highlighted in Appendix 1 or read the updated version of the PIL available online (links above).

You should not suddenly stop taking this medicine. If you want to stop taking this medicine, discuss this with your prescriber first. If you have any questions about your medicine or changes to the PIL or are concerned about side effects, talk to your healthcare professional. The quality of the medicine itself is not affected. As for all medicines, any suspected adverse reactions should also be reported via the MHRAs Yellow Card scheme.

Further Information

For medical information queries please contact thorntonross@medinformation.co.uk. Upon request, Thornton & Ross Ltd will provide hard copies of the updated PIL to pharmacy teams.

Recipients of this Medicines Notification should bring it to the attention of relevant contacts by copy of this notice. NHS regional teams are asked to forward this to community pharmacists and dispensing general practitioners for information.

Yours faithfully

Telephone +44 (0)20 3080 6574

DMRC@mhra.gov.uk

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Class 4 Medicines Defect Information: Thornton & Ross Ltd, Methadone 1mg/mL Oral Solution BP - Sugar Free, Methadone Mixture 1mg/ml , EL(23)A/07