Accord-UK Ltd have informed us that important safety warnings for the excipient Propylene glycol are missing from the patient information leaflet (PIL).

MDR Number

MDR 006-03/21

Company name

Accord-UK Ltd

Product description

Diazepam 2mg/5ml Oral Solution Sugar Free

The following batches have been packed and are waiting QP certification:

Diazepam 2mg/5ml Oral Solution Sugar Free

Brief description of the problem

Accord-UK Ltd have informed us that important safety warnings for the excipient Propylene glycol are missing from the patient information leaflet (PIL) used in the above batches (including the batches waiting QP certification) which should be present in accordance with the current annex to the Excipient Guidelines. Additionally, the warnings for sorbitol need updating although similar warnings are already present. The product is not subject to recall due to supply and shortage considerations.

The following excipient warnings have now been added to the PIL for future batches:

• Diazepam oral solution contains 409mg Propylene glycol per 5ml. If your child is less than 5 years old, talk to your doctor or pharmacist before giving them this medicine, in particular if they use other medicines that contain propylene glycol or alcohol. If you suffer from a liver or kidney disease, do not take this medicine unless recommended by your doctor. Your doctor may carry out extra checks while you are taking this medicine.
• Diazepam oral solution contains 1.91g to 2.58g of sorbitol per 5ml solution. Sorbitol is a source of fructose. If your doctor has told you that you (or your child) have an intolerance to some sugars or if you have been diagnosed
  

  Advice for healthcare professionals

  Healthcare professionals are requested when prescribing this medicine to inform patient’s and notify them of the information above. There is no risk to product quality as a result of this issue, therefore the associated batches are not being recalled at this time. The product is not subject to recall due to supply and shortage considerations with hereditary fructose intolerance (HFI), a rare genetic disorder in which a person cannot break down fructose, talk to your doctor before you (or your child) take or receive this medicine. Sorbitol may cause gastrointestinal discomfort and mild laxative effect. Calorific value 2.6 kcal/g sorbitol.

• Accord-UK have confirmed that they will be providing hard copies of the updated PIL to wholesalers and pharmacies so that any remaining stock in the dispensary can be supplemented with the updated PIL information.
• Additionally, for all batches which have not been certified and are due to be released as per the notification above, Accord-UK have confirmed that they will be providing hard copies of the updated PIL with each delivery.
• Healthcare Professionals can also contact Accord-UK Ltd via the Customer Services Team on 0800373573 and request a hard copy of the updated PIL to be sent to them by post.
• The updated PIL information is available via the eMC website should healthcare professionals need access before hard copies are available: https://www.medicines.org.uk/emc/product/5783/smpc#gref

For full guidance and to download the accompanying documentation, please click here