Flamingo Pharma Ltd. has issued a Class 4 Medicines Defect Information – Caution in Use. THIS IS NOT A RECALL. In relation to:
Amitriptyline Hydrochloride 10mg Tablets (PL: 43461/0054)
Amitriptyline Hydrochloride 25mg Tablets (PL: 43461/0055)
Amitriptyline Hydrochloride 50mg Tablets (PL: 43461/0056)
Brief description of the problem
Flamingo Pharma UK Ltd has informed the MHRA that the Patient Information Leaflet (PIL) in the products listed in this notification do not contain all the required safety information. The errors were identified following an MHRA Good Pharmacovigilance Practice (GPvP) inspection and further investigation by the Marketing Authorisation Holder, Flamingo Pharma UK Ltd.
In the section, “Warnings and precautions”: The use of Buprenorphine together with Amitriptyline tablets can lead to serotonin syndrome, a potentially life-threatening condition (see “Other medicines and Amitriptyline Hydrochloride Tablets’).
While the Flamingo Pharma UK CIU affects multiple products and batches (See attached notification document) the table below details the affected products and batches sold through by NVS.
|
NVS Product Code(s) |
Product Description | Affected Batch No’s | Expiry Date |
| 79467
82028 |
AMITRIPTYLINE TABS 10MG
AMITRIPTYLINE TABS 25MG |
1404540
1404640 |
28/12/2025
28/02/2026 |
Advice for healthcare professionals
The issue impacts all batches of Flamingo Pharma UK Ltd Amitriptyline Hydrochloride 10mg, 25mg and 50mg Film Coated Tablets. The Patient Information Leaflet for these batches contains out of date safety information, i.e. missing safety information concerning the following:
- Serotonin Syndrome
- Dry Eye
There is no risk to product quality or impact to safety of the medicines listed in this notification – see full notification for required actions.
What to do next –
- Please read the attached notification letter and follow advise (Please click here) to access the updated PIL.
- Please bringing this issue to the attention of all relevant colleagues within your business.
