Alert: Amitriptyline hydrochloride 10mg, 25mg, 50mg tablets

Flamingo Pharma UK Ltd has advised of missing Patient Information Leaflet (PIL) in several batches of amitriptyline hydrochloride 10mg, 25mg, 50mg tablets

The missing information relates to

What you need to know before you take Amitriptyline Hydrochloride tablets

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’).

Possible side effects

In the section, “Not known: frequency cannot be estimated from the available data”:

Dry eyes

Please see Amitriptyline HCl 10mg, 25mg, 50mg Film Coated Tablets PIL for the correct information.

Hard copies of the updated PIL are available from quality@flamingopharma.co.uk, citing your address, product with batch details, required number of leaflets.

Affected batches are not being recalled. Healthcare teams are asked to make patients aware of the missing PIL information and supply updated PIL information where required.

MHRA alert