Warning issued over barcode error on urinary drug

The Medicines and Healthcare products Regulatory Agency (MHRA) have issued a class 4 medicines defect notification for several batches of Quadrant Pharmaceuticals Limited's product vesomni, which is typically used to treat urinary problems in men, due to a barcode error.

Quadrant Pharmaceuticals Limited have informed the MHRA that their parallel imported packs of vesomni 6 mg/0.4 mg modified release tablets have been printed with the incorrect barcode/GTIN on the carton.

The GTIN printed on the affected packs is the GTIN for their parallel imported solaraze 3% gel 2 x 25 g packs (containing diclofenac). The other product details on the carton, including the name, strength and pharmaceutical form of the medicine are correct.

Product quality of the vesomni 6 mg/0.4 mg modified release tablets has not been impacted by this labelling issue and, therefore, the affected batches are not being recalled.

Vesomni is a combination of two different medicines called solifenacin and tamsulosin in one tablet. Solifenacin belongs to a group of medicines called anticholinergics and tamsulosin belongs to a group of medicines called alpha-blockers.

Vesomni is used in men to treat both moderate to severe storage symptoms and voiding symptoms of the lower urinary tract which are caused by bladder problems and an enlarged prostate (benign prostatic hyperplasia). Vesomni is used when previous treatment with a monoproduct for this condition did not relieve symptoms adequately.

Healthcare professionals are advised not to use this batch of medicine in robotic or automated dispensing or stocking systems, and instead to carry out manual dispensing and stocking, as appropriate.

Patients who experience adverse reactions or have any questions about their medication should seek medical attention. Any suspected adverse reactions should also be reported via the MHRA Yellow Card scheme.