MHRA Class 4 Medicines Defect Information: Propantheline Tablets 15mg (Genesis Pharmaceuticals livery (Chelonia Healthcare Limited))

Class 4 Medicines Defect Information: Propantheline Tablets 15mg (Genesis Pharmaceuticals livery (Chelonia Healthcare Limited))

Drug alert number: EL (24)A/27

Date issued: 9 July 2024

The Medicines and Health products Regulatory Agency (MHRA) has issued a class 4 medicines defect information notice for: Propantheline Tablets 15mg (Genesis Pharmaceuticals livery (Chelonia Healthcare Limited))

Company name: Chelonia Healthcare Limited

Product name: Propantheline Tablets 15mg (Genesis Pharmaceuticals livery (Chelonia Healthcare Limited)), PL 33414/0094

SNOMED Code: 42639811000001102

Active Pharmaceutical Ingredient: propantheline bromide

Brief description of the problem

Chelonia Healthcare Limited has informed the MHRA that an error relating to the product description was identified in the Patient Information Leaflet (PIL) for the batches listed in this notification. In the PIL supplied, the product is described in Section 6 as being “pale pink in colour”, whereas the tablet is actually orange in colour.

Advice for healthcare professionals

There is no risk to product quality or safety because of this issue. Therefore the affected batches are not being recalled. Due to supply considerations, batches 2402107, 2402108, 2402109 and 2402110 have been recently distributed and were not repackaged with the updated PIL prior to distribution. Chelonia Healthcare Limited has confirmed that all future batches of the product will contain an updated PIL.

Healthcare professionals, including those involved in prescribing and dispensing, should note the correct description of the tablets as “round and convex in shape, and orange in colour”, as shown in the images below.

View full alert here.

Advice for patients

Patients do not need to take any action. The medicine itself is not affected. Patients should continue to take medicines from these batches as prescribed by your healthcare professional.

Patients receiving the medicine via dosette boxes should continue to take the medicine in line with their prescription

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.

Further Information

For stock control queries please contact info@genesis-pharma.com (Tel 020 7201 0400)

For Medical queries please contact eupvg@genreg.eu (Tel: 020 7201 0421).