Class 4 Drug Alert (Caution in use only) Convulex 500mg Capusles

G.L. Pharma GmbH would like to inform Healthcare professionals that they are aware that there is an error on the carton for batches 5E048A and 5H155A in relation to the strength. Inadvertently, the information "Each capsule contains 150 mg valproic acid." was printed on one side of the cartons instead of the correct "Each capsule contains 500 mg valproic acid." All other information, especially the main headings on the package ("Convulex® capsules 500 mg"), however is correct on the carton. G.L. Pharma GmbH confirms that capsules are 500mg strength. The correct strength is also given on the primary blister pack and the patient information leaflet. G.L. Pharma GmbH have informed the MHRA and the MHRA have approved the continued distribution of batches 5E048A and 5H155A until replacement stock is available.