Information about printing error in the package leaflet of certain batches of Xeloda
16.06.2014
The Agency for Medicinal Products and Medical Devices (HALMED) has received a quality defect report for Xeloda (capecitabine). This is due to a printing error in the package leaflet of certain batches of Xeloda.
In the paragraph 1 of the package leaflet "What is Xeloda and what is it used for”, there is an incorrect statement that the medicine contains 150 mf of capecitabine instead of 500 mg capecitabine. The affected batches containing the correct amount of 500 mg of capecitabine per tablet, which ia clearly stated in other parts of the package leaflet and labelling. The following batches have been affected by this quality defect , which means a printing error: B3010B02, B3024B03, X3197B05, X3164B02, X3111B02, X3048B02 and B3038B04.
Exceptionally, in order to prevent a possible interruption in the supply chain of the Croatian market, HALMED has approved the continuation of supply chain with this batches of Xeloda.
The representative of the marketing authorisation holder in the Republic of Croatia, Roche d.o.o., has made a commitment as caution assumption to inform about this quality defect all wholesalers and pharmacies who have received these batches and to inform them at any further delivery of the affected batches. At every dispensing of the affected batches, pharmacists should inform patients about this error in the package leaflet and advise them to take the prescribed medicine exactly according to the instructions of the prescribing doctor.
HALMED has not received by now any suspected adverse reaction to Xeloda.
We remind healthcare professionals that they should report any adverse reaction to HALMED, as well as quality defect. Patients who have developed any adverse reaction to medicinal product may report it directly to HALMED via form or on-line application, with recommendation regarding any adverse reaction they discover to consult with their doctor or pharmacist about the continuation of their therapy.
