Direct Healthcare Professional Communication on discontinuation of supply of Tegretol® Chewtabs (carbamazepine) Dear Healthcare Professional, Novartis would like to advise you of the discontinuation of supply of Tegretol (carbamazepine) Chewtabs (100 mg and 200 mg). Based on current demand, supply of the 100 mg Chewtab tablet is expected to be depleted by May 2015 and of the 200 mg Chewtab tablet by end of October 2014. The discontinuation is not related to any safety issue and has arisen due to the closure of the manufacturing site where the formulations were produced for the UK. Unfortunately, it has not been possible to identify an alternative manufacturing site in the Novartis network that was capable of producing Tegretol Chewtab within the registered specifications that are necessary to meet regulatory standards. Tegretol is indicated for the treatment of epilepsy (generalised tonic-‐clonic and partial seizures), paroxysmal pain of trigeminal neuralgia and prophylaxis of manic-‐depressive psychosis in patients unresponsive to lithium therapy. Considerations for you and your patients: • Novartis would advise that no new patients are initiated on Tegretol Chewtabs and that alternatives are sought for patients currently prescribed them. • Abrupt withdrawal of Tegretol may precipitate seizures, therefore withdrawal should be gradual. If treatment with Tegretol Chewtabs has to be withdrawn abruptly in a patient with epilepsy, the changeover to another anti-‐epileptic drug should be performed under the cover of a suitable drug. Please refer to the SmPC for further safety information. • Novartis is not in a position to be able to recommend alternative medications, as this would need to be a clinical decision based on the individual patient’s medical history. For full prescribing information please refer to the Tegretol Chewtabs SmPC, which can be found at http://www.medicines.org.uk/emc. Call for Reporting Please continue to report suspected adverse drug reactions (ADRs) to the MHRA through the Yellow Card Scheme. Please report: • all suspected ADRs that are serious or result in harm. (Serious reactions are those that are fatal, life-‐threatening, disabling or incapacitating, those that cause a congenital abnormality or result in hospitalisation, and those that are considered medically significant for any other reason.) • all suspected ADRs associated with new drugs and vaccines identified by the black triangle ▼ It is easiest and quickest to report ADRs online via the Yellow Cards website: www.mhra.gov.uk/yellowcard. Alternatively, prepaid Yellow Cards for reporting are available: • by writing to FREEPOST YELLOW CARD (no other address details necessary) • by emailing [email protected] • at the back of the British National Formulary (BNF) • by telephoning the Commission on Human Medicines (CHM) free phone line: 0800-‐731-‐6789 • or by downloading and printing a form from the Yellow Card section of the MHRA website When reporting please provide as much information as possible, including information about medical history, any concomitant medication, onset, treatment dates, and product brand name. Adverse events for Novartis products should also be reported to Novartis on 01276 698 370 or via the following link: https://psi.novartis.com If you have any questions on the discontinuation of the Tegretol Chewtabs or require further information, please contact Novartis Medical Information department on 01276 698370 or email [email protected]. Yours faithfully, Dr Dimitrios Georgiopoulos, MD Chief Scientific Officer Novartis Pharmaceuticals UK Ltd. TEG14-‐C002 September 2014