SmPC - Furosemide Tablets BP 500mg: Change history

Description of update: SmPC sections 4.1 (20mg only), 4.2 (20, 500mg only), 4.3, 4.4, 4.5, 4.6, 4.7, 4.8, 4.9, 5.1, and 5.2 have been updated in line with the reference product Furosemide 40 mg Tablets - PL 28278/0014 by MAH Ipca Laboratories UK Ltd, dated 20/10/2020. Consequentially, the PIL has been updated. Additional QRD, excipient and typographical amends have been made throughout the SmPC and PIL; including heading updates to SmPC sections 1, 4.1, 4.2, 6.1, 6.6, 7, 8, and 9. Recently approved PRAC changes for interaction with aliskiren in SmPC section 4.5 and PIL have been consolidated with these TII approved changes.

SmPC Sections updated: 1, 4.1, 4.2, 4.3, 4.4, 4.5, 4.6, 4.7, 4.8, 4.9, 5.1, 5.2, 6.1, 6.6, 7, 8, 9 and 10.

Description of update: To remove obsolete alternative "COX" tablet marking from the finished product specification. In addition, Section 3 of SmPC and PIL have been updated to add the full product description, section 2 of the SmPC have been updated to add Lactose warning and editorial updated has been made to 500mg PIL.

SmPC Sections updated: 2, 3 and 10.