PIL - Verapamil Tablets BP 40mg, 80mg, 120mg, 160mg: Change history

To update sections 4.4 and 4.5 of SPC in line with reference product Securon SR (PL 46302/0027). Consequently, the PIL has been updated.

Additional editorial updates in the PIL.

Variation Description:

1) To update sections 4.3 and 4.8 of the SmPC and to update the PIL in line with the reference product (Securon SR 240mg Tablets, PL 46302/0027, MAH: Mylan Generics, SPC updated 05/08/2022).

2) To update section 4.4 of the SmPC and to update the PIL section 2 to include the sodium free statement, in line with the latest EC guidelines on excipients (EMA/CHMP/302620/2017). The cartons have been updated to remove non-compulsory excipients.

Additional updates have been made to the PIL to align the information with the SmPC and to bring in line with the latest QRD template (Version 10.3, 09/2022).