SmPC - Levothyroxine Tablets BP 50 micrograms: Change history

Description of update: To update sections 4.3, 4.5, 5.1 and 5.2 of the SmPC and section 2 of the PIL  in line with the reference product, Eltroxin tablets. Additional editorial updates have been made to the PIL.

SmPC Sections updated: 4.3, 4.5, 5.1, 5.2 & 10.

Variation Description: 1) To update sections 4.2, 4.6 and 4.8 of the SmPC and PIL in line with reference product (Eltroxin 50mcg tablets, PL 10972/0031, MAH: Mercury Pharma Group Ltd, SPC updated 01/08/2022).

2) To update sections 4.4 and 4.5 and PIL section 2 to include interactions with biotin, St John's Wort (Hypericum perforatum L.) and proton pump inhibitors (PPIs) in line with the PRAC PSUSA/00001860/202201.

3) To update section 4.6 of the SmPC to include information on treatment with thyroxine during pregnancy. Page 25 of the Assessment Report (AR) states that global wording should be added by the MAHs if similar information has not already been included in the product information.

4) To update section 4.2 of the SmPC and PIL section 3 in line with the administration advice stated on the BNF website.

In addition the product information has been updated in line with the QRD template (version 10.3 rev. 09/2022).

SmPC sections updated – 4.2, 4.3, 4.4, 4.5, 4.6, 4.8 and 10.