PIL - Levothyroxine 50mcg, 100mcg Tablets: Change history

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).

PIL sections updated - Heading, introduction, 2, 3, 4 and 6.