PIL - Indometacin 25mg, 50mg Capsules: Change history

Description of update: To update 4.3, 4.4, 4.5, 4.6, 4.8, 4.9(50mg), 5.1 and 5.3 of the SmPC in line with the QRD update following reference product comparison with Indocid Capsules 50mg (PL 39699/012, 013; MAH: Aspen Pharma Trading Limited). Consequently, the PIL has been updated. Additional QRD updates throughout the SPC and PIL. Including updates to section headings in SPC section 1, 4.1, 6.6, 7, 8 and 9.

PIL sections updated: Heading, index, 2, 3, 4, 5 and 6.

Single Variation

Variation type: IB C.I.3.z

Variation Description:

To update section 4.6 of the SmPC to bring in line with PRAC recommendations for all systemic NSAIDs use during pregnancy. Consequently, the PIL has been updated.

Additional typographical updates in the PIL and spelling correction of ‘corticosteriods’ to ‘corticosteroids’.