SmPC- Naproxen 250mg Gastro-resistant Tablets: Change history

To update section 4.4 and 4.8 of the SmPC to update ADRs to include DRESS, FDE and use in pregnancy warnings in line with PSUSA/02125/202308. The PIL has been updated accordingly.

• Description of update:

  1. IB, B.II.b.3.z   To register a change in the manufacturing process of the finished product by removing the polishing step and making some editorial corrections. Consequently, section 6.1 of the SmPC and the PIL has been updated. Also editorial corrections to M3.2.P.3.3 Manufacturing Process and Process Controls (250mg, 375mg, 500mg dosage strengths) to correct the name for Lactose in M3.2.P.3.3 to reflect what is registered in M3.2.P.1, M3.2.P.3.2, leaflet and SmPCs.            

  2. IB, B.II.b.3.z   To register a change in the manufacturing formula of the finished product by deletion of historical references in M3.2.P.3.2 Batch Formula to 19%w/w coating weight gain (as not in line with M3.2.P.3.3 and M3.2.P.1 and to reflect current practice; 17%w/w coating weight gain is correct). Also editorial corrections to M3.2.P.3.2 Batch Formula (250mg, 375mg, 500mg dosage strengths):

                 1. Consequential correction of historical typographical errors for Crospovidone content from 9.75kg to 3.77kg.

                 2. Consequential correction of historical typographical errors for nomenclature of Eudragit L 100-55 from Coplymer to Copolymer.

  3. IB C.I.2.a     To update section 4.6 of the SmPC to bring in line with the reference product Naprosyn 250mg tablets (PL 43252/0004, MAH: Atnahs Pharma UK Ltd). Consequently the PIL has been updated. Additional typographical updates made in the PIL.

  SmPC Sections updated: 4.6, 6.1 and 10.

Variation Description: To update section 4.6 of the SmPC and the PIL in line with the PRAC recommendations for all systemic NSAIDs used during pregnancy. In addition, to correct 'toxic epidermal necrosis' to `toxic epidermal necrolysis' in line with IME term in section 4.8 of the SmPC and the PIL. Additionally, to correct the grammar and spelling throughout the PIL as well as update section 4 of the PIL to remove the repetition of the wording `not known frequency cannot be estimated from the available data'.

SmPC sections updated – 4.6, 4.8 and 10