PIL - Lamotrigine Accord 25 mg, 50 mg, 100 mg, 200 mg Tablets: Change history
View Patient Information Leaflet (PIL - Lamotrigine Accord 25 mg, 50 mg, 100 mg, 200 mg Tablets)
Last updated on this site: 20 Apr 2026
Update to SPC sections 4.2, 4.4, 4.5, 4.8 in line with reference product Lamictal 25, 50, 100, 200 mg tablets (PL 00003/0272, 0273, 0274, 0297, MAH: GlaxoSmithKline UK, dated 05/11/2025). Consequently the PIL has been updated. Additional editorial updates in SPC sections 4.7, 5.1, 5.2, 5.3 and PIL.
PIL sections updated: 2, 3, 4 and 6
Variation approval date: 13/04/2026
Last updated on this site: 20 Apr 2026
Update to SPC sections 4.2, 4.4, 4.5, 4.8 in line with reference product Lamictal 25, 50, 100, 200 mg tablets (PL 00003/0272, 0273, 0274, 0297, MAH: GlaxoSmithKline UK, dated 05/11/2025). Consequently the PIL has been updated. Additional editorial updates in SPC sections 4.7, 5.1, 5.2, 5.3 and PIL.
PIL sections updated: 2, 3, 4 and 6
Variation approval date: 13/04/2026
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Changes: (Updated: 20 Apr 2026)
Update to SPC sections 4.2, 4.4, 4.5, 4.8 in line with reference product Lamictal 25, 50, 100, 200 mg tablets (PL 00003/0272, 0273, 0274, 0297, MAH: GlaxoSmithKline UK, dated 05/11/2025). Consequently the PIL has been updated. Additional editorial updates in SPC sections 4.7, 5.1, 5.2, 5.3 and PIL.
PIL sections updated: 2, 3, 4 and 6
Variation approval date: 13/04/2026
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Changes: (Updated: 24 Jul 2025)
SmPC sections 4.4, 4.8, 5.3 and the PIL have been updated in line with the reference product Lamictal 25mg Tablets (PL 00003/0272; MAH: The Wellcome Foundation Ltd) dated 25th November 2024.
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Changes: (Updated: 09 Aug 2024)
To update sections 4.2, 4.4, 4.5, 4.6, 4.8, 4.9, and 5.3 of the SmPC and the PIL for Lamotrigine Accord 25, 50, 100, 200mg Tablets in line with the reference product Lamictal tablets (PL 00003/0272, 0273, 0274, 0297; MAH: The Wellcome Foundation Ltd) dated 2nd November 2023. In addition, editorial updates have been made to PIL.
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Changes: (Updated: 14 Nov 2023)
Description of update: To update sections 4.4, 4.8 and 4.9 of the SmPC in line with PSUSA/00001825/202211 recommendations for HLA-B*1502 allele, tics, pseudolymphoma, and use of intravenous lipid therapy. The PIL is updated as a consequence. Additional updates to excipient and ADR information. Typographical and QRD updates in the PIL.
PIL sections updated: Heading, introduction, index, 1, 2, 3, 4, 5 and 6.
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Changes: (Updated: 07 Jun 2023)
Website administration update - no change to content
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Changes: (Updated: 28 Mar 2023)
Description of update: To update sections 4.2, 4.4, 4.5, 4.6, 4.8, 4.9, 5.1 and 5.3 of the SmPC to bring in line with the reference product information Lamictal (PL 00003/0272-0273-0274-0297).Consequently, the PIL has been updated.
Updated sections of PIL: 1, 2, 3, 4, 6.
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Changes: (Updated: 21 Sep 2022)
initial upload