PIL - Gabapentin Accord 600mg, 800mg Film-coated Tablets: Change history
View Patient Information Leaflet (PIL - Gabapentin Accord 600mg, 800mg Film-coated Tablets)
Last updated on this site: 03 Mar 2026
Grouped IB variation:
1) Update to SPC sections 4.2, 4.4, 4.8, 4.9, PIL and labelling in line with the MHRA Safety Review recommendations to improve communication of risks for Gabapentinoid, Benzodiazepine and Z-drug classes of medications.
2)Update to SPC sections 4.4, 4.8 and PIL in line with PSUSA/00001499/202502 to add warning for exacerbation of myasthenia gravis, and withdrawal reactions following dose reduction.
MAH has taken the opportunity to make some editorial amends and corrections, including editorial amends in the PIL, minor text correction in 800mg SPC section 4.3, and correction to remove PL number from foil component mock-ups.
Approval date: 27/02/2026
PIL sections updated: Heading, Introduction, 1, 2, 3, 4 and 6.
Last updated on this site: 03 Mar 2026
Grouped IB variation:
1) Update to SPC sections 4.2, 4.4, 4.8, 4.9, PIL and labelling in line with the MHRA Safety Review recommendations to improve communication of risks for Gabapentinoid, Benzodiazepine and Z-drug classes of medications.
2)Update to SPC sections 4.4, 4.8 and PIL in line with PSUSA/00001499/202502 to add warning for exacerbation of myasthenia gravis, and withdrawal reactions following dose reduction.
MAH has taken the opportunity to make some editorial amends and corrections, including editorial amends in the PIL, minor text correction in 800mg SPC section 4.3, and correction to remove PL number from foil component mock-ups.
Approval date: 27/02/2026
PIL sections updated: Heading, Introduction, 1, 2, 3, 4 and 6.
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Changes: (Updated: 03 Mar 2026)
Grouped IB variation:
1) Update to SPC sections 4.2, 4.4, 4.8, 4.9, PIL and labelling in line with the MHRA Safety Review recommendations to improve communication of risks for Gabapentinoid, Benzodiazepine and Z-drug classes of medications.
2)Update to SPC sections 4.4, 4.8 and PIL in line with PSUSA/00001499/202502 to add warning for exacerbation of myasthenia gravis, and withdrawal reactions following dose reduction.
MAH has taken the opportunity to make some editorial amends and corrections, including editorial amends in the PIL, minor text correction in 800mg SPC section 4.3, and correction to remove PL number from foil component mock-ups.
Approval date: 27/02/2026
PIL sections updated: Heading, Introduction, 1, 2, 3, 4 and 6.
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Changes: (Updated: 17 Jun 2025)
The following changes have been notified:
Type IAIN - B.II.b.1.a - addition of a manufacturing site for part or all of the manufacturing process of the finished product - secondary packaging site - addition of Accord Healthcare Single Member S.A., Greece as a secondary packaging site.
Type IAIN - B.II.b.2.c.2 - change to batch release arrangements and quality control testing of the finished product - addition of a manufacturer responsible for importation and/or batch release - including batch control/testing - addition of Accord Healthcare Single Member S.A., Greece as a site responsible for batch certification and chemical/physical & microbiological non-sterility quality control testing.
The manufacturers in Section 6 of the PIL have been updated.
PIL sections updated: Section 6 only.
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Changes: (Updated: 08 Apr 2025)
To update SmPC sections 4.4, 4.6, 4.8, 4.9, 5.1 and PIL section in line with the reference product Neurontin 600 mg film-coated tablets (EU procedure number: DE/H/0899/004, MAH: Upjohn EESV, Ref Revision date: 03/2024).
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Changes: (Updated: 22 Jun 2023)
Description of update: Type IA group variation for:
• Type IAIN (C.I.3.a); To update the SPC and PIL in-line with wording of PSUSA (PSUSA/00001499/202202 published on EC) procedure.
• Type IA (A.6) variation to update the ATC Code for “Gabapentin” as published by WHO.
PIL sections updated: 2, 3, 4, 6.
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Changes: (Updated: 22 Sep 2022)
Initial upload