SmPC - Lotprosin XL 24mg Prolonged-release Capsules, hard: Change history
View Summary of Product Characteristics (SmPC - Lotprosin XL 24mg Prolonged-release Capsules, hard)
Last updated on this site: 11 Jun 2026
Description of update: IAIN C.3.a -Update to SmPC section 4.8 and PIL section 4 in line with PRAC recommendation (EPITT No: 20196) to add ADR ‘Nightmares’.
Date of approval: 15/05/2026.
SmPC sections updated: 4.8 and 10
Last updated on this site: 11 Jun 2026
Description of update: IAIN C.3.a -Update to SmPC section 4.8 and PIL section 4 in line with PRAC recommendation (EPITT No: 20196) to add ADR ‘Nightmares’.
Date of approval: 15/05/2026.
SmPC sections updated: 4.8 and 10
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Changes: (Updated: 11 Jun 2026)
Description of update: IAIN C.3.a -Update to SmPC section 4.8 and PIL section 4 in line with PRAC recommendation (EPITT No: 20196) to add ADR ‘Nightmares’.
Date of approval: 15/05/2026.
SmPC sections updated: 4.8 and 10
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Changes: (Updated: 25 May 2023)
Variation Description:
To update sections 4.1, 4.2, 4.4, 4.5, 4.8, 4.9 (16mg only) and 5.1 of the SmPC and sections 2 and 4 of PIL in line with the reference product REMINYL XL 8, 16, 24mg prolonged-release capsules, hard (PL 16189/0119, 0120, 0121; MAH: Takeda UK Limited; dated 18/05/2022).
In Addition updates to SmPC section 4.8 and PIL of the national reporting system wording, in line with QRD template Appendix V (Version 10.3).
Editorial updates have been made to SmPC section 4.1.
Additional minor typographical changes throughout the SmPCs and PIL.
SmPC sections updated- 4.1, 4.2, 4.4, 4.5, 4.8, 4.9 (16mg only), 5.1 and 10.
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Changes: (Updated: 22 Sep 2022)
Initial upload