SmPC - Trimethoprim Tablets BP 200mg: Change history
View Summary of Product Characteristics (SmPC - Trimethoprim Tablets BP 200mg)
Last updated on this site: 02 Apr 2026
Description of update:
SmPC sections 4.3, 4.4, 4.6, 4.8 and PIL for the above-listed MAs have been updated in line with PSUSA/00003045/202501 – for causal relationship between trimethoprim and DRESS, congenital malformations / spontaneous abortions, and hallucinations. Section 4.8 has also been updated to correct the ADR frequency ‘Unknown’ to ‘Not known’ in line with QRD. Additionally, SmPC section 6.1 has been updated to add in the excipient name ‘microcrystalline cellulose’ next to E460 as requested by the MHRA in the grant letter for variation PL 00142/0224 – 0076.
Date of approval: 20/03/2026
SmPC sections updated: 4.3, 4.4, 4.6, 4.8 and 6.1
Last updated on this site: 02 Apr 2026
Description of update:
SmPC sections 4.3, 4.4, 4.6, 4.8 and PIL for the above-listed MAs have been updated in line with PSUSA/00003045/202501 – for causal relationship between trimethoprim and DRESS, congenital malformations / spontaneous abortions, and hallucinations. Section 4.8 has also been updated to correct the ADR frequency ‘Unknown’ to ‘Not known’ in line with QRD. Additionally, SmPC section 6.1 has been updated to add in the excipient name ‘microcrystalline cellulose’ next to E460 as requested by the MHRA in the grant letter for variation PL 00142/0224 – 0076.
Date of approval: 20/03/2026
SmPC sections updated: 4.3, 4.4, 4.6, 4.8 and 6.1
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Changes: (Updated: 02 Apr 2026)
Description of update:
SmPC sections 4.3, 4.4, 4.6, 4.8 and PIL for the above-listed MAs have been updated in line with PSUSA/00003045/202501 – for causal relationship between trimethoprim and DRESS, congenital malformations / spontaneous abortions, and hallucinations. Section 4.8 has also been updated to correct the ADR frequency ‘Unknown’ to ‘Not known’ in line with QRD. Additionally, SmPC section 6.1 has been updated to add in the excipient name ‘microcrystalline cellulose’ next to E460 as requested by the MHRA in the grant letter for variation PL 00142/0224 – 0076.
Date of approval: 20/03/2026
SmPC sections updated: 4.3, 4.4, 4.6, 4.8 and 6.1
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Changes: (Updated: 04 Feb 2025)
To update section 5.1 of the SmPC to bring in line with EMA guidance to relocate MIC data from the product information.
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Changes: (Updated: 31 May 2023)
Description of update: 1) To register section 3.2.P.7 of the dossier to reflect details of the blister packaging material. 2) To remove reference to the heat seal lacquer from section 6.5 of the SmPC.
There have been no changes to the blister packaging material itself, only an update in the supporting dossier details. There are no changes to the leaflet and labelling text.
SmPC section(s) updated– 6.5, 10
No changes to artwork
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Changes: (Updated: 21 Mar 2023)
Variation Description: To update sections 4.4, 4.5, 4.6, 4.8 and 5.2 of the SmPC in line with the reference product, Trimethoprim 100mg Tablets (PL 06453/0043, MAH: Athlone Laboratories Limited) dated 16th June 2022. Consequently, the PIL has been updated. In addition, section 2 of the SmPC has been updated to follow the standard QRD wording at the request of the MHRA.
SmPC sections updated – 2, 4.4, 4.5, 4.6, 4.8, 5.2 and 10.
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Changes: (Updated: 22 Sep 2022)
Initial upload