PIL - Trimethoprim Tablets BP 200mg: Change history
View Patient Information Leaflet (PIL - 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.
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.
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.
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: 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.
PIL sections updated – 2, 4, 5 and 6.
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Changes: (Updated: 22 Sep 2022)
Initial upload