SmPC - Digoxin Tablets BP 250 micrograms: Change history
View Summary of Product Characteristics (SmPC - Digoxin Tablets BP 250 micrograms)
Last updated on this site: 09 Sep 2025
Description of update:
SmPC sections 4.4, 4.5 and PIL section 2 have been updated in line with the PRAC recommendationEMA/PRAC/179172/2025 (EPITT No 20134) - laboratory interference leading to falsely elevated digoxin levels by enzalutamide.
SmPC section 4.5 has been updated in line with the reference product Digoxin 125 micrograms tablets - PL 39699/0009 (MAH: Aspen Pharma Trading Limited), dated 09/01/2025. Consequential update to the PIL.
Additional update to SmPC sections 2, 4.4 and PIL to correct Lactose excipient wording in line with QRD and excipient guideline.
The PIL has also been updated throughout to align with QRD and to correct typographical and grammatical errors.
Date of approval: 03/09/2025
SmPC sections updated: 2, 4.4, 4.5 and 10
Last updated on this site: 09 Sep 2025
Description of update:
SmPC sections 4.4, 4.5 and PIL section 2 have been updated in line with the PRAC recommendationEMA/PRAC/179172/2025 (EPITT No 20134) - laboratory interference leading to falsely elevated digoxin levels by enzalutamide.
SmPC section 4.5 has been updated in line with the reference product Digoxin 125 micrograms tablets - PL 39699/0009 (MAH: Aspen Pharma Trading Limited), dated 09/01/2025. Consequential update to the PIL.
Additional update to SmPC sections 2, 4.4 and PIL to correct Lactose excipient wording in line with QRD and excipient guideline.
The PIL has also been updated throughout to align with QRD and to correct typographical and grammatical errors.
Date of approval: 03/09/2025
SmPC sections updated: 2, 4.4, 4.5 and 10
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Changes: (Updated: 09 Sep 2025)
Description of update:
SmPC sections 4.4, 4.5 and PIL section 2 have been updated in line with the PRAC recommendationEMA/PRAC/179172/2025 (EPITT No 20134) - laboratory interference leading to falsely elevated digoxin levels by enzalutamide.
SmPC section 4.5 has been updated in line with the reference product Digoxin 125 micrograms tablets - PL 39699/0009 (MAH: Aspen Pharma Trading Limited), dated 09/01/2025. Consequential update to the PIL.
Additional update to SmPC sections 2, 4.4 and PIL to correct Lactose excipient wording in line with QRD and excipient guideline.
The PIL has also been updated throughout to align with QRD and to correct typographical and grammatical errors.
Date of approval: 03/09/2025
SmPC sections updated: 2, 4.4, 4.5 and 10
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Changes: (Updated: 17 Aug 2023)
To register section 3.2.P.7 Container Closure System for the 20μ Aluminium/250μ PVC blister packaging. There are also updates to section 6.5 of the SmPC (removal of reference to the heat seal lacquer). The label and leaflet are unaffected by this variation.
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Changes: (Updated: 18 May 2023)
Document formatting update only - no change to content
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Changes: (Updated: 20 Sep 2022)
Initial upload