PIL - Digoxin 62.5mcg, 125mcg, 250mcg Tablets: Change history
View Patient Information Leaflet (PIL - Digoxin 62.5mcg, 125mcg, 250mcg Tablets)
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: 20 Sep 2022)
Initial upload