SmPC - Digoxin Tablets BP 62.5 micrograms: Change history
View Summary of Product Characteristics (SmPC - Digoxin Tablets BP 62.5 micrograms)
Last updated on this site: 09 Sep 2025
SmPC sections 4.4, 4.5 and PIL section 2 have been updated in line with the PRAC recommendation EMA/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
SmPC sections 4.4, 4.5 and PIL section 2 have been updated in line with the PRAC recommendation EMA/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)
SmPC sections 4.4, 4.5 and PIL section 2 have been updated in line with the PRAC recommendation EMA/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: 04 Jan 2023)
Variation Description: To reduce the finished product shelf life from 3 years to 2 years for product packed in PVC/Aluminium blister packs due to a stability study failure for tablet dissolution at 36 months. Section 6.3 of the SmPC is updated accordingly.
SmPC section(s) updated– 6.3, 10.
No changes to artwork.
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Changes: (Updated: 20 Sep 2022)
Initial upload