SmPC - Eplerenone 25, 50mg Film-coated Tablets: Change history
View Summary of Product Characteristics (SmPC - Eplerenone 25, 50mg Film-coated Tablets)
Last updated on this site: 06 Dec 2022
Section 5.1 – addition of “In a ten week study of paediatric patients with hypertension (age range four to 17 years, n=304), eplerenone, at doses (from 25 mg up to 100 mg per day) that produced exposure similar to that in adults, did not lower blood pressure effectively. In this study and in a one-year paediatric safety study in 149 patients, the safety profile was similar to that of adults. Eplerenone has not been studied in hypertensive patients less than four years old because the study in older paediatric patients showed a lack of efficacy. (See section 4.2).”
Section 5.2 – minor addition and deletion
Last updated on this site: 06 Dec 2022
Section 5.1 – addition of “In a ten week study of paediatric patients with hypertension (age range four to 17 years, n=304), eplerenone, at doses (from 25 mg up to 100 mg per day) that produced exposure similar to that in adults, did not lower blood pressure effectively. In this study and in a one-year paediatric safety study in 149 patients, the safety profile was similar to that of adults. Eplerenone has not been studied in hypertensive patients less than four years old because the study in older paediatric patients showed a lack of efficacy. (See section 4.2).”
Section 5.2 – minor addition and deletion
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Changes: (Updated: 06 Dec 2022)
Section 5.1 – addition of “In a ten week study of paediatric patients with hypertension (age range four to 17 years, n=304), eplerenone, at doses (from 25 mg up to 100 mg per day) that produced exposure similar to that in adults, did not lower blood pressure effectively. In this study and in a one-year paediatric safety study in 149 patients, the safety profile was similar to that of adults. Eplerenone has not been studied in hypertensive patients less than four years old because the study in older paediatric patients showed a lack of efficacy. (See section 4.2).”
Section 5.2 – minor addition and deletion
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Changes: (Updated: 20 Sep 2022)
Initial upload