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Entresto must not be initiated until 36 hours after taking the last dose of ACE inhibitor therapy.

Patients with mild and moderate renal impairment are more at risk of developing hypotension (see section 4.2).

There is very limited clinical experience in patients with severe renal impairment (estimated GFR Use of Entresto may be associated with decreased renal function.

There is limited experience in patients not currently taking an ACE inhibitor or an ARB or taking low doses of these medicinal products, therefore a starting dose of 24 mg/26 mg twice daily and slow dose titration (doubling every 3-4 weeks) are recommended in these patients (see “Titration” in section 5.1).

Treatment should not be initiated in patients with serum potassium level Elderly population The dose should be in line with the renal function of the elderly patient.

If patients experience tolerability issues (systolic blood pressure [SBP] ≤95 mm Hg, symptomatic hypotension, hyperkalaemia, renal dysfunction), adjustment of concomitant medicinal products, temporary down–titration or discontinuation of Entresto is recommended (see section 4.4).

In PARADIGM-HF study, Entresto was administered in conjunction with other heart failure therapies, in place of an ACE inhibitor or other angiotensin II receptor blocker (ARB) (see section 5.1).

• Hereditary or idiopathic angioedema (see section 4.4).

• Concomitant use with aliskiren-containing medicinal products in patients with diabetes mellitus or in patients with renal impairment (e GFR • The combination of Entresto with an ACE inhibitor is contraindicated due to the increased risk of angioedema (see section 4.3).

This medicinal product is subject to additional monitoring.


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