sacutril

Take orally, with or without food, twice daily (morning and evening). Swallow the tablet whole.

Sacubitril is a neprilysin inhibitor that increases levels of natriuretic peptides, leading to vasodilation, natriuresis, and diuresis. Valsartan is an angiotensin II receptor blocker (ARB) that blocks the effects of angiotensin II, leading to vasodilation and reduced aldosterone secretion.

• Hypersensitivity to the active substances or to any of the excipients.
• Concomitant use with ACE inhibitors (a 36-hour washout period is required between stopping ACEI and starting sacubitril/valsartan).
• History of angioedema related to previous ACE inhibitor or ARB therapy.
• Hereditary or idiopathic angioedema.
• Concomitant use with aliskiren in patients with diabetes mellitus or renal impairment (eGFR <60 mL/min/1.73m²).
• Severe hepatic impairment, biliary cirrhosis and cholestasis.
• Pregnancy.

Store below 30°C in a dry place, protected from light and moisture. Keep out of reach of children.

Limited data on overdose. The most likely symptoms are severe hypotension, which may be managed by symptomatic treatment. If symptomatic hypotension occurs, supportive therapy (e.g., intravenous fluids) should be administered.

CONTRAINDICATED in pregnancy due to risk of fetal injury or death. It is not known whether sacubitril/valsartan is excreted in human milk; however, due to the potential for serious adverse reactions in breastfed infants, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.

• Hypersensitivity to the active substances or to any of the excipients.
• Concomitant use with ACE inhibitors (a 36-hour washout period is required between stopping ACEI and starting sacubitril/valsartan).
• History of angioedema related to previous ACE inhibitor or ARB therapy.
• Hereditary or idiopathic angioedema.
• Concomitant use with aliskiren in patients with diabetes mellitus or renal impairment (eGFR <60 mL/min/1.73m²).
• Severe hepatic impairment, biliary cirrhosis and cholestasis.
• Pregnancy.

Store below 30°C in a dry place, protected from light and moisture. Keep out of reach of children.

Limited data on overdose. The most likely symptoms are severe hypotension, which may be managed by symptomatic treatment. If symptomatic hypotension occurs, supportive therapy (e.g., intravenous fluids) should be administered.

CONTRAINDICATED in pregnancy due to risk of fetal injury or death. It is not known whether sacubitril/valsartan is excreted in human milk; however, due to the potential for serious adverse reactions in breastfed infants, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.