Dual blockade of the renin-angiotensin-aldosterone system (RAAS) through combination w/ ACE inhibitors or aliskiren is not recommended. Not to be used concomitantly w/ ACE inhibitors in patients w/ diabetic nephropathy. Not recommended in patients w/ primary aldosteronism. Increased risk of severe hypotension & renal insufficiency in patients w/ bilateral renal artery stenosis or stenosis of the artery to a single functioning kidney. Hyperkalemia may occur especially in the presence of renal impairment, overt proteinuria due to diabetic renal disease, &/or heart failure. Acute hypotension, azotemia, oliguria, or rarely acute renal failure in patients whose vascular tone & renal function depend predominantly on the activity of the RAAS eg, patients w/ severe CHF or underlying renal disease including renal artery stenosis. Excessive BP decrease in patients w/ ischemic cardiopathy or CV disease could result in MI or stroke. Caution in patients suffering from aortic or mitral stenosis, or obstructive hypertrophic cardiomyopathy. Less favorable effects on renal & CV events in both women & non-white subjects w/ advanced renal disease. Less effective in lowering BP in black people. Correct vol- &/or Na-depletion (eg, in patients w/ vigorous diuretic therapy, dietary salt restriction, diarrhea or vomiting) prior to administration. Periodic monitoring of K & creatinine serum levels is recommended in patients w/ renal impairment. Combination w/ lithium is not recommended. Not to be taken by patients w/ galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption. Dizziness or weariness may occur & should be taken into account when driving vehicles or operating machines. No experience in patients w/ severe hepatic impairment; recent kidney transplant. Not recommended during 1st trimester of pregnancy & should not be initiated during pregnancy. Safety & efficacy have not been established in childn.