* Therapeutic Indications: – Essential hypertension. & & – Treatment of patients with heart failure && impaired left ventricle systolic function (left ventricular ejection & & as add-on therapy to ACE inhibitors or when ACE inhibitors are not tolerated . * Posology && Method of Administration: & & # Dosage in Hypertension: & & – The recommended initial && usual maintenance dose of Atacand is 8 mg once daily. In patients who require further & & blood pressure reduction, a dose increase to 16 mg once daily is recommended. The maximal antihypertensive effect & & is attained within 4 weeks of initiation of treatment. & & In patients with less than optimal blood pressure reduction of Atacand, combination with a thiazide diuretic is recommended. & & – Use in elderly: No initial dosage adjustment is necessary in eldely patients. & & – Use in impaired renal function: & & No initial dosage adjustment is necessary in patients with mild to moderate renal impairment (i.e. creatinine clearance >/= & & 30 mL/min/1.73 m2 BSA). In patients with severe renal impairment (i.e. creatinine clearance <30 mlmin1.73 m2 bsa, & & the clinical experience is limited and a lower initial dose of 4 mg should be considered. & & – Use in impaired hepatic function: & & No initial dosage adjustment is necessary in patients with mild to moderate chronic liver disease. There is only limited & & experience available in patients with severe hepatic impairment and/or cholestasis. A lower initial dose of 4 mg should & & therefore be considered in these patients. & & – Concomitant therapy: Addition of a thiazide-type diuretic such as hydrochlorothiazide has been shown to have an additive & & antihypertensive effect with Atacand. (Atacand may be administered with other antihypertensive agents). & & # Dosage in Heart Failure: & & – The usual recommended initial dose of Atacand is 4 mg once daily. Up-titration to the target dose of 32 mg once daily or & & the highest tolerated dose is done by doubling the dose at intervals of at least 2 weeks. & & – Special patient populations: No initial dose adjustment is necessary for eldely patients or in patients with renal or hepatic & & impairment. & & – Concomitant therapy: Atacand can be administered with other heart failure treatment, including ACE inhibitors, beta-blockers, & & diuretics && digitalis or a combination of these medicinal products. & & # Administration: Atacand should be taken once daily with or without food. & & # Use in children && adolescents: The safety && efficacy of Atacand have not been established in children && adolescents & & under 18 years. * Contraindications: & & – Hypersensitivity to any component of Atacand. & & – Pregnancy and lactation. * Special warnings and precautions for use: & & # Renal impairment: & & – As with other agents inhibiting the renin-angiotensin-aldosterone system, changes in renal function may be anticipated & & in susceptible patients treated with Atacand. & & – When Atacand is used in hypertensive patients with renal impairment, periodic monitoring of serum potassium and & & creatinine levels is recommended. There is limited experience in patients with very severe or end-stage renal impairment & & (i.e. creatinine clearance<15 mlmin). & & – Evaluation of patients with heart failure should include periodic assessments of renal function, especially in elderly patients & & 75 years or older, and patients with impaired renal function. During dose titration of Atacand, monitoring of serum creatinine & & and potassium is recommended. Clinical trials in heart failure did not include patients with serum creatinine >265 ?mol/L (>3 mg/dL). & & # Concomitant therapy with an ACE inhibitor in heart failure: & & The risk of adverse events, especially renal function impairment and hyperkalaemia, may increase when candesartan is & & used in combination with an ACE inhibitor (see section 4.8 Undesirable effects). Patients with such treatment should be & & monitored regularly and carefully. & & # Renal artery stenosis: & & Other drugs that affect the renin-angiotensin-aldosterone system, i.e. angiotensin converting enzyme (ACE) inhibitors, & & may increase blood urea and serum creatinine in patients with bilateral renal artery stenosis or stenosis of the artery & & to a solitary kidney. A similar effect may be anticipated with angiotensin II receptor antagonists. & & # Kidney transplantation: & & There is no experience regarding the administration of Atacand therapy in patients with a recent kidney transplantation. & & # Hypotension: & & Hypotension may occur during treatment with Atacand in heart failure patients. As described for other agents acting on & & the renin-angiotensin-aldosterone system, it may also occur in hypertensive patients with intravascular volume depletion & & such as those receiving high dose diuretics. Caution should be observed when initiating therapy and correction & & of hypovolemia should be attempted. & & # Anaesthesia and surgery: & & Hypotension may occur during anaesthesia and surgery in patients treated with angiotensin II antagonists due to blockade & & of the renin-angiotensin system. Very rarely, hypotension may be severe such that it may warrant the use of intravenous & & fluids and/or vasopressors. & & # Aortic and mitral valve stenosis (obstructive hypertrophic cardiomyopathy): & & As with other vasodilators, special caution is indicated in patients suffering from haemodynamically relevant aortic or mitral & & valve stenosis, or obstructive hypertrophic cardiomyopathy. & & # Primary hyperaldosteronism: & & Patients with primary hyperaldosteronism will not generally respond to antihypertensive drugs acting through inhibition & & of the renin-angitensin-aldosterone system. Therefore, the use of Atacand is not recommended. & & # Hyperkalaemia: & & – Based on experience with the use of other medicinal products that affect the renin-angiotensin-aldosterone system, & & concomitant use of Atacand with potassium-sparing diuretics, potassium supplements, salt substitutes containing potassium, & & or other drugs that may increa