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Dual blockade of the renin-angiotensin-aldosterone system (RAAS) with aliskiren-containing medicines: Dual blockade of the renin-angiotensin-aldosterone system (RAAS) by combining Blopress and aliskiren is not recommended since there is an increased risk of hypotension, hyperkalemia, and changes in renal function.
The use of Blopress with aliskiren is contraindicated in patients with diabetes or moderate to severe renal impairment (GFR <60 ml/min/1.73 m2).
Renal impairment: As with other agents inhibiting the renin-angiotensin-aldosterone system, changes in renal function may be anticipated in susceptible patients treated with Blopress.
When Blopress 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 (Clcreatinine <15 ml/min). In these patients Blopress should be carefully titrated with thorough monitoring of blood pressure.
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 Blopress, monitoring of serum creatinine and potassium is recommended. Clinical trials in heart failure did not include patients with serum creatinine >265 µmol/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 Blopress is used in combination with an ACE inhibitor. Patients with such treatment should be monitored regularly and carefully.
Hemodialysis: During dialysis the blood pressure may be particularly sensitive to AT1-receptor blockade as a result of reduced plasma volume and activation of the renin-angiotensin-aldosterone system. Therefore, Blopress should be carefully titrated with thorough monitoring of blood pressure in patients on haemodialysis.
Renal artery stenosis: Renal function may worsen in patients with renal artery stenosis.
Other medicinal products 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 Blopress in patients with a recent kidney transplantation.
Hypotension: Hypotension may occur during treatment with Blopress 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 medicinal products acting through inhibition of the renin-angiotensin-aldosterone system. Therefore, the use of Blopress is not recommended.
Hyperkalaemia: Co-administration with potassium - sparing diuretics may result in increased potassium level.
Based on experience with the use of other medicinal products that affect the renin-angiotensin-aldosterone system, concomitant use of Blopress with potassium-sparing diuretics, potassium supplements, salt substitutes containing potassium, or other medicinal products that may increase potassium levels (e.g. heparin) may lead to increase in serum potassium in hypertensive patients.
In heart failure patients treated with Blopress, hyperkalaemia may occur. During treatment with Blopress in patients with heart failure, periodic monitoring of serum potassium is recommended, especially when taken concomitantly with ACE inhibitors and potassium-sparing diuretics such as spironolactone.
Severe hepatic impairment and/or cholestasis: There is no experience in patients with severe hepatic impairment and/or cholestasis.
General: In patients whose vascular tone and renal function depend predominantly on the activity of the renin-angiotensin-aldosterone system (e.g. patients with severe congestive heart failure or underlying renal disease, including renal artery stenosis), treatment with other medicinal products that affect this system has been associated with acute hypotension, azotaemia, oluguria or, rarely, acute renal failure. The possibility of similar effects cannot be excluded with angiotensin II receptor antagonists. As with any antihypertensive agent, excessive blood pressure decrease in patients with ischaemic cardiopathy or ischaemic cerebrovascular disease could result in a myocardial infarction or stroke. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.
Effects on ability to drive and use machines: The effect of candesartan on the ability to drive and use machines has not been studied but based on its pharmacodynamic properties is unlikely to affect this ability. When driving vehicles or operating machines it should be taken into account that dizziness or weariness may occur during treatment.
