Candesartan Cilexetil 4 mg Tablets

• Hypersensitivity to candesartan cilexetil or to any of the excipients listed in section 6.1. • Second and third trimesters of pregnancy (see sections 4.4 and 4.6). • Severe hepatic impairment and/or cholestasis. • The concomitant use of Candesartan Cilexetil with aliskiren-containing …

… ant use of Candesartan Cilexetil with aliskiren-containing products is contraindicated in patients with diabetes mellitus or renal impairment (GFR < 60 ml/min/1.73 m2) (see sections 4.5 and 5.1). • Children aged below 1 year (see section 5.3).

• Hypersensitivity to candesartan cilexetil or to any of the excipients listed in section 6.1. • Second and third trimesters of pregnancy (see sections 4.4 and 4.6). • Severe hepatic impairment and/or cholestasis. • The concomitant use of Candesartan Cilexetil with aliskiren-containing products is contraindicated in patients with diabetes mellitus or renal i …

… andesartan cilexetil or to any of the excipients listed in section 6.1. • Second and third trimesters of pregnancy (see sections 4.4 and 4.6). • Severe hepatic impairment and/or cholestasis. • The concomitant use of Candesartan Cilexetil with aliskiren-containing products is contraindicated in patients with diabetes mellitus or renal impairment (GFR < 60 ml/min/1.73 m2) (see sections 4.5 and 5.1). • Children aged below 1 year (see section 5.3).

… andesartan cilexetil or to any of the excipients listed in section 6.1. • Second and third trimesters of pregnancy (see sections 4.4 and 4.6). • Severe hepatic impairment and/or cholestasis. • The concomitant use of Candesartan Cilexetil with aliskiren-containing products is contraindicated in patients with diabetes mellitus or renal impairment (GFR < 60 ml/min/1.73 m2) (see sections 4.5 and 5.1). • Children aged below 1 year (see section 5.3).

… n patients with very severe or end-stage renal impairment (Clcreatinine < 15 ml/min). In these patients Candesartan Cilexetil 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 Candesartan Cilexetil, 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 reactions, especially hypotension, hyperkalaemia and decreased renal function (including acute renal failure), may …

… 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. Prima …

… cur during treatment with Candesartan Cilexetil in heart failure patients. 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, h …

… n patients with very severe or end-stage renal impairment (Clcreatinine < 15 ml/min). In these patients Candesartan Cilexetil 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 Candesartan Cilexetil, 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 reactions, especially hypotension, hyperkalaemia and decreased renal function (including acute renal failure), may …

… enal impairment As with other agents inhibiting the renin-angiotensin-aldosterone system, changes in renal function may be anticipated in susceptible patients treated with Candesartan Cilexetil. When Candesartan Cilexetil 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 Candesartan Cilexetil 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 d …

… ion), Candesartan Cilexetil treatment should be initiated under close medical supervision and a lower starting dose should be considered (see section 4.2). Special warnings regarding excipients This medicinal product contains lactose. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicinal product. This medicinal product contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially “sodium-free”.

… ion), Candesartan Cilexetil treatment should be initiated under close medical supervision and a lower starting dose should be considered (see section 4.2). Special warnings regarding excipients This medicinal product contains lactose. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicinal product. This medicinal product contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially “sodium-free”.

… nt close monitoring of renal function, electrolytes and blood pressure. ACE-inhibitors and angiotensin II receptor blockers should not be used concomitantly in patients with diabetic nephropathy. Haemodialysis 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 …

… 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 reactions, especially hypotension, hyperkalaemia and decreased renal function (including acute renal failure), may increase when Candesartan Cilexetil is used in combination with an ACE inhibitor (see section 4.8). Triple combination of an ACE-inhibitor, a mineralocorticoid receptor antagonist and candesartan is also not recommended. Use of these combinations should be under specialist supervision and subject …

… ion), Candesartan Cilexetil treatment should be initiated under close medical supervision and a lower starting dose should be considered (see section 4.2). Special warnings regarding excipients This medicinal product contains lactose. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicinal product. This medicinal product contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially “sodium-free”.

… dicinal product contains lactose. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicinal product. This medicinal product contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially “sodium-free”.

… e and activation of the renin-angiotensin-aldosterone system. Therefore Candesartan Cilexetil should be carefully titrated with thorough monitoring of blood pressure in patients on haemodialysis. Renal artery stenosis Medicinal products that affect the renin-angiotensin-aldosterone system, including angiotensin II receptor antagonists (AIIRAs), may increase blood urea and serum creatinine in patients with bilat …

… ve 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 suc …

… otassium-sparing diuretic (e.g. spironolactone) and Candesartan Cilexetil is not recommended and should be considered only after careful evaluation of the potential benefits and risks. 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, oliguria or, rarely, acute renal failure. The possibility of similar effects cannot be excluded with AIIRAs. 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. The antihypertensive effect of candesartan may be enhanced by other medicinal products with blood pressure lowering properties, whether prescribed as an antihypertensive or prescribed for other indi …

… trimester of pregnancy, ultrasound check of renal function and skull is recommended. Infants whose mothers have taken AIIRAs should be closely observed for hypotension (see sections 4.3 and 4.4). Breast-feeding Because no information is available regarding the use of Candesartan Cilexteil during breast-feeding, Candesartan Cilexteil is not recommended and alternative treatments with better established sa …

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Not found in the sections read for this label. Not the same as the label being silent.