Amias 2 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. Children aged below 1 year (see section 5.3). The concomitant use of Amias with …

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

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. Children aged below 1 year (see section 5.3). The concomitant use of Amias with aliskiren-containing products is contraindicated in patients with diab …

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

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

… ion of an ACE inhibitor, a potassium-sparing diuretic (e.g. spironolactone) and Amias is not recommended and should be considered only after careful evaluation of the potential benefits and risks. Intestinal angioedema Intestinal angioedema has been reported in patients treated with angiotensin II receptor antagonists, including candesartan cilexetil (see section 4.8). These patients presented with abdominal pai …

… ted experience in patients with very severe or end-stage renal impairment (Clcreatinine < 15 ml/min). In these patients Amias 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 Amias, 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). Use in p …

… 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. Primar …

… nosis of the artery to a solitary kidney. Kidney transplantation There is no experience regarding the administration of Amias in patients with a recent kidney transplantation. Hypotension Hypotension may occur during treatment with Amias 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. For children with possible intravascular volume depletion (e.g. patients treated with diuretics, particularly those with impaired renal function), candesartan treatment should be initiated under clo …

… ted experience in patients with very severe or end-stage renal impairment (Clcreatinine < 15 ml/min). In these patients Amias 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 Amias, 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). Use in p …

Dual blockade of the renin-angiotensin-aldosterone system (RAAS) There is evidence that the concomitant use of ACE inhibitors, angiotensin II receptor blockers or aliskiren increases the risk of hypotension, hyperkalaemia and decreased renal function (including acute renal failure). Dual blockade of RAAS through the combined use of ACE-inhibitors, angiotensin II receptor blockers or aliskiren is therefore not recommended (see Section 4.5 and 5.1). If dual blockade therapy is considered absolutely necessary, this should only occur under specialist supervision and subject to frequent close monitoring of renal function, electrolytes and blood pr …

… hypertensive effect of candesartan may be enhanced by other medicinal products with blood pressure lowering properties, whether prescribed as an antihypertensive or prescribed for other indications. Amias contains lactose. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine. Pregnancy AIIRAs should not be initiated during pregnancy. Unless continued AIIRA therapy is considered essential, patients planning pregnancy should be changed to alternative antihypertensive …

… hypertensive effect of candesartan may be enhanced by other medicinal products with blood pressure lowering properties, whether prescribed as an antihypertensive or prescribed for other indications. Amias contains lactose. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine. Pregnancy AIIRAs should not be initiated during pregnancy. Unless continued AIIRA therapy is considered essential, patients planning pregnancy should be changed to alternative antihypertensive …

… 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 …

Dual blockade of the renin-angiotensin-aldosterone system (RAAS) There is evidence that the concomitant use of ACE inhibitors, angiotensin II receptor blockers or aliskiren increases the risk of hypotension, hyperkalaemia and decreased renal function (including acute renal failure). Dual blockade of RAAS through the combined use of ACE-inhibitors, angiotensin II receptor blockers or aliskiren is therefore not recommended (see Section 4.5 and 5.1). If dual blockade therapy is considered absolutely necessary, this should only occur under specialist supervision and subject to frequent close monitoring of renal function, electrolytes and blood pr …

… hypertensive effect of candesartan may be enhanced by other medicinal products with blood pressure lowering properties, whether prescribed as an antihypertensive or prescribed for other indications. Amias contains lactose. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine. Pregnancy AIIRAs should not be initiated during pregnancy. Unless continued AIIRA therapy is considered essential, patients planning pregnancy should be changed to alternative antihypertensive …

… ced plasma volume and activation of the renin-angiotensin-aldosterone system. Therefore, Amias 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 …

… etics, particularly those with impaired renal function), candesartan treatment should be initiated under close medical supervision and a lower starting dose should be considered (see section 4.2). 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 …

… s. If intestinal angioedema is diagnosed, candesartan cilexetil should be discontinued and appropriate monitoring should be initiated until complete resolution of symptoms has occurred. 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). Breastfeeding Because no information is available regarding the use of Amias during breastfeeding, Amias is not recommended and alternative treatments with better established safety profiles during breast-feedi …

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

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