Candesartan cilexetil 8mg tablets

Hypersensitivity to candesartan cilexetil or to any of the excipientslisted 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 Candesartan …

… itivity to candesartan cilexetil or to any of the excipientslisted 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 Candesartan with aliskiren-containing products is contra-indicated in patients with diabetes mellitus or renal impairment (GFR < 60 ml/min/1.73 m2) (see Sections 4.5 and 5.1).

Hypersensitivity to candesartan cilexetil or to any of the excipientslisted 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 Candesartan with aliskiren-containing products is contra-indicated in patients wi …

… he excipientslisted 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 Candesartan with aliskiren-containing products is contra-indicated in patients with diabetes mellitus or renal impairment (GFR < 60 ml/min/1.73 m2) (see Sections 4.5 and 5.1).

… he excipientslisted 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 Candesartan with aliskiren-containing products is contra-indicated in patients with diabetes mellitus or renal impairment (GFR < 60 ml/min/1.73 m2) (see Sections 4.5 and 5.1).

… ossibility of pregnancy should be evaluated on a regular basis.Appropriate information should be given and/or action taken to prevent the risk of exposure during pregnancy (see sections 4.3 and 4.6) Intestinal angioedema Intestinal angioedema has been reported in patients treated with angiotensin II receptor antagonists, [including Candesartan] (see section 4.8). These patients presented with abdominal pain, nausea …

… 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). Paediatric population, including paediatric patients with renal impairment Candesartan Cilexetil has not been studied in children with a glomerular filtration rate less than 30 ml/min/1.73m2 (s …

… 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 …

… the artery to a solitary kidney. Kidney transplantation There is limited clinical evidence regarding candesartan cilexetil use in patients who have undergone renal transplant. Hypotension Hypotension may occur 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. 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 o …

… 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). Paediatric population, including paediatric patients with renal impairment Candesartan Cilexetil has not been studied in children with a glomerular filtration rate less than 30 ml/min/1.73m2 (s …

Renal 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 …

… antagonists. If intestinal angioedema is diagnosed, Candesartan should be discontinued and appropriate monitoring should be initiated until complete resolution of symptoms has occurred. Lactose This medicine contains lactose monohydrate. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.

… antagonists. If intestinal angioedema is diagnosed, Candesartan should be discontinued and appropriate monitoring should be initiated until complete resolution of symptoms has occurred. Lactose This medicine contains lactose monohydrate. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.

… ent 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 …

… Candesartan Cilexetil has not been studied in children with a glomerular filtration rate less than 30 ml/min/1.73m2 (see section 4.2). 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 is used in combination with an ACE-inhibitor. Use of this combination should be under specialist supervision and subject to frequent 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 …

… receptor antagonists. If intestinal angioedema is diagnosed, Candesartan should be discontinued and appropriate monitoring should be initiated until complete resolution of symptoms has occurred. Lactose This medicine contains lactose monohydrate. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medic …

… 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 …

… ticularly those with impaired renal function), Candesartan Cilexetil 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 …

… potassium-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 cilexetil during breastfeeding, Candesartan cilexetil is not recommended and alternative treatments with better established saf …

Lactose monohydrate Hydroxypropyl cellulose Carmellose calcium Magnesium Aluminometasilicate Propylene glycol Magnesium stearate Iron oxide red (E172)

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