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Atacand«
candesartan cilexetil


Composition
Each tablet contains 8 mg or 16 mg candesartan cilexetil.

Pharmaceutical form
Atacand 8 mg are round (diameter 7 mm), light pink tablets with a score and marked A/CG on one side and marked 008 on the other side.
Atacand 16 mg are round (diameter 7 mm), pink tablets with a score and marked A/CH on one side and marked 016 on the other side.

Therapeutic indication
Treatment of hypertension.
Treatment of patients with heart failure and impaired left ventricle systolic function (left ventricular ejection fraction ≤40%) as add-on therapy to ACE inhibitors or when ACE inhibitors are not tolerated.

Posology and method of administration
Dosage in Hypertension
The recommended initial dose and usual maintenance dose is 8 mg once daily. The dose may be increased to 16 mg once daily. If blood pressure is not sufficiently controlled after 4 weeks of treatment with 16 mg once daily, the dose may be further increased to a maximum of 32 mg once daily (see Pharmacodynamic properties). If blood pressure control is not achieved with this dose, alternative strategies should be considered.


Therapy should be adjusted according to blood pressure response. Most of the antihypertensive effect is attained within 4 weeks of initiation of treatment.


Use in the elderly
No initial dosage adjustment is necessary in elderly patients.


Use in patients with intravascular volume depletion
An initial dose of 4 mg may be considered in patients at risk for hypotension, such as patients with possible volume depletion (see Special warnings and special precautions for use).


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 ml/ min/1.73 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.


Use in black patients
The antihypertensive effect of candesartan is less in black than non-black patients. Consequently, uptitration of Atacand and concomitant therapy may be more frequently needed for blood pressure control in black than non-black patients (see also Pharmacodynamic properties).


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 (see section Special warnings and special precautions for use).
Special patient populations
No initial dose adjustment is necessary for elderly patients or in patients with intravascular volume depletion, renal impairment or mild to moderate hepatic impairment.


Concomitant therapy
Atacand can be administered with other heart failure treatment, including ACE inhibitors, beta-blockers, diuretics and digitalis or a combination of these medicinal products (see also section Special warnings and special precautions for use and Pharmacodynamic properties).


Administration
Atacand should be taken once daily with or without food.


Use in children and adolescents
The safety and efficacy of Atacand have not been established in children and adolescents (under 18 years).

Contraindications
Hypersensitivity to candesartan cilexetil or to any of the excipients.

Pregnancy and lactation (see Pregnancy and lactation).

 

Special warnings and special 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 severe 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 (CIcreatinine <15 ml/min). In these patients Atacand 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 Atacand, monitoring of serum creatinine and potassium is recommended. Clinical trials in heart failure did not include patients with serum creatinine >265 Ámol/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 Undesirable effects). Patients with such treatment should be monitored regularly and carefully.


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, Atacand should be carefully titrated with thorough monitoring of blood pressure in patients on haemodialysis.


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 Atacand 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 medicinal products 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-angiotensinaldosterone system, concomitant use of Atacand 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 increases in serum potassium in hypertensive patients.


In heart failure patients treated with Atacand, hyperkalaemia may occur. During treatment with Atacand 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.


General
In patients whose vascular tone and renal function depend predominantly on the activity of the reninangiotensin-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 angiotensin II receptor antagonists. As with any anti hypertensive 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 glucosegalactose malabsorption should not take this medicinal product.

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