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* Therapeutic Indications: Essential hypertension, where monotherapy with candesartan cilexetil or hydrochlorothiazide is not sufficient.
* Posology && Method of Administration:
# Dosage:
– The recommended dose of Atacand Plus is 1 tablet once daily.
– The dose of candesartan cilexetil should be titrated before switching to Atacand Plus. When clinically appropriate a direct
& change from monotherapy to Atacand Plus may be considered. Most of the antihypertensive effect is usually attained within
& 4 weeks of initiation of treatment.
# Administration: Atacand Plus should be taken once daily with or without food.
# Use in the elderly: Dose titration of candesartan cilexetil is recommended in elderly patients before treatment with Atacand Plus.
# Use in impaired renal function
& Loop diuretics are preferred to thiazides in this population. Dose titration of candesartan cilexetil is recommended in
& patients with renal impairment whose creatinine clearance is ³ 30 ml/min/1.73 m2 BSA before treatment with Atacand
& Plus (the recommended starting dose of candesartan cilexetil is 4 mg in patients with mild to moderate renal impairment).
& Atacand Plus should not be used in patients with severe renal impairment (creatinine clearance < 30 ml/min/1.73m2 BSA).
# Use in impaired hepatic function:
& Dose titration of candesartan cilexetil is recommended in patients with mild to moderate hepatic impairment before treatment
& with Atacand Plus (the recommended starting dose of candesartan cilexetil is 2 mg in these patients).
& Atacand Plus should not be used in patients with severe hepatic impairment &&/or cholestasis.
# Use in children: The safety && efficacy of Atacand Plus have not been established in children.
* Contra-indications:
– Hypersensitivity to the active substances or to any of the excipients or to sulfonamide derived drugs (hydrochlorothiazide
& is a sulfonamide derived drug).
– Pregnancy and lactation.
– Severe renal impairment (creatinine clearance <30 ml/min/1.73 m2 BSA).
– Severe hepatic impairment and/or cholestasis.
– Refractory hypokalaemia and hypercalcaemia.
– Gout.
* Special warnings and special precautions for use:
# Renal impairment/Kidney transplantation:
& Loop diuretics are preferred to thiazides in this population. When Atacand Plus is used in patients with impaired renal function,
& a periodic monitoring of potassium, creatinine and uric acid levels is recommended.
& There is no experience regarding the administration of Atacand Plus in patients with a recent kidney transplantation.
# Renal artery stenosis:
& Other drugs that affect the renin-angiotensin-aldosterone system, i.e. angiotensin converting enzyme (ACE) inhibitors,
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