ATACAND TABLET 16 MG [SIN10880P]

Product Info

ATACAND TABLET 16 MG

[SIN10880P]

4.1 Therapeutic indications

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 (see section Pharmacodynamic properties – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

4.2 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 section Pharmacodynamic properties – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). 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 section Special warnings and special precautions for use – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Use in impaired renal function

The starting dose is 4 mg in patients with renal impairment, including patients on haemodialysis. The dose should be titrated according to response. There is limited experience in patients with very severe or end-stage renal impairment (Cl_creatinine < 15 ml/min) (see section Special warnings and special precautions for use – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Use in impaired hepatic function

Patients with hepatic impairment: Dose titration is recommended in patients with mild to moderate chronic liver disease, and a lower initial dose of 4 mg should be considered. Atacand should not be used in patients with severe hepatic impairment and/or cholestasis (see section Contraindications).

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 section Pharmacodynamic properties – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

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 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

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 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

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).

4.3 Contraindications

Hypersensitivity to candesartan cilexetil or to any of the excipients.

Pregnancy and lactation (see section Pregnancy and lactation – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Severe hepatic impairment and/or cholestasis.

The concomitant use of Atacand with aliskiren-containing products is contraindicated in patients with diabetes mellitus or renal impairment (GFR < 60 ml/min/1.73 m²) (see section Interaction with other medicinal products and other forms of interaction – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).