ATACAND PLUS TABLET

4.1 Therapeutic indications

Hypertension, where monotherapy with candesartan cilexetil or hydrochlorothiazide is not sufficient.

4.3 Contraindications

Hypersensitivity to the active substances or to any of the excipients or to sulfonamide derived drugs (hydrochlorothiazide is a sulfonamide derived drug) or to any of the excipients.

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

Severe renal impairment (creatinine clearance < 30 ml/min/1.73 m2 BSA).

Severe hepatic impairment and/or cholestasis.

Refractory hypokalaemia and hypercalcaemia.

Gout.

The concomitant use of Atacand Plus 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 form of interaction – 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 dose of Atacand Plus is 1 tablet once daily.

The dose of candesartan cilexetil should be titrated before switching to Atacand Plus.

Most of the antihypertensive effect is usually attained within 4 weeks of initiation of treatment.

When clinically appropriate a direct change from monotherapy to Atacand Plus may be considered. Dose titration of candesartan cilexetil is recommended when switching from hydrochlorothiazide monotherapy.

Administration

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

Use in the elderly

No dosage adjustment is necessary in elderly patients.

Use in patients with intravascular volume depletion

Dose titration of candesartan cilexetil is recommended in patients at risk for hypotension, such as patients with possible volume depletion (an initial dose of candesartan cilexetil of 4 mg may be considered in these patients).

Use in impaired renal function

In patients with mild to moderate renal impairment (ie, creatinine clearance between 30–80 ml/min/1.73 m2 BSA), a dose titration is recommended.

Atacand Plus should not be used in patients with severe renal impairment (creatinine clearance < 30 ml/min/1.73 m2 BSA).

Use in impaired hepatic function

Patients with hepatic impairment: Dose titration is recommended in patients with mild to moderate chronic liver disease.

Atacand Plus should not be used in patients with severe hepatic impairment and/or cholestasis.

Use in children

The safety and efficacy of Atacand Plus have not been established in children.