CO-DIOVAN 160/12.5 TABLET [SIN11339P]

Product Info

CO-DIOVAN 160/12.5 TABLET

[SIN11339P]

INDICATIONS

Treatment of hypertension in adults, 18 years of age and older.

Co-Diovan may be used for the treatment of hypertension in patients whose blood pressure is not adequately controlled by monotherapy.

DOSAGE REGIMEN AND ADMINISTRATION

Dosage regimen

The recommended dose of Co-Diovan is 1 coated tablet per day. When clinically appropriate either 80 mg valsartan and 12.5 mg hydrochlorothiazide or 160 mg valsartan and 12.5 mg hydrochlorothiazide or 320 mg valsartan and 12.5 mg hydrochlorothiazide may be used. When necessary 160 mg valsartan and 25 mg hydrochlorothiazide or 320 mg valsartan and 25 mg hydrochlorothiazidemay be used. The maximum daily dose is 320 mg/25 mg.

The maximum antihypertensive effect is seen within 2 to 4 weeks.

Renal impairment

No dosage adjustment is required for patients with mild to moderate renal impairment (creatinine clearance>30 mL/min). Due to the hydrochlorothiazide component, Co-Diovan is contraindicated in patients with anuria and severe renal impairment (creatinine clearance <30mL/min) (see section WARNINGS AND PRECAUTIONS, CONTRAINDICATIONS and CLINICAL PHARMACOLOGY subsection PHARMACOKINETICS – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Hepatic impairment

No dosage adjustment is required in patients with mild to moderate hepatic impairment. Due to the hydrochlorothiazide component, Co-Diovan is contraindicated in patients with severe hepatic impairment. Due to the valsartan component, Co-Diovan should be used with particular caution in patients with biliary obstructive disorders (see sections CONTRAINDICATIONS and WARNINGS AND PRECAUTIONS – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Pediatric patients (below 18 years)

The safety and efficacy of Co-Diovan have not been established in children below the age of 18 years.

CONTRAINDICATIONS

Known hypersensitivity to valsartan, hydrochlorothiazide, other sulphonamide derived medicinal products or to any of the excipients of Co-Diovan.

Pregnancy (see section PREGNANCY, LACTATION, FEMALES AND MALES OF REPRODUCTIVE POTENTIAL – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Biliary cirrhosis and cholestasis.

Because of hydrochlorothiazide, Co-Diovan is contraindicated in patients with anuria.

Severe hepatic impairment, severe renal impairment (creatinine clearance <30mL/min), refractory hypokalemia, hyponatremia, hypercalcemia, and symptomatic hyperuricemia.

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