Posology : מינונים

4.2   Posology and method of administration

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 may be used. When necessary 160 mg valsartan and 25 mg may be used. The maximum daily dose is 320 mg/25 mg. The maximum antihypertensive effect is seen within 2 to 4 weeks. Co-Diovan must not be used in combination with aliskiren in patients with diabetes mellitus.
Renal Impairment
No dosage adjustment is required for patients with mild to moderate renal impairment (Glomerular Filtration Rate (GFR) ≥ 30 mL/min). Due to the hydrochlorothiazide component, Co-Diovan is contraindicated in patients with anuria (see section 4.3) and should be used with caution in patients with severe renal impairment (GFR < 30 mL/min) (see sections 4.4 and 5.1).
Thiazide diuretics are ineffective as monotherapy in severe renal impairment (GFR < 30 mL/min) but may be useful in these patients, when used with due caution in combination with a loop diuretic even in patients with GFR < 30 mL/min. Concomitant use of Co-Diovan with aliskiren is contraindicated in patients with renal impairment (GFR < 60 ml/min/1.73 m2 ) (see section 4.3).

Hepatic Impairment
CO-DIO API APR22 V1                                       Page 1 of 18      Sweden SmPC 03.2022 No dosage adjustment is required in patients with mild to moderate hepatic impairment . Due to the hydrochlorothiazide component, Co-Diovan should be used with particular caution 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 4.4).

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