CONVERIUM TABLETS 150MG

4.1. Therapeutic indications

Treatment of essential hypertension.

Treatment of renal disease in patients with hypertension and type 2 diabetes mellitus as part of an antihypertensive medicinal product regimen (see sections 4.3, 4.4, 4.5 and 5.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

4.3. Contraindications

USE IN PREGNANCY

When used in pregnancy during the second and third trimesters, drugs that act directly on the renin angiotensin system can cause injury and even death to the developing fetus. When pregnancy is detected, Irbesartan should be discontinued as soon as possible.

Hypersensitivity to any component of the product ( see section 6.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Second and third trimester of pregnancy ( see sections 4.4 and 4.6 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Lactation ( see section 4.6 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Do not co-administer Converium with aliskiren-containing medicines in patients with diabetes or with moderate to severe renal impairment (glomerular filtration rate (GFR) <60 ml/min/1.73 m2) ( see sections 4.4 and 4.5 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Do not administer Converium with angiotensin-converting enzyme inhibitors (ACEIs) in patients with diabetic nephropathy ( see sections 4.4 and 4.5 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

4.2. Posology and method of administration

Posology

The usual recommended initial and maintenance dose is 150mg once daily, with or without food.

Converium at a dose of 150 mg once daily generally provides a better 24 hour blood pressure control than 75 mg. However, initiation of therapy with 75 mg could be considered, particularly in haemodialysed patients and in the elderly over 75 years.

In patients insufficiently controlled with 150 mg once daily, the dose of Converium can be increased to 300 mg, or other anti-hypertensive agents can be added (see sections 4.3, 4.4, 4.5 and 5.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). In particular, the addition of a diuretic such as hydrochlorothiazide has been shown to have an additive effect with Converium (see section 4.5 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

In hypertensive type 2 diabetic patients, therapy should be initiated at 150mg irbesartan once daily and titrated up to 300mg once daily as the preferred maintenance dose for treatment of renal disease. The demonstration of renal benefit of Converium in hypertensive type 2 diabetic patients is based on studies where irbesartan was used in addition to other antihypertensive agents, as needed, to reach target blood pressure (see section 5.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Renal impairment

No dosage adjustment is necessary in patients with impaired renal function. A lower starting dose (75 mg) should be considered for patients undergoing hemodialysis. (see section 4.4 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information)

Intravascular volume depletion: volume and/or sodium depletion should be corrected prior to administration of Converium.

Hepatic impairment

No dosage adjustment is necessary in patients with mild to moderate hepatic impairment. There is no clinical experience in patients with severe hepatic impairment.

Elderly patients

Although consideration should be given to initiating therapy with 75 mg in patients over 75 years of age, dosage adjustment is not usually necessary for the elderly.

Pediatric population

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

Method of administration

Oral administration.