IRBETAS 300 FILM COATED TABLET 300 MG [SIN16192P]

Product Info

IRBETAS 300 FILM COATED TABLET 300 MG

[SIN16192P]

4.1 Therapeutic indications

Irbesartan is indicated in adults for the treatment of essential hypertension.

It is also indicated for the treatment of renal disease in adult 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).

Irbesartan can be used alone or in combination with other antihypertensive agents (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).

4.2 Posology and method of administration

Posology

The usual recommended initial and maintenance dose is 150 mg once daily, with or without food. Irbesartan Tablets 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 Irbesartan Tablets 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 Irbesartan Tablets. (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 150 mg irbesartan once daily and titrated up to 300 mg once daily as the preferred maintenance dose for treatment of renal disease.

The demonstration of renal benefit of Irbesartan Tablets in hypertensive type 2 diabetic patients is based on studies where Irbesartan was used in addition to other anti-hypertensive agents, as needed, to reach target blood pressure (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).

Special Populations

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 haemodialysis (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 Irbesartan Tablets.

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.

Older People: 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 Older People.

Paediatric population: the safety and efficacy of irbesartan in children aged 0 to 18 has not been established. Currently available data are described in sections 4.8, 5.1, and 5.2 but no recommendation on a posology can be made – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.

Method of Administration

For oral use.

4.3 Contraindications

Hypersensitivity to the active substance, or to any of the excipients listed in 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).

The concomitant use of Irbesartan Tablets with aliskiren-containing products is contraindicated in patients with diabetes mellitus or renal impairment (glomerular filtration rate (GFR) < 60 ml/min/1.73 m²) (see sections 4.5 and 5.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Do not administer Irbesartan Tablets 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).