1. NAME OF THE MEDICINAL PRODUCT
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 75 mg of irbesartan.
Excipient with known effect: 15.37 mg of lactose monohydrate per tablet.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Tablet.
White to off-white, biconvex, and oval-shaped with a heart debossed on one side and the number 2771 engraved on the other side.
4. CLINICAL PARTICULARS
4.1 Therapeutic indications
Karvea 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).
4.2 Posology and method of administration
Posology
The usual recommended initial and maintenance dose is 150 mg once daily, with or without food. Karvea 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 Karvea can be increased to 300 mg, or other antihypertensive agents can be added (see sections 4.3, 4.4, 4.5 and 5.1). In particular, the addition of a diuretic such as hydrochlorothiazide has been shown to have an additive effect with Karvea (see section 4.5).
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 Karvea 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 sections 4.3, 4.4, 4.5 and 5.1).
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