Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
CANDESARTAN CILEXETIL
Rowex Ltd
32 Milligram
Tablets
2009-09-04
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Catasart 32 mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 32 mg of candesartan cilexetil Excipient: each tablet contains 278.27 mg of lactose monohydrate For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet. Pink, mottled, round biconvex tablet, debossed with 32 on one side and scored on the other side. The tablet can be divided into equal halves. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Catasart is indicated for the: Treatment of essential hypertension in adults. Treatment of adult patients with heart failure and impaired left ventricle systolic function (left ventricular ejection fraction 40%) as add-on therapy to Angiotensin Converting Enzyme (ACE) inhibitors or when ACE- inhibitors are not tolerated (see section 5.1). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology in Hypertension The recommended initial dose and usual maintenance dose is 8 mg once daily. Most of the antihypertensive effect is attained within 4 weeks. In some patients whose blood pressure is not adequately controlled, the dose can be increased to 16 mg once daily and to a maximum of 32 mg once daily. Therapy should be adjusted according to blood pressure response. Catasart may also be administered with other antihypertensive agents. Addition of hydrochlorothiazide has been shown to have an additive antihypertensive effect with various doses of Catasart. _Elderly population_ No initial dosage adjustment is necessary in elderly patients. _Patients with intravascular volume depletion_ An initial dose of 4 mg may be considered in patients at risk for hypotension, such as patients with possible volume depletion (see also 4.4). _Patients with renal impairment_ The starting dose is 4 Read the complete document