Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
CANDESARTAN CILEXETIL
Teva Pharma B.V.
2 Milligram
Tablets
2011-12-21
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Candesartan Teva 2 mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 2 mg candesartan cilexetil. Excipients: Lactose: 42.20 mg lactose monohydrate / 2 mg tablet For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet. White to off white, round standard convex tablet. One side of the tablet is debossed with the number "2". The other side of the tablet is debossed with "C". 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Candesartan Teva is indicated for the: Treatment of essential hypertension in adults. Treatment of adult patients with heart failure and impaired left ventricular 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 of Candesartan Teva 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. Candesartan Teva may also be administered with other antihypertensive agents. Addition of hydrochlorothiazide has been shown to have an additive antihypertensive effect with various doses of Candesartan Teva. _Elderly population_ No initial dose 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 sec Read the complete document