Šalis: Airija
kalba: anglų
Šaltinis: HPRA (Health Products Regulatory Authority)
CANDESARTAN CILEXETIL
Profind Wholesale Ltd
CANDESARTAN CILEXETIL
8 Milligram
Tablets
Product subject to prescription which may be renewed (B)
Withdrawn
0000-00-00
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Atacand 8mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 8mg candesartan cilexetil. Excipients: Contains lactose monohydrate For a full list of excipients, see 6.1 3 PHARMACEUTICAL FORM Tablets _Product imported from the UK:_ Round, pale pink tablets with a single score line on both sides. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Atacand is indicated for the: o Treatment of essential hypertension in adults. o 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 Atacand 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. Atacand may also be administered with other antihypertensive agents. Addition of hydrochlorothiazidehas been shown to have an additive antihypertensive effect with various doses of Atacand. _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 section 4.4). IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Perskaitykite visą dokumentą