Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
CANDESARTAN CILEXETIL
B & S Healthcare
16 Milligram
Tablets
2006-10-06
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Atacand 16 mg Tablets. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 16 mg candesartan cilexetil. Excipient: Lactose. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet. _Product imported from France, Greece and Portugal:_ Pink, round tablets with a scoreline and marked ‘A/CH’ on one side and marked ‘016’ on the other side. _Product imported from the UK:_ Pink, round tablets with one convex side embossed '16' and one flat side with a scoreline. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Atacand 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 Pharmacodynamic properties). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology in Hypertension The recommended initial dose and usual maintenance dose of Atacand is 8mg 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 16mg once daily and to a maximum of 32mg once daily. Therapy should be adjusted according to blood pressure response. Atacand may also be administered with other antihypertensive agents. Addition of hydrochlorothiazide has been shown to have an additive antihypertensive effect with various doses of Atacand. _Elderly population_ No initial dosage adjustment is necessary in elderly patients. _Patients with intravascular volume depletion_ An initial dose of 4mg may be considered in patients at risk Read the complete document