Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
CANDESARTAN CILEXETIL
AstraZeneca UK Limited
32 Milligram
Tablets
2005-07-22
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Atacand 32 mg tablets. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 32 mg candesartan cilexetil. Each 32 mg tablet contains 163 mg lactose monohydrate. For a full list of excipients, _see section 6.1._ 3 PHARMACEUTICAL FORM Tablet Atacand 32 mg are round (diameter 9.5 mm), pink tablets with a score and marked A/CL on one side and marked 032 on the other side. Atacand 32 mg tablets can be divided into equal halves. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Essential hypertension. Treatment of patients with heart failure and impaired left ventricle systolic function (left ventricular ejection fraction 40%) as add-on therapy to ACE inhibitors or when ACE inhibitors are not tolerated _(see section 5.1 Pharmacodynamic_ _properties)._ 4.2 POSOLOGY AND METHOD OF ADMINISTRATION _Dosage in Hypertension_ The recommended initial dose and usual maintenance dose is 8 mg once daily. The dose may be increased to 16 mg once daily. If blood pressure is not sufficiently controlled after 4 weeks of treatment with 16 mg once daily, the dose may be further increased to a maximum of 32 mg once daily _(see section 5.1 Pharmacodynamic properties). _If blood pressure control is not achieved with this dose, alternative strategies should be considered. Therapy should be adjusted according to blood pressure response. Most of the antihypertensive effect is attained within 4 weeks of initiation of treatment. _Use in the elderly_ No initial dosage adjustment is necessary in elderly patients. _Use in 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 Special warnings and Read the complete document