देश: आयरलैंड
भाषा: अंग्रेज़ी
स्रोत: HPRA (Health Products Regulatory Authority)
CANDESARTAN CILEXETIL HYDROCHLOROTHIAZIDE
PCO Manufacturing
16/12.5 Milligram
Tablets
2004-01-26
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Atacand Plus 16/12.5mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 16 mg candesartan cilexetil and 12.5 mg hydrochlorothiazide. Excipients: Contains Lactose Monohydrate For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet. _Product imported from the Netherlands:_ Peach, oval, biconvex tablets marked ‘A/CS’ on one side and scored on both sides. _Product imported from Italy:_ Pink, oval tablets marked 16/C and scored on both sides or Peach, oval biconvex tablets marked A/CS on one side and scored on both sides. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Essential hypertension, where monotherapy with candesartan cilexetil or hydrochlorothiazide is not sufficient. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION _DOSAGE_ The recommended dose of Atacand Plus is 1 tablet once daily. The dose of candesartan cilexetil should be titrated before switching to Atacand Plus. When clinically appropriate a direct change from monotherapy to Atacand Plus may be considered. Most of the antihypertensive effect is usually attained within 4 weeks of initiation of treatment. _ADMINISTRATION_ Atacand Plus should be taken once daily with or without food. _USE IN THE ELDERLY_ No initial dosage adjustment is necessary in elderly patients. Use in patients with intravascular volume depletion Dose titration of candesartan cilexetil is recommended in patients at risk for hypotension, such as patients with possible volume depletion (an initial dose of candesartan cilexetil of 4 mg may be considered in these patients). _USE IN IMPAIRED RENAL FUNCTION_ No dosage adjustment is necessary in patients with mild renal impairment. In patients with moderate to severe renal impairment, an initial dose पूरा दस्तावेज़ पढ़ें