Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
CANDESARTAN CILEXETIL, HYDROCHLOROTHIAZIDE
Chemilines Healthcare (Ireland) Limited
C09DA06
CANDESARTAN CILEXETIL, HYDROCHLOROTHIAZIDE
16/12.5 Milligram
Tablets
Product subject to prescription which may be renewed (B)
Angiotensin II antagonists and diuretics
Authorised
2013-08-02
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Atacand Plus 16/12.5 mg tablets. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION One Atacand Plus tablet contains 16 mg candesartan cilexetil and 12.5 mg hydrochlorothiazide. Each tablet contains lactose monohydrate. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablets _Product imported from Greece:_ Atacand Plus are peach, oval, biconvex tablets with a score on both sides and engraved A/CS on one side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Atacand Plus is indicated for the: o Treatment of essential hypertension in adult patients whose blood pressure is not optimally controlled with candersartan cilexetil or hydrochlorothiazide monotherapy. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology The recommended dose of Atacand Plus is one tablet once daily. Dose titration with the individual components (candesartan cilexetil and hydrochlorothiazide) is recommended. When clinically appropriate a direct change from monotherapy to Atacand Plus may be considered. Dose titration of candesartan cilexetil is recommended when switching from hydrochlorothiazide monotherapy. Atacand Plus may be administered in patients whose blood pressure is not optimally controlled with candesartan cilexetil or hydrochlorothiazide monotherapy or Atacand Plus at lower doses. Most of the antihypertensive effect is usually attained within 4 weeks of initiation of treatment. Special populations _Elderly population_ No dose adjustment is necessary in elderly patients. _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 pa Read the complete document