CANDESARTAN CILEXETIL
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
02-04-2023
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Active ingredient:
CANDESARTAN CILEXETIL
Available from:
Ranbaxy Ireland Limited
Dosage:
16 Milligram
Pharmaceutical form:
Tablets
Authorization date:
2010-11-05
Summary of Product characteristics
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Summary of Product Characteristics
1 NAME OF THE MEDICINAL PRODUCT
Candesartan cilexetil 16mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 16 mg candesartan cilexetil.
Excipient:
151.5 mg of lactose monhydrate tablet
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet.
Pink capsule shaped tablet with ‘C’ & ‘11’ debossed on either side of breakline on one side and breakline on other side.
The tablet can be divided into equal halves.
4 CLINICAL PARTICULARS
4.1 Therapeutic Indications
CANDESARTAN CILEXETIL 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).
4.2 Posology and method of administration
Posology in Hypertension
The recommended initial dose and usual maintenance dose of CANDESARTAN CILEXETIL 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
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