CO-DIOVAN Film Coated Tablet 160/25 Milligram
국가: 아일랜드
언어: 영어
출처: HPRA (Health Products Regulatory Authority)
제품 특성 요약
(SPC)
20-04-2024
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유효 성분:
VALSARTAN HYDROCHLOROTHIAZIDE
제공처:
Clear Pharmacy
복용량:
160/25 Milligram
약제 형태:
Film Coated Tablet
승인 날짜:
2010-10-15
제품 특성 요약
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Co-Diovan 160 mg/25 mg film-coated tablets.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 160 mg of valsartan and 25 mg of hydrochlorothiazide.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
_Product imported from Italy:_
Brown, ovaloid tablet imprinted with "HXH" on one side and "NVR" on the other side.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment of essential hypertension in adults.
Co-Diovan fixed-dose combination is indicated in patients whose blood pressure is not adequately controlled on
valsartan or hydrochlorothiazide monotherapy.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
_Posology_
The recommended dose of Co-Diovan 160 mg/25 mg is one film-coated tablet once daily. Dose titration with the
individual components is recommended. In each case, up-titration of individual components to the next dose should be
followed in order to reduce the risk of hypotension and other adverse events.
When clinically appropriate direct change from monotherapy to the fixed combination may be considered in patients
whose blood pressure is not adequately controlled on valsartan or hydrochlorothiazide monotherapy, provided the
recommended dose titration sequence for the individual components is followed.
The clinical response to Co-Diovan should be evaluated after initiating therapy and if blood pressure remains
uncontrolled, the dose may be increased by increasing either one of the components to a maximum dose of Co-Diovan
320 mg/25 mg.
The antihypertensive effect is substantially present within 2 weeks.
In most patients, maximal effects are observed within 4 weeks. However, in some patients 4
-8 weeks treatment may be
required. This should be taken into a
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