CO-DIOVAN Film Coated Tablet 160/25 Milligram
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
22-03-2023
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Active ingredient:
VALSARTAN HYDROCHLOROTHIAZIDE
Available from:
Clear Pharmacy
Dosage:
160/25 Milligram
Pharmaceutical form:
Film Coated Tablet
Authorization date:
2010-10-15
Summary of Product characteristics
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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 hydrochlorothiaz
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