SALDANAR 160 Milligram Film Coated Tablet
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
02-05-2024
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Active ingredient:
VALSARTAN
Available from:
Laboratorios LICONSA, S.A.
INN (International Name):
VALSARTAN
Dosage:
160 Milligram
Pharmaceutical form:
Film Coated Tablet
Prescription type:
Product subject to prescription which may be renewed (B)
Authorization status:
Withdrawn
Authorization date:
2013-04-16
Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Saldanar 160 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Once film-coated tablet contains 160 mg of valsartan.
EXCIPIENTS:
Each tablet contains
sorbitol 18.5 mg
lactose 2.2 mg
sodium 0.64 mg (0.03 mmol)
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
Cylindrical, coated, scored on one side, ochre film-coated tablets.
The tablet can be divided into equal halves.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Hypertension
Treatment of essential hypertension.
Recent myocardial infarction
Treatment of clinically stable patients with symptomatic heart failure or asymptomatic left ventricular systolic
dysfunction after a recent (12 hours-10 days) myocardial infarction (see sections 4.4 and 5.1).
Heart failure
Treatment of symptomatic heart failure when Angiotensin Converting Enzyme (ACE) inhibitors cannot be used, or as
add-on therapy to ACE inhibitors when beta blockers cannot be used (see sections 4.4 and 5.1).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Hypertension
The recommended starting dose of Saldanaris 80 mg once daily. The antihypertensive effect is substantially present
within 2 weeks, and maximal effects are attained within 4 weeks. In some patients whose blood pressure is not
adequately controlled, the dose can be increased to 160 mg and to a maximum of 320 mg.
Saldanarmay also be administered with other antihypertensive agents. The addition of a diuretic such as
hydrochlorothiazide will decrease blood pressure even further in these patients.
Recent myocardial infarction
In clinically stable patients, therapy may be initiated as early as 12 hours after a myocardial infarction. After an initial
dose of 20 mg twice daily, valsartan should be
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