CUENCA 40 Milligram Film Coated Tablet
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
11-05-2024
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Active ingredient:
VALSARTAN
Available from:
Laboratorios LICONSA, S.A.
INN (International Name):
VALSARTAN
Dosage:
40 Milligram
Pharmaceutical form:
Film Coated Tablet
Prescription type:
Product subject to prescription which may be renewed (B)
Authorization status:
Withdrawn
Authorization date:
2013-04-23
Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Cuenca 40 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One film-coated tablet contains 40 mg of valsartan
EXCIPIENTS:
Each tablet contains:
sorbitol 4.6 mg
lactose 0.5 mg
sodium 0.16 mg (0.01 mmol)
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
Cylindrical, coated, scored on one side, yellow film-coated tablets.
The tablet can be divided into equal halves.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
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
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 titrated to 40 mg, 80 mg, and 160 mg twice daily over the next few
weeks. The starting dose is provided by the 40 mg divisible tablet.
The target maximum dose is 160 mg twice daily. In general, it is recommended that patients achieve a dose level of 80
mg twice daily by two weeks after treatment initiation and that the target maximum dose, 160 mg twice daily, be
achieved by three months, based on the patient's tolerability. If symptomatic hypotension or renal dysfunction occur,
consideration should be given to a dosage reduction.
Valsartan may
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