LOSARTAN POTASSIUM LICONSA
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
12-05-2024
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Active ingredient:
LOSARTAN POTASSIUM
Available from:
Laboratorios LICONSA, S.A.
Dosage:
12.5 Milligram
Pharmaceutical form:
Tablets
Authorization date:
2007-10-12
Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Losartan Potassium Liconsa 12.5 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Losartan Potassium Liconsa contains 12.5 mg of the active ingredient losartan potassium.
Excipients:
Lactose monohydrate 25.27 mg and other excipients.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablets.
Round, blue, film-coated tablets.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
•
Treatment of essential hypertension.
•
Treatment of renal disease in patients with hypertension and type 2 diabetes mellitus with proteinuria
0.5
g/day as part of an antihypertensive treatment.
•
Treatment of chronic heart failure (in patients
60 years), when treatment with ACE inhibitors is not
considered suitable due to incompatibility, especially cough, or contraindication. Patients with heart failure who
have been stabilised with an ACE inhibitor should not be switched to losartan. The patients should have a left
ventricular ejection fraction
40% and should be stabilised under the treatment of the chronic heart failure.
•
Reduction in the risk of stroke in hypertensive patients with left ventricular hypertrophy documented by ECG
(see section 5.1 LIFE study, Race).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Losartan tablets should be swallowed with a glass of water.
Losartan Potassium Liconsa may be administered with or without food.
Hypertension
The usual starting and maintenance dose is 50 mg once daily for most patients. The maximal antihypertensive effect is
attained 3-6 weeks after initiation of therapy. Some patients may receive an additional benefit by increasing the dose to
100 mg once daily (in the morning). Losartan Potassium Liconsa may be administered with other antihypertensive
ag
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