COZAAR Film Coated Tablet 50 Milligram
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
13-05-2024
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Active ingredient:
LOSARTAN POTASSIUM
Available from:
Profind Wholesale Ltd.
Dosage:
50 Milligram
Pharmaceutical form:
Film Coated Tablet
Authorization date:
2009-06-19
Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Cozaar 50mg Film-Coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 50mg Losartan potassium.
Excipients-Contains Lactose Monohydrate
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film Coated Tablet
_Product imported from _UK
White, oval tablet marked ‘952’ on one side and with a score line on the other side.
The score line allows the tablet to be divided into equal halves
_Product imported from Italy_
White, oval tablet marked ‘952’ on one side and with a score line on the other side.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
•
Treatment of essential hypertension in adults and in children and adolescents 6 – 18 years of age.
•
Treatment of renal disease in adult 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 adult patients when treatment with Angiotensin-converting enzyme (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 clinically stable and on an established treatment
regimen for chronic heart failure.
•
Reduction in the risk of stroke in adult 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.
Cozaar may be administered with or without food.
HYPERTENSION
The usual starting and maintenance dose is 50 mg
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