COZAAR Film Coated Tablet 100 Milligram
Country: Írland
Tungumál: enska
Heimild: HPRA (Health Products Regulatory Authority)
Vara einkenni
(SPC)
30-04-2024
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Virkt innihaldsefni:
LOSARTAN POTASSIUM
Fáanlegur frá:
IPS Healthcare Limited
Skammtar:
100 Milligram
Lyfjaform:
Film Coated Tablet
Leyfisdagur:
2010-10-08
Vara einkenni
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Cozaar 100mg Film-coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Cozaar 100 mg tablet contains 100 mg of losartan potassium.
Excipients: lactose monohydrate.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film coated tablet
_Product imported from the UK:_
White, teardrop-shaped film-coated tablets marked "960" on one side and plain on the other.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
o
Treatment of essential hypertension in adults and in children and adolescents 6 – 18 years of age.
o
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.
o
Treatment of chronic heart failure in adult 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.
o
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
Posology
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 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 do
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