COZAAR Film Coated Tablet 50 Milligram
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
27-04-2024
Some documents for this product are not currently available, you can send a request to our customer service and we will notify you as soon as we are able to obtain them.
Send request.
Send request.
Active ingredient:
LOSARTAN POTASSIUM
Available from:
G & A Licensing Limited
Dosage:
50 Milligram
Pharmaceutical form:
Film Coated Tablet
Authorization date:
2010-10-15
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 Cozaar 50mg Tablet contains 50mg of losartan potassium.
Excipient: Each Cozaar 50mg Tablet contains lactose monohydrate.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated Tablets.
_Product imported from _the UK:
White, oval film-coated tablets, marked ‘952’ on one side and scored on the other.
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 patients
60 years), 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 once daily for most patients. The maximal antihypertensive effect is
attained 3-6 weeks after initiation of therapy. Some patients may receive an additional bene
Read the complete document
