COZAAR COMP
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
26-04-2024
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Active ingredient:
LOSARTAN POTASSIUM HYDROCHLOROTHIAZIDE
Available from:
G & A Licensing Limited
Dosage:
50/12.5 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 Comp 50mg/12.5mg Film-coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 50mg of losartan potassium and 12.5mg of hydrochlorothiazide (HCTZ).
Excipients: Each 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:
Yellow, oval film-coated tablets, marked ‘717’ on one side and plain on the other.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Cozaar Comp is indicated for the treatment of essential hypertension in patients whose blood pressure is not adequately
controlled on losartan or hydrochlorothiazide alone.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Cozaar Comp may be administered with other antihypertensive agents.
Cozaar Comp tablets should be swallowed with a glass of water
Cozaar Comp may be administered with or without food.
Hypertension
Losartan and hydrochlorothiazide is not for use as initial therapy, but in patients whose blood pressure is not adequately
controlled by losartan potassium or hydrochlorothiazide alone.
Dose titration with the individual components (losartan and hydrochlorothiazide) is recommended.
When clinically appropriate direct change from monotherapy to the fixed combination may be considered in patients
whose blood pressure is not adequately controlled.
The usual maintenance dose of Cozaar Comp is one tablet of Cozaar Comp 50 mg/12.5 mg
(losartan 50 mg/HCTZ 12.5 mg) once daily. For patients who do not respond adequately to Cozaar
Comp 50 mg/12.5 mg, the dosage may be increased to one tablet of Cozaar Comp 100 mg/25 mg (losartan 100 mg/
HCTZ 25 mg) once daily. The maximum dose is one tablet of Cozaar Comp 100 mg/25 mg once daily. In g
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