COZAAR COMP
Country: Írland
Tungumál: enska
Heimild: HPRA (Health Products Regulatory Authority)
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(SPC)
08-05-2024
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Virkt innihaldsefni:
LOSARTAN POTASSIUM HYDROCHLOROTHIAZIDE
Fáanlegur frá:
Clear Pharmacy
Skammtar:
50/12.5 Milligram
Lyfjaform:
Film Coated Tablet
Leyfisdagur:
2011-01-21
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SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Cozaar Comp 50 mg/12.5 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 50 mg of losartan potassium and 12.5 mg of hydrochlorothiazide (HCTZ).
Excipient: each tablet contains 63.13 mg lactose monohydrate.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film coated tablet.
_Product imported from the UK:_
Yellow, oval film-coated tablets marked 717 on one side and plain or scored on the other.
The scoreline is only to facilitate breaking for ease of swallowing and not to divide into equal doses.
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
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