País: Irlanda
Idioma: anglès
Font: HPRA (Health Products Regulatory Authority)
LOSARTAN POTASSIUM HYDROCHLOROTHIAZIDE
IPS Healthcare Limited
100/12.5 Milligram
Film Coated Tablet
2010-10-08
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Cozaar Comp 100mg/12.5mg film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 100 mg of losartan potassium and 12.5 mg of hydrochlorothiazide (HCTZ). Cozaar Comp 100 mg/12.5 mg: each tablet contains 88.40 mg lactose monohydrate. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film coated tablet _Product imported from the UK:_ White, oval film-coated tablets marked '745' on one side and plain on the other. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Cozaar Comp is indicated for 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 Llegiu el document complet