Ország: Írország
Nyelv: angol
Forrás: HPRA (Health Products Regulatory Authority)
Losartan potassium; Hydrochlorothiazide
Organon Pharma (Ireland) Limited
C09DA; C09DA01
Losartan potassium; Hydrochlorothiazide
100 mg/12.5 milligram(s)
Film-coated tablet
Angiotensin II antagonists and diuretics; losartan and diuretics
Marketed
2008-02-22
[Organon] Proprietary PACKAGE LEAFLET: INFORMATION FOR THE PATIENT COZAAR® COMP 50 MG/12.5 MG FILM-COATED TABLETS COZAAR® COMP 100 MG/12.5 MG FILM-COATED TABLETS COZAAR® COMP 100 MG/25 MG FILM-COATED TABLETS LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. • Keep this leaflet. You may need to read it again. • If you have any further questions, ask your doctor, pharmacist, or nurse. • This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. • If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Cozaar Comp is and what it is used for 2. What you need to know before you take Cozaar Comp 3. How to take Cozaar Comp 4. Possible side effects 5. How to store Cozaar Comp 6. Contents of the pack and other information 1. WHAT COZAAR COMP IS AND WHAT IT IS USED FOR Cozaar Comp is a combination of an angiotensin II receptor antagonist (losartan) and a diuretic (hydrochlorothiazide). Angiotensin II is a substance produced in the body which binds to receptors in blood vessels, causing them to tighten. This results in an increase in blood pressure. Losartan prevents the binding of angiotensin II to these receptors, causing the blood vessels to relax which in turn lowers the blood pressure. Hydrochlorothiazide works by making the kidneys pass more water and salt. This also helps to reduce blood pressure. Cozaar Comp is indicated for the treatment of essential hypertension (high blood pressure). 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE COZAAR COMP DO NOT TAKE COZAAR COMP • if you are allergic to losartan, hydrochlorothiazide or to any of the other ingredients of this medicine (listed in section 6), • if you are allergic to other sulfonamide-derived substances (e.g. other thiazid Olvassa el a teljes dokumentumot
Health Products Regulatory Authority 01 July 2022 CRN00CR0V Page 1 of 15 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Cozaar Comp 100 mg/12.5 mg film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 100 mg of losartan potassium and 12.5 mg of hydrochlorothiazide (HCTZ). Each tablet contains 88.40 mg lactose monohydrate. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film coated tablets (tablets) 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 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 Posology 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 general, the antihypertensive effect is attained within three to four weeks after initiation of therapy. Cozaar Comp 100/12.5 (losartan 100 mg/ HCTZ 12.5 mg) is available for those patients titrated to 100 mg of Cozaar who require additional blood pressure control. Use in patients with renal impairment and haemodialysis patients No initial dosage adjustment is necessary Olvassa el a teljes dokumentumot