Страна: Ирландия
Език: английски
Източник: HPRA (Health Products Regulatory Authority)
Losartan potassium; Hydrochlorothiazide
Accord Healthcare Ireland Ltd.
C09DA; C09DA01
Losartan potassium; Hydrochlorothiazide
100/12.5 milligram(s)
Film-coated tablet
Angiotensin II antagonists and diuretics; losartan and diuretics
Marketed
2012-03-02
_ _ _ _ PACKAGE LEAFLET: INFORMATION FOR THE USER COSARTAL PLUS 50 MG/12.5 MG FILM-COATED TABLETS COSARTAL PLUS 100 MG/12.5 MG FILM-COATED TABLETS COSARTAL PLUS 100 MG/25 MG FILM-COATED TABLETS Losartan potassium/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 or pharmacist. - 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 or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Cosartal Plus is and what it is used for 2. What you need to know before you take Cosartal Plus 3. How to take Cosartal Plus 4. Possible side effects 5. How to store Cosartal Plus 6. Contents of the pack and other information 1. WHAT COSARTAL PLUS IS AND WHAT IT IS USED FOR Cosartal Plus 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. Cosartal Plus is indicated for the treatment of essential hypertension (high blood pressure). 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE COSARTAL PLUS DO NOT TAKE COSARTAL PLUS: - 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 (hypersensitive) to other sulfonamide-derived substances (e. g. other thiazides, some ant Прочетете целия документ
Health Products Regulatory Authority 01 March 2022 CRN00CQT9 Page 1 of 15 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Cosartal Plus 100 mg/12.5 mg Film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 100 mg losartan potassium and 12.5 mg hydrochlorothiazide For the full list of excipients see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet. Cosartal Plus 100 mg/12.5 mg film-coated tablets: Yellow colored, 10 mm, round shaped, biconvex film coated tablets debossed with "KK2" on one side and plain on other side. The tablets are not scored. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Cosartal Plus 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 Cosartal Plus is one tablet of Cosartal Plus 50 mg/12.5 mg (losartan 50 mg/HCTZ 12.5 mg) once daily. For patients who do not respond adequately to Cosartal Plus 50 mg/12.5 mg, the dosage may be increased to one tablet of Cosartal Plus 100 mg/25 mg (losartan 100 mg/ HCTZ 25 mg) once daily. The maximum dose is one tablet of Cosartal Plus 100 mg/25 mg once daily. In general, the antihypertensive effect is attained within three to four weeks after initiation of therapy. Other tablets containing losartan 100 mg/ HCTZ 12.5 mg may be available for those patients titrated to 100 mg of losartan who require additional blood pressure control. _Use in patients with r Прочетете целия документ