Šalis: Airija
kalba: anglų
Šaltinis: HPRA (Health Products Regulatory Authority)
LOSARTAN POTASSIUM, HYDROCHLOROTHIAZIDE
Bluefish Pharmaceuticals AB
C09DA01
LOSARTAN POTASSIUM, HYDROCHLOROTHIAZIDE
50/12.5 Milligram
Film Coated Tablet
Product subject to prescription which may be renewed (B)
Angiotensin II antagonists and diuretics
Authorised
2011-02-25
PACKAGE LEAFLET : INFORMATION FOR THE USER LOSARTAN/HYDROCHLOROTHIAZIDE BLUEFISH 50 MG/12.5 MG AND 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 of the 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 Losartan/Hydrochlorothiazide Bluefish is and what it is used for 2. What you need to know before you take Losartan/Hydrochlorothiazide Bluefish 3. How to take Losartan/Hydrochlorothiazide Bluefish 4. Possible side effects. 5. How to store Losartan/Hydrochlorothiazide Bluefish 6. Contents of the pack and other information 1. WHAT LOSARTAN/HYDROCHLOROTHIAZIDE BLUEFISH IS AND WHAT IT IS USED FOR Losartan/Hydrochlorothiazide Bluefish is a combination of an angiotensin II receptor antagonist (losartan) and a diuretic (hydrochlorothiazide). Losartan/Hydrochlorothiazide Bluefish is indicated for the treatment of essential hypertension (high blood pressure). 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE LOSARTAN/HYDROCHLOROTHIAZIDE BLUEFISH DO NOT TAKE LOSARTAN/HYDROCHLOROTHIAZIDE BLUEFISH if you are allergic to losartan, hydrochlorothiazide or to any of the other ingredients of this medicine (listed in section 6). if you Perskaitykite visą dokumentą
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Losartan/Hydrochlorothiazide Bluefish 50 mg/12.5 mg film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Losartan/Hydrochlorothiazide Bluefish 50 mg/12.5 mg film-coated tablet contains: 50 mg of losartan potassium and 12.5 mg of hydrochlorothiazide. Excipient: Losartan/Hydrochlorothiazide Bluefish 50 mg/12.5 mg film-coated tablet contains 155.00 mg lactose monohydrate. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet. Losartan/Hydrochlorothiazide Bluefish 50 mg/12.5 mg film-coated tablets are yellow and oblong with a score line. The score-line is only to facilitate breaking for ease of swallowing and not to divide into equal doses. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Losartan/Hydrochlorothiazide Bluefish 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 This medicinal product is available in 2 strengths: 50 mg/12.5 mg and 100 mg/25 mg 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 Losartan/Hydrochlorothiazide Bluefish is one tablet of Losartan/Hydrochlorothiazide Bluefish 50 mg/12.5 mg (losartan 50 mg/hydrochlorothiazide 12.5 mg) once daily. For patients who do not respond adequately to Losartan/Hydrochlorothiazide Bluefish 50 mg/12.5 mg, the dosage may be increased to one tablet of Losartan/Hydrochlorothiazide Bluefish 100 mg/25 mg (losartan 100 mg/Hydrochlorothiazide25 mg) once daily. The ma Perskaitykite visą dokumentą