国: アイルランド
言語: 英語
ソース: HPRA (Health Products Regulatory Authority)
LOSARTAN POTASSIUM HYDROCHLOROTHIAZIDE
McDermott Laboratories Ltd t/a Gerard Laboratories
LOSARTAN POTASSIUM HYDROCHLOROTHIAZIDE
100/25 Milligram
Film Coated Tablet
Product subject to prescription which may be renewed (B)
Authorised
0000-00-00
PAGE 1 OF 9 PACKAGE LEAFLET PAGE 2 OF 9 PACKAGE LEAFLET PAGE 3 OF 9 PACKAGE LEAFLET: INFORMATION FOR THE USER Losartan Potassium/Hydrochlorothiazide 50 mg/12.5 mg Film-coated Tablets Losartan Potassium/Hydrochlorothiazide 100 mg/12.5 mg Film-coated Tablets Losartan Potassium/Hydrochlorothiazide 100 mg/25 mg Film-coated Tablets (losartan potassium and hydrochlorothiazide) READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE. - 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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. - If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. IN THIS LEAFLET: 1. What Losartan Potassium/Hydrochlorothiazide is and what it is used for 2. Before you take Losartan Potassium/Hydrochlorothiazide 3. How to take Losartan Potassium/Hydrochlorothiazide 4. Possible side effects 5. How to store Losartan Potassium/Hydrochlorothiazide 6. Further information 1. WHAT LOSARTAN POTASSIUM/HYDROCHLOROTHIAZIDE IS AND WHAT IT IS USED FOR Losartan Potassium/Hydrochlorothiazide is a combination of an angiotensin II receptor antagonist (losartan) and a diuretic (hydrochlorothiazide). Angiotensin II is a substance produced by 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 pres 完全なドキュメントを読む
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Losartan/Hydrochlorothiazide Mylan 100 mg/25 mg Film-coated Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 100 mg of Losartan Potassium and 25 mg of Hydrochlorothiazide as active ingredients. _Excipients_ Each tablet contains 240 mg lactose monohydrate. For a full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Film-coated tablet Light yellow, film-coated, oval, biconvex, beveled edged tablet debossed with ‘M’ on one side and ‘LH6’ on the other side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Losartan/Hydrochlorothiazide Mylan 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 For oral administration. Losartan/Hydrochlorothiazide Mylan may be administered with other antihypertensive agents. Losartan/Hydrochlorothiazide Mylan tablets should be swallowed with a glass of water Losartan/Hydrochlorothiazide Mylan may be administered with or without food. Hypertension Losartan/Hydrochlorothiazide Mylan 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 Mylan is one tablet of Losartan/Hydrochlorothiazide Mylan 50 mg/12.5 mg (losartan 50 mg/hydrochlorothiazide 12.5 mg) once daily. For patients who do not respond adequately to Losartan/ 完全なドキュメントを読む