Страна: Ірландія
мова: англійська
Джерело: HPRA (Health Products Regulatory Authority)
LOSARTAN POTASSIUM, HYDROCHLOROTHIAZIDE
McDermott Laboratories Ltd t/a Gerard Laboratories
C09DA01
LOSARTAN POTASSIUM, HYDROCHLOROTHIAZIDE
100/12.5 Milligram
Film Coated Tablet
Product subject to prescription which may be renewed (B)
Angiotensin II antagonists and diuretics
Authorised
2011-06-17
PAGE 2 OF 9 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT Losartan/Hydrochlorothiazide Mylan 50 mg/12.5 mg Film-coated Tablets Losartan/Hydrochlorothiazide Mylan 100 mg/12.5 mg Film-coated Tablets Losartan/Hydrochlorothiazide Mylan 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 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 Losartan/Hydrochlorothiazide Mylan is and what it is used for 2. What you need to know before you take Losartan/Hydrochlorothiazide Mylan 3. How to take Losartan/Hydrochlorothiazide Mylan 4. Possible side effects 5. How to store Losartan/Hydrochlorothiazide Mylan 6. Contents of the pack and other information 1. WHAT LOSARTAN/HYDROCHLOROTHIAZIDE MYLAN IS AND WHAT IT IS USED FOR Losartan/Hydrochlorothiazide Mylan 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 al Прочитайте повний документ
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Losartan/Hydrochlorothiazide Mylan 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. _Excipient with known effect:_ Each tablet contains 240 mg lactose monohydrate. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet White to off white, film coated, oval, biconvex, beveled edged tablet debossed with ‘M’ on one side of the tablet and ‘LH5’ 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 Posology 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/Hydrochlorothiazide Mylan 50 mg/12.5 mg, the dosage may be increased to one tablet of Losartan/Hydrochlorothiazide Mylan 100 mg/25 mg (losartan 100 mg/ hydrochlorothiazide 25 mg) once daily. The maximum dose is one tablet of Losartan/Hy Прочитайте повний документ