Država: Irska
Jezik: engleski
Izvor: HPRA (Health Products Regulatory Authority)
VALSARTAN HYDROCHLOROTHIAZIDE
Actavis Group PTC ehf
VALSARTAN HYDROCHLOROTHIAZIDE
320/25 Milligram
Film Coated Tablet
Product subject to prescription which may be renewed (B)
Withdrawn
2013-04-29
PACKAGE LEAFLET: INFORMATION FOR THE USER VALSARTAN/HYDROCHLOROTHIAZIDE 320 MG/12.5 MG FILM-COATED TABLETS VALSARTAN/HYDROCHLOROTHIAZIDE 320 MG/25 MG FILM-COATED TABLETS Valsartan/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. WHAT IS IN THIS LEAFLET: 1. What Valsartan/Hydrochlorothiazide is and what it is used for 2. What you need to know before you take Valsartan/Hydrochlorothiazide 3. How to take Valsartan/Hydrochlorothiazide 4. Possible side effects 5. How to store Valsartan/Hydrochlorothiazide 6. Contents of the pack and other information 1. WHAT VALSARTAN/HYDROCHLOROTHIAZIDE IS AND WHAT IT IS USED FOR Valsartan/Hydrochlorothiazide film-coated tablets contain two active substances called valsartan and hydrochlorothiazide. Both of these substances help to control high blood pressure (hypertension). VALSARTAN belongs to a class of medicines known as “angiotensin II receptor antagonists”, which help to control high blood pressure. Angiotensin II is a substance in the body that causes vessels to tighten, thus causing your blood pressure to increase. Valsartan works by blocking the effect of angiotensin II. As a result, blood vessels relax and blood pressure is lowered. HYDROCHLOROTHIAZIDE belongs to a group of Pročitajte cijeli dokument
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Valsartan/Hydrochlorothiazide 320 mg/25 mg Film-coated Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 320 mg of valsartan and 25 mg of hydrochlorothiazide. Excipients with known effect: Each Valsartan/Hydrochlorothiazide 320 mg/25 mg film-coated tablet contains 143.88 mg lactose monohydrate and 1.01 mg lecithin (contains soya oil) For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Yellow, oval, biconvex film-coated tablets, 18.9 x 7.5 mm, score on one face and side-scores, marked ‘V’ on one side and ‘H’ on the other. The tablet can be divided into equal halves. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of essential hypertension in adults. Valsartan/Hydrochlorothiazide fixed-dose combination is indicated in patients whose blood pressure is not adequately controlled on valsartan or hydrochlorothiazide monotherapy. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION _Posology_ The recommended dose of Valsartan/Hydrochlorothiazide is one Valsartan/Hydrochlorothiazide 320 mg/25 mg film- coated tablet once daily. Dose titration with the individual components is recommended. In each case, up- titration of individual components to the next dose should be followed in order to reduce the risk of hypotension and other adverse events. When clinically appropriate direct change from monotherapy to the fixed combination may be considered in patients whose blood pressure is not adequately controlled on valsartan or hydrochlorothiazide monotherapy, provided the recommended dose titration sequence for the individual components is followed. The clinical response to Valsartan/Hydrochlorothiazide should be evaluated after initiating therapy and if blood pressure remains uncontrolled, the d Pročitajte cijeli dokument