Nazione: Irlanda
Lingua: inglese
Fonte: HPRA (Health Products Regulatory Authority)
VALSARTAN
Milpharm Limited
C09CA03
VALSARTAN
80 Milligram
Film Coated Tablet
Product subject to prescription which may be renewed (B)
Angiotensin II antagonists, plain
Authorised
2012-04-05
PACKAGE LEAFLET: INFORMATION FOR THE USER VALSARTAN AUROBINDO 40 MG FILM-COATED TABLETS VALSARTAN AUROBINDO 80 MG FILM-COATED TABLETS VALSARTAN AUROBINDO 160 MG FILM-COATED TABLETS VALSARTAN AUROBINDO 320 MG FILM-COATED TABLETS Valsartan 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 Valsartan Aurobindo is and what it is used for 2. What you need to know before you take Valsartan Aurobindo 3. How to take Valsartan Aurobindo 4. Possible side effects 5. How to store Valsartan Aurobindo 6. Contents of the pack and other information 1. WHAT VALSARTAN AUROBINDO IS AND WHAT IT IS USED FOR Valsartan belongs to a class of medicines known as angiotensin II receptor antagonist, 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. Valsartan Aurobindo 40 mg film-coated tablets CAN BE USED IN THE FOLLOWING DIFFERENT CONDITIONS: TO TREAT HIGH BLOOD PRESSURE IN CHILDREN AND ADOLESCENTS 6 TO 18 YEARS OF AGE. High blood pressure increases the workload on the heart and arteries. If not treated it can damage the blood vessels of the brain, heart, a Leggi il documento completo
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Valsartan Aurobindo 80 mg film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 80 mg of valsartan Excipients with known effect: Each film-coated tablet contains 48 mg lactose monohydrate. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet. Pale red coloured, round (9.3 mm in diameter), beveled edge, biconvex, film coated tablets debossed with ‘I’ on one side and ‘74’ on the other side with score line separating 7 and 4. The tablet can be divided into equal doses. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Hypertension Treatment of essential hypertension in adults, and hypertension in children and adolescents 6 to 18 years of age. Recent myocardial infarction Treatment of clinically stable adult patients with symptomatic heart failure or asymptomatic left ventricular systolic dysfunction after a recent (12 hours-10 days) myocardial infarction (see sections 4.4 and 5.1). Heart failure Treatment of adult patients with symptomatic heart failure when ACE-inhibitors are not tolerated or in beta-blocker intolerant patients as add-on therapy to ACE-inhibitors when mineralocorticoid receptor antagonists cannot be used (see Sections 4.2, 4.4, 4.5 and 5.1). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION _Posology_ Hypertension The recommended starting dose of Valsartan Aurobindo is 80 mg once daily. The antihypertensive effect is substantially present within 2 weeks, and maximal effects are attained within 4 weeks. In some patients whose blood pressure is not adequately controlled, the dose can be increased to 160 mg and to a maximum of 320 mg. Valsartan Aurobindo may also be administered with other antihypertensive agents. The additi Leggi il documento completo