Država: Irska
Jezik: angleščina
Source: HPRA (Health Products Regulatory Authority)
Valsartan
Teva Pharma B.V.
C09CA; C09CA03
Valsartan
80 milligram(s)
Film-coated tablet
Product subject to prescription which may be renewed (B)
Angiotensin II antagonists, plain; valsartan
Marketed
2009-08-28
Valsartan, DK/H/1517/001-004, 10.10.23 1 PACKAGE LEAFLET: INFORMATION FOR THE USER [VALSARTAN 40 MG FILM-COATED TABLETS AND ASSOCIATED NAMES] [VALSARTAN 80 MG FILM-COATED TABLETS AND ASSOCIATED NAMES] [VALSARTAN 160 MG FILM-COATED TABLETS AND ASSOCIATED NAMES] [VALSARTAN 320 MG FILM-COATED TABLETS AND ASSOCIATED NAMES] 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] is and what it is used for 2. What you need to know before you take [Valsartan] 3. How to take [Valsartan] 4. Possible side effects 5. How to store [Valsartan] 6. Contents of the pack and other information 1. WHAT [VALSARTAN] 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] 40 mg film-coated tablets CAN BE USED FOR THREE DIFFERENT CONDITIONS: - TO TREAT HIGH BLOOD PRESSURE IN CHILDREN AND ADOLESCENTS 6 TO LESS THAN 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, and kidneys, and may result in a stroke, heart failure, or kidney failure. High blood pressure increases the risk of heart attacks. Lowering your blood pressure to normal reduces the risk o Preberite celoten dokument
Health Products Regulatory Authority 04 May 2022 CRN00CC2F Page 1 of 15 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Valsartan Teva 80 mg Film-coated Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 80 mg of valsartan. _Excipient with known effect:_ Each film-coated tablet contains 0.085 mg of sunset yellow FCF (E110). For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Pink, oval-shaped, film-coated tablet, scored on one side and debossed with “V” on one side of the score line and “80” on the other side of the score line. 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 less than 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 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 may also be administered with other antihypertensive agents (see sections 4.3, 4.4, 4.5 and 5.1). The addition of a diuretic such as hydrochlorothiazide will decrease blood pressure even further in these patients. Recent myocardial infarction (only 40 mg, 80 mg and 160 mg) Preberite celoten dokument