Land: Australien
Språk: engelska
Källa: Department of Health (Therapeutic Goods Administration)
valsartan, Quantity: 160 mg
Novartis Pharmaceuticals Australia Pty Ltd
Tablet, film coated
Excipient Ingredients: colloidal anhydrous silica; crospovidone; microcrystalline cellulose; magnesium stearate; titanium dioxide; hypromellose; macrogol 8000; iron oxide yellow; iron oxide red; iron oxide black
Oral
28 tablets, 30 tablets, 56 tablets, 14 tablets, 7 tablets
(S4) Prescription Only Medicine
Treatment of hypertension. Treatment of heart failure (NYHA class II-IV) in patients receiving usual therapy (e.g. diuretics, digitalis) who are intolerant to ACE inhibitors. To improve survival following myocardial infarction in clinically stable patients with clinical or radiological evidence of left ventricular failure and/or with left ventricular systolic dysfunction (see "CLINICAL TRIALS").
Visual Identification: Ovaloid, grey-orange and debossed with DX/DX on the scored side and NVR on the other side.; Container Type: Blister Pack; Container Material: PA/Al/PVC/Al - polyamide-aluminium foil-polyvinylchloride/aluminium foil; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure
Registered
2001-11-13
DIOVAN ® _Valsartan_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Diovan. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. The information in this leaflet was last updated on the date listed on the final page. More recent information on the medicine may be available. YOU SHOULD ENSURE THAT YOU SPEAK TO YOUR PHARMACIST OR DOCTOR TO OBTAIN THE MOST UP TO DATE INFORMATION ON THE MEDICINE. YOU CAN ALSO DOWNLOAD THE MOST UP TO DATE LEAFLET FROM WWW.NOVARTIS.COM.AU. Those updates may contain important information about the medicine and its use of which you should be aware. All medicines have risks and benefits. Your doctor has weighed the risks of you taking this medicine against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT DIOVAN IS USED FOR Diovan belongs to a group of medicines called angiotensin II receptor antagonists (AIIRAs). _HYPERTENSION_ Diovan is used to control high blood pressure, also called hypertension. Everyone has blood pressure. This pressure helps get your blood around your body. Your blood pressure may be different at different times of the day, depending on how busy or worried you are. You have hypertension when your blood pressure stays higher than is needed, even when you are calm and relaxed. There are usually no symptoms of hypertension. The only way of knowing that you have it is to have your blood pressure checked regularly. High blood pressure increases the workload of the heart and blood vessels. If it continues for a long time, it can damage the blood vessels in the brain, heart and kidneys. This can lead to stroke, heart failure or kidney failure. High blood pressure increases the risk of heart attacks. Lowering your blood pressure reduces the chance of these disorders happening. _HEART FAILURE_ Diovan is Läs hela dokumentet
1 AUSTRALIAN PRODUCT INFORMATION DIOVAN 40 (VALSARTAN) FILM-COATED TABLET DIOVAN 80 (VALSARTAN) FILM-COATED TABLET DIOVAN 160 (VALSARTAN) FILM-COATED TABLET DIOVAN 320 (VALSARTAN) FILM-COATED TABLET 1 NAME OF THE MEDICINE Valsartan. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION The active ingredient of Diovan is: N-Pentanoyl-N-[2’-(1H-tetrazol-5-yl)biphenyl-4ylmethyl]-L-valine (INN = valsartan). Valsartan is a white to practically white fine powder. It is soluble in ethanol and methanol and slightly soluble in water. For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS. 3 PHARMACEUTICAL FORM Diovan 40 mg tablet: Film-coated tablet containing 40 mg valsartan; yellow, ovaloid, scored on one side with “DO” on scored side and “NVR” on other side. Diovan 80 mg tablet: Film-coated tablet containing 80 mg valsartan; pale red, round, scored on one side with “D/V” on scored side and “NVR” on other side. Diovan 160 mg tablet: Film-coated tablet containing 160 mg valsartan; grey-orange, ovaloid, scored on one side with “DX/DX” on scored side and “NVR” on other side. Diovan 320 mg tablet: Film-coated tablet containing 320 mg valsartan; grey-violet, ovaloid, with “DXL” on one side and “NVR” on other side. 4 CLINICAL PARTICULARS 4.1 T HERAPEUTIC INDICATIONS Treatment of hypertension. Treatment of heart failure (NYHA class II-IV) in patients receiving usual therapy (e.g. diuretics, digitalis) who are intolerant to ACE inhibitors. To improve survival following myocardial infarction in clinically stable patients with clinical or radiological evidence of left ventricular failure and/or with left ventricular systolic dysfunction (see Section 5.2 PHARMACOKINETIC PROPERTIES -Clinical Trials). 4.2 D OSE AND METHOD OF ADMINISTRATION HYPERTENSION: The recommended dose of Diovan is 80 mg once daily, irrespective of race, age or gender. The maximum antihypertensive effect is seen after 4 weeks. In patients whose blood pressure is not adequately controlled, the daily dose may be Läs hela dokumentet