Kraj: Australia
Język: angielski
Źródło: Department of Health (Therapeutic Goods Administration)
valsartan, Quantity: 320 mg; hydrochlorothiazide, Quantity: 25 mg; amlodipine besilate, Quantity: 13.87 mg (Equivalent: amlodipine, Qty 10 mg)
Novartis Pharmaceuticals Australia Pty Ltd
amlodipine besilate,Hydrochlorothiazide,Valsartan
Tablet, film coated
Excipient Ingredients: magnesium stearate; colloidal anhydrous silica; crospovidone; microcrystalline cellulose; hypromellose; purified talc; iron oxide yellow; macrogol 4000
Oral
30, 14, 56, 7, 28
Medicine Registered
(S4) Prescription Only Medicine
AMLODIPINE/VALSARTAN/HCT NOVARTIS is indicated ONLY as substitution therapy for the treatment of hypertension in patients whose blood pressure is already adequately controlled on the triple combination of amlodipine, valsartan and hydrochlorothiazide taken either as three single component formulations or as dual-component formulation with a single component formulation, all components at the same dose level. Treatment should not be initiated with these fixed-dose combinations (see DOSAGE AND ADMINISTRATION).
Visual Identification: brown-yellow, non-scored, ovaloid, biconvex film-coated tablet with bevelled edge, debossed with "NVR" on one side and "VFL" on the other.; Container Type: Blister Pack; Container Material: PA/Al/PVC/Al - polyamide-aluminium foil-polyvinylchloride/aluminium foil; Container Life Time: 2 Years; Container Temperature: Store below 30 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Licence status A
2010-04-09
AMLODIPINE/ VALSARTAN/ HCT NOVARTIS ® _5/160/12.5, 5/160/25, 10/160/12.5, 10/160/25, 10/320/25_ _amlodipine besilate/valsartan/hydrochlorothiazide_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about AMLODIPINE/ VALSARTAN/HCT NOVARTIS. 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 AMLODIPINE/ VALSARTAN/HCT NOVARTIS IS USED FOR AMLODIPINE/VALSARTAN/HCT NOVARTIS is used to control high blood pressure, also called hypertension. Everybody has blood pressure. This pressure helps get your blood all 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 (high blood pressure) when your blood pressure stays higher than is needed, even when you are calm and relaxed. 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. AMLODIPINE/VALSARTAN/HCT NOVARTIS Przeczytaj cały dokument
1 AUSTRALIAN PRODUCT INFORMATION AMLODIPINE/VALSARTAN/HCT NOVARTIS 5/160/12.5 (AMLODIPINE /VALSARTAN/HYDROCHLOROTHIAZIDE) FILM-COATED TABLET AMLODIPINE/VALSARTAN/HCT NOVARTIS 5/160/25 (AMLODIPINE /VALSARTAN/HYDROCHLOROTHIAZIDE) FILM-COATED TABLET AMLODIPINE/VALSARTAN/HCT NOVARTIS 10/160/25 (AMLODIPINE /VALSARTAN/HYDROCHLOROTHIAZIDE) FILM-COATED TABLET AMLODIPINE/VALSARTAN/HCT NOVARTIS 10/160/12.5 (AMLODIPINE /VALSARTAN/HYDROCHLOROTHIAZIDE) FILM-COATED TABLET AMLODIPINE/VALSARTAN/HCT NOVARTIS 10/320/25 (AMLODIPINE /VALSARTAN/HYDROCHLOROTHIAZIDE) FILM-COATED TABLET 1 NAME OF THE MEDICINE Amlodipine /valsartan/hydrochlorothiazide 2 QUALITATIVE AND QUANTITATIVE COMPOSITION AMLODIPINE/VALSARTAN/HCT NOVARTIS 5/160/12.5 ® , AMLODIPINE/VALSARTAN/HCT NOVARTIS 5/160/25 ® , AMLODIPINE/VALSARTAN/HCT NOVARTIS 10/160/12.5 ® , AMLODIPINE/VALSARTAN/HCT NOVARTIS 10/160/25 ® , and AMLODIPINE/VALSARTAN/HCT NOVARTIS 10/320/25 ® are available as film-coated tablets in five strengths containing amlodipine (5 or 10 mg), valsartan (160 or 320 mg) and hydrochlorothiazide (12.5 or 25 mg) as: 5/160/12.5 mg, 5/160/25 mg, 10/160/12.5 mg, 10/160/25mg and 10/320/25 mg. For the full list of excipients, see Section 6.1 List of excipients. 3 PHARMACEUTICAL FORM AMLODIPINE/VALSARTAN/HCT NOVARTIS 5/160/12.5 ® (5 mg amlodipine, 160 mg valsartan and 12.5 mg hydrochlorothiazide): white, non-scored, ovaloid, biconvex film-coated tablet with bevelled edge, debossed with “NVR” on one side and “VCL” on the other. AMLODIPINE/VALSARTAN/HCT NOVARTIS 10/160/12.5 ® (10 mg amlodipine, 160 mg valsartan and 12.5 mg hydrochlorothiazide): pale yellow, non-scored, ovaloid, biconvex film-coated tablet with bevelled edge, debossed with “NVR” on one side and “VDL” on the other. AMLODIPINE/VALSARTAN/HCT NOVARTIS 5/160/25 ® (5 mg amlodipine, 160 mg valsartan and 25 mg hydrochlorothiazide): yellow, non-scored, ovaloid, biconvex film-coated tablet with bevelled edge, debossed with “NVR” on one side and “VEL” on the other. Przeczytaj cały dokument