Country: Australia
Bahasa: Inggeris
Sumber: Department of Health (Therapeutic Goods Administration)
amlodipine besilate, Quantity: 6.94 mg (Equivalent: amlodipine, Qty 5 mg); valsartan, Quantity: 80 mg
Novartis Pharmaceuticals Australia Pty Ltd
amlodipine besilate,Valsartan
Tablet, film coated
Excipient Ingredients: microcrystalline cellulose; magnesium stearate; crospovidone; colloidal anhydrous silica; titanium dioxide; hypromellose; purified talc; macrogol 4000; iron oxide yellow
Oral
56 Tablets, 7 Tablets, 14 Tablets, 28 Tablets, 30 Tablets
(S4) Prescription Only Medicine
AMLODIPINE/VALSARTAN NOVARTIS is indicated for the treatment of hypertension. Treatment should not be initiated with this fixed dose combination.
Visual Identification: Dark yellow, round film-coated tablet with bevelled edge, debossed with NVR on one side and NV on the other.; 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 30 degrees Celsius
Licence status A
2008-08-12
AMLODIPINE / VALSARTAN NOVARTIS ® _5/80; 5/160; 10/160; 5/320; 10/320_ _amlodipine besylate/valsartan_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about AMLODIPINE/ VALSARTAN 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 NOVARTIS IS USED FOR AMLODIPINE/VALSARTAN 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 NOVARTIS contains valsartan and amlodipine besylate. These medicines Baca dokumen lengkap
1 AUSTRALIAN PRODUCT INFORMATION – AMLODIPINE/VALSARTAN NOVARTIS 5/80 (AMLODIPINE /VALSARTAN) FILM-COATED TABLET AMLODIPINE/VALSARTAN NOVARTIS 5/160 (AMLODIPINE /VALSARTAN) FILM-COATED TABLET AMLODIPINE/VALSARTAN NOVARTIS 10/160 (AMLODIPINE /VALSARTAN) FILM-COATED TABLET AMLODIPINE/VALSARTAN NOVARTIS 5/320 (AMLODIPINE /VALSARTAN) FILM-COATED TABLET AMLODIPINE/VALSARTAN NOVARTIS 10/320 (AMLODIPINE /VALSARTAN) FILM-COATED TABLET 1 NAME OF THE MEDICINE Amlodipine/valsartan 2 QUALITATIVE AND QUANTITATIVE COMPOSITION AMLODIPINE/VALSARTAN NOVARTIS 5/80, AMLODIPINE/VALSARTAN NOVARTIS 5/160, AMLODIPINE/VALSARTAN NOVARTIS 10/160, AMLODIPINE/VALSARTAN NOVARTIS 5/320 and AMLODIPINE/VALSARTAN NOVARTIS 10/320 are available as film-coated tablets in five strengths containing amlodipine (5 or 10 mg) and valsartan (80, 160 mg or 320mg) as: 5/80 mg, 5/160 mg, 10/160 mg, 5/320 mg and 10/320 mg. For the full list of excipients, see Section 6.1 List of excipients. 3 PHARMACEUTICAL FORM AMLODIPINE/VALSARTAN NOVARTIS 5/80 (5 mg amlodipine and 80 mg valsartan): Dark yellow, round film-coated tablet with bevelled edge, debossed with NVR on one side and NV on the other. AMLODIPINE/VALSARTAN NOVARTIS 5/160 (5 mg amlodipine and 160 mg valsartan): Dark yellow, ovaloid film-coated tablet with bevelled edge, debossed with NVR on one side and ECE on the other. AMLODIPINE/VALSARTAN NOVARTIS 10/160 (10 mg amlodipine and 160 mg valsartan): Light yellow, ovaloid film-coated tablet with bevelled edge, debossed with NVR on one side and UIC on the other. AMLODIPINE/VALSARTAN NOVARTIS 5/320 (5 mg amlodipine and 320 mg valsartan): Very dark yellow, ovaloid film-coated tablet with bevelled edge, debossed with NVR on one side and CSF on the other. AMLODIPINE/VALSARTAN NOVARTIS 10/320 (10 mg amlodipine and 320 mg valsartan): Dark yellow, ovaloid film-coated tablet with bevelled edge, debossed with NVR on one side and LUF on the other. 2 4 CLINICAL PARTICULARS 4.1 T HERAPEUTIC INDICATIONS AMLODIPINE/VALSARTAN NOVARTIS is indicated for Baca dokumen lengkap