Nchi: Australia
Lugha: Kiingereza
Chanzo: Department of Health (Therapeutic Goods Administration)
amlodipine besilate, Quantity: 6.94 mg (Equivalent: amlodipine, Qty 5 mg); valsartan, Quantity: 160 mg
Novartis Pharmaceuticals Australia Pty Ltd
amlodipine besilate,Valsartan
Tablet, film coated
Excipient Ingredients: magnesium stearate; crospovidone; microcrystalline cellulose; colloidal anhydrous silica; hypromellose; purified talc; iron oxide yellow; macrogol 4000; titanium dioxide
Oral
28 tablets (4 x 7 tabs), 56 tablets, 7 tablets, 30 tablets, 14 tablets
(S4) Prescription Only Medicine
Treatment of hypertension. Treatment should not be initiated with this fixed dose combination.
Visual Identification: Dark yellow, ovaloid film-coated tablet with bevelled edge, debossed with NVR on one side and ECE 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
2008-02-05
EXFORGE ® _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 EXFORGE. 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 EXFORGE IS USED FOR EXFORGE 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. EXFORGE contains valsartan and amlodipine besylate. These medicines reduce blood pressure in two different ways. 1. Valsartan blocks the effect of angiotensin II, which is a substanc Soma hati kamili
1 AUSTRALIAN PRODUCT INFORMATION EXFORGE 5/80 EXFORGE 5/160 EXFORGE 10/160 EXFORGE 5/320 EXFORGE 10/320 (amlodipine besylate and valsartan) film-coated tablets 1 NAME OF THE MEDICINE amlodipine besylate/valsartan 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Exforge 5/80, Exforge 5/160, Exforge 10/160, Exforge 5/320 and Exforge 10/320 are available as film-coated tablets in three strengths containing amlodipine besylate (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 Exforge 5/80 (5mg amlodipine and 80mg valsartan): Dark yellow, round film-coated tablet with bevelled edge, debossed with NVR on one side and NV on the other. Exforge 5/160 (5mg amlodipine and 160mg valsartan): Dark yellow, ovaloid film-coated tablet with bevelled edge, debossed with NVR on one side and ECE on the other. Exforge 10/160 (10mg amlodipine and 160mg valsartan): Light yellow, ovaloid film-coated tablet with bevelled edge, debossed with NVR on one side and UIC on the other. Exforge 5/320 (5mg amlodipine and 320mg valsartan): Very dark yellow, ovaloid film-coated tablet with bevelled edge, debossed with NVR on one side and CSF on the other. Exforge 10/320 (10mg amlodipine and 320mg valsartan): Dark yellow, ovaloid film-coated tablet with bevelled edge, debossed with NVR on one side and LUF on the other. 4 CLINICAL PARTICULARS 4.1 T HERAPEUTIC INDICATIONS Exforge is indicated for the treatment of hypertension. Treatment should not be initiated with this fixed dose combination. 4.2 D OSE AND METHOD OF ADMINISTRATION Exforge 5/80, Exforge 5/160, Exforge 10/160, Exforge 5/320 and Exforge 10/320 are available as film-coated tablets in five strengths containing amlodipine besylate (5 or 10 mg) and valsartan (80, 160 or 320 mg) as: 5/80 mg, 5/160 mg , 10/160 mg, 5/320 mg and 10/320 mg. The recommended dose is one tablet per day of either Exforge 5/80 mg, 5/160 mg, 10/160 mg, 5/320 mg o Soma hati kamili