Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
hydrochlorothiazide, Quantity: 25 mg; amlodipine besilate, Quantity: 13.87 mg (Equivalent: amlodipine, Qty 10 mg); valsartan, Quantity: 160 mg
Novartis Pharmaceuticals Australia Pty Ltd
amlodipine besilate,Hydrochlorothiazide,Valsartan
Tablet, film coated
Excipient Ingredients: crospovidone; microcrystalline cellulose; colloidal anhydrous silica; magnesium stearate; hypromellose; purified talc; iron oxide yellow; macrogol 4000
Oral
14, 30, 56, 7, 28
(S4) Prescription Only Medicine
Exforge HCT 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 film coated tablet, ovaloid, biconvex with bevelled edge with "NVR" on one side and "VHL" on the other side.; 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
Registered
2010-04-09
EXFORGE HCT ® _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 Exforge HCT. 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 HCT IS USED FOR Exforge HCT 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 HCT contains amlodipine besilate, valsartan and hydrochlorothiazide. These medicines reduce blood pressure in three d Read the complete document
1 AUSTRALIAN PRODUCT INFORMATION EXFORGE HCT 5/160/12.5 (AMLODIPINE BESILATE/VALSARTAN/HYDROCHLOROTHIAZIDE) FILM-COATED TABLET EXFORGE HCT 5/160/25 (AMLODIPINE BESILATE/VALSARTAN/HYDROCHLOROTHIAZIDE) FILM-COATED TABLET EXFORGE HCT 10/160/25 (AMLODIPINE BESILATE/VALSARTAN/HYDROCHLOROTHIAZIDE) FILM-COATED TABLET EXFORGE HCT 10/160/12.5 (AMLODIPINE BESILATE/VALSARTAN/HYDROCHLOROTHIAZIDE) FILM-COATED TABLET EXFORGE HCT 10/320/25 (AMLODIPINE BESILATE/VALSARTAN/HYDROCHLOROTHIAZIDE) FILM-COATED TABLET 1 NAME OF THE MEDICINE Amlodipine besilate/valsartan/hydrochlorothiazide. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Amlodipine besilate is a white or almost white powder that is slightly soluble in water and sparingly soluble in ethanol. Valsartan is a white to practically white microcrystalline and slightly bitter tasting powder. It is soluble in ethanol and methanol and slightly soluble in water. Hydrochlorothiazide is a white or almost white powder, very slightly soluble in water and freely soluble in dimethylsulfoxide. Exforge HCT 5/160/12.5 ® , Exforge HCT 5/160/25 ® , Exforge HCT 10/160/12.5 ® , Exforge HCT 10/160/25 ® , and Exforge HCT 10/320/25 ® are available as film-coated tablets in five strengths containing amlodipine besilate (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. 2 3 PHARMACEUTICAL FORM Exforge HCT 5/160/12.5 ® (5mg amlodipine, 160mg valsartan and 12.5mg hydrochlorothiazide): white, ovaloid, biconvex film-coated tablet with bevelled edge, debossed with “NVR” on one side and “VCL” on the other. Exforge HCT 10/160/12.5 ® (10mg amlodipine, 160mg valsartan and 12.5mg hydrochlorothiazide): pale yellow, ovaloid, biconvex film-coated tablet with bevelled edge, debossed with “NVR” on one side and “VDL” on the other. Exforge HCT 5/160/25 ® (5mg amlodipine, 160mg valsartan and 25mg hydrochlo Read the complete document