Country: Malaysia
Bahasa: Inggeris
Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
AMLODIPINE BESILATE; VALSARTAN; HYDROCHLOROTHIAZIDE
NOVARTIS CORPORATION (MALAYSIA) SDN. BHD.
AMLODIPINE BESILATE; VALSARTAN; HYDROCHLOROTHIAZIDE
4 x 7tablet Tablets; 1 x 7tablet Tablets; 2 x 7tablet Tablets
NOVARTIS FARMA S.P.A.
EXFORGE HCT ® AMLODIPINE BESYLATE/VALSARTAN/HYDROCHLOROTHIAZIDE 5/160/12.5 mg, 10/160/12.5 mg, and 10/160/25 mg, Film-coated tablets _Consumer Medication Information Leaflet (RiMUP) _ 1 WHAT IS IN THIS LEAFLET 1. WHAT EXFORGE HCT IS USED FOR 2. HOW EXFORGE HCT WORKS 3. BEFORE YOU TAKE EXFORGE HCT 4. HOW TO USE EXFORGE HCT 5. WHILE USING EXFORGE HCT 6. SIDE EFFECTS 7. STORAGE AND DISPOSAL OF EXFORGE HCT 8. PRODUCT DESCRIPTION 9. MANUFACTURER AND PRODUCT REGISTRATION HOLDER 10. DATE OF REVISION WHAT EXFORGE HCT IS USED FOR Your medicine is called Exforge HCT and is available as a film-coated tablet. Exforge HCT contains three medicines: Amlodipine, a medicine that belongs to the class of calcium antagonists, valsartan, which belongs to the class of so-called angiotensin-II receptor antagonists and hydrochlorothiazide, a diuretic which belongs to the sulfonamides. All three medicines help in different ways to control high blood pressure. Exforge HCT is used to treat high blood pressure in patients whose blood pressure is not adequately controlled with a dual combination of blood pressure lowering drugs, or for patients on separate antihypertensive drugs who wish to take one tablet with all three components. If high blood pressure persists for a long time, it can damage the blood vessels of the brain, heart, and kidneys, and may result in a stroke, heart failure, kidney failure or damage to the retina of the eye. High blood pressure increases the risk of heart attacks. Lowering your blood pressure to normal levels reduces the risk of developing these disorders. HOW EXFORGE HCT WORKS Exforge HCT contains three medicines: Amlodipine blocks calcium channels at the blood vessels level. This has a relaxant effect on the blood vessels. Valsartan works by blocking the effect of angiotensin II. Angiotensin II is a substance produced by the body that causes blood vessels to tighten, thus increasing the blood pressure. Hydrochlorothiazide reduces the amount of salt and water in the body by increasing the flow of urine. As a r Baca dokumen lengkap
Novartis Page 2 Malaysia Package Leaflet 10-Sep-2018 Exforge HCT EXFORGE HCT Angiotensin II antagonists combinations plain (valsartan) with dihydropyridine derivatives (amlodipine) and thiazide diuretics (HCTZ) DESCRIPTION AND COMPOSITION PHARMACEUTICAL FORM Film-coated tablets (FCT). Three strengths are available. • 5 mg of amlodipine (as amlodipine besylate), 160 mg of valsartan and 12.5 mg hydrochlorothiazide, White film-coated tablet, ovaloid, biconvex with beveled edge with debossing “NVR” on one side and “VCL” on the other side. • 10 mg of amlodipine (as amlodipine besylate), 160 mg of valsartan and 12.5 mg hydrochlorothiazide, Pale yellow film-coated tablet, ovaloid, biconvex with beveled edge with debossing “NVR” on one side and “VDL” on the other side. • 10 mg of amlodipine (as amlodipine besylate) and 160 mg of valsartan and 25 mg hydrochlorothiazide, Brown-yellow film-coated tablet, ovaloid, biconvex with beveled edge with debossing “NVR” on one side and “VHL” on the other side. Exforge HCT FCT are non-divisible and cannot be divided into equal doses. ACTIVE SUBSTANCES Amlodipine besylate Valsartan Hydrochlorothiazide EXCIPIENTS 5/160/12.5 mg: cellulose microcrystalline; crospovidone; silica, colloidal anhydrous; magnesium stearate; hypromellose, macrogol 4000, talc, titanium dioxide (E171). 10/160/12.5 mg: cellulose microcrystalline; crospovidone; silica, colloidal anhydrous; magnesium stearate; hypromellose, macrogol 4000, talc, titanium dioxide (E171), iron oxide, yellow (E172), iron oxide, red (E 172). 10/160/25 mg: cellulose microcrystalline; crospovidone; silica, colloidal anhydrous, magnesium stearate, hypromellose, macrogol 4000, talc, iron oxide, yellow (E172). Pharmaceutical formulations may vary between countries. INDICATIONS Treatment of essential hypertension. Novartis Page 3 Malaysia Package Leaflet 10-Sep-2018 Exforge HCT This fixed combination drug is not indicated for the initial therapy of hypertension (see section DOSAGE AND ADMINISTRATION). DOSAGE R Baca dokumen lengkap