Country: Malaysia
Bahasa: Inggeris
Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
VALSARTAN
NOVARTIS CORPORATION (MALAYSIA) SDN. BHD.
VALSARTAN
7Tablet Tablets; 28Tablet Tablets; 14Tablet Tablets
NOVARTIS FARMA S.P.A.
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ DIOVAN ® FILM-COATED TABLET Valsartan (40mg, 80mg, and 160mg) _ _ 1 WHAT IS IN THIS LEAFLET 1. WHAT DIOVAN IS USED FOR 2. HOW DIOVAN WORKS 3. BEFORE YOU USE DIOVAN 4. HOW TO USE DIOVAN 5. WHILE YOU ARE USING DIOVAN 6. SIDE EFFECTS 7. STORAGE AND DISPOSAL OF DIOVAN 8. PRODUCT DESCRIPTION 9. MANUFACTURER AND PRODUCT REGISTRATION HOLDER 10. DATE OF REVISION WHAT DIOVAN IS USED FOR Diovan is used to treat high blood pressure in adults. High blood pressure increases the workload of the heart and arteries. If it continues for a long time, it can damage the blood vessels of the brain, heart, and kidneys, and may result in a stroke, heart failure, or kidney failure. High blood pressure increases the risk of heart attacks. Lowering your blood pressure to normal reduces the risk of developing these disorders. Diovan is used to treat adult heart failure patients. Heart failure is associated with shortness of breath, and swelling of the feet and legs due to fluid build-up. Heart failure means that the heart muscle cannot pump blood strongly enough to supply all the blood needed throughout the body. Diovan can also be used to treat adults after a heart attack (myocardial infarction) to improve survival and reduce further heart problems. HOW DIOVAN WORKS Angiotensin II is a natural substance in the body that causes blood vessels to tighten, thus causing your blood pressure to increase. Diovan works by blocking the effect of angiotensin II. As a result, blood vessels relax and blood pressure is lowered. If you have any question about how Diovan works or why this medicine has been prescribed for you, ask your doctor. BEFORE YOU USE DIOVAN Follow all the doctor’s instructions carefully. They may differ from the general information contained in this leaflet. _-When you must not use it _ • If you have ever had an unusual or allergic reaction to valsartan or to any other ingredients of this product listed at the end of this leaflet. • If you are pregnant or planning to become Baca dokumen lengkap
Novartis Page 2 Malaysia Package Leaflet 10-Sep-2018 Diovan film-coated tablets DIOVAN Angiotensin II antagonist DESCRIPTION AND COMPOSITION PHARMACEUTICAL FORM FILM-COATED TABLET (FCT) Diovan 40 mg: Yellow, ovaloid with bevelled edges, scored on one side; with debossing “DO” on the scored side and “NVR” on the other side. The score line on one side of Diovan 40mg FCT is to divide the tablet into equal doses. Diovan 80 mg: Pale red, round with bevelled edges, scored on one side; with debossing “D/V” on the scored side and “NVR” on the other side. Diovan 160 mg: Grey-orange, ovaloid, scored on one side; with debossing “DX/DX” on the scored side and “NVR” on the other side. The score line on one side of Diovan 80mg, or 160mg FCT is only to facilitate breaking for ease of swallowing and not to divide into equal doses. Appearance of tablets may differ between countries. Certain dosage strengths may not be available in all countries. ACTIVE SUBSTANCE One tablet contains 40 mg, 80 mg, or 160 mg of valsartan . EXCIPIENTS TABLETS : microcrystalline cellulose, crospovidone, colloidal anhydrous silica, magnesium stearate, hypromellose, titanium dioxide (E171), macrogol 8000, red iron oxide (E172), yellow iron oxide (E172), black iron oxide (E172; 40 mg, and 160 mg tablets only). Pharmaceutical formulations may vary between countries. INDICATIONS HYPERTENSION Treatment of hypertension. HEART FAILURE Treatment of heart failure (NYHA class II-IV) in patients receiving usual therapy (such as diuretics, digitalis) who are intolerant to ACE inhibitors. Diovan improves morbidity in these patients, primarily via reduction in hospitalization for heart failure. Diovan also slows the progression of heart failure, improves NYHA functional Novartis Page 3 Malaysia Package Leaflet 10-Sep-2018 Diovan film-coated tablets class, ejection fraction and signs and symptoms of heart failure and improves quality of life versus placebo (see section CLINICAL PHARMACOLOGY). POST-MYOCARDIAL INFARCTION Diovan is indicated Baca dokumen lengkap