Land: Malaysia
Språk: engelsk
Kilde: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
VALSARTAN
DKSH MALAYSIA SDN. BHD.
VALSARTAN
28 Tablets; 30 Tablets
NOVARTIS FARMA S.P.A.
_Consumer Medication Information Leaflet (RiMUP) _ VALSARTAN SANDOZ FILM-COATED TABLET VALSARTAN (80MG, 160MG) 1 WHAT IS IN THIS LEAFLET: 1. What VALSARTAN SANDOZ is used for 2. How VALSARTAN SANDOZ works 3. Before you use VALSARTAN SANDOZ 4. How to use VALSARTAN SANDOZ 5. While you are using it 6. Side effects 7. Storage and Disposal of VALSARTAN SANDOZ 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of Revision WHAT VALSARTAN SANDOZ IS USED FOR VALSARTAN SANDOZ is used for treating high blood pressure (hypertension) in adults. It is also taken for treating a heart condition known as heart failure in adults where the heart does not pump your blood around your body as well as it should. VALSARTAN SANDOZ can also be used to treat adults after a heart attack (myocardial infarction) to improve survival and reduce further heart problems. HOW VALSARTAN SANDOZ WORKS VALSARTAN SANDOZ is a type of medicine called an angiotensin II receptor antagonist, which by blocking the effects of the hormone angiotensin II causes the blood vessels to relax and widen. This results in a lowering of your blood pressure, and makes it easier for your heart to pump blood to all parts of your body. BEFORE YOU USE VALSARTAN SANDOZ Do not take VALSARTAN SANDOZ if you are pregnant, think you might be pregnant or considering becoming pregnant. You must tell your doctor if you think you are (or might become) pregnant. VALSARTAN SANDOZ may cause serious harm or even death to your baby if used during pregnancy. - _When you must not use it_ • If you are pregnant or planning to become pregnant. • If you are allergic to any of the ingredients in VALSARTAN SANDOZ. • If you are a Type 2 diabetic patients taking VALSARTAN SANDOZ and aliskiren concomitantly. - _Before you start to use it _ Please talk to your doctor or pharmacist before taking this medicine: • If you have any liver problems. • If you have any kidney problems. • If you are suffering from vomiting or diarrhea or are taking high doses of a diureti Les hele dokumentet
1. NAME OF THE MEDICINAL PRODUCT Valsartan Sandoz Film-coated Tablet 80 mg Valsartan Sandoz Film-coated Tablet 160 mg 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Valsartan Sandoz 80 mg: One film-coated tablet contains 80 mg of valsartan. Valsartan Sandoz 160 mg: One film-coated tablet contains 160 mg of valsartan. For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet. Valsartan Sandoz 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. Valsartan Sandoz 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 Valsartan Sandoz Film-coated Tablet 80 mg or 160 mg is only to facilitate breaking for ease of swallowing and not to divide into equal doses. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC 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. Valsartan Sandoz improves morbidity in these patients, primarily via reduction in hospitalization for heart failure. Valsartan also slows the progression of heart failure, improves NYHA functional class, ejection fraction and signs and symptoms of heart failure and improves quality of life versus placebo (see section PHARMACOLOGICAL PROPERTIES). Post-myocardial infarction Valsartan Sandoz is indicated to improve survival following myocardial infarction in clinically stable patients with signs, symptoms or radiological evidence of left ventricular failure and/or with left ventricular systolic dysfunction (see section PHARMACOLOGICAL PROPERTIES). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION DOSAGE Hypertension The recommended dose of Valsartan is 80 mg or 160 mg film-coated tablet once daily, irrespective of race, age, or gender. The antihypertensive effect is substantially present within 2 weeks and Les hele dokumentet