Land: Malaysia
Språk: engelsk
Kilde: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
VALSARTAN; AMLODIPINE BESYLATE
NOVUGEN PHARMA SDN. BHD.
VALSARTAN; AMLODIPINE BESYLATE
10 Tablets; 100 Tablets; 30 Tablets; 500 Tablets; 1000 Tablets; 14 Tablets; 28 Tablets; 56 Tablets; 84 Tablets; 112 Tablets; 168 Tablets
NOVUGEN PHARMA SDN. BHD.
_Consumer Medication Information Leaflet (RiMUP) _ AMVAL FILM COATED TABLETS Amlodipine/Valsartan 5mg/80mg, 5mg/160mg, 10mg/160mg 1 WHAT IS IN THIS LEAFLET 1. What Amval is used for 2. How Amval works 3. Before you use Amval 4. How to use Amval 5. While you are using Amval 6. Side effects 7. Storage and Disposal of Amval 8. Product description 9. Manufacturer and Product Registration Holder 10. Date of revision 11. Serial number WHAT AMVAL IS USED FOR Amval contains amlodipine, a medicine that belongs to the class of calcium antagonists and valsartan, which belongs to angiotensin-II receptor antagonists. They both help to control high blood pressure. Amval is indicated to treat high blood pressure which is not adequately controlled by a single drug. HOW AMVAL WORKS Amlodipine blocks calcium channels at the blood vessels. Angiotensin II is a natural substance produced by the body that causes blood vessels to tighten, thus increasing the blood pressure. Valsartan works by blocking the effect of angiotensin II. As a result of both mechanisms, blood vessels relax and blood pressure is lowered. If you have any questions about how Amval works or why this medicine has been prescribed for you, ask your doctor. BEFORE YOU USE AMVAL Follow your doctor’s instructions carefully. They may differ from the general instructions in this leaflet. − _When you must not use it _ • If you have ever had an unusual or allergic reaction to amlodipine besylate or valsartan or to any other ingredients of this product listed at the end of this leaflet. If you think you may be allergic, ask your doctor for advice. • If you are pregnant or planning to become pregnant. • If you have high level of sugar in the blood and you are suffering from type 2 diabetes (also called non-insulin dependent diabetes mellitus) while you are taking a blood pressure lowering medicine called aliskiren • If you have severe liver impairment; biliary cirrhosis (blocking of bile ducts in the liver) and cholestasis (bile cannot flow from liver to intestine Les hele dokumentet
AMVAL 5MG/80MG AMVAL 5MG/160MG AMVAL 10MG/160MG FILM COATED TABLETS 1. NAME OF THE MEDICINAL PRODUCT Amval 5mg/80mg Film Coated Tablets Amval 5mg/160mg Film Coated Tablets Amval 10mg/160mg Film Coated Tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION AMVAL 5MG/80MG FILM COATED TABLETS: Each tablet contains 6.934mg of Amlodipine besylate equivalent to Amlodipine 5mg and Valsartan 80mg. AMVAL 5MG/160MG FILM COATED TABLETS: Each tablet contains 6.934mg of Amlodipine besylate equivalent to Amlodipine 5mg and Valsartan 160mg. AMVAL 10MG/160MG FILM COATED TABLETS: Each tablet contains 13.868mg of Amlodipine besylate equivalent to Amlodipine 10mg and Valsartan 160mg. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film coated tablet. AMVAL 5MG/80MG FILM COATED TABLETS: Light yellow, round shaped film-coated tablets, debossed with “N” on one side and “7” on the other side. AMVAL 5MG/160MG FILM COATED TABLETS: Light yellow, capsule shaped film-coated tablets, debossed with “N 5” on one side and plain on the other side. AMVAL 10MG/160MG FILM COATED TABLETS: Light yellow, capsule shaped film-coated tablets, debossed with “N 4” on one side and plain on the other side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of essential hypertension. Amval is indicated in patients whose blood pressure is not adequately controlled by monotherapy. Amval is indicated for the initial treatment of hypertension. The choice of Amval for initial treatment should be based on an assessment of the potential benefits and risks. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION GENERAL TARGET POPULATION A patient whose blood pressure is not adequately controlled on monotherapy may be switched to combination therapy with Amval. The recommended dose is one tablet per day. When clinically appropriate direct change from monotherapy to the fixed-dose combination may be considered. For convenience, patients receiving valsartan and amlodipine from separate tablets may be switched to Amval containing the s Les hele dokumentet