Quốc gia: Malaysia
Ngôn ngữ: Tiếng Anh
Nguồn: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
sacubitril/valsaran
NOVARTIS CORPORATION (MALAYSIA) SDN. BHD.
sacubitril/valsaran
56tablet Tablets; 60tablet Tablets
NOVARTIS FARMA S.P.A.
_Consumer Medication Information Leaflet (RiMUP) _ ENTRESTO ® FILM-COATED TABLETS sacubitril/valsartan (50mg, 100mg, 200mg) 1 WHAT IS IN THIS LEAFLET 1. What Entresto is used for 2. How Entresto works 3. Before you take Entresto 4. How to use Entresto 5. While you are using Entresto 6. Side effects 7. Storage and Disposal of Entresto 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of Revision WHAT ENTRESTO IS USED FOR Entresto is a medicine known as an angiotensin receptor neprilysin inhibitor. It dissociates into two active substances, sacubitril and valsartan. They both help to treat heart failure and control high blood pressure. Entresto is used to treat a type of long-term heart failure in adults. This type of heart failure occurs when the heart is weak and cannot pump enough blood to the lungs and the rest of the body. The most common symptoms of heart failure are breathlessness, fatigue, tiredness and ankle swelling. Entresto is also 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. HOW ENTRESTO WORKS Entresto works by blocking the effects of neprilysin via sacubitril and angiotensin-II receptor via valsartan. As a result, blood vessels relax and less water is retained by the body which is beneficial to treat heart failure and high blood pressure. If you have any questions about how Entresto works or why this medicine has been prescribed for you, ask your doctor or pharmacist. BEFORE YOU TAKE ENTRESTO _ _ _When you must not use it: _ DO NOT TAKE ENTRESTO • if you are allergic to sacubitril, valsartan or any of the other ingredients of this medicine (listed in section 8 “Product description”). If you think Đọc toàn bộ tài liệu
Novartis Page 2 Malaysia Package Leaflet 19 May 2021 ENTRESTO ® 2 ENTRESTO ® 1. NAME OF THE MEDICINAL PRODUCT Entresto ® 50 mg film-coated tablets Entresto ® 100 mg film-coated tablets Entresto ® 200 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Entresto ® 50 mg film-coated tablets Each film-coated tablet contains 24.3 mg sacubitril and 25.7 mg valsartan (as sacubitril valsartan sodium salt complex). Entresto ® 100 mg film-coated tablets Each film-coated tablet contains 48.6 mg sacubitril and 51.4 mg valsartan (as sacubitril valsartan sodium salt complex). Entresto ® 200 mg film-coated tablets Each film-coated tablet contains 97.2 mg sacubitril and 102.8 mg valsartan (as sacubitril valsartan sodium salt complex). Entresto ® contains a salt complex of the anionic forms of sacubitril and valsartan, sodium cations, and water molecules in the molar ratio of 1:1:3:2:5 respectively. Following oral adminstration, Entresto ® dissociates into sacubitril (which is further metabolized to LBQ657 [sacubitrilat]) and valsartan. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet (tablet) Entresto ® 50 mg film-coated tablets Violet white ovaloid biconvex film-coated tablet with bevelled edges, unscored, debossed with “NVR” on one side and “LZ” on the other side. Approximate tablet dimensions 13.1 mm x 5.2 mm. Entresto ® 100 mg film-coated tablets Pale yellow ovaloid biconvex film-coated tablet with bevelled edges, unscored, debossed with “NVR” on one side and “L1” on the other side. Approximate tablet dimensions 13.1 mm x 5.2 mm. Entresto ® 200 mg film-coated tablets Light pink ovaloid biconvex film-coated tablet with bevelled edges, unscored, debossed with “NVR” on one side and “L11” on the other side. Approximate tablet dimensions 15.1 mm x 6.0 mm. Novartis Page 3 Malaysia Package Leaflet 19 May 2021 ENTRESTO ® 3 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS HEART FAILURE Entresto is indicated to reduce the risk of cardiov Đọc toàn bộ tài liệu