Χώρα: Μαλαισία
Γλώσσα: Αγγλικά
Πηγή: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
sacubitril/valsartan
ALCON LABORATORIES (MALAYSIA) SDN. BHD.
sacubitril/valsartan
28 Tablets
NOVARTIS SINGAPORE PHARMACEUTICAL MANUFACTURING PTE. LTD.
_Consumer Medication Information Leaflet (RiMUP) _ UPERIO ® FILM-COATED TABLETS sacubitril/valsartan (50mg, 100mg, 200mg) 1 WHAT IS IN THIS LEAFLET 1. What Uperio is used for 2. How Uperio works 3. Before you take Uperio 4. How to use Uperio 5. While you are using Uperio 6. Side effects 7. Storage and Disposal of Uperio 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of Revision WHAT UPERIO IS USED FOR Uperio is a medicine known as an angiotensin receptor neprilysin inhibitor. It dissociates into two active substances, sacubitril and valsartan. Uperio 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. HOW UPERIO WORKS Uperio 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. If you have any questions about how Uperio works or why this medicine has been prescribed for you, ask your doctor or pharmacist. BEFORE YOU TAKE UPERIO _ _ _When you must not use it: _ DO NOT TAKE UPERIO 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 you may be allergic to any component of this medicine, talk to your doctor before taking Uperio. if you are taking another type of medicine called an angiotensin converting enzyme (ACE) inhibitor (for example enalapril, lisinopril or ramipril). ACE inhibitors are used to treat high blood pressure or heart failure. If you have been taking an ACE inhibitor, wait for 36 hours after taking the last dose before you start to take Uperio (see “Taking other medicines”). if you or a member of your family have ever had a reaction called angioedema (swell Διαβάστε το πλήρες έγγραφο
Regulatory Affairs UPERIO ® (sacubitril/valsartan) 50, 100, 200 mg film-coated tablets MALAYSIA PACKAGE LEAFLET (FEB 19; EU PI JUL 18) IPL Creator: Sandhya Sikharam CDS Author(s): Mercy Abraham, Masha Berkhin, Mathieu Weitbruch, Amol Parekh, Cecile Hauschka , Tom Armstrong GLC approval: 12 Nov 2014, 21 Nov 2014, 04 Aug 2015, amended 16 May 2017 Effective date: 10-Jul-2017 Safety Label Change Tracking Number: 2017-PSB/GLC-0871-s Document status: Final Number of pages: 20 Property of Novartis Confidential May not be used, divulged, published or otherwise disclosed without the consent of Novartis Alcon Page 2 Malaysia Package Leaflet 10 Jul 2017 UPERIO UPERIO ® Uperio 50 mg film-coated tablets (sacubitril/valsartan). Uperio 100 mg film-coated tablets (sacubitril/valsartan). Uperio 200 mg film-coated tablets (sacubitril/ valsartan). DESCRIPTION AND COMPOSITION PHARMACEUTICAL FORM Film-coated tablet. 50 mg: Violet white ovaloid biconvex film-coated tablet with beveled edges, unscored, debossed with “NVR” on one side and “LZ” on the other side. 100 mg: Pale yellow ovaloid biconvex film-coated tablet with beveled edges, unscored, debossed with “NVR” on one side and “L1” on the other side. 200 mg: Light pink ovaloid biconvex film-coated tablet with beveled edges, unscored, debossed with “NVR” on one side and “L11” on the other side. ACTIVE SUBSTANCE(S) Sacubitril/valsartan. Uperio 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 administration, Uperio dissociates into sacubitril (which is further metabolized to LBQ657) and valsartan. Uperio film coated tablets contains 50 mg (sacubitril 24.3 mg / valsartan 25.7 mg)*. Uperio film coated tablets contains 100 mg (sacubitril 48.6 mg / valsartan 51.4 mg)*. Uperio film coated tablets contains 200 mg (sacubitril 97.2 mg / valsartan 102.8 mg)*. * Certain dosage strengths may not be available in all countries. EXCIPIENTS microcrystall Διαβάστε το πλήρες έγγραφο