Country: Unjoni Ewropea
Lingwa: Ingliż
Sors: EMA (European Medicines Agency)
sacubitril, valsartan
Novartis Europharm Limited
C09DX04
sacubitril, valsartan
Angiotensin II antagonists, other combinations, Agents acting on the renin-angiotensin system
Heart Failure
Paediatric heart failureEntresto is indicated in children and adolescents aged one year or older for treatment of symptomatic chronic heart failure with left ventricular systolic dysfunction.Adult heart failureEntresto is indicated in adult patients for treatment of symptomatic chronic heart failure with reduced ejection fraction.
Revision: 18
Authorised
2015-11-19
76 B. PACKAGE LEAFLET 77 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT ENTRESTO 24 MG/26 MG FILM-COATED TABLETS ENTRESTO 49 MG/51 MG FILM-COATED TABLETS ENTRESTO 97 MG/103 MG FILM-COATED TABLETS sacubitril/valsartan READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor, pharmacist or nurse. - This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. - If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Entresto is and what it is used for 2. What you need to know before you take Entresto 3. How to take Entresto 4. Possible side effects 5. How to store Entresto 6. Contents of the pack and other information 1. WHAT ENTRESTO IS AND WHAT IT IS USED FOR Entresto is a heart medicine containing an angiotensin receptor neprilysin inhibitor. It delivers two active substances, sacubitril and valsartan. Entresto is used to treat a type of long-term heart failure in adults, children and adolescents (one year and older). 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. 78 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ENTRESTO DO NOT TAKE ENTRESTO • if you are allergic to sacubitril, valsartan or any of the other ingredients of this medicine (listed in section 6). • if you are taking another type of medicine called an angiotensin converting enzyme (ACE) inhibitor (for example enalapril, lisinopril or ramipril), which is 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 sta Aqra d-dokument sħiħ
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Entresto 24 mg/26 mg film-coated tablets Entresto 49 mg/51 mg film-coated tablets Entresto 97 mg/103 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Entresto 24 mg/26 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 49 mg/51 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 97 mg/103 mg film-coated tablets Each film-coated tablet contains 97.2 mg sacubitril and 102.8 mg valsartan (as sacubitril valsartan sodium salt complex). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet (tablet) Entresto 24 mg/26 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 49 mg/51 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 97 mg/103 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. 3 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Adult heart failure Entresto is indicated in adult patients for treatment of symptomatic chronic heart failure with reduced ejection fraction (see section 5.1). Paediatric heart failure Entresto is indicated in children and adolescents aged one year or older for treatment of symptomatic chronic heart failure with left ventricular systolic dysfunction (see section 5.1). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _General considerations Aqra d-dokument sħiħ