Ország: Ausztrália
Nyelv: angol
Forrás: Department of Health (Therapeutic Goods Administration)
valsartan, Quantity: 102.8 mg; sacubitril, Quantity: 97.2 mg
Novartis Pharmaceuticals Australia Pty Ltd
sacubitril,Valsartan
Tablet, film coated
Excipient Ingredients: colloidal anhydrous silica; iron oxide black; magnesium stearate; titanium dioxide; iron oxide red; purified talc; crospovidone; hypromellose; macrogol 4000; hyprolose; microcrystalline cellulose
Oral
60, 56, 14 (sample)
(S4) Prescription Only Medicine
ENTRESTO is indicated in adult patients for the treatment of chronic heart failure (NYHA Class II-IV) with reduced ejection fraction.
Visual Identification: Light pink, ovaloid, biconvex,,film-coated tablet with beveled edges, unscored, debossed with NVR on one side and L11 on the other side.; Container Type: Blister Pack; Container Material: PA/Al/PVC/Al - polyamide-aluminium foil-polyvinylchloride/aluminium foil; Container Life Time: 36 Months; Container Temperature: Store below 30 degrees Celsius
Licence status A
2016-01-20
ENTRESTO ® E n t r e s t o ® CONSUMER MEDICINE INFORMATION (CMI) SUMMARY The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist. 1. WHY AM I USING ENTRESTO? Entresto contains the active ingredients sacubitril and valsartan. Entresto is used to treat a type of heart failure. For more information, see Section 1. Why am I using Entresto? in the full CMI. 2. WHAT SHOULD I KNOW BEFORE I USE ENTRESTO? Do not use if you have ever had an allergic reaction to Entresto or any of the ingredients listed at the end of the CMI. Do not take Entresto if you are pregnant, taking medicines similar to Entresto or have severe liver problems. TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY OTHER MEDICINES, PLAN TO BECOME PREGNANT OR ARE BREASTFEEDING. For more information, see Section 2. What should I know before I use Entresto? in the full CMI. 3. WHAT IF I AM TAKING OTHER MEDICINES? Some medicines may interfere with Entresto and affect how it works. A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI. 4. HOW DO I USE ENTRESTO? • Take one tablet in the morning and one tablet in the evening (your doctor will tell you what strength) either with food or without food. More instructions can be found in Section 4. How do I use Entresto? in the full CMI. 5. WHAT SHOULD I KNOW WHILE USING ENTRESTO? THINGS YOU SHOULD DO • Remind any doctor, dentist or pharmacist you visit that you are using Entresto. • Avoid becoming pregnant while using Entresto. THINGS YOU SHOULD NOT DO • Do not stop using this medicine suddenly. • Do not take another medicine for high blood pressure or heart failure from a class known as angiotensin converting enzyme inhibitor. DRIVING OR USING MACHINES • Entresto may cause dizziness or tiredness in some people. DRINKING ALCOHOL • There are no known interactions between Entresto and alcohol. LOOKING AFTER YOUR MEDICINE • Store it in a cool dry place away from moistu Olvassa el a teljes dokumentumot
1 AUSTRALIAN PRODUCT INFORMATION ENTRESTO 24/26 ENTRESTO 49/51 ENTRESTO 97/103 (sacubitril/valsartan) film-coated tablets 1. NAME OF THE MEDICINE sacubitril and valsartan 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Entresto film-coated tablets are available in 3 strengths: Each Entresto 24/26 film-coated tablet contains 24.3 mg sacubitril and 25.7 mg valsartan (where both drug substances are combined as a sodium salt hydrate complex). This has been rounded to 24 mg/26 mg throughout the document. Each Entresto 49/51 film-coated tablet contains 48.6 mg sacubitril and 51.4 mg valsartan (where both drug substances are combined as a sodium salt hydrate complex). This has been rounded to 49 mg/51 mg throughout the document. Each Entresto 97/103 film-coated tablet contains 97.3 mg sacubitril and 102.8 mg valsartan (where both drug substances are combined as a sodium salt hydrate complex). This has been rounded to 97 mg/103 mg throughout the document. For the full list of excipients, _see Section 6.1 List of excipients_ . 3. PHARMACEUTICAL FORM Entresto 24/26 (24.3 mg sacubitril/25.7 mg valsartan): Violet white, ovaloid, biconvex, film- coated tablet with beveled edges; unscored, debossed with “NVR” on one side and “LZ” on the other side. Entresto 49/51 (48.6 mg sacubitril/51.4 mg valsartan): Pale yellow, ovaloid, biconvex, film- coated tablet with beveled edges; unscored, debossed with “NVR” on one side and “L1” on the other side. Entresto 97/103 (97.3 mg sacubitril/102.8 mg valsartan): Light pink, ovaloid, biconvex, film- coated tablet with beveled edges; unscored, debossed with “NVR” on one side and “L11” on the other side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Entresto is indicated in adult patients for the treatment of chronic heart failure (NYHA Class II-IV) _ _ with reduced ejection fraction. 4.2 DOSE AND METHOD OF ADMINISTRATION For oral use. Entresto may be administered with or without food _(see Section 5.2 _ 2 _Pharmacokinetic properties; Absorption)_ . Entrest Olvassa el a teljes dokumentumot