País: Austràlia
Idioma: anglès
Font: Department of Health (Therapeutic Goods Administration)
sacubitril, Quantity: 97.2 mg; valsartan, Quantity: 102.8 mg
Pharmacor Pty Ltd
Tablet, film coated
Excipient Ingredients: magnesium stearate; purified talc; microcrystalline cellulose; colloidal anhydrous silica; hyprolose; sodium starch glycollate type A; titanium dioxide; hypromellose; iron oxide yellow; iron oxide red; macrogol 4000; iron oxide black
Oral
168's, 56's, 60's, 180's
(S4) Prescription Only Medicine
PHARMACOR SACUBITRIL/VALSARTAN is indicated in adult patients for the treatment of chronic heart failure (NYHA Class II-IV) with reduced ejection fraction.
Visual Identification: Light pink to pink, ovaloid biconvex, film-coated tablets with bevelled edge unscored, debossed with 'SV2' on one side and plain on the other side.; Container Type: Bottle; Container Material: HDPE; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure
Registered
2023-04-02
[medicine name]* 3 [ PHARMACOR SACUBITRIL/VALSARTAN FILM-COATED TABLETS 24/26 MG, 49/51MG, 97/103 MG ]* ACTIVE INGREDIENT(S): _(sacubitril/valsartan)_ CONSUMER MEDICINE INFORMATION (CMI) This leaflet provides important information about using P YOU SHOULD ALSO SPEAK TO YOUR DOCTOR OR PHARMACIST IF YOU WOULD LIKE FURTHER INFORMATION OR IF YOU HAVE ANY CONCERNS OR QUESTIONS ABOUT USING [MEDICINE NAME]. WHERE TO FIND INFORMATION IN THIS LEAFLET: 1. Why am I using [medicine name]? 2. What should I know before I use [medicine name]? 3. What if I am taking other medicines? 4. How do I use [medicine name]? 5. What should I know while using [medicine name]? 6. Are there any side effects? 7. Product details 1. WHY AM I USING PHARMACOR SACUBITRIL/VALSARTAN? PHARMACOR SACUBITRIL/VALSARTAN 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. PHARMACOR SACUBITRIL/VALSARTAN is an angiotensin receptor neprilysin inhibitor (ARNI), which contains sacubitril (a neprilysin inhibitor), and valsartan (an nerves so that seizures do not happen. angiotensin receptor blocker or ARB). PHARMACOR SACUBITRIL/VALSARTAN 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. ASK YOUR DOCTOR, NURSE PRACTITIONER OR PHARMACIST IF YOU HAVE ANY QUESTIONS ABOUT WHY THIS MEDICINE HAS BEEN PRESCRIBED FOR YOU. Your doctor may have prescribed it for another reason. This medicine is only available with a doctor's prescription. It is not addictive. There is not enough information to recommend this medicine for use in children or adolescents under 18 years old. 2. WHAT SHOULD I KNOW BEFORE I USE PHARMACOR SACUBITRIL/VALSARTAN? WARNINGS DO NOT USE PHARMACOR SACUBITRIL Llegiu el document complet
AUSTRALIAN PRODUCT INFORMATION PHARMACOR SACUBITRIL / VALSARTAN FILM-COATED TABLETS 24/26 MG, 49/51MG, 97/103 MG (SACUBITRIL/VALSARTAN) 1. NAME OF THE MEDICINE Sacubitril and Valsartan 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Pharmacor Sacubitril / Valsartan film-coated tablets are available in 3 strengths: Each Pharmacor Sacubitril / Valsartan 24/26 film-coated tablet contains 24.3 mg sacubitril and 25.7 mg valsartan (combined as a sodium salt amorphous mixture). This has been rounded to 24 mg/26 mg throughout the document. Each Pharmacor Sacubitril / Valsartan 49/51 film-coated tablet contains 48.6 mg sacubitril and 51.4 mg valsartan (combined as a sodium salt amorphous mixture). This has been rounded to 49 mg/51 mg throughout the document. Each Pharmacor Sacubitril / Valsartan 97/103 film-coated tablet contains 97.3 mg sacubitril and 102.8 mg valsartan (combined as a sodium salt amorphous mixture). 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 Pharmacor Sacubitril / Valsartan 24/26 (24.3 mg sacubitril/25.7 mg valsartan): Off white to light pink, ovaloid biconvex, film-coated tablets with bevelled edge unscored, debossed with 'SV5' on one side and plain on the other side. Pharmacor Sacubitril / Valsartan 49/51 (48.6 mg sacubitril/51.4 mg valsartan): Pale yellow to yellow, ovaloid biconvex, film-coated tablets with bevelled edge unscored, debossed with 'SV1' on one side and plain on the other side. Pharmacor Sacubitril / Valsartan 97/103 (97.2 mg sacubitril/102.8 mg valsartan): Light pink to pink, ovaloid biconvex, film-coated tablets with bevelled edge unscored, debossed with 'SV2' on one side and plain on the other side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Pharmacor Sacubitril / Valsartan 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. SACUBITRIL/VALSARTAN M Llegiu el document complet