Negara: Israel
Bahasa: Inggris
Sumber: Ministry of Health
SACUBITRIL/VALSARTAN AS SODIUM SALT COMPLEX
NOVARTIS ISRAEL LTD
C09DX04
FILM COATED TABLETS
SACUBITRIL/VALSARTAN AS SODIUM SALT COMPLEX 97/103 MG
PER OS
Required
NOVARTIS PHARMA AG.,SWITZERLAND
VALSARTAN AND SACUBITRIL
EntrestoTM is indicated for the treatment of heart failure (NYHA class II-IV) in patients with systolic dysfunction. EntrestoTM has been shown to reduce the rate of cardiovascular death and heart failure hospitalisation compared to angiotensin converting enzyme (ACE) inhibitor therapy
2020-11-30
ENT APL JUL23 V3 EU PIL 05.2023 Patient leaflet in accordance with the Pharmacists' Regulations (Preparations) - 1986 This medicine is dispensed with a doctor's prescription only Entresto 50 mg Entresto 100 mg Entresto 200 mg Film-coated tablets Film-coated tablets Film-coated tablets Active ingredient: Each film-coated tablet contains: 24 mg sacubitril and 26 mg valsartan as sodium salt complex Active ingredient: Each film-coated tablet contains: 49 mg sacubitril and 51 mg valsartan as sodium salt complex Active ingredient: Each film-coated tablet contains: 97 mg sacubitril and 103 mg valsartan as sodium salt complex Inactive ingredients and allergens in the medicine - see section 6 ‘Additional information’. Read the entire leaflet carefully before you start using this medicine. This leaflet contains concise information about this medicine. If you have any further questions, consult your doctor or pharmacist. This medicine has been prescribed to treat your illness. Do not pass it on to others. It may harm them, even if it seems to you that their illness is similar to yours. 1. What is this medicine intended for? Entresto is indicated for the treatment of heart failure (NYHA class II-IV) in patients with systolic dysfunction. Entresto has been shown to reduce the rate of cardiovascular death and heart failure hospitalisation compared to angiotensin converting enzyme (ACE) inhibitor therapy. Therapeutic group: Entresto belongs to a group of medicines that act on the renin-angiotensin system; angiotensin II receptor blockers (ARBs), different combinations. 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, tiredness and ankle swelling . 2. Before using this medicine Do not use this medicine if: you are sensitive (allergic) to the active ingredients sacubitril, valsartan or to any of the other ingredients in this medicine (listed in section 6). you are taking another type of medicine Baca dokumen lengkapnya
ENT API JUL23 V3 1 EU SmPC 05.2023 1. NAME OF THE MEDICINAL PRODUCT Entresto ® 50 mg Entresto ® 100 mg Entresto ® 200 mg 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Entresto ® 50 mg Each 50 mg film-coated tablet contains 24 mg sacubitril and 26 mg valsartan as sodium salt complex. Entresto ® 100mg Each 100 mg film-coated tablet contains 49 mg sacubitril and 51 mg valsartan as sodium salt complex. Entresto ® 200mg Each 200 mg film-coated tablet contains 97 mg sacubitril and 103 mg valsartan as sodium salt complex. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated 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. 4. CLINICAL PARTICULARS 4.1 Therapeutic indications Entresto ® is indicated for the treatment of heart failure (NYHA class II-IV) in patients with systolic dysfunction. Entresto ® has been shown to reduce the rate of cardiovascular death and heart failure hospitalisation compared to angiotensin-converting enzyme (ACE) inhibitor therapy. 4.2 Posology and method of administration Posology Entresto should not be co-administered with an angiotensin-converting enzyme (ACE) inhibitor or an angiotensin II receptor blocker (ARB). Due to the potential risk of angioedema when used concomitantly with an ACE inhibitor, it must not be started for at least 36 hours after discontinuing ACE inhibitor therapy (see sections 4.3, 4.4 and 4.5). ENT A Baca dokumen lengkapnya