Nchi: Indonesia
Lugha: Kiindonesia
Chanzo: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency
METOPROLOL SUCCINATE
ASTRAZENECA INDONESIA - Indonesia
METOPROLOL SUCCINATE
47.5 MG
TABLET PELEPASAN LAMBAT
DUS, 2 BLISTER @ 14 TABLET PELEPASAN LAMBAT
ASTRAZENECA AB - Sweden
2021-12-10
SUMMARY OF PRODUCT CHARACTERISTICS BETALOC ® ZOK 25 & 50 MG PROLONGED RELEASE TABLET METOPROLOL SUCCINATE NAME OF THE MEDICINAL PRODUCT Betaloc® ZOK 25 mg prolonged release tablet Betaloc® ZOK 50 mg prolonged release tablet QUALITATIVE AND QUANTITATIVE COMPOSITION 1 prolonged release tablet contains: 23.75 mg, 47.5 mg metoprolol succinate corresponding to 25 mg, 50 mg metoprolol tartarte respectively. For a complete list of excipients, see section “List of excipients”. PHARMACEUTICAL FORM Prolonged release tablet Prolonged release tablets 25 mg: White, oval with a size of 5.5 mm × 10.5 mm, bisected, marked A/ß. Prolonged release tablets 50 mg: White, round with a diameter of 9 mm, bisected, marked A/mO. The score mark is not intended to divide the tablet into two equal doses. It is only intended to facilitate swallowing. CLINICAL PARTICULARS THERAPEUTIC INDICATIONS • Hypertension, • Angina pectoris • _Heart Failure, to reduce the risk of cardiovascular mortality and heart failure hospitalizations in _ _patients with heart failure _ • Maintenance treatment after myocardial infarction. WARNINGS: ISCHEMIC HEART DISEASE Following abrupt cessation of therapy with certain beta-blocking agents, exacerbations of angina pectoris and, in some cases, myocardial infarction have occurred. When discontinuing chronically administered BETALOC ZOK, particularly in patients with ischemic heart disease, the dosage should be gradually reduced over a period of 1 - 2 weeks and the patient should be carefully monitored. If angina markedly worsens or acute coronary insufficiency develops, BETALOC ZOK administration should be reinstated promptly, at least temporarily, and other measures appropriate for the management of unstable angina should be taken. Warn patients against interruption or discontinuation of therapy without the physician’s advice. Because coronary artery disease is common and may be unrecognized, it may be prudent not to discontinue BETALOC ZOK therapy abruptly even in patients treated only for hyperte Soma hati kamili