BETALOC ZOK

Kraj: Indonezja

Język: indonezyjski

Źródło: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency

Składnik aktywny:

METOPROLOL SUCCINATE

Dostępny od:

ASTRAZENECA INDONESIA - Indonesia

INN (International Nazwa):

METOPROLOL SUCCINATE

Dawkowanie:

47.5 MG

Forma farmaceutyczna:

TABLET PELEPASAN LAMBAT

Sztuk w opakowaniu:

DUS, 2 BLISTER @ 14 TABLET PELEPASAN LAMBAT

Wyprodukowano przez:

ASTRAZENECA AB - Sweden

Data autoryzacji:

2021-12-10

Charakterystyka produktu

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