NEBILET

Negara: Indonesia

Bahasa: Bahasa Indonesia

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

Bahan aktif:

NEBIVOLOL HYDROCHLORIDE

Tersedia dari:

MENARINI INDRIA LABORATORIES - Indonesia

INN (Nama Internasional):

NEBIVOLOL HYDROCHLORIDE

Dosis:

5.45 MG

Bentuk farmasi:

TABLET

Unit dalam paket:

DUS, 2 BLISTER @ 14 TABLET

Diproduksi oleh:

BERLIN-CHEMIE AG - Federal Republic of Germany

Tanggal Otorisasi:

2020-08-26

Karakteristik produk

_Menarini International Operations Luxembourg S.A._
1
SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
NEBILET 5 mg tablets
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Nebilet tablet contains 5 mg of nebivolol (as nebivolol
hydrochloride): 2.5 mg of
SRRR-nebivolol (or d-nebivolol) and 2.5 mg of RSSS-nebivolol (or
l-nebivolol).
Excipient with known effect: each tablet contains 141.75 mg of lactose
monohydrate (see
section 4.4 and
6.1).
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Tablet.
White, round, cross-scored tablet.
The tablet can be divided in equal quarters.
4. CLINICAL PARTICULARS
4.1. THERAPEUTIC INDICATIONS
Hypertension
Treatment of essential hypertension.
Chronic heart failure (CHF)
Treatment of stable mild and moderate chronic heart failure in
addition to standard therapies
in elderly patients > 70 years.
4.2. POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Hypertension
_Adults_
The dose is one tablet (5 mg) daily, preferably at the same time of
the day.
The blood pressure lowering effect becomes evident after 1-2 weeks of
treatment.
Occasionally, the optimal effect is reached only after 4 weeks.
_Combination with other antihypertensive agents_
Beta-blockers can be used alone or concomitantly with other
antihypertensive agents. To
date, an additional antihypertensive effect has been observed only
when Nebilet 5 mg is
combined with hydrochlorothiazide 12.5-25 mg.
DISETUJUI OLEH BPOM : 11/01/2022
EREG10043712100125
_Menarini International Operations Luxembourg S.A._
2
_Patients with renal insufficiency_
In patients with renal insufficiency, the recommended starting dose is
2.5 mg daily. If
needed, the daily dose may be increased to 5 mg.
_Patients with hepatic insufficiency_
Data in patients with hepatic insufficiency or impaired liver function
are limited. Therefore the
use of Nebilet in these patients is contra-indicated.
_Older people_
In patients over 65 years, the recommended starting dose is 2.5 mg
daily. If needed, the daily dose
may be increased