Χώρα: Ινδονησία
Γλώσσα: Ινδονησιακά
Πηγή: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency
NEBIVOLOL HYDROCHLORIDE
MENARINI INDRIA LABORATORIES - Indonesia
NEBIVOLOL HYDROCHLORIDE
5.45 MG
TABLET
DUS, 2 BLISTER @ 14 TABLET
BERLIN-CHEMIE AG - Federal Republic of Germany
2020-08-26
_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 Διαβάστε το πλήρες έγγραφο