Nebivolol STADA

Country: আর্মেনিয়া

ভাষা: ইংরেজি

সূত্র: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

সক্রিয় উপাদান:

nebivolol (nebivolol hydrochloride)

থেকে পাওয়া:

STADA Arzneimittel AG

INN (International Name):

nebivolol (nebivolol hydrochloride)

ডোজ:

5mg

ফার্মাসিউটিকাল ফর্ম:

tablets

প্রেসক্রিপশন টাইপ:

Prescription

পণ্য বৈশিষ্ট্য

SmPC Nebivolol NL803+4 CSP+QRD adaption
2014-04-29/AR
1
SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Nebivolol STADA 5 mg tablets
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains nebivolol hydrochlorideequivalent to 5 mg of
nebivolol
Excipient with known effect: 167.05 mg lactose monohydrate/tablet (see
section 4.4 and 6.1).
For thefull list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Tablet
White, round, cross-scored tablet.
The tablet can be divided in equal quarter doses.
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
_ _
_When used for the indication hypertension _
Adults
The dose is one tablet (5 mg) daily, preferably at the same time of
the day. Tablets may be
taken with meals.
The blood pressure lowering effect becomes evident after 1-2 weeks of
treatment. Occasio-
nally, 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 nebivolol 5 mg is
combined with hydrochlorothiazide 12.5-25 mg.
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 Nebivolol STADA 5 mg in these patients is contraindicated (see
section 4.3).
SmPC Nebivolol NL803+4 CSP+QRD adaption
2014-04-29/AR
2
_ _
Elderly
In patients over 65 years, the recommended starting dose is 2.5 mg
daily. If needed, the dai-
ly dose may be increased to 5 mg. However, in view of the limit