Nebilet tablets

البلد: أرمينيا

اللغة: الإنجليزية

المصدر: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

العنصر النشط:

nebivolol (nebivolol hydrochloride)

متاح من:

Berlin-Chemie AG

ATC رمز:

C07AB12

INN (الاسم الدولي):

nebivolol (nebivolol hydrochloride)

جرعة:

5mg

الشكل الصيدلاني:

tablets

الوحدات في الحزمة:

(7/1x7/) in blister, (14/1x14/) in blister, (28/2x14/) in blister

نوع الوصفة الطبية :

Prescription

الوضع إذن:

Registered

تاريخ الترخيص:

2019-05-23

خصائص المنتج

Page 1 of 10
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.
Off-white, circular, biconvex tablet with one-sided dividing cross
score.
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.
_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 _
Page 2 of 10
Data in patients with hepatic insufficiency or impaired liver function
are limited. Therefore the use of
Nebilet in these patients is contra-indicated.
_Elderly _
In the elderly over 65 years, the recommended starting dose is 2.5 mg
daily. If needed, the daily dose
may be increased to 5 mg. However, in view of the limited experience
in patients ab