Nebivolol STELLA Tablet 5mg

Country: Malaysia

Bahasa: Inggeris

Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Bahan aktif:

NEBIVOLOL HYDROCHLORIDE

Boleh didapati daripada:

STADPHARM SDN. BHD.

INN (Nama Antarabangsa):

NEBIVOLOL HYDROCHLORIDE

Unit dalam pakej:

30 Tablets

Dikeluarkan oleh:

STELLAPHARM J.V. Co., LTD. - BRANCH 1

Risalah maklumat

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
NEBIVOLOL STELLA TABLET 5MG
Nebivolol (as nebivolol hydrochloride) 5 mg
Page no. 1
WHAT IS IN THIS LEAFLET
1.
What Nebivolol STELLA Tablet
5mg is used for
2.
How
Nebivolol
STELLA
Tablet
5mg works
3.
Before
you
use
Nebivolol
STELLA Tablet 5mg
4.
How
to
use
Nebivolol
STELLA
Tablet 5mg
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of Nebivolol
STELLA Tablet 5mg
8.
Product Description
9.
Manufacturer
10.
Product Registration Holder
11.
Date of revision
12.
Serial Number
WHAT NEBIVOLOL STELLA TABLET 5MG IS
USED FOR

It is used to treat raised blood pressure
(hypertension).

Nebivolol is also used to treat mild and
moderate
chronic
heart
failure
in
patients
aged
70
years
or
over,
in
addition to other therapies.
HOW NEBIVOLOL STELLA TABLET 5MG
WORKS
Nebivolol STELLA Tablet 5mg tablets
contains
nebivolol,
a
cardiovascular
drug
belonging
to
the
group
of
selective
beta-blocking
agents
(i.e.
with
a
selective
action
on
the
cardiovascular
system).
It
prevents
increased
heart
rate,
controls
heart
pumping
strength.
It
also
exerts
a
dilating action on blood vessels, which
contributes as well to lower the blood
pressure.
BEFORE
YOU
USE
NEBIVOLOL
STELLA
TABLET 5MG
-
_When you must not use it _

If you are allergic to nebivolol or any
of
the
other
ingredients
of
this
medicine.

If
you
have
one
or
more
of
the
following disorders:
˗
low blood pressure
˗
serious circulation problems in the
arms or legs
˗
very
slow
heartbeat
(less
than
60
heart beats per minute)
˗
certain
other
serious
heart
rhythm
problems
(e.g.
2
nd
and
3
rd
degree
atrioventricular
block,
heart
conduction disorders)
˗
heart failure, which has just occurred
or which has recently become worse,
or
you are receiving treatment
for
circulatory shock due to acute heart
failure by intravenous drip feed to
help your heart work
˗
asthma or wheezing (now or in the
past)
˗
untreated
phaeochromocytoma
a
tumour located on top of the kidneys
(in the adrenal glands)
˗
liver function disorder
�

Ciri produk

_RX PRESCRIPTION ONLY_
1.
NAME OF THE MEDICINAL PRODUCT
NEBIVOLOL STELLA TABLET 5MG
2.
SPECIAL NOTICE AND RECOMMENDATION
Keep out of reach of children
Read the package insert carefully before use
3.
COMPOSITION
_Each tablet contains:_
Nebivolol (as nebivolol hydrochloride)
........................................................... 5 mg
4.
PHARMACEUTICAL FORM
Tablet.
White, round, biconvex tablet with cross score.
5.
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 of ≥ 70 years.
6.
ADMINISTRATION AND DOSAGE
_ADMINISTRATION_
Oral use.
The tablet can be taken with or without food.
_DOSAGE_
Hypertension
_Adults_
The dose is 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 nebivolol 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 in these patients is contraindicated.
_Elderly_
In patients 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 above 75 years, caution must be exercised and
these
patients should be monitored closely.
_Paediatric population_
The efficacy and safety of nebivolol in children and adolescents aged
below 18
years has not been established. No data are ava