NEBILET TABLET

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

NEBIVOLOL HCI

Boleh didapati daripada:

A. MENARINI SINGAPORE PTE. LTD.

INN (Nama Antarabangsa):

NEBIVOLOL HCI

Unit dalam pakej:

28Tablet Tablets

Dikeluarkan oleh:

BERLIN-CHEMIE AG

Risalah maklumat

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
NEBILET 5MG TABLETS
Nebivolol
WHAT IS IN THIS LEAFLET
1.
What
is
Nebilet
5mg
tablets
used for.
2.
How
Nebilet
5mg
tablets
works.
3. Before you take Nebilet 5mg
tablets
4.
How
to
take
Nebilet
5mg
tablets.
5. Side effects
6. After using Nebilet 5mg tablets
7 .Product description
8. Manufacturer
9. Product Registration Holder
10. Date of revision.
WHAT
IS
NEBILET
5MG
TABLETS
USED FOR
.
Nebilet
5mg
tablets
is
used
to
treat
raised
blood
pressure
(hypertension).
Nebilet 5mg tablets is also used to
treat mild and moderate chronic
heart failure in patients aged 70 or
over,
in
addition
to
other
therapies.
HOW NEBILET 5MG TABLETS WORKS
Nebilet
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 blood pressure
BEFORE
YOU
TAKE
NEBILET
5MG
TABLETS
_- When you must not take it _
Do not take Nebilet 5mg tablets
•
if
you
are
allergic
(hypersensitive) to nebivolol
or
any
of
the
other
ingredients
of
Nebilet
5mg
tablets
•
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 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
•
a
metabolic
disorder
(metabolic
acidosis),
for
example,
diabetic
ketoacidosis.
_- Before you start to take it _

Ciri produk

NEBILET
®
Nebivolol 5 mg
COMPOSITION
One Nebilet tablet contains nebivolol hydrochloride 5.45 mg (eq. to 5
mg nebivolol).
_Excipients: _Polysorbate 80, hypromellose, lactose monohydrate, maize
starch, croscarmellose sodium,
microcrystalline cellulose, colloidal anhydrous silica, magnesium
stearate.
PHARMACEUTICAL FORM
Tablet.
Off-white, circular, biconvex tablet with one-sided dividing cross
score.
The tablet can be divided in equal quarters.
PHARMACOLOGICAL PROPERTIES
_PHARMACODYNAMIC PROPERTIES_
Beta blocking agent, selective. ATC code: C07AB12
Nebivolol is a racemate of two enantiomers, SRRR-nebivolol (or
d-nebivolol) and RSSS-nebivolol
(or l-nebivolol). It combines two pharmacological activities: It is a
competitive and selective beta-
receptor antagonist: this effect is attributed to the SRRR-enantiomer
(d-enantiomer).
It has mild
vasodilating properties, possibly due to an interaction with the
L-arginine/nitric oxide pathway. Single
and repeated doses of nebivolol reduce heart rate and blood pressure
at rest and during exercise, both
in normotensive subjects and in hypertensive patients. The
antihypertensive effect is maintained during
chronic treatment. At therapeutic doses, nebivolol is devoid of
alpha-adrenergic antagonism.
During
acute and chronic treatment with nebivolol in hypertensive patients
systemic vascular resistance is
decreased. Despite heart rate reduction, reduction in cardiac output
during rest and exercise may be
limited due to an increase in stroke volume. The clinical relevance of
these haemodynamic differences
as compared to other beta1 receptor antagonists has not been fully
established.
In hypertensive patients, nebivolol increases the NO-mediated vascular
response to acetylcholine (ACh)
which is reduced in patients with endothelial dysfunction. In a
mortality–morbidity, placebo-controlled
trial performed in 2128 patients
≥
70 years (median age 75.2 years) with stable chronic heart failure
with
or without impaired left ventricular ejection fraction (mean LVEF: 36
±
12.3%, with t