NODON (Nebivolol Tablets 5 mg)

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

NEBIVOLOL HYDROCHLORIDE

Boleh didapati daripada:

PAHANG PHARMACY SDN. BHD.

INN (Nama Antarabangsa):

NEBIVOLOL HYDROCHLORIDE

Unit dalam pakej:

28 Tablets

Dikeluarkan oleh:

CADILA PHARMACEUTICALS LIMITED

Risalah maklumat

SECTION D: LABELLING
NEBIVOLOL TABLETS 5MG
D4 PATIENT INFORMATION LEAFLET (PIL)
1389, TRASAD ROAD, DHOLKA – 382 225, DIST: AHMEDABAD, GUJARAT STATE,
INDIA.
PAGE 1 OF 5
_Consumer Medication Information Leaflet (RiMUP) _
NODON
(NEBIVOLOL TABLETS 5 MG)
Nebivolol Tablets 5mg
PAGE 2 OF 5
WHAT IS IN THIS LEAFLET:
1.
What Nodon is used for
2.
How Nodon works
3.
Before you take Nodon
4.
How to take Nodon
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of Nodon
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
WHAT NODON IS USED FOR
Nebivolol
belongs
to
a
group
of
medicines called beta-blockers that
are used to lower blood pressure.
Nebivolol is used to treat:

high
blood
pressure
(hypertension)


elderly patients suffering from
mild to moderate heart failure in
addition tostandard therapy (e.g.
with
diuretics,
digoxin,
ACE
inhibitors,
angiotensin
II
antagonists).

HOW NODON WORKS
Nebivolol works by relaxing blood
vessels and
slowing
heart rate
to
improve blood flow and decrease
blood pressure.
BEFORE YOU TAKE NODON

_DO NOT TAKE NODON IF YOU _

are allergic to nebivolol or any of
the
other
ingredients
of
this
medicine


An allergic reaction may include
rash,
itching,
swelling
or
difficulty breathing


have liver problems


have had a heart attack, have
heart
failure
which
might
be
getting
worse
or
have
had
intravenous
medical
treatment
for heart failure.


Have
missed
heart
beats
(conditions such as sick sinus
syndrome,
sinoatrial
block
or
second
or
third
degree
heart
block) but have not been fitted
with a pacemaker


have
or
have
had
asthma
or
other serious breathing problems


have a tumour of the adrenal
gland
called
a
phaeochromocytoma
that
is
not being treated


have
a
condition
called
metabolic acidosis


suffer from a slow heart beat
(fewer
than 60
beats
per
minute,
known
as
bradycardia)


suffer
from
low
blood
pressure or have very poor
circulation

_BEFORE YOU TAKE IT _
Talk to

Ciri produk

PACKAGE INSERT
NEBIVOLOL TABLETS 5 MG
1389, TRASAD ROAD, DHOLKA – 382 225, DIST: AHMEDABAD, GUJARAT STATE,
INDIA
NODON (NEBIVOLOL TABLETS 5 MG)
QUALITATIVE AND QUANTITATIVE COMPOSITION
NODON
Each Uncoated tablet contains:
Nebivolol Hydrochloride
equivalent to Nebivolol ................ 5.00 mg
PHARMACEUTICAL FORM
Uncoated tablet
White to off-white, round, uncoated tablets with cross break line on
both side.
CLINICAL PARTICULARS 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 old or above.
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. Till 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 _
The recommended starting dose for patients with renal insufficiency is
2.5mg daily. If needed, the
daily dose may be increased to 5mg.
_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 2.5mg
daily. If needed, the daily dose may
be increased to 5mg. However, in view of the limited experience in
patients above 75 years, caution
must be exercised and these patients 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 available. Therefore, use in