Novtor 20mg Film Coated Tablets

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

ROSUVASTATIN CALCIUM

Boleh didapati daripada:

NOVUGEN PHARMA SDN. BHD.

INN (Nama Antarabangsa):

ROSUVASTATIN CALCIUM

Unit dalam pakej:

1x10 Tablets; 3x10 Tablets; 10x10 Tablets; 50x10 Tablets; 100x10 Tablets; 1x14 Tablets; 2x14 Tablets; 4x14 Tablets; 6x14 Tablets; 8x14 Tablets; 12x14 Tablets

Dikeluarkan oleh:

NOVUGEN PHARMA SDN. BHD.

Risalah maklumat

_Consumer Medication Information Leaflet (RiMUP) _
NOVTOR FILM COATED TABLETS
Rosuvastatin 5mg, 10mg, 20mg
1
WHAT IS IN THIS LEAFLET
1.
What Novtor is used for
2.
How Novtor works
3.
Before you use Novtor
4.
How to use Novtor
5.
While you are using it
6.
Side effects
7.
Storage and disposal of Novtor
8.
Product description
9.
Manufacturer
and
Product
Registration Holder
10.
Date of revision
11.
Serial number
WHAT NOVTOR IS USED FOR
You
have
been
prescribed
Novtor
because you have a high cholesterol
level.
This means
you
are
at
risk
from a heart attack or stroke.
HOW NOVTOR WORKS
Novtor is used to correct the levels
of
fatty
substances
in
the
blood
called lipids, the most common of
which is cholesterol.
There
are
different
types
of
cholesterol
found
in
the
blood
–
‘bad’
cholesterol
(LDL-C)
and
‘good’ cholesterol (HDL-C).
•
Novtor
can
reduce
the
‘bad’
cholesterol and increase the ‘good’
cholesterol.
•
It works by helping to block your
body’s
production
of
‘bad’
cholesterol. It also improves your
body’s ability to remove it from
your blood.
For
most
people,
high
cholesterol
does not affect the way
they
feel
because
it
does
not
produce
any
symptoms.
However,
if
it
is
left
untreated, fatty deposits can build up
in the walls of your blood vessels
causing them to narrow.
Sometimes,
these
narrowed
blood
vessels can get blocked which can
cut off the blood supply to the heart
or brain leading to a heart attack or a
stroke. By lowering your cholesterol
levels, you can reduce your risk of
having a heart attack, a stroke or
related health problems.
You
need
to
keep
taking
Novtor,
even if it has got your cholesterol to
the right level, because it prevents
your cholesterol levels from creeping
up again and causing build up of
fatty deposits.
BEFORE YOU USE NOVTOR
-
_When you must not use it _
Do not take Novtor:
•
If you have ever had an allergic
reaction
to
Novtor
or
similar
medicines,
or
to
any
of
its
ingredients.
Novtor
contains
lactose,
which
may
cause
a
problem
in
a
small
number
of
patients

Ciri produk

NOVTOR 5MG
NOVTOR 10MG
NOVTOR 20MG
FILM COATED TABLETS
1.
NAME OF THE MEDICINAL PRODUCT
Novtor 5mg Film Coated Tablets
Novtor 10mg Film Coated Tablets
Novtor 20mg Film Coated Tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
NOVTOR 5MG FILM COATED TABLETS:
Each tablet contains 5.198mg of Rosuvastatin Calcium equivalent
to 5mg Rosuvastatin.
NOVTOR 10MG FILM
COATED TABLETS:
Each tablet contains 10.395mg of Rosuvastatin Calcium
equivalent to 10mg Rosuvastatin.
NOVTOR 20MG FILM COATED TABLETS:
Each tablet contains 20.790mg of Rosuvastatin Calcium
equivalent to 20mg Rosuvastatin.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film Coated Tablet.
NOVTOR 5MG FILM COATED TABLETS:
Pink coloured round shape film-coated tablet, debossed with ‘N’
on one side and ‘23’ on other side.
NOVTOR 10MG FILM COATED TABLETS:
Pink coloured round shape film-coated tablet, debossed with ‘N’
on one side and ‘22’ on other side.
NOVTOR 20MG FILM COATED TABLETS:
Pink coloured round shape film-coated tablet, debossed with ‘N’
on one side and ‘21’ on other side.
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
Rosuvastatin is indicated as an adjunct to diet, at least equivalent
to the Adult Treatment Panel III (ATP
III TLC diet), for the reduction of elevated total cholesterol,
LDL-cholesterol, ApoB, the total
cholesterol: HDL-cholesterol ratio and triglycerides and for
increasing HDL-C, in hyperlipidemic and
dyslipidemic conditions, when response to diet and exercise alone has
been inadequate including:
Prevention of Cardiovascular Events. In adult patients with an
increased risk of atherosclerotic
cardiovascular disease based on the presence of cardiovascular disease
risk markers such as an elevated
hsCRP level, age, hypertension, low HDL-C, smoking or a family history
of premature coronary heart
disease, Rosuvastatin is indicated to reduce total mortality and the
risk of major cardiovascular events
(cardiovascular death, stroke, MI, unstable angina, or arterial
revascularization).
Rosuv