Vivacor 10mg Film coated tablet

البلد: ماليزيا

اللغة: الإنجليزية

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

العنصر النشط:

ROSUVASTATIN CALCIUM

متاح من:

ZUELLIG PHARMA SDN BHD

INN (الاسم الدولي):

ROSUVASTATIN CALCIUM

الوحدات في الحزمة:

28tablet Tablets

المصنعة من قبل:

IPR PHARMACEUTICALS INC

نشرة المعلومات

VIVACOR
® TABLET
ROSUVASTATIN 10 MG & 20 MG
_CONSUMER MEDICATION INFORMATION LEAFLET _
_(RIMUP)_
1
WHAT IS IN THIS LEAFLET
1.
What Vivacor is used for
2.
How Vivacor works
3.
Before you use Vivacor
4.
How to use Vivacor
5.
While you are using it
6.
Side effects
7.
Storage and disposal of
Vivacor
8.
Product description
9.
Manufacturer
10.
Product Registration Holder
11.
Date of revision
WHAT VIVACOR IS USED FOR
You have been prescribed Vivacor
because you have a high
cholesterol level. This means you
are at risk from a heart attack or
stroke.
HOW VIVACOR WORKS
Vivacor 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).
•
Vivacor 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 Vivacor,
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 VIVACOR
_ _
-
_When you must not use it _
Do not take Vivacor:
•
If you have ever had an allergic
reaction to Vivacor or similar
medicines, or to any of its
ingredients. Vivacor contains
lactose, which may cause a
problem in a small number of
patients who are

خصائص المنتج

VIVACOR
®
10 mg, 20 mg
Film-coated Tablet
COMPOSITION
Each tablet contains 10 mg or 20 mg of rosuvastatin as rosuvastatin
calcium.
PHARMACEUTICAL FORM
Oral tablets.
10mg tablet: Pink, film-coated, round, biconvex, approximately 7mm
(diameter) intagliated
tablet; obverse side “ZD4522 10”, reverse side none.
20mg tablet: Pink, film-coated, round, biconvex, approximately 9.1mm
(diameter) intagliated
tablet; obverse side “ZD4522 20”, reverse side none.
THERAPEUTIC INDICATIONS
Vivacor (rosuvastatin calcium) 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, Vivacor is
indicated to reduce total
mortality and the risk of major cardiovascular events (cardiovascular
death, stroke, MI,
unstable angina, or arterial revascularization).
Vivacor
is
indicated
as
an
adjunct
to
diet
for
the
treatment
of
patients
with
primary
dysbetalipoproteinemia (Type III Hyperlipoproteinemia).
Primary
hypercholesterolaemia
(Type
IIa
including
heterozygous
familial
hypercholesterolaemia and severe non-familial hypercholesterolaemia).
Combined (mixed) dyslipidemia (Type IIb).
Homozygous familial hypercholesterolaemia where Vivacor is used either
alone or as an
adjunct to diet and other lipid lowering treatment such as apheresis.
Vivacor is indicated as adjunctive therapy to diet to slow the
progression of atherosclerosis in
adult patients as part of a treatment strategy to lower Total-C and
LDL-C to ta