ROSUVASTATIN GENERICHEALTH rosuvastatin (as calcium) 10 mg film-coated tablets blister pack
Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Patient Information leaflet
(PIL)
24-08-2020
Summary of Product characteristics
(SPC)
24-08-2020
Public Assessment Report
(PAR)
26-11-2017
Active ingredient:
rosuvastatin calcium
Available from:
Dr Reddys Laboratories Australia Pty Ltd
INN (International Name):
Rosuvastatin calcium
Authorization status:
Registered
Patient Information leaflet
Rosuvastatin generichealth CMI v1
Page 1 of 5
CONSUMER MEDICINE INFORMATION
ROSUVASTATIN GENERICHEALTH
_Rosuvastatin (as calcium) _
WHAT IS IN THIS LEAFLET
READ THIS LEAFLET CAREFULLY
BEFORE TAKING YOUR MEDICINE.
This leaflet answers some of the
common questions about
rosuvastatin. It does not
contain all the information that
is known about rosuvastatin.
It does not take the place of
talking to your doctor and
pharmacist.
All medicines have risks and
benefits.
Your doctor will have
weighed the risks of you taking
this medicine against the
benefits they expect it will have
for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE
MEDICINE. You may need to
read it again.
WHAT ROSUVASTATIN
GENERICHEALTH IS USED FOR
The name of your medicine is
Rosuvastatin
generichealth
. It
contains the active ingredient
rosuvastatin.
Rosuvastatin is used to lower
high cholesterol levels.
Even though you may have
normal cholesterol, rosuvastatin
can also be used to reduce the
risk of you having a stroke or
heart attack if you are a man 50
or more years old or
a women
60 or more years old and have
at least 2 risk factors for having
a heart attack or stroke, such as
high blood pressure, low levels
of good cholesterol (HDL),
smoking or a family history of
premature coronary heart
disease. Your doctor may also
do a blood test to
measure a
substance called C Reactive
Protein to help decide if you
should be given rosuvastatin for
this use.
_CHOLESTEROL AND TRIGLYCERIDES_
Everyone has cholesterol and
triglycerides in their blood.
They are fatty substances
needed by the body for many
things.
Triglycerides are an energy
source for the body.
Cholesterol is used for such
things as building cells, making
bile acids (which help to digest
foods) and making some
hormones.
There are
different types of
cholesterol. Too much of the
"bad" cholesterol (LDL) can
block the blood vessels that
supply your heart and brain
with blood, and can cause heart
attack, angina and stroke. The
"good" chol
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Summary of Product characteristics
Rosuvastatin generichealth PI v1
Page 1 of 22
PRODUCT INFORMATION
ROSUVASTATIN GENERICHEALTH
NAME OF THE MEDICINE
Rosuvastatin (as calcium) tablets.
Chemical name: bis
[(E)‐7‐[4‐(4‐fluorophenyl)‐6‐isopropyl‐2‐[methyl(methylsulfonyl)
amino]pyrimidin‐5‐yl]
(3R, 5S)‐3,5‐dihydroxyhept‐6‐enoic acid] calcium salt.
Structural Formula:
CAS Number:
147098‐20‐2
Molecular formula: (C
22
H
27
FN
3
O6S)2Ca
Molecular weight:
1001.14
Rosuvastatin calcium, is a HMG‐CoA reductase inhibitor for the
treatment of dyslipidaemia.
DESCRIPTION
Rosuvastatin calcium is an amorphous solid, which is soluble in
dimethyl formamide, dimethyl suplhoxide
and acetonitrile. Slightly soluble in acetone, water, ethanol and
methanol and has a pKa of 3.8 (carboxylic
acid group), 4.9 and 5.5 (amine groups). The partition coefficient is
octanol/water 0.13 (pH 7.0).
Rosuvastatin calcium is the
(3_R_,5_S_,6_E_) enantiomer.
Rosuvastatin generichealth film‐coated tablets contain 5 mg, 10 mg,
20 mg and 40 mg of rosuvastatin (as
calcium). The tablets also contain the following inactive ingredients:
crospovidone, lactose,
microcrystalline cellulose, magnesium stearate, and meglumine. The 5
mg tablets also contain opadry II
complete film coating
system 32K520046 YELLOW (PI 108958) whereas the 10 mg, 20 mg and 40 mg
tablets
contain opadry II complete film coating system 32K540017 PINK (PI
108959).
PHARMACOLOGY
Rosuvastatin is a fully synthetic competitive inhibitor of HMG‐CoA
reductase, the rate‐limiting enzyme that
converts 3‐hydroxy‐3‐methylglutaryl coenzyme A to mevalonate, a
precursor of cholesterol. Triglycerides
(TG) and cholesterol in the liver are incorporated, with
apolipoprotein B (ApoB), into very low density
lipoprotein (VLDL) and released
into the plasma for delivery to peripheral tissues. VLDL particles are
TG‐
rich. Cholesterol‐rich low density lipoprotein (LDL) is formed from
VLDL and is cleared primarily through
the high affinity LDL receptor in the liver.
Rosuvastatin generichealth PI v1
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