ROSUVASTATIN SANDOZ rosuvastatin (as calcium) 20 mg film-coated tablets blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

rosuvastatin calcium

Available from:

Sandoz Pty Ltd

INN (International Name):

Rosuvastatin calcium

Authorization status:

Registered

Patient Information leaflet

ROSUVASTATIN SANDOZ
®
1
ROSUVASTATIN SANDOZ
®
_Rosuvastatin calcium film coated tablet _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS
LEAFLET
This leaflet answers some common
questions about Rosuvastatin Sandoz.
It does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have risks and
benefits. Your doctor has 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
SANDOZ IS USED
FOR
This medicine is used to:

Lower high blood cholesterol
levels (hypercholesterolaemia).

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.
It contains the active ingredient
rosuvastatin calcium.
Rosuvastatin calcium belongs to a
group of medicines called HMG-
CoA reductase inhibitors (also
known as 'statins').
Everyone has cholesterol and
triglycerides in their blood. They are
fatty substances needed by the body
for many things.
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" cholesterol (HDL) helps to
remove the bad cholesterol from the
blood vessels. High levels of
triglycerides can be associated with a
low level of "good" cholesterol and
may increase the risk of heart
disease.
Rosuvastatin Sandoz works by
reducing the level of "bad"
cholesterol, and raises the "good"
cholesterol when exercise and
changes to diet are not enough on
their own. Cholesterol is present in
many foods and is also made by your
bod

Summary of Product characteristics

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PRODUCT INFORMATION
ROSUVASTATIN SANDOZ
® 5MG, 10MG, 20MG, 40MG TABLETS
NAME OF THE MEDICINE
_ _
Generic name:
Rosuvastatin, as rosuvastatin calcium.
Chemical name:
bis [(
_E_
)-7-[4-(4-fluorophenyl)-6-isopropyl-2-[methyl
(methylsulfonyl) amino] pyrimidin-5-yl] (3
_R_
, 5
_S_
)-3,5-
dihydroxyhept-6-enoic acid] calcium salt.
Chemical structure:
CAS Number:
147098-20-2
Empirical formula:
(C
22
H
27
FN
3
O
6
S)
2
Ca
MW:
1001.14
DESCRIPTION
_ _
Rosuvastatin Sandoz 5 mg tablets contain 5 mg rosuvastatin (as
calcium).
Rosuvastatin Sandoz 10 mg tablets contain 10 mg rosuvastatin (as
calcium).
Rosuvastatin Sandoz 20 mg tablets contain 20 mg rosuvastatin (as
calcium).
Rosuvastatin Sandoz 40 mg tablets contain 40 mg rosuvastatin (as
calcium).
Rosuvastatin calcium is an amorphous solid, which is slightly soluble
in water (7.8
mg/mL at 37°C), methanol, and ethanol, and has a pKa of 4.6.
Rosuvastatin calcium is
the (3
_R_
,5
_S_
,6
_E_
) enantiomer.
Rosuvastatin Sandoz tablets also contain the inactive ingredients
lactose, colloidal
anhydrous silica, microcrystalline cellulose and silicon dioxide,
maize starch, purified
talc, sodium stearylfumarate, hypromellose, mannitol and macrogol
6000, (titanium
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dioxide, iron oxide yellow and iron oxide red; these colours are only
present in tablets
supplied in bottles).
_ _
_ _
PHARMACOLOGY
Rosuvastatin is a fully synthetic competitive inhibitor of
3-hydroxy-3-methyl-glutaryl-
coenzyme A reductase (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