ROSUVASTATIN LUPIN Rosuvastatin (as calcium) 40 mg tablets blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

rosuvastatin calcium, Quantity: 41.68 mg

Available from:

Generic Health Pty Ltd

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: lactose; magnesium stearate; crospovidone; microcrystalline cellulose; light magnesium oxide; titanium dioxide; lactose monohydrate; hypromellose; sunset yellow FCF aluminium lake; triacetin; brilliant blue FCF aluminium lake; allura red AC aluminium lake

Administration route:

Oral

Units in package:

30 tablets

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

ROSUVASTATIN LUPIN should be used as an adjunct to diet when the response to diet and exercise is inadequate. ,Prevention of Cardiovascular Events ROSUVASTATIN LUPIN is indicated for prevention of major cardiovascular events in men ?50 years old and women ?60 years old with no clinically evident cardiovascular disease but with at least two conventional risk factors for cardiovascular disease (hypertension, low HDL-C, smoking, or a family history of premature coronary heart disease). ROSUVASTATIN LUPIN is indicated to:,? Reduce the risk of nonfatal myocardial infarction ? Reduce the risk of nonfatal stroke ? Reduce the risk of coronary artery revascularisation procedures.,In patients with hypercholesterolaemia ROSUVASTATIN LUPIN is indicated for the treatment of hypercholesterolaemia (including familial hypercholesterolaemia). ,Prior to initiating therapy with ROSUVASTATIN LUPIN , secondary causes of hypercholesterolaemia (e.g. poorly controlled diabetes mellitus, hypothyroidism, nephrotic syndrome, dysproteinaemias, obstructive liver disease, other drug therapy, alcoholism) should be identified and treated.

Product summary:

Visual Identification: Pink, oval, biconvex, film-coated tablet, debossed 40 on one side and R on other side.; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Registered

Authorization date:

2020-10-02

Patient Information leaflet

CONSUMER MEDICINE INFORMATION
ROSUVASTATIN LUPIN
(ROSUVASTATIN CALCIUM) FILM-COATED TABLET
_ _
WHAT IS IN THIS LEAFLET
This leaflet answers some of the
common questions people ask
about Rosuvastatin Lupin. It
does not contain all the
information that is known about
Rosuvastatin Lupin.
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
Rosuvastatin Lupin 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 LUPIN
IS USED FOR
Rosuvastatin Lupin is used to
lower high cholesterol levels.
Even though you may have
normal cholesterol, Rosuvastatin
Lupin 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 Lupin 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" 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" cholester

Summary of Product characteristics

AUSTRALIAN PRODUCT INFORMATION – ROSUVASTATIN LUPIN
(ROSUVASTATIN CALCIUM) FILM-COATED TABLET
1
NAME OF THE MEDICINE
Rosuvastatin calcium.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Rosuvastatin Lupin film-coated tablets contain 5 mg, 10 mg, 20 mg or
40 mg rosuvastatin (as calcium)
per tablet
Ingredients with known effects:
•
Sugars (as lactose).
For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
Rosuvastatin Lupin 5 mg film-coated tablets: Yellow, round, biconvex,
film-coated tablet, debossed “5”
on one side and “R” on other side.
Rosuvastatin Lupin 10 mg film-coated tablets: Pink, round, biconvex,
film-coated tablet, debossed “10”
on one side and “R” on other side.
Rosuvastatin Lupin 20 mg film-coated tablets: Pink, round, biconvex,
film-coated tablet, debossed “20”
on one side and “R” on other side.
Rosuvastatin Lupin 40 mg film-coated tablets: Pink, oval, biconvex,
film-coated tablet, debossed “40” on
one side and “R” on other side.
4
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Rosuvastatin Lupin should be used as an adjunct to diet when the
response to diet and exercise is
inadequate.
PREVENTION OF CARDIOVASCULAR EVENTS
Rosuvastatin Lupin is indicated for prevention of major cardiovascular
events in men ≥ 50 years old and
women ≥ 60 years old with no clinically evident cardiovascular
disease but with at least two conventional
risk factors for cardiovascular disease (hypertension, low HDL-C,
smoking, or a family history of
premature coronary heart disease). Rosuvastatin Lupin is indicated to:
•
Reduce the risk of nonfatal myocardial infarction;
•
Reduce the risk of nonfatal stroke;
•
Reduce the risk of coronary artery revascularisation procedures.
Rosuvastatin Lupin v2.0
(rosuvastatin calcium) film-coated tablet
Page 2 of 26
IN PATIENTS WITH HYPERCHOLESTEROLAEMIA
Rosuvastatin
Lupin
is
indicated
for
the
treatment
of
hypercholesterolaemia
(including
familial
hypercholesterolaemia).
Prior to initiating therapy with Rosuvas