APX-ROSUVASTATIN rosuvastatin (as calcium) 20mg tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

rosuvastatin calcium, Quantity: 20.8 mg

Available from:

Arrotex Pharmaceuticals Pty Ltd

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: lactose monohydrate; magnesium stearate; crospovidone; microcrystalline cellulose; colloidal anhydrous silica; titanium dioxide; hypromellose; sunset yellow FCF aluminium lake; triacetin; allura red AC aluminium lake; indigo carmine aluminium lake; iron oxide red

Administration route:

Oral

Units in package:

7, 30

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

APX ROSUVASTATIN should be used as an adjunct to diet when the response to diet and exercise is inadequate. Prevention of Cardiovascular Events: APX ROSUVASTATIN is indicated for prevention of major cardiovascular events in men greater than or equal to 50 years old and women greater than or equal to 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). APX ROSUVASTATIN 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: APX ROSUVASTATIN is indicated for the treatment of hypercholesterolaemia (including familial hypercholesterolaemia). Prior to initiating therapy with APX ROSUVASTATIN, 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, round, biconvex, coated tablet, debossed with 'ROS' over '20' on one side and plain on the other side.; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Registered

Authorization date:

2020-05-18

Patient Information leaflet

APX-ROSUVASTATIN
_Rosuvastatin calcium _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some of the
common questions people ask
about APX-ROSUVASTATIN. It
does not contain all the
information that is known about
APX-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
APX-ROSUVASTATIN 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 APX-ROSUVASTATIN IS
FOR
APX-ROSUVASTATIN is used to
lower high cholesterol levels.
Although 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 male, 50 years
or over, or female, 60 years or
over, and have at least 2 risk
factors for having a heart attack
or stroke. Examples of such risk
factors would be 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
determine whether Rosuvastatin
should be prescribed for this use.
_CHOLESTEROL AND TRIGYLCERIDES _
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”
cholesterol and may

Summary of Product characteristics

1
AUSTRALIAN PI – APX-ROSUVASTATIN (ROSUVASTATIN CALCIUM)
TABLETS
1
NAME OF THE MEDICINE
Rosuvastatin calcium
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
APX-ROSUVASTATIN tablets contain 5 mg, 10 mg, 20 mg and 40 mg of
rosuvastatin (as calcium).
Excipients with known effect: lactose monohydrate. For the full list
of excipients, see SECTION 6.1 LIST
OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
APX-ROSUVASTATIN 5mg are Yellow, round, biconvex, coated tablet
debossed with “ROS” over “5”
on one side and plain on the other side.
APX-ROSUVASTATIN 10mg are Pink, round, biconvex, coated tablet
debossed with “ROS” over “10”
on one side and plain on the other side
APX-ROSUVASTATIN 20mg are Pink, round, biconvex, coated tablet
debossed with “ROS” over “20”
on one side and plain on the other side.
APX-ROSUVASTATIN 40mg are Pink, oval, biconvex, coated tablet debossed
with “ROS” on one side
and “40” on the other side.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
APX-ROSUVASTATIN is indicated as an adjunct to diet when the response
to diet and exercise is
inadequate.
PREVENTION OF CARDIOVASCULAR EVENTS
APX-ROSUVASTATIN 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). APX-ROSUVASTATIN is
indicated to:
2
• 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
APX-ROSUVASTATIN is indicated for the treatment of
hypercholesterolaemia (including familial
hypercholesterolaemia).
Prior to initiating therapy with APX ROSUVASTATIN, secondary causes of
hypercholesterolaemia (e.g.
poorly controlled diabetes mellitus, hypothyroidism, nephrotic
syndrome, dysproteinaemias,
obstructive liver dise