CROSUVA 40 rosuvastatin (as calcium) 40mg tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Buy It Now

Patient Information leaflet (PIL)

15-12-2021

Summary of Product characteristics (SPC)

24-08-2020

Public Assessment Report (PAR)

28-11-2017

Active ingredient:

rosuvastatin calcium, Quantity: 41.7 mg

Available from:

Arrotex Pharmaceuticals Pty Ltd

INN (International Name):

Rosuvastatin calcium

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: crospovidone; magnesium stearate; colloidal anhydrous silica; lactose monohydrate; microcrystalline cellulose; 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:

30, 7

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

CROSUVA is indicated as an adjunct to diet when the response to diet and exercise is inadequate. Prevention of Cardiovascular Events: CROSUVA 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). CROSUVA 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: CROSUVA is indicated for the treatment of hypercholesterolaemia (including familial hypercholesterolaemia). Prior to initiating therapy with CROSUVA, 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, coated tablet, debossed with 'ROS' on one side and '40' 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:

Licence status A

Authorization date:

2012-02-02

Patient Information leaflet

CROSUVA
_Rosuvastatin calcium _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some of the
common questions people ask
about CROSUVA. It does not
contain all the information that is
known about CROSUVA.
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
CROSUVA 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 CROSUVA IS FOR
CROSUVA 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 increase the
risk of heart disease.
_HOW CROSUVA WORK

Read the complete document

Summary of Product characteristics

1
AUSTRALIAN PI – CROSUVA (ROSUVASTATIN CALCIUM) TABLETS
1
NAME OF THE MEDICINE
Rosuvastatin calcium
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
CROSUVA 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
CROSUVA 5 are Yellow, round, biconvex, coated tablet debossed with
“ROS” over “5” on one side
and plain on the other side.
CROSUVA 10 are Pink, round, biconvex, coated tablet debossed with
“ROS” over “10” on one side
and plain on the other side
CROSUVA 20 are Pink, round, biconvex, coated tablet debossed with
“ROS” over “20” on one side
and plain on the other side.
CROSUVA 40 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
CROSUVA is indicated as an adjunct to diet when the response to diet
and exercise is inadequate.
PREVENTION OF CARDIOVASCULAR EVENTS
CROSUVA 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). CROSUVA is indicated to:
• Reduce the risk of nonfatal myocardial infarction
• Reduce the risk of nonfatal stroke
2
• Reduce the risk of coronary artery revascularisation procedures
IN PATIENTS WITH HYPERCHOLESTEROLAEMIA
CROSUVA is indicated for the treatment of hypercholesterolaemia
(including familial
hypercholesterolaemia).
Prior to initiating therapy with CROSUVA, 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.
4.2
D
OSE AND METHOD OF ADMINISTRATI

Read the complete document