PHARMACOR ROSUVASTATIN 5 Rosuvastatin (as calcium) 5 mg tablets bottle

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

rosuvastatin calcium, Quantity: 5.21 mg

Available from:

Pharmacor Pty Ltd

INN (International Name):

Rosuvastatin calcium

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: crospovidone; lactose; magnesium stearate; microcrystalline cellulose; light magnesium oxide; hypromellose; triacetin; titanium dioxide; lactose monohydrate; iron oxide yellow

Administration route:

Oral

Units in package:

100 tablets in HDPE bottle with CRC, 90 tablets in HDPE bottle with CRC, 500 tablets in HDPE bottle without CRC, 30 tablets in HDPE bottle with CRC

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

PHARMACOR ROSUVASTATIN should be used as an adjunct to diet when the response to diet and exercise is inadequate. ,Prevention of Cardiovascular Events PHARMACOR 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). PHARMACOR 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 PHARMACOR ROSUVASTATIN is indicated for the treatment of hypercholesterolaemia (including familial hypercholesterolaemia). ,Prior to initiating therapy with PHARMACOR 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: Yellow, round, biconvex, film-coated tablet, debossed 5 on one side and R on other side.; Container Type: Bottle; Container Material: HDPE; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure

Authorization status:

Licence status A

Authorization date:

2016-02-04

Patient Information leaflet

PHARMACOR ROSUVASTATIN
_Rosuvastatin calcium _
CONSUMER MEDICINE INFORMATION
Pharmacor Rosuvastatin (V 02)
Page 1 of 4
WHAT IS IN THIS LEAFLET
This leaflet answers some of the
common questions people ask about
PHARMACOR ROSUVASTATIN. It
does not contain all the information
that is known about PHARMACOR
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
PHARMACOR 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 PHARMACOR
ROSUVASTATIN IS FOR
PHARMACOR ROSUVASTATIN is used
to lower high cholesterol levels.
Even though you may have normal
cholesterol, PHARMACOR
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
PHARMACOR 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" cholesterol (HDL) helps to
remove the bad cholesterol from the
blood vessels. High levels of
triglycerides can be asso

Summary of Product characteristics

Pharmacor Rosuvastatin (V 02)
Page 1 of 28
AUSTRALIAN PRODUCT INFORMATION
PHARMACOR ROSUVASTATIN (ROSUVASTATIN (AS CALCIUM) TABLETS
1
NAME OF THE MEDICINE
Rosuvastatin (as calcium)
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Pharmacor Rosuvastatin film-coated tablets contain 5 mg, 10 mg, 20 mg
and 40 mg of rosuvastatin (as
calcium).
Excipients with known effect: lactose, lactose monohydrate.
For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
Pharmacor Rosuvastatin 5 film-coated tablets: Yellow, round, biconvex,
film-coated tablet, debossed “5” on
one side and “R” on other side.
Pharmacor Rosuvastatin 10 film-coated tablets: Pink, round, biconvex,
film-coated tablet, debossed “10” on
one side and “R” on other side.
Pharmacor Rosuvastatin 20 film-coated tablets: Pink, round, biconvex,
film-coated tablet, debossed “20” on
one side and “R” on other side.
Pharmacor Rosuvastatin 40 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
Pharmacor Rosuvastatin should be used as an adjunct to diet when the
response to diet and exercise is
inadequate.
PREVENTION OF CARDIOVASCULAR EVENTS
Pharmacor 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). Pharmacor 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.
Pharmacor Rosuvastatin (V 02)
Page 2 of 28
IN PATIENTS WITH HYPERCHOLESTEROLAEMIA
Pharmacor
Rosuvastatin
is
indicated
for
the
treatment
of
hypercholesterolaemia
(including
familial
hypercholesterolaemia).
Prior to initiating