APO-Rosuvastatin rosuvastatin (as calcium) 10 mg tablets blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

rosuvastatin calcium, Quantity: 10.42 mg

Available from:

Accord Healthcare Pty Ltd

INN (International Name):

Rosuvastatin calcium

Pharmaceutical form:

Tablet, film coated

Composition:

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

Administration route:

Oral

Units in package:

30 tablets in blister pack, 100 tablets in blister pack, 50 tablets in blister pack, 56 tablets in blister pack, 14 tablets in blister pack, 42 tablets in blister pack, 20 tablets in blister pack, 98 tablets in blister pack, 60 tablets in blister pack, 84 tablets in blister pack, 28 tablets in blister pack, 7 tablets in blister pack, 15 tablets in blister pack, 90 tablets in blister pack

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

APO-Rosuvastatin should be used as an adjunct to diet when the response to diet and exercise is inadequate. Prevention of Cardiovascular Events APO-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). APO-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 APO-Rosuvastatin is indicated for the treatment of hypercholesterolaemia (including familial hypercholesterolaemia). ,Prior to initiating therapy with APO-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, film-coated tablet, debossed 10 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

Authorization status:

Licence status A

Authorization date:

2016-02-04

Patient Information leaflet

ROSUVASTATIN APOTEX
CONSUMER MEDICINE INFORMATION
Version: 2.0
-2018- Page 1 of 6
ROSUVASTATIN APOTEX
(ROSUVASTATIN FILM-COATED TABLETS 5, 10, 20 AND 40 MG)
_Rosuvastatin calcium _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some of the
common questions people ask
about ROSUVASTATIN APOTEX.
It does not contain all the
information that is known about
ROSUVASTATIN APOTEX.
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 APOTEX 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
APOTEX IS FOR
ROSUVASTATIN APOTEX is used
to lower high cholesterol levels.
Even though you may have
normal cholesterol,
ROSUVASTATIN APOTEX 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 APOTEX 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 c

Summary of Product characteristics

1
AUSTRALIAN PRODUCT INFORMATION –
ROSUVASTATIN APOTEX (ROSUVASTATIN CALCIUM)
1
NAME OF THE MEDICINE
Rosuvastatin calcium
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
5 mg, 10 mg, 20 mg or 40 mg rosuvastatin (as calcium) per tablet
Ingredients with known effects:
▪
lactose (all tablet strengths contain lactose)
For the full list of excipients, see Section 6.1 List of Excipients.
3
PHARMACEUTICAL FORM
5 mg film-coated tablets: Yellow, round, biconvex, film-coated tablet,
debossed “5” on one
side and “R” on other side.
10 mg film-coated tablets: Pink, round, biconvex, film-coated tablet,
debossed “10” on one
side and “R” on other side.
20 mg film-coated tablets: Pink, round, biconvex, film-coated tablet,
debossed “20” on one
side and “R” on other side.
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 should be used as an adjunct to diet when the response to
diet and exercise is
inadequate.
PREVENTION OF CARDIOVASCULAR EVENTS
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). 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
Rosuvastatin is indicated for the treatment of hypercholesterolaemia
(including familial
hypercholesterolaemia).
Prior to initiating therapy with rosuvastatin, secondary causes of
hypercholesterolaemia (e.g.
poorly controlled diabetes mellitus, hypothyroidism, nephrotic
syndrome, dysproteinaemias,
obstructive liver disease, other drug therapy, alcoholism) should be
identi