CAVSTAT 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:

Accord Healthcare Pty Ltd

INN (International Name):

Rosuvastatin calcium

Pharmaceutical form:

Tablet, film coated

Composition:

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

Administration route:

Oral

Units in package:

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

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

CAVSTAT 5 should be used as an adjunct to diet when the response to diet and exercise is inadequate. ,Prevention of Cardiovascular Events CAVSTAT 5 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). CAVSTAT 5 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 CAVSTAT 5 is indicated for the treatment of hypercholesterolaemia (including familial hypercholesterolaemia). ,Prior to initiating therapy with CAVSTAT 5, 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

CAVSTAT (ROSUVASTATIN)
CONSUMER MEDICINE INFORMATION
Version: 1.0
-2016-
Page 1 of 5
CAVSTAT
(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 Cavstat. It does not contain
all the information that is known
about Cavstat.
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
Cavstat 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 CAVSTAT IS FOR
Cavstat is used to lower high
cholesterol levels.
Even though you may have
normal cholesterol, Cavstat 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
Cavstat 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

Summary of Product characteristics

1
v2 06.21
AUSTRALIAN PRODUCT INFORMATION –
CAVSTAT (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:
▪
Sugars as 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
identified and treated.
2
v2 06.21
4.2