BTC ROSUVASTATIN Rosuvastatin (as calcium) 40 mg tablets blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

rosuvastatin calcium, Quantity: 41.68 mg

Available from:

Accord Healthcare Pty Ltd

INN (International Name):

Rosuvastatin calcium

Pharmaceutical form:

Tablet, film coated

Composition:

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

Administration route:

Oral

Units in package:

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

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

BTC ROSUVASTATIN should be used as an adjunct to diet when the response to diet and exercise is inadequate. ,Prevention of Cardiovascular Events BTC 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). BTC 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 BTC ROSUVASTATIN is indicated for the treatment of hypercholesterolaemia (including familial hypercholesterolaemia). ,Prior to initiating therapy with BTC 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, oval, biconvex, film-coated tablet, debossed 40 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

BTC ROSUVASTATIN
CONSUMER MEDICINE INFORMATION
Version: 2.0
-2016- Page 1 of 5
BTC ROSUVASTATIN
(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 BTC ROSUVASTATIN. It
does not contain all the
information that is known about
BTC 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
BTC 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 BTC
ROSUVASTATIN IS FOR
BTC ROSUVASTATIN is used to
lower high cholesterol levels.
Even though you may have
normal cholesterol, BTC
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 BTC
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 v