ROSUVASTATIN RBX rosuvastatin (as calcium) 5 mg tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

rosuvastatin calcium, Quantity: 5.198 mg

Available from:

Sun Pharma ANZ Pty Ltd

INN (International Name):

Rosuvastatin calcium

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: crospovidone; lactose monohydrate; microcrystalline cellulose; sodium citrate dihydrate; magnesium stearate; titanium dioxide; hypromellose; iron oxide yellow; macrogol 400

Administration route:

Oral

Units in package:

30, 28, 7, 10, 90

Prescription type:

(S4) Prescription Only Medicine

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 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). 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 (excluding Heterozygous 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.

Product summary:

Visual Identification: Light yellow to yellow round film coated tablets with RT1 debossed on one side and plain on other side; Container Type: Blister Pack; Container Material: PA/Al/PVC/Al - polyamide-aluminium foil-polyvinylchloride/aluminium foil; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2012-08-28

Patient Information leaflet

ROSUVASTATIN RBX TABLETS
ROSUVASTATIN CALCIUM
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some of the common questions people ask
about ROSUVASTATIN RBX. It does not contain all the information
that is known about ROSUVASTATIN RBX.
It does not take the place of talking to your doctor and
pharmacist.
This leaflet was last updated on the date at the end of this
leaflet. More recent information may be available. The latest
Consumer Medicine Information is available from
https://www.ebs.tga.gov.au/ and may contain important
information about the medicine and its use of which you should
be aware.
All medicines have risks and benefits. Your doctor will have
weighed the risks of you taking ROSUVASTATIN RBX 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 RBX IS USED FOR
ROSUVASTATIN RBX is used to lower high cholesterol levels. Even
though you may have normal cholesterol, ROSUVASTATIN RBX 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 woman 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 RBX 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.
ROSUVASTATIN TABLETS
CMI V6 Sept 2018
Page 1 of 10
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 �

Summary of Product characteristics

ROSUVASTATIN RBX V8 Dec 2018
1
AUSTRALIAN PRODUCT INFORMATION
ROSUVASTATIN RBX (ROSUVASTATIN CALCIUM) TABLETS
1
NAME OF THE MEDICINE
Rosuvastatin calcium
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
ROSUVASTATIN RBX tablets contain 5 mg, 10 mg, 20 mg or 40 mg of
rosuvastatin (as calcium).
Rosuvastatin calcium is an amorphous solid, which is slightly soluble
in water (7.8 mg/mL at
37°C) and slightly soluble in methanol and ethanol. It has a pKa of
4.6. Rosuvastatin calcium is
the (3R, 5S, 6E) enantiomer.
The formulation contains lactose and sugars. For the full list of
excipients, see Section
6.1
L
IST
OF EXCIPIENTS
.
3
PHARMACEUTICAL FORM
ROSUVASTATIN RBX tablets are presented in the following strengths:
ROSUVASTATIN RBX 5 mg are light yellow to yellow, round, film-coated
tablets with ‘RT 1’
debossed on one side and plain on other side.
ROSUVASTATIN RBX 10 mg are light pink to pink, round, film-coated
tablets with ‘RT 2’
debossed on one side and plain on other side.
ROSUVASTATIN RBX 20 mg are light pink to pink, round, film-coated
tablets with ‘RT 3’
debossed on one side and plain on other side.
ROSUVASTATIN RBX 40 mg are light pink to pink, oval, film-coated
tablets with ‘RT 4’ debossed
on one side and plain on other side.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
ROSUVASTATIN RBX should be used as an adjunct to diet when the
response to diet and
exercise is inadequate.
PREVENTION OF CARDIOVASCULAR EVENTS
ROSUVASTATIN RBX 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 RBX is
indicated to:
• Reduce the risk of nonfatal myocardial infarction
ROSUVASTATIN RBX V8 Dec 2018
2
• Reduce the risk of nonfatal stroke
• Reduce the risk of coronary artery revascularisation procedures.
IN PATIENTS WITH HYPE