ROSUVASTATIN SANDOZ rosuvastatin (as calcium) 40 mg film-coated tablets blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

rosuvastatin calcium, Quantity: 41.583 mg

Available from:

Sandoz Pty Ltd

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: macrogol 6000; mannitol; purified talc; colloidal anhydrous silica; sodium stearylfumarate; microcrystalline cellulose; silicon dioxide; lactose; hypromellose; maize starch; titanium dioxide; iron oxide yellow; iron oxide red

Administration route:

Oral

Units in package:

30 tablets

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Rosuvastatin Sandoz should be used as an adjunct to diet when the response to diet and exercise is inadequate.,Prevention of Cardiovascular Events,Rosuvastatin Sandoz is indicated for prevention of major cardiovascular events in men greater than equal to 50 years old and women greater than 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 Sandoz 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 Sandoz is indicated for the treatment of hypercholesterolaemia (excluding heterozygous familial hypercholesterolaemia).,Prior to initiating therapy with Rosuvastatin Sandoz, 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: Brown, round, film coated tablets with "RSV 40" debossed on one side.; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Registered

Authorization date:

2019-02-26

Patient Information leaflet

ROSUVASTATIN SANDOZ
®
1
ROSUVASTATIN SANDOZ
®
_Rosuvastatin calcium film coated tablet _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS
LEAFLET
This leaflet answers some common
questions about Rosuvastatin Sandoz.
It does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking this medicine
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
SANDOZ IS USED
FOR
This medicine is used to:
•
Lower high blood cholesterol
levels (hypercholesterolaemia).
•
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.
It contains the active ingredient
rosuvastatin calcium.
Rosuvastatin calcium belongs to a
group of medicines called HMG-
CoA reductase inhibitors (also
known as 'statins').
Everyone has cholesterol and
triglycerides in their blood. They are
fatty substances needed by the body
for many things.
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 of "good" cholesterol and
may increase the risk of heart
disease.
Rosuvastatin Sandoz works by
reducing the level of "bad"
cholesterol, and raises the "good"
cholesterol when exercise and
changes to diet are not enough on
their own. Cholesterol is present in
many foods and is also made by your
bod

Summary of Product characteristics

190226-Rosuvastatin Sandoz-pi
Page 1 of 28
AUSTRALIAN PRODUCT INFORMATION
ROSUVASTATIN SANDOZ
®
TABLETS (ROSUVASTATIN CALCIUM)
1.
NAME OF THE MEDICINE
Rosuvastatin, as rosuvastatin calcium.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Rosuvastatin Sandoz 5 mg tablets contain 5 mg rosuvastatin (as
calcium).
Rosuvastatin Sandoz 10 mg tablets contain 10 mg rosuvastatin (as
calcium).
Rosuvastatin Sandoz 20 mg tablets contain 20 mg rosuvastatin (as
calcium).
Rosuvastatin Sandoz 40 mg tablets contain 40 mg rosuvastatin (as
calcium).
Rosuvastatin calcium is an amorphous solid, which is slightly soluble
in water (7.8 mg/mL at
37 °C), methanol, and ethanol, and has a pK
a
of 4.6. Rosuvastatin calcium is the (3
_R_
,5
_S_
,6
_E_
)
enantiomer.
For the full list of excipients, see Section 6.1 List of excipients.
3.
PHARMACEUTICAL FORM
Rosuvastatin Sandoz 5 mg Tablets – Brown, round, film coated
tablets.
Rosuvastatin Sandoz 10 mg Tablets – Brown, round, film coated
tablets with “RSV 10”
debossed on one side.
Rosuvastatin Sandoz 20 mg Tablets – Brown, round, film coated
tablets with “RSV 20”
debossed on one side.
Rosuvastatin Sandoz 40 mg Tablets – Brown, round, film coated
tablets with “RSV 40”
debossed on one side.
4.
CLINICAL PARTICULARS
4.1.
T
HERAPEUTIC INDICATIONS
Rosuvastatin Sandoz is indicated as an adjunct to diet when the
response to diet and exercise
is inadequate.
_PREVENTION OF CARDIOVASCULAR EVENTS _
Rosuvastatin Sandoz 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 Sandoz 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