NOUMED ROSUVASTATIN rosuvastatin (as calcium) 10 mg film-coated tablets blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

rosuvastatin calcium, Quantity: 10.396 mg

Available from:

AVALLON PHARMACEUTICALS PTY LTD

INN (International Name):

Rosuvastatin calcium

Pharmaceutical form:

Tablet, film coated

Composition:

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

Administration route:

Oral

Units in package:

30 tablets

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

NOUMED ROSUVASTATIN is indicated as an adjunct to diet when the response to diet and exercise is inadequate. Prevention of Cardiovascular Events: NOUMED 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). NOUMED 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 NOUMED ROSUVASTATIN is indicated for the treatment of hypercholesterolaemia (excluding familial hypercholesterolaemia). Prior to initiating therapy with NOUMED 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: White to off-white, round, film coated tablets with "RSV 10" 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:

Licence status A

Authorization date:

2017-06-14

Patient Information leaflet

NOUMED ROSUVASTATIN
_Rosuvastatin calcium film coated tablet _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS
LEAFLET
This leaflet answers some common
questions about Noumed
Rosuvastatin.
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.
WHAT NOUMED
ROSUVASTATIN 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.
Noumed Rosuvastatin 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
body. It does not reduce the
cholesterol that comes from fat i

Summary of Product characteristics

_1 _
Product Information
_ _
Noumed Rosuvastatin 5mg, 10mg, 20mg, 40mg Tablets
Mar 2019
Version 03
AUSTRALIAN PRODUCT INFORMATION - NOUMED ROSUVASTATIN
(ROSUVASTATIN)
1.
NAME OF THE MEDICINE
Rosuvastatin, as rosuvastatin calcium.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Noumed Rosuvastatin 5mg tablet contain 5mg rosuvastatin (as calcium).
Noumed Rosuvastatin 10mg tablet contain 10mg rosuvastatin (as
calcium).
Noumed Rosuvastatin 20mg tablet contain 20mg rosuvastatin (as
calcium).
Noumed Rosuvastatin 40mg tablet contain 40mg 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 pKa of 4.6.
Rosuvastatin calcium is
the (3
_R_
,5
_S_
,6
_E_
) enantiomer.
Noumed Rosuvastatin tablets also contain the inactive ingredients
lactose, colloidal
anhydrous silica, microcrystalline cellulose and silicon dioxide,
starch maize, purified
talc, sodium stearylfumarate, hypromellose, mannitol and macrogol
6000.
3.
PHARMACEUTICAL FORM
Noumed Rosuvastatin 5mg Tablets –White to off-white round, film
coated tablets with
“RSV 5” debossed on one side.
Noumed Rosuvastatin 10mg Tablets – White to off-white round, film
coated tablets
with “RSV 10” debossed on one side.
Noumed Rosuvastatin 20mg Tablets - White to off-white round, film
coated tablets
with “RSV 20” debossed on one side.
Noumed Rosuvastatin 40mg Tablets - White to off-white round, film
coated tablets
with “RSV 40” debossed on one side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Noumed Rosuvastatin is indicated as an adjunct to diet when the
response to diet and
exercise is inadequate.
_2 _
Product Information
_ _
Noumed Rosuvastatin 5mg, 10mg, 20mg, 40mg Tablets
Mar 2019
Version 03
Prevention of Cardiovascular Events
Noumed 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 f