Crestor

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Rosuvastatin calcium 10.4mg equivalent to rosuvastatin 10mg;  

Available from:

A. Menarini New Zealand Pty Ltd

INN (International Name):

Rosuvastatin calcium 10.4 mg (equivalent to 10 mg rosuvastatin)

Dosage:

10 mg

Pharmaceutical form:

Film coated tablet

Composition:

Active: Rosuvastatin calcium 10.4mg equivalent to rosuvastatin 10mg   Excipient: Calcium phosphate Crospovidone Hypromellose Iron oxide red Lactose monohydrate   Magnesium stearate Microcrystalline cellulose Purified water Titanium dioxide Triacetin

Units in package:

Blister pack, Al/Al foil sample pack, 7 tablets

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

Avara Avlon Pharma Services Ltd

Therapeutic indications:

CRESTOR should be used as an adjunct to diet when the response to diet and exercise is inadequate. Prevention of Major Cardiovascular events In adult patients without documented history of cardiovascular or cerebrovascular events, but with at least two conventional risk factors for cardiovascular disease, (see Clinical Efficacy) CRESTOR is indicated to: Reduce the risk of nonfatal myocardial infarction Reduce the risk of nonfatal stroke Reduce the risk of coronary artery revascularisation

Product summary:

Package - Contents - Shelf Life: Blister pack, Al/Al foil sample pack - 7 tablets - 36 months from date of manufacture stored at or below 30°C - Blister pack, Al/Al foil - 14 tablets - 36 months from date of manufacture stored at or below 30°C - Blister pack, Al/Al foil - 28 tablets - 36 months from date of manufacture stored at or below 30°C - Blister pack, Al/Al foil - 30 tablets - 36 months from date of manufacture stored at or below 30°C - Blister pack, Al/Al foil - 42 tablets - 36 months from date of manufacture stored at or below 30°C - Blister pack, Al/Al foil - 98 tablets - 36 months from date of manufacture stored at or below 30°C - Bottle, plastic, HDPE - 30 tablets - 36 months from date of manufacture stored at or below 30°C

Authorization date:

2001-08-16

Patient Information leaflet

Crestor 5, 10, 20 and 40 mg Tablets
Copyright
1(6)
CRESTOR®
ROSUVASTATIN 5 MG, 10 MG, 20 MG OR 40 MG TABLETS
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some of the common questions people ask about
CRESTOR. It does not contain all
the information that is known about CRESTOR.
It does not take the place of talking to your doctor or pharmacist.
All medicines have risks and benefits. Your doctor will have weighed
the risks of you taking CRESTOR
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 CRESTOR IS USED FOR
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 essential for
building cells, making bile acids (which help to digest food) 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 of “good”
cholesterol and may increase the risk of
heart disease.
CRESTOR belongs to a group of medicines known as HMG-CoA reductase
inhibitors (also known as
‘statins’). It lowers the “bad” cholesterol, and raises the
“good” cholesterol when exercise and
changes to diet are not enough on their own. It also lowers the risk
of heart attacks and strokes.
Cholesterol is present in many foods and is also made by your body.
While you are taking CRESTOR,
you should reduce saturated fats, trans fats and cholesterol in your
diet, control your weight and
exercise regularly.
High cholesterol is also more likely to occur with certain diseases or
if you have a family history

Summary of Product characteristics

Crestor
®
Data Sheet
1
NEW ZEALAND DATA SHEET
1.
PRODUCT NAME
C
RESTOR
®
5
mg film-coated tablets
C
RESTOR
®
10
mg film-coated tablets
C
RESTOR
®
20
mg film-coated tablets
C
RESTOR
®
40
mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 5 mg, 10 mg, 20 mg or 40 mg of rosuvastatin as
rosuvastatin
calcium.
3.
PHARMACEUTICAL FORM
Film Coated Tablet
C
RESTOR 5 MG: A yellow, film-coated, round, biconvex, 7 mm tablet, impressed
with
“ZD4522 5”.
C
RESTOR 10 MG: A pink, film-coated, round, biconvex, 7 mm tablet, impressed
with
“ZD4522 10”.
C
RESTOR
20 MG: A pink, film-coated, round, biconvex, 9 mm tablet, impressed
with
“ZD4522 20”.
C
RESTOR 40 MG: A pink, film-coated, oval, biconvex, 11.4 x 6.9 mm tablet
impressed
with “ZD4522” on one side and “40” on the other side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
C
RESTOR
should be used as an adjunct to diet when the response to diet and
exercise is inadequate.
PREVENTION OF MAJOR CARDIOVASCULAR EVENTS
In adult patients without documented history of cardiovascular or
cerebrovascular
events, but with at least two conventional risk factors for
cardiovascular disease, (see
section 5.1 Clinical Efficacy and Safety) C
RESTOR
is indicated to:
•
Reduce the risk of nonfatal myocardial infarction
•
Reduce the risk of nonfatal stroke
•
Reduce the risk of coronary artery revascularisation
HYPERCHOLESTEROLAEMIA
C
RESTOR
is indicated to:
•
Reduce elevated LDL-C, total cholesterol, triglycerides and to
increase HDL-
cholesterol in patients with primary hypercholesterolaemia
(heterozygous
familial and non familial) and mixed dyslipidaemia (Fredrickson Types
IIa
and IIb). C
RESTOR
also lowers ApoB, nonHDL-C, VLDL-C, VLDL-TG, the
LDL-C/HDL-C, total C/HDL-C, nonHDL-C/HDL-C, ApoB/ApoA-I ratios and
Crestor
®
Data Sheet
2
increases ApoA-I in these populations.
•
Treat isolated hypertriglyceridaemia (Fredrickson Type IV
hyperlipidaemia).
•
Reduce total cholesterol and LDL-C in patients with homozygous
familial
hy