CRESTOR rosuvastatin (as calcium) 20mg tablet blister pack

Land: Australien

Sprog: engelsk

Kilde: Department of Health (Therapeutic Goods Administration)

Aktiv bestanddel:

rosuvastatin calcium, Quantity: 20.8 mg

Tilgængelig fra:

A Menarini Australia Pty Ltd

INN (International Name):

Rosuvastatin calcium

Lægemiddelform:

Tablet, film coated

Sammensætning:

Excipient Ingredients: iron oxide red; lactose monohydrate; magnesium stearate; triacetin; hypromellose; calcium phosphate; crospovidone; titanium dioxide; microcrystalline cellulose

Indgivelsesvej:

Oral

Enheder i pakken:

7 tablets blister foil packs, 30 tablets blister foil packs

Recept type:

(S4) Prescription Only Medicine

Terapeutiske indikationer:

CRESTOR should be used as an adjunct to diet when the response to diet and exercise is inadequate.,Prevention of Cardiovascular Events,CRESTOR 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).,CRESTOR 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: CRESTOR is indicated for the treatment of hypercholesterolaemia (including familial hypercholesterolaemia). Prior to initiating therapy with CRESTOR , 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.

Produkt oversigt:

Visual Identification: A pink, round, film-coated, biconvex tablet impressed with "ZD4522 20" on one side.; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius

Autorisation status:

Licence status A

Autorisation dato:

2006-04-26

Indlægsseddel

CRESTOR
®
C
R
E
S
T
O
R
®
CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
1.
WHY AM I TAKING CRESTOR?
CRESTOR contains the active ingredient rosuvastatin calcium. CRESTOR
is used to lower high cholesterol levels. Even though
you may have normal cholesterol, CRESTOR can also be used to reduce
the risk of you having a stroke or heart attack. For more
information, see Section 1. Why am I taking CRESTOR? in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I TAKE CRESTOR?
Do not take if you have ever had an allergic reaction to CRESTOR or
any of the ingredients listed at the end of the CMI, or if you
become pregnant while you are taking CRESTOR. TALK TO YOUR DOCTOR IF
YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY
OTHER MEDICINES, ARE PREGNANT, PLAN TO BECOME PREGNANT OR ARE
BREASTFEEDING. For more information, see Section 2. What
should I know before I take CRESTOR? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with CRESTOR and affect how it works. A
list of these medicines is in Section 3. What if I am taking
other medicines? in the full CMI.
4.
HOW DO I TAKE CRESTOR?
•
The usual dose is 5 mg to 20 mg taken once daily, but some patients
may need to increase this to 40 mg once daily. Your
doctor will monitor your cholesterol and triglyceride levels during
your treatment and, if needed, may increase your dose.
•
Swallow each tablet whole with a drink of water. You can take your
tablet at any time of the day, with or without food.
More instructions can be found in Section 4. How do I take CRESTOR? in
the full CMI.
5.
WHAT SHOULD I KNOW WHILE TAKING CRESTOR?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist you visit that you are taking
CRESTOR.
•
Have your blood cholesterol and triglycerides checked when your doctor
says so to make sure
CRESTOR is working.
•
Stop taking CRESTOR and seek medical attention immediately if you
experience a

Produktets egenskaber

CRESTOR PI vA06-0
Page 1 of 24
AUSTRLIAN PRODUCT INFORMATION
CRESTOR
® (ROSUVASTATIN CALCIUM) FILM-COATED TABLETS
1
NAME OF THE MEDICINE
Rosuvastatin calcium.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet of CRESTOR contains 5 mg, 10 mg, 20 mg and 40
mg of rosuvastatin (as
calcium).
Excipient with known effect: Sugars (as lactose).
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
CRESTOR 5 mg are yellow, round, film-coated, biconvex tablets
impressed with “ZD4522 5” on
one side.
CRESTOR 10 mg are pink‚ round, film-coated, biconvex tablets
impressed with “ZD4522 10” on
one side.
CRESTOR 20 mg are pink, round ‚ film-coated, biconvex tablets
impressed with “ZD4522 20” on
one side.
CRESTOR 40 mg are pink‚ oval, film-coated, biconvex tablets,
impressed with “ZD4522” on one
side and “40” on the other side.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
CRESTOR should be used as an adjunct to diet when the response to diet
and exercise is
inadequate.
PREVENTION OF CARDIOVASCULAR EVENTS
CRESTOR 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). CRESTOR 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
CRESTOR
is
indicated
for
the
treatment
of
hypercholesterolaemia
(including
familial
hypercholesterolaemia).
CRESTOR PI vA06-0
Page 2 of 24
Prior to initiating therapy with CRESTOR, secondary causes of
hypercholesterolaemia (e.g. poorly
controlled diabetes mellitus, hypothyroidism, nephrotic syndrome,
dysproteinaemias, obstructive
liver disease, other drug therapy, alcoholism) should be identified