ROSUVASTATIN PCOR rosuvastatin (as calcium) 20 mg film-coated tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

rosuvastatin calcium, Quantity: 20.8 mg

Available from:

Pharmacor Pty Ltd

Pharmaceutical form:

Tablet, film coated

Composition:

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

Administration route:

Oral

Units in package:

10, 30

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

ROSUVASTATIN PCOR should be used as an adjunct to diet when the response to diet and exercise is inadequate.,Prevention of cardiovascular events ROSUVASTATIN PCOR 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 PCOR 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 PCOR is indicated for the treatment of hypercholesterolaemia (including familial hypercholesterolaemia). Prior to initiating therapy with ROSUVASTATIN PCOR, 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: Pink color, circular, biconvex, film coated tablets debossed with R on one side and 20 on the other side.; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Registered

Authorization date:

2022-05-23

Patient Information leaflet

ROSUVASTATIN PCOR
1
ROSUVASTATIN PCOR
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 USING ROSUVASTATIN PCOR?
ROSUVASTATIN PCOR film-coated tablets contains the active ingredient
Rosuvastatin calcium. ROSUVASTATIN PCOR is used to
lower high cholesterol levels.
For more information, see Section 1. Why am I using ROSUVASTATIN PCOR?
in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE ROSUVASTATIN PCOR?
Do not use if you have ever had an allergic reaction to ROSUVASTATIN
PCOR or any of the ingredients listed at the end of the
CMI.
TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY
OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME
PREGNANT OR ARE BREASTFEEDING.
For more information, see Section 2. What should I know before I use
ROSUVASTATIN PCOR?
in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with ROSUVASTATIN PCOR 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 USE ROSUVASTATIN PCOR?
•
The dose of ROSUVASTATIN PCOR is related to body weight for all
patients. Your doctor will calculate the dose you need
and tell you how many tablets to take each day.
•
Take ROSUVASTATIN PCOR once a day, every day, at about the same time
each day with some water.
More instructions can be found in Section 4. How do I use ROSUVASTATIN
PCOR? in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING ROSUVASTATIN PCOR?
THINGS YOU SHOULD
DO
•
Remind any doctor, dentist or pharmacist you visit that you are using
ROSUVASTATIN PCOR.
•
Keep all of your doctor's appointments so that your progress can be
checked. Your doctor will do
regular tests (blood, urine or Magnetic Resonance Imaging (MRI)) to
make sure the medicine is
working and to prevent unwanted side effects. Your doctor will also
use these tests to decide when
you should stop taking ROSUVASTATIN PCOR.
TH

Summary of Product characteristics

AUSTRALIAN PRODUCT INFORMATION
ROSUVASTATIN PCOR (ROSUVASTATIN CALCIUM)
1.
NAME OF THE MEDICINE
Rosuvastatin calcium
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each
film-coated
tablet
of
ROSUVASTATIN
PCOR
contains
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
ROSUVASTATIN PCOR 10 mg are pink color, circular, biconvex, film
coated tablets debossed with
“R” on one side and “10” on the other side.
ROSUVASTATIN PCOR 20 mg are pink color, circular, biconvex, film
coated tablets debossed with
“R” on one side and “20” on the other side.
ROSUVASTATIN PCOR 40 mg are pink color, oval shape, biconvex, film
coated tablets debossed
with “R” on one side and “40” on the other side
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
ROSUVASTATIN PCOR should be used as an adjunct to diet when the
response to diet and exercise
is inadequate.
Prevention of cardiovascular events ROSUVASTATIN PCOR 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 PCOR 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 PCOR is indicated for the treatment of
hypercholesterolaemia (including familial
hypercholesterolaemia).
Prior to initiating therapy with ROSUVASTATIN PCOR, 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.
4.2.
DOSE AND METHOD