ROSUVACOR rosuvastatin (as calcium) 10 mg film-coated tablet bottle pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

rosuvastatin calcium, Quantity: 10.4 mg

Available from:

Pharmacor Pty Ltd

Pharmaceutical form:

Tablet, film coated

Composition:

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

Administration route:

Oral

Units in package:

30, 90

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

ROSUVACOR should be used as an adjunct to diet when the response to diet and exercise is inadequate.,Prevention of cardiovascular events ROSUVACOR 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). ROSUVACOR 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 ROSUVACOR is indicated for the treatment of hypercholesterolaemia (including familial hypercholesterolaemia). Prior to initiating therapy with ROSUVACOR, 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 10 on the other side.; Container Type: Bottle; Container Material: HDPE; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Registered

Authorization date:

2022-05-23

Patient Information leaflet

ROSUVACOR
1
ROSUVACOR
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 ROSUVACOR?
ROSUVACOR film-coated tablets contains the active ingredient
Rosuvastatin calcium. ROSUVACOR is used to lower high
cholesterol levels.
For more information, see Section 1. Why am I using ROSUVACOR?
i
n the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE ROSUVACOR?
Do not use if you have ever had an allergic reaction to ROSUVACOR 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
ROSUVACOR? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with ROSUVACOR and affect how it works.
A list of these medicines is in Section 3. What if I am taking other
medicines? i
n the full CMI.
4.
HOW DO I USE ROSUVACOR?
•
The dose of ROSUVACOR 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 ROSUVACOR 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 ROSUVACOR? i
n the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING ROSUVACOR?
THINGS YOU SHOULD
DO
•
Remind any doctor, dentist or pharmacist you visit that you are using
ROSUVACOR.
•
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 ROSUVACOR.
THINGS YOU SHOULD
NOT DO
•
Do not give this medicine to anyone else, even if their condition
seems similar to yours.
•
Do not use i

Summary of Product characteristics

AUSTRALIAN PRODUCT INFORMATION
ROSUVACOR (ROSUVASTATIN CALCIUM)
1.
NAME OF THE MEDICINE
Rosuvastatin calcium
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet of ROSUVACOR 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
ROSUVACOR 10 mg are pink color, circular, biconvex, film coated
tablets debossed with “R” on
one side and “10” on the other side.
ROSUVACOR 20 mg are pink color, circular, biconvex, film coated
tablets debossed with “R” on
one side and “20” on the other side.
ROSUVACOR 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
ROSUVACOR should be used as an adjunct to diet when the response to
diet and exercise is
inadequate.
Prevention
of
cardiovascular
events
ROSUVACOR
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).
ROSUVACOR 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
ROSUVACOR
is
indicated
for
the
treatment
of
hypercholesterolaemia
(including
familial
hypercholesterolaemia).
Prior to initiating therapy with ROSUVACOR, 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 OF ADMINISTRATION
ROSUVACOR TABLETS ARE AVAILABLE ONLY IN A 10 MG, 20 MG AND 40