APO-ROSUVASTATIN 20 mg rosuvastatin calcium 20 mg tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

rosuvastatin calcium

Available from:

Apotex Pty Ltd

INN (International Name):

Rosuvastatin calcium

Authorization status:

Registered

Patient Information leaflet

APO-ROSUVASTATIN
_5 MG/ 10 MG/ 20 MG/ 40 MG_
_Contains the active ingredient rosuvastatin calcium_
CONSUMER MEDICINE INFORMATION
_FOR A COPY OF A LARGE PRINT LEAFLET PH: 1800 195 055_
WHAT IS IN THIS LEAFLET
READ THIS LEAFLET CAREFULLY BEFORE
TAKING YOUR MEDICINE.
This leaflet answers some common
questions about rosuvastatin. It does
not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
The information in this leaflet was
last updated on the date listed on the
last page. More recent information on
this medicine may be available.
ASK YOUR DOCTOR OR PHARMACIST:
•
if there is anything you do not
understand in this leaflet,
•
if you are worried about taking
your medicine, or
•
to obtain the most up-to-date
information.
You can also download the most up
to date leaflet from
www.apotex.com.au.
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.
Pharmaceutical companies cannot
give you medical advice or an
individual diagnosis.
Keep this leaflet with your medicine.
You may need to read it again.
WHAT THIS MEDICINE IS
USED FOR
The name of your medicine is APO-
Rosuvastatin. It contains the active
ingredient rosuvastatin (as
rosuvastatin calcium).
This medicine is used to lower high
cholesterol levels.
Even though you may have normal
cholesterol, this medicine can also be
used to reduce the risk of you having
a stroke or heart attack if you are a
man 50 or more years old or a
woman 60 or more years old and
have at least 2 risk factors for having
a heart attack or stroke. Risk factors
include: high blood pressure, low
levels of good cholesterol (HDL),
smoking or a family history of
premature coronary heart disease.
Your doctor may also do a blood test
to measure a substance called C
Reactive Protein to help decide if you
should be given this medicine for this
use.
_CHOLESTEROL AND_
_TRIGLYCERIDES_
Everyone has cholesterol and
triglycerides in their blood. The

Summary of Product characteristics

1
AUSTRALIAN PRODUCT INFORMATION –
APO-ROSUVASTATIN
(ROSUVASTATIN)
1
NAME OF THE MEDICINE
Rosuvastatin calcium.
2
AND 3 QUALITATIVE AND QUANTITATIVE COMPOSITION AND
PHARMACEUTICAL FORM
Each tablet contains 5 mg, 10 mg, 20 mg or 40 mg rosuvastatin calcium,
as the active ingredient. In
addition, each tablet contains the following inactive ingredients:
lactose, cellulose-microcrystalline,
crospovidone,
magnesium
stearate,
colloidal
anhydrous
silica,
hypromellose,
hydroxypropylcellulose, macrogol 8000.
5 MG TABLETS
White, round, biconvex, film coated tablet, engraved “APO” on one
side, “ROS” over “5” on the other
side.
10 MG TABLETS
White, round, biconvex, film-coated tablet, engraved “APO” on one
side, “ROS” over “10” on the
other side.
20 MG TABLETS
White, round, biconvex, film-coated tablet, engraved “APO” on one
side, “ROS” over “20” on the
other side.
40 MG TABLETS
White, oval, biconvex, film-coated tablet, engraved “APO” on one
side, “ROS40” on the other side.
Not all strengths, pack types and/or pack sizes may be available.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Rosuvastatin should be used as an adjunct to diet when the response to
diet and exercise is
inadequate.
PREVENTION OF CARDIOVASCULAR EVENTS
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 for cardiovascular disease (hypertension,
low HDL-C, smoking, or a family
history of premature coronary heart disease).
Rosuvastatin is indicated to:
•
Reduce the risk of nonfatal myocardial infarction
2
•
Reduce the risk of nonfatal stroke
•
Reduce the risk of coronary artery revascularisation procedures.
IN PATIENTS WITH HYPERCHOLESTEROLAEMIA
Rosuvastatin
is
indicated
for
the
treatment
of
hypercholesterolaemia
(including
familial
hypercholesterolaemia).
Prior to initiating therapy with Rosuvastatin, secondary causes of
hypercholester