APO-ATORVASTATIN atorvastatin (as calcium trihydrate) 40 mg tablets bottle

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

atorvastatin calcium trihydrate, Quantity: 43.38 mg (Equivalent: atorvastatin, Qty 40 mg)

Available from:

Arrotex Pharmaceuticals Pty Ltd

INN (International Name):

atorvastatin calcium trihydrate

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: calcium carbonate; microcrystalline cellulose; hyprolose; croscarmellose sodium; polysorbate 80; magnesium stearate; lactose monohydrate; Candelilla Wax; titanium dioxide; macrogol 8000; hypromellose; purified talc; purified water; sodium chloride; dimeticone 100; benzoic acid; sorbic acid; methylcellulose; polysorbate 65; glyceryl distearate; silicon dioxide; dimeticonol; PEG-4 stearate

Administration route:

Oral

Units in package:

100

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

As an adjunct to diet for the treatment of patients with hypercholesterolaemia. Prior to initiating therapy with atorvastatin, secondary causes of hypercholesterolaemia (e.g. poorly controlled diabetes mellitus, hypothyroidism, nephrotic syndrome, dysproteinaemias, obstructive liver disease, other drug therapy and alcoholism) should be identified and treated.,Indicated in hypertensive patients with multiple risk factors for coronary heart disease (CHD), which may include diabetes, history of stroke or other cerebrovascular disease, peripheral vascular disease or existing asymptomatic CHD (see CLINICAL TRIALS, Prevention of Cardiovascular Disease) to reduce the risk of non-fatal myocardial infarction and non-fatal stroke. These effects do not replace the need to independently control known causes of cardiovascular mortality and morbidity such as hypertension, diabetes and smoking.

Product summary:

Visual Identification: White to off-white, elliptical, film-coated tablets debossed 'AS40' on one side and plain on the other side.; Container Type: Bottle; Container Material: HDPE; Container Life Time: 48 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure

Authorization status:

Licence status A

Authorization date:

2011-09-23

Patient Information leaflet

APO-ATORVASTATIN
1
APO-ATORVASTATIN
_Atorvastatin calcium trihydrate _
CONSUMER MEDICINE INFORMATION
_FOR A COPY OF A LARGE PRINT LEAFLET, PH: 1800 195 055 _
WHAT IS IN THIS LEAFLET
This leaflet answers some of the
more common questions about APO-
Atorvastatin. It does not contain all
of the available information. It does
not take the place of talking to your
doctor or pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking this medicine
against the benefits he/she expects it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
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-
Atorvastatin. It contains the active
ingredient atorvastatin.
Atorvastatin is used to lower high
cholesterol levels.
It is also used to help reduce the risk
of having a heart attack or stroke in
people who have high blood pressure
and coronary heart disease (CHD).
Examples of risk factors for CHD
include diabetes, a history of stroke,
or small blood vessel disease.
_WHAT IS CHOLESTEROL? _
Everyone has cholesterol in their
blood. It is a type of blood fat needed
by the body for many things, such as
building the cell lining, making bile
acids (which help to digest food) and
some hormones. However, too much
cholesterol can be a problem.
Cholesterol is present in many foods
and is also made in your body by the
liver. If your body makes too much
cholesterol or you have too much
cholesterol in your diet, then your
level becomes too high.
High cholesterol is more likely to
occur with certain diseases or if you
have a family history of high
cholesterol.
There are different types of
cholesterol. LDL, or low-density
lipoprotein, is the 'bad' cholesterol
that can block your blood vessels.
HDL, or high density lipoprotein,
cholesterol is the 'good' cholesterol
that is thought to remove the bad
cholesterol from the blood vessels.
When you have high levels of 'bad'
cholesterol in

Summary of Product characteristics

1
AUSTRALIAN PRODUCT INFORMATION –
APO-ATORVASTATIN (ATORVASTATIN CALCIUM
TRIHYDRATE) TABLETS
1
NAME OF THE MEDICINE
Atorvastatin as calcium trihydrate.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains atorvastatin calcium trihydrate equivalent to 10
mg, 20 mg, 40 mg and
80 mg atorvastatin.
EXCIPIENTS WITH KNOWN EFFECT
Contains sugars as lactose monohydrate.
For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
10 MG TABLETS
White to off-white, elliptical, film-coated tablets debossed
‘AS10’ on one side and plain on the
other side.
20 MG TABLETS
White to off-white, elliptical, film-coated tablets debossed
‘AS20’ on one side and plain on the
other side.
40 MG TABLETS
White to off-white, elliptical, film-coated tablets debossed
‘AS40’ on one side and plain on the
other side.
80 MG TABLETS
White to off-white, elliptical, film-coated tablets debossed
‘AS80’ on one side and plain on the
other side.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Atorvastatin
is
indicated
as
an
adjunct
to
diet
for
the
treatment
of
patients
with
hypercholesterolaemia.
Prior to initiating therapy with atorvastatin, secondary causes of
hypercholesterolaemia (e.g.
poorly controlled diabetes mellitus, hypothyroidism, nephrotic
syndrome, dysproteinaemias,
obstructive liver disease, other drug therapy, and alcoholism) should
be identified and treated.
Atorvastatin is indicated in hypertensive patients with multiple risk
factors for coronary heart
disease (CHD) which may include diabetes, history of stroke or other
cerebrovascular disease,
peripheral
vascular
disease
or
existing
asymptomatic
CHD
(see
SECTION
5.1
PHARMACODYNAMIC
PROPERTIES
-
CLINICAL
TRIALS,
PREVENTION
OF
CARDIOVASCULAR
DISEASE) to reduce the risk of non-fatal myocardial infarction and
non-fatal stroke.
2
These
effects
do
not
replace
the
need
to
independently
control
known
causes
of
cardiovascular (CV) mortality and morbidity such as hypertension,
diabetes and smoking.
4.2
DOSE AND METHOD OF ADMINISTRATION