AKM-ATORVASTATIN atorvastatin (as calcium trihydrate) 40 mg film-coated tablet blister pack

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:

Pharmacor Pty Ltd

INN (International Name):

atorvastatin calcium trihydrate

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: hyprolose; lactose monohydrate; calcium carbonate; croscarmellose sodium; magnesium stearate; polysorbate 80; microcrystalline cellulose; titanium dioxide; macrogol 8000; hypromellose; purified talc

Administration route:

Oral

Units in package:

10's, 30's

Prescription type:

(S4) Prescription Only Medicine

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, 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 elliptical shaped, film coated tablets, debossed with "40" on one side and 'ATS' on other side.; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Licence status A

Authorization date:

2017-09-11

Patient Information leaflet

AKM-ATORVASTATIN (Version-04) Page 1 of 5
AKM-ATORVASTATIN
_ _
_Atorvastatin (as calcium trihydrate)_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some of the
more common questions about
AKM-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
AKM-
Atorvastatin
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 AKM-ATORVASTATIN
IS USED FOR
AKM-Atorvastatin is used to lower
high cholesterol levels.
AKM-Atorvastatin
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) or who are at
risk of 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
your
blood,
it
may
begin to 'stick' to the inside of your
blood vessels in

Summary of Product characteristics

AKM ATORVASTATIN (Version-06)
Page 1
AUSTRALIAN
PRODUCT
INFORMATION
-
AKM
ATORVASTATIN (ATORVASTATIN (AS CALCIUM TRIHYDRATE))
1.
NAME OF THE MEDICINE
atorvastatin (as calcium trihydrate)
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
AKM ATORVASTATIN 10 MG
– Each tablets contains 10 mg atorvastatin (as calcium
trihydrate)
AKM ATORVASTATIN 20 MG
– Each tablets contains 20 mg atorvastatin (as calcium
trihydrate)
AKM ATORVASTATIN 40 MG
– Each tablets contains 40 mg atorvastatin (as calcium
trihydrate)
AKM ATORVASTATIN 80 MG
– Each tablets contains 80 mg atorvastatin (as calcium
trihydrate)
EXCIPIENTS WITH KNOWN EFFECT
– sugars as lactose monohydrate
For the full list of excipients, see
SECTION 6.1
,
LIST OF EXCIPIENTS
3.
PHARMACEUTICAL FORM
AKM ATORVASTATIN is supplied as White elliptical shaped film coated
tablets, 10, 20, 40
and 80 mg atorvastatin as
atorvastatin
calcium.
Each
tablet is
debossed with
the tablet
strength on one side and ‘ATS’ on the other as follows:
10 mg: debossed ‘10’ on one side and ‘ATS’ on the other.
20 mg: debossed ‘20’ on one side and ‘ATS’ on the other.
40 mg: debossed ‘40’ on one side and ‘ATS’ on the other.
80 mg: debossed ‘80’ on one side and ‘ATS’ on the other.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
AKM 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.
AKM ATORVASTATIN (Version-06)
Page 2
AKM 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,