APO-ATORVASTATIN atorvastatin (as calcium propylene glycol solvate) 80 mg film-coated tablet blister pack

Maa: Australia

Kieli: englanti

Lähde: Department of Health (Therapeutic Goods Administration)

Aktiivinen ainesosa:

atorvastatin calcium propylene glycol solvate

Saatavilla:

Apotex Pty Ltd

INN (Kansainvälinen yleisnimi):

Atorvastatin calcium propylene glycol solvate

Valtuutuksen tilan:

Registered

Pakkausseloste

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 common
questions about APO-Atorvastatin. It
does not contain all 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 they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE 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 lowers high cholesterol
levels.
It is also used in people who have
high blood pressure and coronary
heart disease (CHD) or who are at
risk of CHD (for example, if they
have diabetes, a history of stroke, or
small blood vessel disease). In these
people, this medicine is used to
reduce the risk of having a heart
attack or stroke.
_WHAT IS CHOLESTEROL?_
Everyone has cholesterol in their
blood. It is a type of fat needed by
the body for many things, such as
building cell walls, 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 take 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 is the 'bad'
cholesterol that can block your blood
vessels. HDL 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 ins

Valmisteyhteenveto

1
AUSTRALIAN PRODUCT INFORMATION
APO-ATORVASTATIN TABLET
(ATORVASTATIN CALCIUM)
1
NAME OF THE MEDICINE
Atorvastatin Calcium
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
APO-Atorvastatin 10 mg tablet contains atorvastatin calcium equivalent
to 10 mg atorvastatin
APO-Atorvastatin 20 mg tablet contains atorvastatin calcium equivalent
to 20 mg atorvastatin
APO-Atorvastatin 40 mg tablet contains atorvastatin calcium equivalent
to 40 mg atorvastatin
APO-Atorvastatin 80 mg tablet contains atorvastatin calcium equivalent
to 80 mg atorvastatin
Excipient with known effects: Each tablet contains 32.805 mg of
lactose monohydrate.
For the full list of excipients, see Section 6.1 list of excipients.
3
PHARMACEUTICAL FORM
Tablet.
10 mg: White to off-white, elliptical, film-coated tablet debossed
‘AS10’ on one side and plain on
the other side.
20 mg: White to off-white, elliptical, film-coated tablet debossed
‘AS20’ on one side and plain on
the other side.
40 mg: White to off-white, elliptical, film-coated tablet debossed
‘AS40’ on one side and plain on
the other side.
60 mg: White to off-white, elliptical, film-coated tablet debossed
‘AS60’ on one side and plain on
the other side.
80 mg: White to off-white, elliptical, film-coated tablet 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.
2
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
5.1
PHARMACODYNAMIC
PROPERTIES
-
CL