TORVASTAT atorvastatin (as calcium) 40mg tablet bottle

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

atorvastatin calcium, Quantity: 41.44 mg (Equivalent: atorvastatin, Qty 40 mg)

Available from:

Medis Pharma Pty Ltd

INN (International Name):

Atorvastatin calcium

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: mannitol; purified talc; methionine; magnesium stearate; crospovidone; microcrystalline cellulose; sodium carbonate; povidone; titanium dioxide; hypromellose; macrogol 6000

Administration route:

Oral

Units in package:

30 tablets

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

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 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 oval biconvex tablet with "40" on one side and "A" on reverse.; Container Type: Bottle; Container Material: HDPE; Container Life Time: 24 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:

2012-05-08

Patient Information leaflet

TORVASTAT CMI 191112
1
TORVASTAT
®
_contains the active ingredient atorvastatin calcium _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some of the
more common questions about
TORVASTAT.
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 benefits and
risks. Your doctor has weighed the
risks of you taking TORVASTAT
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 TORVASTAT IS USED
FOR
TORVASTAT is used to lower high
cholesterol levels.
TORVASTAT can be 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. Some
examples of risk factors for CHD
are 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. Low Density
Lipoprotein (LDL) is the “bad”
cholesterol that can block your
blood vessels. High Density
Lipoprotein (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 instead of
being carried to the parts

Summary of Product characteristics

Torvastat PI Jan 2019
AUSTRALIAN PRODUCT INFORMATION – TORVASTAT® (ATORVASTATIN
CALCIUM)
1.
NAME OF THE MEDICINE
Atorvastatin calcium
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
TORVASTAT tablets contain atorvastatin calcium equivalent to 10, 20,
and 40 mg
atorvastatin. The tablets also contain the following inactive
ingredients: Mannitol,
Microcrystalline cellulose, Crospovidone, Sodium carbonate anhydrous,
Povidone,
Methionine, Magnesium stearate,Talc and Opadry 03F28446 White (ARTG
107577).
3.
PHARMACEUTICAL FORM
TORVASTAT is available in three strengths:
10 mg: white oval biconvex tablet with “10” on one side and
“A” on reverse.
20 mg: white oval biconvex tablet with “20” on one side and
“A” on reverse.
40 mg: white oval biconvex tablet with “40” on one side and
“A” on reverse.
4.
CLINICAL PARTICULARS
4.1
INDICATIONS
TORVASTAT 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.
TORVASTAT 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.
These effects do not replace the need to independently control known
causes of
cardiovascular mortality and morbidity such as hypertension, diabetes
and smoking.
4.2
DOSE AND METHOD OF ADMINISTRATION
TORVASTAT can be administered within the dosage range of 10–80
mg/day as a
single daily dose. TORVASTAT can be taken at any time of the day, with
or without
food. Therapy should b