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

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

atorvastatin calcium, Quantity: 41.36 mg (Equivalent: atorvastatin, Qty 40 mg)

Available from:

Arrotex Pharmaceuticals Pty Ltd

INN (International Name):

Atorvastatin calcium

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: hyprolose; activated attapulgite; magnesium stearate; colloidal anhydrous silica; pregelatinised maize starch; microcrystalline cellulose; titanium dioxide; lactose monohydrate; hypromellose; macrogol 4000

Administration route:

Oral

Units in package:

40, 50, 30, 20, 10

Prescription type:

(S4) Prescription Only Medicine, (S3) Pharmacist 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, oblong bi-convex tablets; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2011-09-16

Patient Information leaflet

Atorvastatin AMNEAL CMI v7.0
- 1 -
ATORVASTATIN AMNEAL
Consumer Medicine Information
Atorvastatin calcium film coated tablets
_ _
WHAT IS IN THIS LEAFLET
This
leaflet
answers
some
of
the
more
common
questions
about
Atorvastatin
AMNEAL.
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 Atorvastatin AMNEAL 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 IS ATORVASTATIN AMNEAL USED FOR
Atorvastatin AMNEAL is used to lower high cholesterol levels.
Atorvastatin AMNEAL 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.
Atorvastatin AMNEAL CMI v7.0
- 2 -
When you have high levels of 'bad' cholesterol in your blood, it may
begin

Summary of Product characteristics

1
AUSTRALIAN PRODUCT INFORMATION – ATORVACHOL
(ATORVASTATIN CALCIUM) FILM COATED TABLETS
1
NAME OF THE MEDICINE
Atorvastatin calcium
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
ATORVACHOL tablets contain atorvastatin calcium equivalent to 10, 20,
40 and 80 mg atorvastatin.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
ATORVACHOL is available as:
10mg white, oval, biconvex, film-coated tablets.
20mg white, oval, biconvex, film-coated tablets with a breakline on
one side.
40mg white, oblong, biconvex, film-coated tablets.
80mg white, oblong, biconvex, film-coated tablets with a breakline on
one side.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
ATORVACHOL 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.
ATORVACHOL 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 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._ _
2
4.2
D
OSE AND METHOD OF ADMINISTRATION
DOSAGE
ATORVACHOL can be administered within the dosage range of 10–80
mg/day as a single daily dose.
Therapy should be individualised according to the target lipid levels,
the recommended goal of
therapy and the patient's response. After initiation and/or upon
titration of ATORVACHOL, lipid
levels should be re-analysed within 4 weeks and dosage adjuste