TROVAS atorvastatin (as calcium trihydrate) 40 mg tablets blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

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Patient Information leaflet (PIL)

24-08-2020

Summary of Product characteristics (SPC)

24-08-2020

Public Assessment Report (PAR)

28-11-2017

Active ingredient:

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

Available from:

Sun Pharma ANZ Pty Ltd

INN (International Name):

atorvastatin calcium trihydrate

Pharmaceutical form:

Tablet, film coated

Composition:

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

Administration route:

Oral

Units in package:

30, 6

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: Blister Pack; Container Material: PA/Al/PVC/Al - polyamide-aluminium foil-polyvinylchloride/aluminium foil; Container Life Time: 48 Months; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2011-09-23

Patient Information leaflet

TROVAS
1
TROVAS
_Atorvastatin Calcium 10/20/40/80 mg Tablets _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about TROVAS.
It does not contain all the available
information.
It does not take the place of talking to
your doctor or pharmacist.
This leaflet was last updated on the
date at the end of this leaflet. More
recent information may be available.
The latest Consumer Medicine
Information is available from
https://www.ebs.tga.gov.au/ and may
contain important information about
the medicine and its use of which
you should be aware.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking TROVAS
against the benefits it is expected to
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 TROVAS IS USED
FOR
TROVAS is used to lower high
cholesterol levels in your blood.
TROVAS also helps reduce the risk
of having a heart attack or stroke in
people who have high blood pressure
and coronary heart disease (CHD) or
who have multiple risk factors for
CHD, including diabetes, a history of
stroke, or small blood vessel disease.
Cholesterol is a type of blood fat
needed by the body for many things,
such as building 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 its level
may become too high.
High cholesterol is more likely to
occur with certain diseases or if you
have a family history of high
cholesterol.
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 of the body where it is
needed. Over time, this can form
hard patches called plaque on the
walls of your blood vessels, m

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Summary of Product characteristics

TROVAS PI V10
Page 1 of 20
AUSTRALIAN PRODUCT INFORMATION
TROVAS
Atorvastatin calcium 10, 20, 40 and 80 mg Tablets
1 NAME OF THE MEDICINE
Atorvastatin calcium
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
TROVAS 10 mg tablet contain atorvastatin calcium equivalent to 10 mg
atorvastatin
TROVAS 20 mg tablet contain atorvastatin calcium equivalent to 20 mg
atorvastatin
TROVAS 40 mg tablet contain atorvastatin calcium equivalent to 40 mg
atorvastatin
TROVAS 80 mg tablet contain atorvastatin calcium equivalent to 80 mg
atorvastatin
Excipients with known effects: lactose monohydrate (the 10 mg, 20 mg,
40 mg and 80 mg
contains lactose monohydrate).
For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS.
3 PHARMACEUTICAL FORM
TROVAS 10 mg tablets are white to off-white, elliptical, film-coated
tablets debossed
‘AS10’ on one side and plain on the other side.
TROVAS 20 mg tablets are white to off-white, elliptical, film-coated
tablets debossed
‘AS20’ on one side and plain on the other side.
TROVAS 40 mg tablets are white to off-white, elliptical, film-coated
tablets debossed
‘AS40’ on one side and plain on the other side.
TROVAS 80 mg tablets are 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
TROVAS
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.
TROVAS 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,
TROVAS PI V10
Page 2 of 20
peripheral
vascular
disease
or
existing
asymptomatic
CHD
(see
Section
5.1
PHARMACOLOGICAL PROPERTIES, CLINICAL T

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