ATORVASTATIN SZ atorvastatin (as calcium trihydrate) 10 mg tablets blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

atorvastatin calcium trihydrate, Quantity: 10.845 mg (Equivalent: atorvastatin, Qty 10 mg)

Available from:

Sandoz Pty Ltd

INN (International Name):

atorvastatin calcium trihydrate

Pharmaceutical form:

Tablet, film coated

Composition:

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

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 with "AS10" 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

ATORVASTATIN SZ
1
ATORVASTATIN SZ
_atorvastatin calcium trihydrate _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about ATORVASTATIN
SZ.
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
ATORVASTATIN SZ 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 ATORVASTATIN
SZ IS USED FOR
ATORVASTATIN SZ is used to
lower high cholesterol levels in your
blood.
ATORVASTATIN SZ 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 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. Itis 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.
There are different types of
cholesterol. LDL-C, or low-density-
lipoprotein cholesterol, is the 'bad'
cholesterol that can block your blood
vessels. HDL-C, 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 instead of being carried
to the part

Summary of Product characteristics

210430-Atorvastatin SZ-pi
Page 1 of 21
AUSTRALIAN PRODUCT INFORMATION
ATORVASTATIN SZ (ATORVASTATIN CALCIUM TRIHYDRATE)
TABLETS
1
NAME OF THE MEDICINE
Atorvastatin calcium trihydrate
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
ATORVASTATIN SZ tablets contain atorvastatin calcium trihydrate
equivalent to 10, 20, 40
and 80 mg atorvastatin.
_Excipients with known effect: _
Sugars as lactose monohydrate
_ _
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
ATORVASTATIN SZ
10 mg tablets are white to off-white; elliptical, film-coated tablets
debossed ‘AS10’ on one side and plain on the other side.
ATORVASTATIN SZ
20 mg tablets are white to off-white; elliptical, film-coated tablets
debossed ‘AS20’ on one side and plain on the other side.
ATORVASTATIN SZ
40 mg tablets are white to off-white; elliptical, film-coated tablets
debossed ‘AS40’ on one side and plain on the other side.
ATORVASTATIN SZ
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
T
HERAPEUTIC INDICATIONS
ATORVASTATIN SZ 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 SZ 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 cardiovascu