Zarator

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Atorvastatin calcium 86.8mg Equivalent to 80 mg Atorvastatin;  

Available from:

Viatris Limited

INN (International Name):

Atorvastatin calcium 86.8 mg (Equivalent to 80 mg Atorvastatin)

Dosage:

80 mg

Pharmaceutical form:

Film coated tablet

Composition:

Active: Atorvastatin calcium 86.8mg Equivalent to 80 mg Atorvastatin   Excipient: Calcium carbonate Croscarmellose sodium Hyprolose Lactose monohydrate Magnesium stearate Microcrystalline cellulose Opadry white YS-1-7040 Polysorbate 80 Simeticone

Units in package:

Blister pack, Foil-Foil, 10 tablets

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

Pfizer Ireland Pharmaceuticals

Therapeutic indications:

ZARATOR is indicated as an adjunct to diet to reduce elevated total-C, LDL-C and TG levels in patients with primary hypercholesterolaemia or mixed dyslipidaemia where the primary abnormality is either elevated cholesterol or triglycerides when response to diet and other non-pharmacological measures is inadequate. ZARATOR is also indicated to reduce total-C and LDL-C in patients with heterozygous and homozygous familial hypercholesterolaemia.

Product summary:

Package - Contents - Shelf Life: Blister pack, Foil-Foil - 10 tablets - 36 months from date of manufacture stored at or below 25°C - Blister pack, Foil-Foil - 30 tablets - 36 months from date of manufacture stored at or below 25°C - Bottle, plastic, HDPE, CRC - 30 tablets - 36 months from date of manufacture stored at or below 25°C - Bottle, plastic, HDPE, CRC - 90 tablets - 36 months from date of manufacture stored at or below 25°C

Authorization date:

2010-01-06

Patient Information leaflet

ZARATOR
®
Page 1 of 5
ZARATOR
®
_Atorvastatin calcium _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some of the more
common questions about Zarator.
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 Zarator 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 ZARATOR IS
USED FOR
Zarator is used to lower high
cholesterol levels.
Zarator 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.
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

Summary of Product characteristics

Version: ujdzarat10821
Supersedes: pfdzarat10520
Page 1 of 24
NEW ZEALAND DATA SHEET
1. PRODUCT NAME
ZARATOR
®
10 mg, 20 mg, 40 mg and 80 mg tablets
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 10 mg tablet contains 10 mg atorvastatin (as calcium)
Each 20 mg tablet contains 20 mg atorvastatin (as calcium)
Each 40 mg tablet contains 40 mg atorvastatin (as calcium)
Each 80 mg tablet contains 80 mg atorvastatin (as calcium)
Excipients with known effects:
•
Lactose monohydrate
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
ZARATOR tablets are white round film-coated tablets, debossed with the
tablet strength on
one side and ‘ATV’ on the other.
10 mg: debossed ‘10’ on one side and ‘ATV’ on the other
20 mg: debossed ‘20’ on one side and ‘ATV’ on the other
40 mg: debossed ‘40’ on one side and ‘ATV’ on the other
80 mg: debossed ‘80’ on one side and ‘ATV’ on the other
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
ZARATOR is indicated as an adjunct to diet to reduce elevated total
cholesterol (total-C), low
density lipoprotein cholesterol (LDL-C) and triglycerides (TG) levels
in patients with primary
hypercholesterolaemia or mixed dyslipidaemia where the primary
abnormality is either
elevated cholesterol or triglycerides when response to diet and other
non-pharmacological
measures is inadequate.
ZARATOR is also indicated to reduce total-C and LDL-C in patients with
heterozygous and
homozygous familial hypercholesterolaemia.
ZARATOR is indicated to increase plasma high density lipoprotein
cholesterol (HDL-C) and
decrease the LDL-C/HDL-C and total-C/HDL-C ratios.
Version: ujdzarat10821
Supersedes: pfdzarat10520
Page 2 of 24
ZARATOR is indicated as an adjunct to diet for the treatment of
patients with elevated serum
triglyceride
levels
(hypertriglyceridaemia),
and
for
the
treatment
of
patients
with
dysbetalipoproteinaemia who do not respond adequately to diet.
ZARATOR is indicated for the reduction of cardiac ischaemic events in
patients with
asymptoma