Rosuvastatin Viatris

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Rosuvastatin calcium 20.792mg equivalent to rosuvastatin 20 mg

Available from:

Viatris Limited

INN (International Name):

Rosuvastatin calcium 20.792 mg (equivalent to rosuvastatin 20 mg)

Dosage:

20 mg

Pharmaceutical form:

Film coated tablet

Composition:

Active: Rosuvastatin calcium 20.792mg equivalent to rosuvastatin 20 mg Excipient: Colloidal silicon dioxide Crospovidone Iron oxide red Lactose monohydrate Light magnesium oxide Magnesium stearate Microcrystalline cellulose Opadry Pink

Units in package:

Blister pack, laminate layer (polyamide/aluminium/LDPE dessicant-HDPE)/aluminium foil, 30 tablets

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

Assia Chemical Industries Ltd

Therapeutic indications:

Rosuvastatin calcium is indicated to: · Reduce elevated LDL-C, total cholesterol, triglycerides and to increase HDLcholesterol in patients with primary hypercholesterolemia (heterozygous familial and non familial) and mixed dyslipidaemia (Fredrickson Types IIa and IIb). Rosuvastatin calcium also lowers ApoB, nonHDL-C, VLDL-C, VLDL-TG, the LDL-C/HDL-C, total C/HDL-C, nonHDL-C/HDL-C, ApoB/ApoA-I ratios and increase Apo-A-I in these populations. · Treat isolated hypertriglyceridaemia (Fredrickson Type IV hyperlipidaemia). · Reduce total cholesterol and LDL-C in patients with homozygous familial hypercholesterolemia, as an adjunct to diet and other lipid lowering treatments (e.g. LDL apheresis) or alone if such treatments are unavailable.

Product summary:

Package - Contents - Shelf Life: Blister pack, PVC/Polyamide/Al - 30 tablets - 24 months from date of manufacture stored at or below 25°C - Blister pack, PVC/Aclar/Al - 30 tablets - 24 months from date of manufacture stored at or below 25°C - Blister pack, laminate layer (polyamide/aluminium/LDPE dessicant-HDPE)/aluminium foil - 30 tablets - 24 months from date of manufacture stored at or below 25°C - Bottle, plastic, HDPE white bottle/PP screw closure - 30 tablets - 24 months from date of manufacture stored at or below 25°C - Bottle, plastic, HDPE white bottle/PP screw closure - 500 tablets - 24 months from date of manufacture stored at or below 25°C

Authorization date:

2013-04-03

Patient Information leaflet

Page 1 of 5
NEW ZEALAND CONSUMER MEDICINE INFORMATION
ROSUVASTATIN VIATRIS
_ROSUVASTATIN FILM COATED TABLET 5 MG, 10 MG, 20 MG & 40 MG_
WHAT IS IN THIS LEAFLET
Please read this leaflet carefully
before you start taking
ROSUVASTATIN VIATRIS.
This leaflet answers some common
questions about ROSUVASTATIN
VIATRIS.
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
ROSUVASTATIN VIATRIS against
the benefits they expect it will 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
ROSUVASTATIN
VIATRIS IS USED FOR
ROSUVASTATIN VIATRIS is used
to treat
•
High levels of “bad”
cholesterol
It reduces the
•
risk of heart attacks
•
risk of strokes
•
need for a heart bypass
ROSUVASTATIN VIATRIS contains
the active ingredient rosuvastatin. It
belongs to a group of medicines
called HMG-CoA reductase
inhibitors (also known as ‘statins’).
It works by lowering the "bad"
cholesterol and raising the "good"
cholesterol when exercise and
changes to diet are not enough on
their own. It also lowers the risk of
heart attacks and strokes.
Everyone has cholesterol and
triglycerides in their blood. They are
fatty substances needed by the
body for many things. Triglycerides
are an energy source for the body.
Cholesterol is essential for such
things as building cells, making bile
acids (which help to digest food)
and making some hormones.
There are different types of
cholesterol. Too much of the "bad"
cholesterol (LDL) can block the
blood vessels that supply your heart
and brain with blood, and can cause
heart attack, angina and stroke. The
"good" cholesterol (HDL) helps to
remove the bad cholesterol from the
blood vessels. High levels of
triglycerides can be associated with
a low level of "good" cholesterol and
may increase the risk of heart
disease.
Cholestero

Summary of Product characteristics

Page 1 of 21
NEW ZEALAND DATA SHEET
ROSUVASTATIN VIATRIS
1. PRODUCT NAME
ROSUVASTATIN VIATRIS, 5 mg, 10 mg, 20 mg & 40 mg, film coated tablet.
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film coated tablet contains 5 mg, 10 mg, 20 mg or 40 mg of
rosuvastatin (as rosuvastatin
calcium).
Excipients with known effect: lactose.
Allergen Declaration: Contains sugars as lactose.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
ROSUVASTATIN VIATRIS 5 mg: A yellow, film-coated, round, biconvex
tablet, debossed with "M"
on one side and “RS” on the other side.
ROSUVASTATIN VIATRIS 10 mg: A pink, film-coated, round, biconvex
tablet, debossed with “M” on
one side and “RS1” on the other side.
ROSUVASTATIN VIATRIS 20 mg: A pink, film-coated, round, biconvex
tablet, debossed with "M" on
one side and “RS2” on the other side.
ROSUVASTATIN VIATRIS 40 mg: A pink, film-coated, oval, biconvex
tablet, debossed with "M" on
one side and "RS4" on the other side.
DO NOT HALVE THE TABLET.
4. CLINICAL PARTICULARS
_4.1 _
_THERAPEUTIC INDICATIONS_
ROSUVASTATIN VIATRIS should be used as an adjunct to diet when the
response to diet and
exercise is inadequate.
_PREVENTION OF MAJOR CARDIOVASCULAR EVENTS_
In adult patients without documented history of cardiovascular or
cerebrovascular events, but with
at least two conventional risk factors for cardiovascular disease (see
section 5.1), ROSUVASTATIN
VIATRIS is indicated to:
•
Reduce the risk of nonfatal myocardial infarction
•
Reduce the risk of nonfatal stroke
•
Reduce the risk of coronary artery revascularisation
Page 2 of 21
_HYPERCHOLESTEROLAEMIA_
ROSUVASTATIN VIATRIS is indicated to:
•
Reduce elevated LDL-C, total cholesterol, triglycerides and to
increase HDL-cholesterol in
patients with primary hypercholesterolaemia (heterozygous familial and
non familial) and mixed
dyslipidaemia (Fredrickson Types Ila and lIb). ROSUVASTATIN VIATRIS
also lowers ApoB,
nonHDL-C, VLDL-C, VLDL-TG, the LDL-C/HDL-C, total C/HDL-C,
nonHDL-C/HDL-C,
ApoB/ApoA-I rati