Atoris Film-Coated Tablet 20 mg

Country: Malaysia

Language: English

Source: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Active ingredient:

ATORVASTATIN CALCIUM

Available from:

PAHANG PHARMACY SDN. BHD.

INN (International Name):

ATORVASTATIN CALCIUM

Units in package:

90Tablet Tablets

Manufactured by:

KRKA

Patient Information leaflet

Not Applicable

Summary of Product characteristics

1.3.1
Atorvastatin
SPC, Labeling and Package Leaflet
MY-Malaysia
PI_Text013189_2
- Updated:
Page 1 of 12
ATORIS
_Atorvastatin_
COMPOSITION
Atoris film-coated tablets 10 mg
Each film-coated tablet contains 10 mg of atorvastatin as atorvastatin
calcium.
Atoris film-coated tablets 20 mg
Each film-coated tablet contains 20 mg of atorvastatin as atorvastatin
calcium .
Atoris film-coated tablets 40 mg
Each film-coated tablet contains 40 mg of atorvastatin as atorvastatin
calcium .
PRODUCT DESCRIPTION
10 mg tablets: White, round, slightly convex, film-coated tablet,
bevel-edged.
20 mg tablets: White, round, slightly convex, film-coated tablet,
bevel-edged.
40 mg tablets: White, round, slightly convex, film-coated tablet,
bevel-edged.
THERAPEUTIC INDICATIONS
Hypercholesterolemia
Atoris is indicated as an adjunct to diet for reduction of elevated
total cholesterol (total-C), LDL-
cholesterol (LDL-C), apolipoprotein B, and triglycerides in adults,
adolescents and children aged 10
years
or
older
with
primary
hypercholesterolaemia
including
familial
hypercholesterolaemia
(heterozygous variant) or combined (mixed) hyperlipidaemia
(Corresponding to Types IIa and IIb of
the Fredrickson classification) when response to diet and other
nonpharmacological measures is
inadequate.
Atoris
is
also
indicated
to
reduce
total-C
and
LDL-C
in
adults
with
homozygous
familial
hypercholesterolaemia as an adjunct to other lipid-lowering treatments
(e.g. LDL apheresis) or if such
treatments are unavailable.
Prevention of cardiovascular disease
Prevention of cardiovascular events in adult patients estimated to
have a high risk for a first
cardiovascular event, as an adjunct to correction of other risk
factors.
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The patient should be placed on a standard cholesterol-lowering diet
before receiving Atoris and
should continue on this diet during treatment with Atoris.
The dose should be individualised according to baseline LDL-C levels,
the goal of therapy, and patient
response.
The usual starting dose is