Atormac 10 (Atorvastatin Film Coated Tablet 10mg)

Country: Malaysia

Language: English

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

Active ingredient:

ATORVASTATIN CALCIUM TRIHYDRATE

Available from:

Macleods Pharmaceuticals Sdn. Bhd.

INN (International Name):

ATORVASTATIN CALCIUM TRIHYDRATE

Units in package:

10X10 Tablets

Manufactured by:

Macleods Pharmaceuticals Limited

Patient Information leaflet

Page 1 of 3 _CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
_ _
ATORMAC TABLET
Atorvastatin Film Coated Tablets (10, 40 mg)
WHAT IS IN THIS LEAFLET
1.
What Atormac is used for
2.
How Atormac works
3.
Before you use Atormac
4.
How to use Atormac
5.
While you are using Atormac
6.
Side effects
7.
Storage and Disposal of Atormac
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of Revision
11.
Serial Number
WHAT ATORMAC IS USED FOR:
Atormac
belongs to a group of medicines
known as statins, which are lipid (fat)
regulating medicines.
Atormac is used to lower lipids
known as cholesterol [total
cholesterol, low density lipoprotein
cholesterol (LDL-C)] and other fats
(triglycerides) and to increase high
density lipoprotein cholesterol (HDL-
C) in the blood when a low fat diet
and lifestyle changes on their own
have failed.
Atormac can lower the risk for heart
attack, stroke, certain types of heart
surgery and chest pain in patients who
have heart disease or risk factors for
heart disease such as:
-
Age, smoking, high blood pressure,
low HDL-C, heart disease in the
family.
Atormac can lower the risk for heart
attack or stroke in patients with
diabetes and risk factors such as:
-
Eye problems, kidney problems,
smoking or high blood pressure.
_Cholesterol: _
Everyone has cholesterol and
triglycerides in their blood. They are
types of blood fat needed by the body
for many things, including building
cell walls, making bile acids (which
help to digest food) and certain
hormones. However, too much
cholesterol can be a problem.
Your body makes cholesterol, but it
also comes from food. Normally the
body balances the cholesterol it makes
with the cholesterol it gets from food.
This means if more cholesterol comes
from food, less is made by the body.
However, if you eat a diet high in fat,
your body may not keep this balance
and your cholesterol levels rise. 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

Summary of Product characteristics

1
FOR THE USE ONLY OF A REGISTERED MEDICAL PRACTITIONER OR A HOSPITAL OR
A
LABORATORY
ATORMAC 10/40 MG
Atorvastatin Film Coated Tablet 10 mg and 40 mg
COMPOSITION:
Each film coated tablet contains:
Atorvastatin Calcium USP equivalent to Atorvastatin….10/40mg
PRODUCT DESCRIPTION:
10 mg: White to off white, oval shaped, biconvex, film-coated tablets
debossed
with “M35” on one side and plain on other side.
40 mg: White to off white, oval shaped, biconvex, film-coated tablets
debossed
with “M37” on one side and plain on other side.
PHARMACODYNAMICS:
PHARMACODYNAMIC PROPERTIES:
Atorvastatin is a selective, competitive inhibitor of HMG-CoA
reductase, the
rate-limiting enzyme responsible for the conversion of
3-hydroxy-3-methyl-
glutaryl-coenzyme
A
to
mevalonate,
a
precursor
of
sterols,
including
cholesterol. Triglycerides and cholesterol in the liver are
incorporated into very
low-density lipoproteins (VLDL) and released into the plasma for
delivery to
peripheral tissues. Low density lipoprotein (LDL) is formed from VLDL
and is
catabolised primarily through the receptor with high affinity to LDL
(LDL
receptor).
Atorvastatin lowers plasma cholesterol and lipoprotein serum
concentrations
by inhibiting HMG-CoA reductase and subsequently cholesterol
biosynthesis
in the liver and increases the number of hepatic LDL receptors on the
cell
surface for enhanced uptake and catabolism of LDL.
Atorvastatin
reduces
LDL
production
and
the
number
of
LDL
particles.
Atorvastatin produces a profound and sustained increase in LDL
receptor
activity coupled with a beneficial change in the quality of
circulating LDL
particles.
Atorvastatin
is
effective
in
reducing
LDL-C
in
patients
with
homozygous familial hypercholesterolaemia, a population that has not
usually
responded to lipid-lowering medicinal products.
Atorvastatin has been shown to reduce concentrations of total-C (30% -
46%),
LDL-C (41% - 61%), apolipoprotein B (34% - 50%), and triglycerides
(14% -
33%) while producing variable increases in HDL-C and apolipoprotein A1
in