AURO-SIMVASTATIN

देश: ऑस्ट्रेलिया

भाषा: अंग्रेज़ी

स्रोत: Department of Health (Therapeutic Goods Administration)

सक्रिय संघटक:

Simvastatin

थमां उपलब्ध:

Aurobindo Pharma Australia Pty Ltd

वर्ग:

Medicine Registered

सूचना पत्रक

AURO-SIMVASTATIN 
                              CONSUMER MEDICINE
INFORMATION                   
VERSION 2.2 
AURO-SIMVASTATIN 5, 10, 20, 40 & 80  
SIMVASTATIN 
CONSUMER MEDICINE INFORMATION 

1 
WHAT IS IN THIS LEAFLET? 

This leaflet answers some of the 
common questions about AURO-
SIMVASTATIN. It does not contain 
all of the available information.  

IF YOU HAVE ANY CONCERNS ABOUT 
USING AURO-SIMVASTATIN, ASK 
YOUR DOCTOR OR PHARMACIST. YOUR 
DOCTOR AND PHARMACIST HAVE MORE 
INFORMATION. 

KEEP THIS LEAFLET WITH YOUR AURO-
SIMVASTATIN TABLETS. 

You may need to read it again. 

AURO-SIMVASTATIN helps to 
lower cholesterol and triglyceride 
levels.  

AURO-SIMVASTATIN is used in 
people who have coronary heart 
disease (CHD) or who are at high risk 
of CHD (for example, if they have 
diabetes, a history of stroke, or other 
blood vessel disease).  

AURO-SIMVASTATIN may be used 
in these people, regardless of their 
cholesterol level to: 
•  Help prolong life by reducing the 
risk of a heart attack 
•  Reduce the risk of stroke 
•  Reduce the need for surgery to 
increase blood flow to the heart  
•  Reduce the need for hospitalisation 
due to angina. 
_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 ris

उत्पाद विशेषताएं

 
Product Information:   
Auro-Simvastatin 5, 10, 20,
40, 80 (Simvastatin 5mg, 10mg, 20mg, 40mg, 80mg)         

  Ver 2.3 

Page 1 of 23 

PRODUCT INFORMATION 

AURO-SIMVASTATIN 5 (5 MG SIMVASTATIN TABLETS)   
AURO-SIMVASTATIN 10 (10 MG SIMVASTATIN TABLETS)  
AURO-SIMVASTATIN 20 (20 MG SIMVASTATIN TABLETS) 
AURO-SIMVASTATIN 40 (40 MG SIMVASTATIN TABLETS) 
AURO-SIMVASTATIN 80 (80 MG SIMVASTATIN TABLETS) 

Simvastatin is a lipid lowering agent derived synthetically from a
fermentation product of 
_Aspergillus terreus_. 

NAME OF MEDICINE 

The name of the medicine is Simvastatin.

CHEMICAL
NAME: (1_S_,3_R_,7_S_,8_S_,8a_R_)-8-[2-[(2_R_,4_R_)-4-hydroxy-6-oxotetrahydro-2_H_-pyran-2-
yl]ethyl]-3,7-dimethyl-1,2,3,7,8,8a-hexahydronaphthalen-1-yl
2,2-dimethylbutanoate. 
MOLECULAR FORMULA: C
25
H
38
O
5 
MOLECULAR WEIGHT: 418.6 
CAS REGISTRY NUMBER: _[79902-63-9]_ 

INACTIVE: Ascorbic acid, lactose, microcrystalline cellulose,
pregelatinised maize starch, citric acid 
monohydrate, butylated hydroxyanisole, magnesium stearate, Opadry
yellow 20A52229-Proprietary 
ingredient ARTG number 12350 (Auro-Simvastatin 5),

Opadry pink 20A54239-Proprietary 
ingredient ARTG number 11891 (Auro-Simvastatin 10 & 20) and Opadry
pink 20A54211-
Proprietary ingredient ARTG number 12531 (Auro-Simvastatin 40 & 80).

DESCRIPTION

Simvastatin is a white crystalline powder, practically insoluble in
water and freely soluble in 
chloroform, methanol and ethanol.   

PHARMACOLOGY 

The involvement of low density lipoprotein cholesterol (LDL-C) in
atherogenesis has been well 
documented in clinical and pathological studies, as well as in many
animal experiments. 
Epidemiological studies have established that high LDL-C and low high
density lipoprotein 
cholesterol (HDL-C) are both risk factors for coronary heart disease
(CHD). 

Product Information:   
Auro-Simvastatin