RANSIM

País: Austràlia

Idioma: anglès

Font: Department of Health (Therapeutic Goods Administration)

ingredients actius:

Simvastatin

Disponible des:

Ranbaxy Australia Pty Ltd

clase:

Medicine Registered

Informació per a l'usuari

RANSIM CMI V7 Mar 2013

Page 1 of 10 
RANSIM  
_SIMVASTATIN TABLETS_ 
CONSUMER MEDICINE INFORMATION 

WHAT IS IN THIS LEAFLET  
This leaflet answers some common questions about RANSIM  tablets 
(simvastatin).  
It does not contain all the available information. 
It does not take the place of talking to your doctor or pharmacist. 
This leaflet was last updated on the date at the end of this 
leaflet. More recent information may be available. The latest 
Consumer Medicine Information is available from 
https://www.ebs.tga.gov.au/

and may contain important 
information about the medicine and its use of which you should 
be aware. 
All medicines have risks and benefits. Your doctor has weighed the 
risks of you taking RANSIM  against the benefits it is expected
to 
have for you. 
IF YOU HAVE ANY CONCERNS ABOUT USING/TAKING THIS MEDICINE, ASK YOUR 
DOCTOR OR PHARMACIST. 
Keep this leaflet with this medicine. You may need to read it
again. 

WHAT RANSIM TABLETS ARE USED FOR 
RANSIM tablets help to lower cholesterol and triglyceride levels. 

RANSIM  tablets are  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). 

RANSIM  tablets  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. 
RANSIM C

Fitxa tècnica

   
RANSIM PI V10 Mar 2013 

Page 1 of 24

RANSIM 
SIMVASTATIN 10, 20, 40 & 80 MG TABLETS 

NAME OF THE MEDICINE 

Simvastatin 

Chemical structure: (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-1,2,3,7,8,8ahexahydronaphthalen-1-yl 2,2-
dimethylbutanoate 
Chemical formula: C
25
 H
38 
O
5

Molecular weight: 418.6  
Chemical structure: 

CAS Registry Number: 79902-63-9 

DESCRIPTION 

Simvastatin is a white or almost white crystalline powder,
practically insoluble in 
water and very soluble in methylene chloride, freely soluble in
ethanol (96 per cent). 
Ransim
(simvastatin) is a lipid-lowering agent derived synthetically from a 
fermentation product of _Aspergillus terreus_. 

RANSIM film-coated tablets contains lactose
monohydrate, pregelatinised maize 
starch, ascorbic acid, citric acid
monohydrate, microcrystalline cellulose, 
butylhydroxyanisole, croscarmellose sodium, magnesium stearate,
Opadry 20A54963 
Pink - 10 mg (Proprietary Ingredient # 11689), Opadry 20A56532
Brown - 20 mg 
(Proprietary Ingredient #11701), Opadry 20A54964 Pink - 40
mg (Proprietary 
Ingredient # 11702), Opadry 20A54614 Pink - 80
mg (Proprietary Ingredient # 
11703).

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).  

RANSIM PI V10 Mar 2013 

Page 2 of 24

After oral ingestion, simvastatin, which is an inactive lactone,
is hydrolysed to the 
corresponding 
β-hydroxyacid form. This is a principal metabolite and an
inhibitor of 
3-hydroxy