RANSIM simvastatin 40mg tablet blister pack

País: Austràlia

Idioma: anglès

Font: Department of Health (Therapeutic Goods Administration)

ingredients actius:

Simvastatin

Disponible des:

Sun Pharma ANZ Pty Ltd

Designació comuna internacional (DCI):

Simvastatin

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 CMI V7 Mar 2013
Page 2 of 10
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

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-3- methylglutaryl-coenzyme A (HMG-CoA) reductase, an enzyme
which
catalyses an early and rate-limiting step in the biosynthesis of
cholesterol. As a result,
in clinical studies simvastatin reduced total plasma cholesterol
(total-C), LDL-C and
very low-density