Simvastatin simvastatin 80mg tablet blister pack

Land: Australien

Sprache: Englisch

Quelle: Department of Health (Therapeutic Goods Administration)

Wirkstoff:

simvastatin

Verfügbar ab:

Novotech Australia Pty Ltd

INN (Internationale Bezeichnung):

Simvastatin

Klasse:

Medicine Registered

Berechtigungsstatus:

Registered

Gebrauchsinformation

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CMI v3 02/05/2013
CONSUMER MEDICINE INFORMATON
Simvastatin Tablets
WHAT IS IN THIS LEAFLET
This leaflet answers some common questions about Simvastatin. It does
not contain
all the available information.
It does not take the place of talking to your doctor or pharmacist.
All medicines have risks and benefits. Your doctor has weighed the
risks of you
taking Simvastatin against the benefits they expect it will have for
you.
_If you have any concerns about taking this medicine, ask your doctor
or pharmacist. _
_Keep this leaflet with the medicine. _
You may need to read it again.
WHAT SIMVASTATIN IS USED FOR
Simvastatin helps to lower cholesterol and triglyceride levels.
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).
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 rise.
High cholesterol is more likely to occur with certain diseases or if
you have a family
history of high cholesterol.
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When you have high levels of cholesterol, it may 'stick' to the inside
of your blood
vessels instead of being carried to th

Fachinformation

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PRODUCT INFORMATION
NAME OF THE MEDICINE
SIMVASTATIN TABLETS
Simvastatin is a lipid-lowering agent derived synthetically from a
fermentation
product of
_Aspergillus terreus._
Simvastatin is a white crystalline powder, practically
insoluble in water and freely soluble in chloroform, methanol and
ethanol.
Simvastatin is described chemically as [1S-[1

, 3

, 7

, 8

(2S*,4S*),8a

]]-
1,2,3,7,8,8a-
hexahydro-3,7-dimethyl-8-[2-(tetrahydro-4-hydroxy-6-oxo-2
_H_
-pyran-2-
yl) ethyl]-1-naphthalenyl 2,2-dimethylbutanoate.
Structure:
Empirical formula: C
25
H
38
O
5
Molecular weight: 418.57.
CAS: 79902-63-9
DESCRIPTION
Each tablet for oral administration contains either 10 mg, 20 mg, 40
mg or 80 mg of
simvastatin and the following excipients: lactose monohydrate, starch
pregelatinised,
cellulose microcrystalline, butylated hydroxyanisole, magnesium
stearate, ascorbic
acid, citric acid monohydrate, hydroxypropylcellulose, talc purified,
titanium dioxide
and Opadry white. Each tablet may also contain one or both of the
following: yellow
iron oxide CI77492 and red iron oxide CI77491.
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).
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After oral ingestion, simvastatin, which is an inactive lactone, is
hydrolysed to the
corresponding

-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 lipoprotein -cholesterol (VLDL-C) concentrations. In
addition,
simvastatin increases HDL-C