SIMVASTATIN AN simvastatin 5 mg tablet blister pack

Nchi: Australia

Lugha: Kiingereza

Chanzo: Department of Health (Therapeutic Goods Administration)

Viambatanisho vya kazi:

simvastatin, Quantity: 5 mg

Inapatikana kutoka:

Amneal Pharma Australia Pty Ltd

INN (Jina la Kimataifa):

Simvastatin

Dawa fomu:

Tablet, film coated

Tungo:

Excipient Ingredients: magnesium stearate; microcrystalline cellulose; pregelatinised maize starch; butylated hydroxyanisole; lactose monohydrate; citric acid monohydrate; ascorbic acid; titanium dioxide; hypromellose; hyprolose; purified talc; iron oxide yellow

Njia ya uendeshaji:

Oral

Vitengo katika mfuko:

30 tablets

Dawa ya aina:

(S4) Prescription Only Medicine

Matibabu dalili:

Adjunct to diet for treatment of hypercholesterolaemia. Prior to initiating therapy with simvastatin, secondary causes of hypercholesterolaemia (e.g. poorly controlled diabetes mellitus, hypothyroidism, nephrotic syndrome, dysproteinaemias, obstructive liver disease, other drug therapy, alcoholism) should be identified and treated. Simvastatin is indicated in patients at high risk of coronary heart disease (CHD) (with or without hypercholesterolaemia) including patients with diabetes, history of stroke or other cerebrovascular disease, peripheral vessel disease, or with existing CHD to reduce the risk of cardiovascular death, major cardiovascular events including stroke, and hospitalisation due to angina pectoris. These effects do not replace the need to independently control known causes of cardiovascular mortality and morbidity such as hypertension, diabetes and smoking.

Bidhaa muhtasari:

Visual Identification: Yellow coloured, round shaped, biconvex, film coated tablets, debossed with 'A' on one side and '15' on the other side.; Container Type: Blister Pack; Container Material: PVC/PE/PVDC/Al; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

Idhini hali ya:

Registered

Idhini ya tarehe:

2010-11-01

Taarifa za kipeperushi

_Simvastatin AN tablets – Consumer Medicine Information _
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_Simvastatin AN CMI v3.0 _
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_Page 1 _
SIMVASTATIN AN TABLETS
_Simvastatin _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This
leaflet
answers
some
common
questions
about
Simvastatin
AN.
It
does
not
contain
all
of
the
available
information.
IF
YOU
HAVE
ANY
CONCERNS
ABOUT USING SIMVASTATIN
AN,
ASK
YOUR
DOCTOR
OR
PHARMACIST.
YOUR
DOCTOR
OR
PHARMACIST
MAY
HAVE
MORE
INFORMATION.
Keep
this
leaflet
with
your
Simvastatin AN tablets.
You may need to read it again.
WHAT SIMVASTATIN AN
IS USED FOR
Simvastatin AN helps to lower
cholesterol
and
triglyceride
levels.
SIMVASTATIN
AN
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 AN 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.
When you have high levels of
cholesterol, it may 'stick' to the
inside
of
your
blood
vessels
instead of being carried to the
parts
of
the
body
where
it
is
needed. Over time, this can f

Tabia za bidhaa

_Simvastatin AN tablets Product Information _
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_ Amneal Pharma Australia Pty Ltd _
Simvastatin AN PI v2.0
Page 1 of 22
SIMVASTATIN AN
_ _
_(SIMVASTATIN TABLETS) _
_ _
PRODUCT INFORMATION
_ _
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_]
DESCRIPTION
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.
INACTIVE: Ascorbic acid, Lactose, Microcrystalline cellulose (Avicel
PH 101 & 112), Pre-gelatinised
maize starch, Citric acid monohydrate, Butylated hydroxyanisole,
Magnesium stearate, Opadry
yellow 20A52229-Proprietary ingredient ARTG number 12350 (Simvastatin
AN 5 mg), Opadry pink
20A54239-Proprietary ingredient ARTG number 11891 (Simvastatin AN 10
mg & 20 mg) and
Opadry pink 20A54211-Proprietary ingredient ARTG number 12531
(Simvastatin AN 40 mg & 80
mg).
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).
_Simvastatin AN tablets Product Information _
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_ Amneal Pharma Australia Pty Ltd _
Simvastatin AN PI v2.0
Page 2 of 22
After oral ingestion, simvastatin, which is an inactive lactone, is
hydrolysed to the corresponding
beta-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