SIMVAR 20 simvastatin 20 mg tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

simvastatin, Quantity: 20 mg

Available from:

Arrotex Pharmaceuticals Pty Ltd

Pharmaceutical form:

Tablet, film coated

Composition:

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

Administration route:

Oral

Units in package:

30, 5 tablets

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

SIMVASTATIN ARW is indicated as an adjunct to diet for treatment of hypercholesterolaemia. Prior to initiating therapy with SIMVASTATIN ARW, 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 ARW is indicated in patients at high risk of 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. SIMVASTATIN ARW is indicated as an adjunct to diet in adolescent boys and girls who are at least one year post-menarche, 10-17 years of age, with heterozygous familial hypercholesterolaemia (HeFH). Prior to initiating therapy with SIMVASTATIN ARW 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.

Product summary:

Visual Identification: Tan coloured, oval shaped, film-coated tablet, coded with 'E34' on one side and plain 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; Container Closure: Child resistant closure

Authorization status:

Registered

Authorization date:

2003-11-26

Patient Information leaflet

SIMVAR
®
- Consumer Medicine Information
Page 1 of 5
SIMVAR
®
_Simvastatin _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about SIMVAR. 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 SIMVAR
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 SIMVAR IS USED
FOR
SIMVAR helps to lower cholesterol
and triglyceride levels.
SIMVAR 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).
SIMVAR 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
w

Summary of Product characteristics

1
AUSTRALIAN PRODUCT INFORMATION – SIMVAR (SIMVASTATIN)
TABLETS
1
NAME OF THE MEDICINE
Simvastatin
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Simvastatin
is
a
white
crystalline
powder,
practically
insoluble
in
water
and
freely
soluble
in
chloroform, methanol and ethanol.
SIMVAR 10 contain 10 mg simvastatin.
SIMVAR 20 contain 20 mg simvastatin.
SIMVAR 40 contain 40 mg simvastatin.
SIMVAR 80 contain 80 mg simvastatin.
Excipients with known effect: lactose monohydrate.
For full list of excipients, see section 6.1 LIST OF EXCIPIENTS
3
PHARMACEUTICAL FORM
SIMVAR 10 - peach coloured, oval-shaped film-coated tablet, coded
‘E33’ on one side and plain on the
other side.
SIMVAR 20 - tan coloured, oval-shaped film-coated tablet, coded
‘E34’ on one side and plain on the
other side.
SIMVAR 40 - brick red coloured, oval-shaped, film-coated tablet, coded
‘E35’ on one side and plain on
the other side.
SIMVAR 80 - brick red, capsule-shaped, film-coated tablet, coded
‘E37’ on one side and plain on the
other side.
2
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
•
SIMVAR is indicated as an adjunct to diet for treatment of
hypercholesterolaemia. Prior to
initiating therapy with SIMVAR, 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.
•
SIMVAR is indicated in patients at high risk of 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.
•
SIMVAR is indicated as an adjunct to diet in adolescent boys and girls
who a