CHEMMART SIMVASTATIN simvastatin 80 mg tablet blister pack
Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Patient Information leaflet
(PIL)
18-12-2018
Summary of Product characteristics
(SPC)
18-12-2018
Public Assessment Report
(PAR)
26-11-2017
Active ingredient:
simvastatin
Available from:
Apotex Pty Ltd
INN (International Name):
Simvastatin
Authorization status:
Registered
Patient Information leaflet
CHEMMART SIMVASTATIN
TABLETS
_Simvastatin_
CONSUMER MEDICINE INFORMATION
_FOR A COPY OF A LARGE PRINT LEAFLET, PH: 1800 195 055_
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 using this medicine
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 want to read it again.
WHAT THIS MEDICINE IS
USED FOR
Simvastatin is used:
•
to help lower high cholesterol and
triglyceride levels (together with
dietary changes)
•
in people who have coronary
heart disease (CHD)
•
in people with a high risk of CHD
(e.g. diabetes, stroke or other
blood vessel disease)
Simvastatin can reduce the risk of a
heart attack or stroke, and can reduce
the need for hospitalisation due to
angina.
CHOLESTEROL:
Everyone has cholesterol and
triglycerides in their blood. The body
uses them for many things, such as
building cell walls and hormones.
Your body makes cholesterol, but it
also comes from food. 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 high-fat
diet, your body may not keep this
balance and your cholesterol levels
rise.
Too much cholesterol or triglycerides
can be a problem. 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 form hard areas
(called plaque) on the walls of blood
vessels, making it more difficult for
the blood to flow. This blocking of
your blood vessels can lead to heart
attacks, angina and stroke. High
cholesterol is more likely to occur
with certain diseases or if you have a
family history of
Read the complete document
Summary of Product characteristics
1
AUSTRALIAN PRODUCT INFORMATION –CHEMMART
SIMVASTATIN (SIMVASTATIN) - TABLET
1
NAME OF THE MEDICINE
Simvastatin.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
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.
Each tablet contains simvastatin 10 mg, 20 mg, 40 mg or 80 mg.
For the full list of excipients see section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
10 MG TABLET
Light pink coloured, oval, biconvex film-coated tablets, marked “SVN
10” on one and ‘NEO’
on the other side.
20 MG TABLET
Tan coloured, oval, biconvex film-coated tablets, marked with “SVN
20” on one side and
‘NEO’ on the other side.
40 MG TABLET
Pink coloured, oval, biconvex film coated tablets, marked “SVN 40”
on one side ‘NEO’ on the
other side.
80 MG TABLET
Pink coloured, capsule-shaped, biconvex film-coated tablets marked
with “SVN 80” on one
side and “NEO” on the other side.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Simvastatin is indicated as an 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 CHD (with or
without hypercholesterolaemia)
including patients with diabetes, history of stroke or other
cerebrovascular disease, peripheral
2
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.
4.2
DOSE AND MET
Read the complete document
