SIMVASTATIN-DRLA simvastatin 10mg tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

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Patient Information leaflet (PIL)

24-08-2020

Summary of Product characteristics (SPC)

24-08-2020

Public Assessment Report (PAR)

28-11-2017

Active ingredient:

simvastatin, Quantity: 10 mg

Available from:

Dr Reddys Laboratories Australia Pty Ltd

INN (International Name):

Simvastatin

Pharmaceutical form:

Tablet

Composition:

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

Administration route:

Oral

Units in package:

28 tablet, 100 tablet, 7 tablet, 90 tablet, 10 tablet, 5 tablet, 60 tablet, 30 tablet

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

SIMVASTATIN-DRLA is indicated as an adjunct to diet for treatment of hypercholesterolaemia. Prior to initiating therapy with SIMVASTATIN-DRLA, 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-DRLA 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-DRLA is indicated as an adjunct to diet in adolescent boys and girls who are at least one year post-mena

Product summary:

Visual Identification: brown coloured, round, biconvex, film coated tablets debossed 'RDY' on one side and '198' on the other side; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 18 Months; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2012-06-01

Patient Information leaflet

SIMVASTATIN-DRLA
_Simvastatin _
CONSUMER MEDICINE INFORMATION
PAGE 1 OF 6
Simvastatin-DRLA_CMI_v02_January, 2012
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about SIMVASTATIN-
DRLA. 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-DRLA
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-
DRLA IS USED FOR?
SIMVASTATIN-DRLA helps to lower
cholesterol and triglyceride levels.
SIMVASTATIN-DRLA 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-DRLA 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

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Summary of Product characteristics

Dr Reddy’s Laboratories (Australia) Pty Ltd
Product Information
SIMVASTATIN-DRLA_PI_v03_Mar, 2013
Page 1 of 21
PRODUCT INFORMATION
SIMVASTATIN-DRLA TABLETS
Simvastatin is a lipid-lowering agent derived synthetically from a
fermentation product of
Aspergillusterreus.
NAME OF THE MEDICINE
Simvastatin is described chemically as [1_S_-[1α, 3α, 7β, 8β
(2_S_*,4_S_*),8aβ]]-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.
Its empirical formula is C
25
H
38
O
5
and its molecular weight is 418.57. Its structural formula is:
Simvastatin chemical abstract number is - CAS−79902-63-9
DESCRIPTION
Simvastatin is a whitecrystalline powder, practically insoluble in
water and freely soluble in chloroform,
methanol and ethanol.
Each tablet for oral administration contains either 10 mg, 20 mg, 40
mg or 80 mg of simvastatin and the
following
non-medicinal
ingredients:
butylatedhydroxyanisole,
ascorbic
acid,
citric
acid-anhydrous,
cellulose-microcrystalline,
starch-pregelatinised
maize,
magnesium
stearate,
lactose,
hypromellose,
hydroxypropylcellulose,
titanium
dioxide,
iron
oxide
red
C177491,
iron
oxideyellowC177492,
iron
oxideblackC177499.
PHARMACOLOGY
CLINICAL 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).
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 simvastatinreduced total
plasma cholesterol (total-C), LDL-C
and very low-de

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