SIMVASTATIN SANDOZ simvastatin 20mg tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

simvastatin, Quantity: 20 mg

Available from:

Sandoz Pty Ltd

INN (International Name):

Simvastatin

Pharmaceutical form:

Tablet, film coated

Composition:

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

Administration route:

Oral

Units in package:

30 tablets

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Adjunct to diet for treatment of hypercholesterolaemia. Prior to initiating therapy with Simvastatin Sandoz, 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 Sandoz 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, 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 Sandoz 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 Sandoz, 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: Orange, coated, oval, scored, convex tablets, coded "SIM 20" on one side.; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Registered

Authorization date:

2005-02-14

Patient Information leaflet

SIMVASTATIN SANDOZ
®
1
SIMVASTATIN SANDOZ
®
_simvastatin _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Simvastatin Sandoz.
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 risk of you taking this medicine
against the benefits it is expected to
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
SANDOZ IS USED FOR
Simvastatin Sandoz helps to lower
cholesterol and triglyceride levels.
Simvastatin Sandoz 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 Sandoz 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, such as 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
bei

Summary of Product characteristics

210423-simvastatin-sandoz-pi
Page 1 of 32
AUSTRALIAN PRODUCT INFORMATION
SIMVASTATIN SANDOZ
®
(SIMVASTATIN)
1
NAME OF THE MEDICINE
Simvastatin
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Simvastatin Sandoz
®
5 mg film coated tablet contains 5 mg simvastatin.
Each Simvastatin Sandoz
®
10 mg film coated tablet contains 10 mg simvastatin.
Each Simvastatin Sandoz
®
20 mg film coated tablet contains 20 mg simvastatin.
Each Simvastatin Sandoz
®
40 mg film coated tablet contains 40 mg simvastatin.
Each Simvastatin Sandoz
®
80 mg film coated tablet contains 80 mg simvastatin.
_Excipient with known effect:_
Sugars as lactose monohydrate
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Simvastatin Sandoz 5 mg film-coated tablets are yellow coated, oval,
scored, convex tablets,
coded ‘SIM 5’ on one side.
Simvastatin Sandoz 10 mg film-coated tablets are pale pink coated,
oval, scored, convex
tablets, coded ‘SIM 10’ on one side.
Simvastatin Sandoz 20 mg film-coated tablets are orange coated, oval,
scored, convex tablets,
coded ‘SIM 20’ on one side.
Simvastatin Sandoz 40 mg film-coated tablets are pink coated, oval,
scored, convex tablets,
coded ‘SIM 40’ on one side.
Simvastatin Sandoz 80 mg film-coated tablets are light green coated,
oval, scored, convex
tablets, coded ‘SIM 80’ on one side.
_Not all strengths may be available in Australia. _
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
•
Adjunct to diet for treatment of hypercholesterolaemia.
Prior
to
initiating
therapy
with
Simvastatin
Sandoz,
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 Sandoz 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, periphera