SIMVASTATIN GENERICHEALTH simvastatin 10mg tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

simvastatin, Quantity: 10 mg

Available from:

Generic Health Pty Ltd

INN (International Name):

Simvastatin

Pharmaceutical form:

Tablet, film coated

Composition:

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

Administration route:

Oral

Units in package:

30 tablets

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Simvastatin generichealth tablets are 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 generichealth tablets are 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 hospitilisation 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 generichealth tablets are 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, 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: Peach coloured, oval shaped, biconvex, film-coated tablets, debossed with '10' on one side and breakline 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

Authorization status:

Registered

Authorization date:

2007-07-17

Patient Information leaflet

CONSUMER MEDICINE INFORMATION
SIMVASTATIN GENERICHEALTH
(SIMVASTATIN) FILM-COATED TABLET
WHAT IS IN THIS LEAFLET
This leaflet answers some
common questions about
Simvastatin generichealth. 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 generichealth
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
GENERICHEALTH IS USED FOR
Simvastatin generichealth helps
to lower cholesterol and
triglyceride levels.
Simvastatin generichealth 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 generichealth 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 ma

Summary of Product characteristics

AUSTRALIAN PRODUCT INFORMATION – SIMVASTATIN GENERICHEALTH
(SIMVASTATIN) FILM COATED TABLET
1
NAME OF THE MEDICINE
Simvastatin.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet for oral administration contains either 10 mg, 20 mg, 40
mg or 80 mg of simvastatin.
List of excipients with known effect: sugars (as lactose monohydrate).
For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
Simvastatin generichealth 10 mg:
Peach
coloured,
oval
shaped,
biconvex,
film-coated
tablets,
debossed with ‘10’ on one side and a breakline on the other side.
Simvastatin generichealth 20 mg:
Tan coloured, oval shaped, biconvex, film-coated tablets, debossed
with ‘20’ on one side and a breakline on the other side.
Simvastatin generichealth 40 mg:
Brick
red
coloured,
oval
shaped,
biconvex,
film-coated
tablets,
debossed with ‘40’ on one side and a breakline on the other side.
Simvastatin generichealth 80 mg:
Brick red coloured, capsule shaped, biconvex, film-coated tablets,
debossed with ‘80’ on one side and a breakline on the other side.
4
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
•
Simvastatin generichealth is indicated as an adjunct to diet for
treatment of hypercholesterolaemia.
Prior to initiating therapy with simvastatin, secondary causes of
hypercholesterolaemia (eg. poorly
controlled diabetes mellitus, hypothyroidism, nephrotic syndrome,
dysproteinaemias, obstructive
liver disease, other drug therapy, alcoholism) should be identified
and treated.
•
Simvastatin
generichealth
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,