ZIMSTAT simvastatin 10mg tablet blister pack

Land: Australië

Taal: Engels

Bron: Department of Health (Therapeutic Goods Administration)

Werkstoffen:

simvastatin, Quantity: 10 mg

Beschikbaar vanaf:

Alphapharm Pty Ltd

farmaceutische vorm:

Tablet, film coated

Samenstelling:

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

Toedieningsweg:

Oral

Eenheden in pakket:

30 tablets, 28 tablets, 90 tablets, 7 tablets - starter pack, 10 tablets - starter pack, 100 tablets, 5 tablets - starter pack, 60 tablets

Prescription-type:

(S4) Prescription Only Medicine

therapeutische indicaties:

ZIMSTAT is indicated as an adjunct to diet for treatment of hypercholesterolaemia. Prior to initiating therapy with ZIMSTAT, 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. ZIMSTAT 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, 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. ZIMSTAT 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 ZIMSTAT, 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 samenvatting:

Visual Identification: Dark peach to pink coloured, oval shaped, film-coated tablet with "G" on one side and "SM" scoreline "10" on the other side.; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

Autorisatie-status:

Registered

Autorisatie datum:

2003-07-18

Bijsluiter

ZIMSTAT
_simvastatin_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Zimstat.
It does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have benefits and
risks. Your doctor has weighed the
risks of you taking Zimstat against
the benefits they expect it will have
for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, TALK TO YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH YOUR
MEDICINE.
You may need to read it again.
WHAT ZIMSTAT IS USED
FOR
Zimstat helps to lower cholesterol
and triglyceride levels.
Zimstat 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).
Zimstat 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
where it is needed. Over time, this
can form har

Productkenmerken

AUSTRALIAN PRODUCT INFORMATION
ZIMSTAT
_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.
Each tablet for oral administration contains either 5 mg, 10 mg, 20
mg, 40 mg or 80 mg of simvastatin
Excipients with known effect: Contains sugars as lactose
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Zimstat 5
:
Dark buff coloured, oval shaped, film-coated tablet, with “G” on
one side and “SM”
scoreline “5” on the other side.
Zimstat 10
:
Dark peach to pink coloured, oval shaped, film-coated tablet with
“G” on one side and
“SM” scoreline “10” on the other side.
Zimstat 20
:
Dark tan coloured, oval shaped film-coated tablet with “G” on one
side and “SM”
scoreline “20” on the other side.
Zimstat 40
:
Pink coloured, oval shaped, film-coated tablet with “G” on one
side and “SM40” on the
other side.
Zimstat 80
:
Pink to brick red coloured capsule shaped, film-coated tablet with
“G” on one side and
“SM80” on the other side.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
•
ZIMSTAT is indicated as an adjunct to diet for treatment of
hypercholesterolaemia.
Prior to initiating therapy with ZIMSTAT, 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 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, and hospitalisation due to
angina pectoris.
These effects do not replace the need to