NOUMED SIMVASTATIN simvastatin 20mg film coated tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

simvastatin, Quantity: 20 mg

Available from:

AVALLON PHARMACEUTICALS PTY LTD

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 Noumed 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. Noumed 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 independently control known causes of cardiovascular mortality and morbidity such as hypertension, diabetes and smoking.

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:

2018-02-02

Patient Information leaflet

NOUMED SIMVASTATIN
1
NOUMED SIMVASTATIN
_simvastatin tablets _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about NOUMED
SIMVASTATIN.
It does not contain all of 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 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 NOUMED
SIMVASTATIN IS USED
FOR
NOUMED SIMVASTATIN tablets
contain the active ingredient
simvastatin.
Simvastatin belongs to a group of
medicines called HMG-CoA
reductase inhibitors or ‘statins’.
These are drugs that help people
control their high cholesterol and
triglyceride levels.
It is also used in people who have
coronary heart disease (CHD), or
who are at high risk of CHD, for
example those with diabetes, a
history of stroke or other blood
vessel disease, regardless of their
cholesterol level. If you are in this
group, NOUMED SIMVASTATIN
may be prescribed by your doctor 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 because of angina
(chest pain).
CHOLESTEROL
Everyone has cholesterol in their
blood. It is a type 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.
Cholesterol is present in many foods
and is also made in your body by the
liver. If your body does not balance
the amount of cholesterol it makes
with the amount of cholesterol taken
from food, then your cholesterol
levels become too high.
There are two main types of
cholesterol, known as LDL and
HDL. LDL is the 'bad' cholesterol
that can block your blood vessels,
while HDL is the 'good' cholester

Summary of Product characteristics

Product Information - Australia
Page 1 of 26
AUSTRALIAN PRODUCT INFORMATION -
NOUMED SIMVASTATIN
(SIMVASTATIN FILM-COATED TABLETS]
1. NAME OF THE MEDICINE
Simvastatin
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet for oral administration contains either 5 mg, 10 mg, 20
mg, 40 mg or 80 mg of simvastatin.
Excipients with known effect: sugars (as lactose monohydrate). For the
full list of excipients, see SECTION
6.1 LIST OF EXCIPIENTS.
3. PHARMACEUTICAL FORM
NOUMED SIMVASTATIN 5mg film-coated tablets are yellow coated, oval,
scored, convex tablets, coded
‘SIM 5’ on one side.
NOUMED SIMVASTATIN 10mg film-coated tablets are pale pink coated,
oval, scored, convex tablets,
coded ‘SIM 10’ on one side.
NOUMED SIMVASTATIN 20mg film-coated tablets are orange coated, oval,
scored, convex tablets, coded
‘SIM 20’ on one side.
NOUMED SIMVASTATIN 40mg film-coated tablets are pink coated, oval,
scored, convex tablets, coded
‘SIM 40’ on one side.
NOUMED SIMVASTATIN 80mg film-coated tablets are light green coated,
oval, scored, convex tablets,
coded ‘SIM 80’ on one side.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
•
Adjunct to diet for treatment of hypercholesterolaemia.
Prior
to
initiating
therapy
with
NOUMED
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.
•
NOUMED 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 independently control known
causes of cardiovascular
mortality and morbidity such as hypertension, diabetes and