Lipex

País: Nueva Zelanda

Idioma: inglés

Fuente: Medsafe (Medicines Safety Authority)

Ingredientes activos:

Simvastatin 20mg

Disponible desde:

Merck Sharp & Dohme (New Zealand) Limited

Designación común internacional (DCI):

Simvastatin 20 mg

Dosis:

20 mg

formulario farmacéutico:

Film coated tablet

Composición:

Active: Simvastatin 20mg Excipient: Ascorbic acid Butylated hydroxyanisole Carnauba wax Citric acid monohydrate Hyprolose Hypromellose Iron oxide red Iron oxide yellow Lactose monohydrate Magnesium stearate Microcrystalline cellulose Pregelatinised maize starch Purified talc Titanium dioxide

Unidades en paquete:

Blister pack, 30 tablets

clase:

Prescription

tipo de receta:

Prescription

Fabricado por:

MSD International GmbH (Ireland)

indicaciones terapéuticas:

Patients at High Risk of Coronary Heart Disease (CHD) or With Existing CHD In patients at high risk of CHD (with or without hyperlipidaemia but with a total cholesterol of >3.5 mmol/L), ie., patients with diabetes, history of stroke or other cerebrovascular disease, peripheral vessel disease, or with existing CHD, LIPEX is indicated to: · Reduce the risk of total mortality by reducing CHD deaths; · Reduce the risk of major vascular events (a composite of non-fatal myocardial infarction, CHD death, stroke, or revascularisation procedures; · Reduce the risk of major coronary events (a composite of non-fatal myocardial infarction or CHD deaths); · Reduce the risk of stroke; · Reduce the need for coronary revascularisation procedures (including coronary artery bypass grafting and percutaneous transluminal coronary angioplasty); · Reduce the need for peripheral and other non-coronary revascularisation procedures; · Reduce the risk of hospitalisation for angina pectoris. In patients with diabetes, LIPEX reduces the risk of developing peripheral macrovascular complications (a composite of peripheral revascularisation procedures, lower limb amputations, or leg ulcers). In hypercholesterolaemic patients with coronary heart disease, LIPEX slows the progression of coronary atherosclerosis, including reducing the development of new lesions and new total occlusions.

Resumen del producto:

Package - Contents - Shelf Life: Blister pack, - 30 tablets - 24 months from date of manufacture stored at or below 30°C

Fecha de autorización:

1988-12-15

Información para el usuario

LIPEX
®
1
LIPEX
®
_Simvastatin _
NEW ZEALAND CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about LIPEX. 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 LIPEX 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 LIPEX IS USED
FOR
LIPEX helps to lower cholesterol and
triglyceride levels.
LIPEX 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).
LIPEX 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

Ficha técnica

NEW ZEALAND DATA SHEET
Page
1
of
21
1 LIPEX (SIMVASTATIN) TABLETS
LIPEX (simvastatin) 10 mg tablet
LIPEX (simvastatin) 20 mg tablet
LIPEX (simvastatin) 40 mg tablet
LIPEX (simvastatin) 80 mg tablet
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 10 mg tablet contains simvastatin 10 mg
Each 20 mg tablet contains simvastatin 20 mg
Each 40 mg tablet contains simvastatin 40 mg
Each 80 mg tablet contains simvastatin 80 mg
Excipients with known effect
Each 10 mg tablet contains 70.7 mg lactose monohydrate.
Each 20 mg tablet contains 141.5 mg lactose monohydrate.
Each 40 mg tablet contains 283 mg lactose monohydrate.
Each 80 mg tablet contains 565.5 mg lactose monohydrate.
For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM
LIPEX 10 mg is a peach coloured oval shaped biconvex film coated
tablet imprinted
MSD735 on one side and unmarked on the other. Dimensions 8.51 mm x
5.05 mm.
LIPEX 20 mg is a tan coloured oval shaped biconvex film coated tablet
imprinted MSD740
on one side and unmarked on the other. Dimensions 11.10 mm x 6.35 mm.
LIPEX 40 mg is a brick red oval shaped biconvex film coated tablet
imprinted MSD749 on
one side and unmarked on the other. Dimensions 8 mm x 14 mm.
LIPEX 80 mg is a brick red capsule shaped tablet imprinted 543 on one
side and 80 on the
other. Dimensions 17.46 mm x 7.5 mm.
4 CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Patients at High Risk of Coronary Heart Disease (CHD) or With Existing
CHD
In patients at high risk of CHD (with or without hyperlipidaemia but
with a total cholesterol of
>3.5 mmol/L), ie., patients with diabetes, history of stroke or other
cerebrovascular disease,
peripheral vessel disease, or with existing CHD, LIPEX is indicated
to:
•
Reduce the risk of total mortality by reducing CHD deaths;
•
Reduce the risk of major vascular events (a composite of non-fatal
myocardial
infarction, CHD death, stroke, or revascularisation procedures;
NEW ZEALAND DATA SHEET
Page
2
of
21
•
Reduce the risk of major coronary events (a composite of non-fatal
myocar