Arrow-Simva 20

Pays: Nouvelle-Zélande

Langue: anglais

Source: Medsafe (Medicines Safety Authority)

Ingrédients actifs:

Simvastatin 20mg;  ;  ;  ;  

Disponible depuis:

Teva Pharma (New Zealand) Limited

DCI (Dénomination commune internationale):

Simvastatin 20 mg

Dosage:

20 mg

forme pharmaceutique:

Film coated tablet

Composition:

Active: Simvastatin 20mg         Excipient: Butylated hydroxyanisole Hyprolose Hypromellose Lactose Magnesium stearate Microcrystalline cellulose Pregelatinised maize starch Purified talc   Purified water Titanium dioxide

Unités en paquet:

Blister pack, PVC/PE/PVDC, 30 tablets

classe:

Prescription

Type d'ordonnance:

Prescription

Fabriqué par:

Biocon Limited

indications thérapeutiques:

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), i.e. patients with diabetes, history of stroke or other cerebrovascular disease, peripheral vessel disease, or with existing CHD, simvastatin 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 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, simvastatin 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, simvastatin slows the progress of coronary atherosclerosis, including reducing the development of new lesions and new total occlusions.

Descriptif du produit:

Package - Contents - Shelf Life: Blister pack, PVC/PE/PVDC - 30 tablets - 36 months from date of manufacture stored at or below 25°C - Blister pack, PVC/PE/PVDC - 90 tablets - 36 months from date of manufacture stored at or below 25°C

Date de l'autorisation:

2008-07-31

Notice patient

CONSUMER MEDICINE INFORMATION
ARROW - SIMVA
SIMVASTATIN 10 MG, 20 MG, 40 MG AND 80 MG TABLETS
WHAT IS IN THIS LEAFLET
This leaflet answers some common questions about ARROW - SIMVA.
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 benefits and risks. Your doctor has weighed the
risks of you taking
ARROW - SIMVA against the benefits he/she expects 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 ARROW - SIMVA IS USED FOR
ARROW - SIMVA helps lower high cholesterol and triglyceride levels.
Your doctor has prescribed ARROW - SIMVA to reduce the health risks
associated with
coronary heart disease (CHD). If you have CHD, diabetes, history of
stroke or other vessel
disease (regardless of the amount of cholesterol in your blood), ARROW
- SIMVA:
•
can prolong your life by reducing the risk of heart attack or stroke
•
reduces the need for surgery to increase blood flow to the legs and
major organs such as
the heart
•
reduces the need for hospitalisation for chest pain (also known as
angina).
CHOLESTEROL
Everyone has cholesterol and triglycerides in their blood. They are
the types of blood fat
needed by the body for building cell walls, making bile acids (which
help to digest food) and
certain hormones, and other functions.
There are different types of cholesterol, for example, low-density
lipoprotein (LDL) and high-
density lipoprotein (HDL) cholesterol. LDL cholesterol is the 'bad'
cholesterol that can block
your blood vessels. HDL cholesterol is the 'good' cholesterol that is
thought to remove the
bad cholesterol from the blood vessels.
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

Résumé des caractéristiques du produit

Version 1.0
1
NEW ZEALAND DATA SHEET
1.
PRODUCT NAME
Arrow – Simva 10, film coated tablets, 10 mg
Arrow - Simva 20, film coated tablets, 20 mg
Arrow - Simva 40, film coated tablets, 40 mg
Arrow - Simva 80, film coated tablets, 80 mg
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains simvastatin 10 mg, 20 mg, 40 mg or 80 mg.
Excipient with known effect:
lactose
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Arrow - Simva 10: White oblong biconvex film coated tablet, score line
and “10” on one side and
“SVT” on the reverse side.
Arrow - Simva 20:
White oblong biconvex film coated tablet, score line and “20” on
one side and
“SVT” on the reverse side.
Arrow - Simva 40: White oblong biconvex film coated tablet, score line
and “40” on one side and
“SVT” on the reverse side.
Arrow - Simva 80: White oblong biconvex film coated tablet, score line
and “80” on one side and
“SVT” on the reverse side.
The tablet can be divided into equal doses.
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), i.e. patients with diabetes, history of stroke or other
cerebrovascular disease, peripheral
vessel disease, or with existing CHD, simvastatin 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 hospitalis