Simvastatin Viatris

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Simvastatin 20mg;  ;  

Available from:

Viatris Limited

INN (International Name):

Simvastatin 20 mg

Dosage:

20 mg

Pharmaceutical form:

Film coated tablet

Composition:

Active: Simvastatin 20mg     Excipient: Ascorbic acid Butylated hydroxytoluene Citric acid monohydrate Colloidal silicon dioxide Hypromellose Iron oxide red Iron oxide yellow Isopropyl alcohol Lactose monohydrate Macrogol 400 Magnesium stearate Maize starch Microcrystalline cellulose Pregelatinised maize starch Purified talc Purified water   Sodium starch glycolate Titanium dioxide

Units in package:

Blister pack, PVDC/PVC/Aluminium foil, 10 tablets

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

Krebs Biochemicals & Industries Limited

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 >3.5mmol/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 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 progression of coronary atherosclerosis, including reducing the development of new lesions and new total occlusions.

Product summary:

Package - Contents - Shelf Life: Blister pack, PVDC/PVC/Aluminium foil - 10 tablets - 36 months from date of manufacture stored at or below 25°C - Blister pack, PVDC/PVC/Aluminium foil - 14 tablets - 36 months from date of manufacture stored at or below 25°C - Blister pack, PVDC/PVC/Aluminium foil - 20 tablets - 36 months from date of manufacture stored at or below 25°C - Blister pack, PVDC/PVC/Aluminium foil - 28 tablets - 36 months from date of manufacture stored at or below 25°C - Blister pack, PVDC/PVC/Aluminium foil - 30 tablets - 36 months from date of manufacture stored at or below 25°C - Blister pack, PVDC/PVC/Aluminium foil - 50 tablets - 36 months from date of manufacture stored at or below 25°C - Blister pack, PVDC/PVC/Aluminium foil - 56 tablets - 36 months from date of manufacture stored at or below 25°C - Blister pack, PVDC/PVC/Aluminium foil - 60 tablets - 36 months from date of manufacture stored at or below 25°C - Blister pack, PVDC/PVC/Aluminium foil - 84 tablets - 36 months from date of manufacture stored at or below 25°C - Blister pack, PVDC/PVC/Aluminium foil - 90 tablets - 36 months from date of manufacture stored at or below 25°C - Blister pack, PVDC/PVC/Aluminium foil - 98 tablets - 36 months from date of manufacture stored at or below 25°C - Blister pack, PVDC/PVC/Aluminium foil - 100 tablets - 36 months from date of manufacture stored at or below 25°C - Blister pack, PVDC/PVC/Aluminium foil - 500 tablets - 36 months from date of manufacture stored at or below 25°C

Authorization date:

2004-06-29

Patient Information leaflet

Page 1 of 5
NEW ZEALAND CONSUMER MEDICINE INFORMATION
SIMVASTATIN VIATRIS
_SIMVASTATIN FILM-COATED TABLETS 10MG, 20MG, 40MG & 80MG_
WHAT IS IN THIS LEAFLET
Please read this leaflet carefully
before you start taking Simvastatin
Viatris.
This leaflet answers some common
questions about Simvastatin Viatris.
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
Viatris 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
VIATRIS IS USED FOR
Simvastatin Viatris helps to lower
high cholesterol and triglyceride
levels, and is used to reduce the
health risks associated with
coronary heart disease (CHD).
If you have CHD, diabetes, history
of stroke, or other blood vessel
disease (regardless of the amount
of cholesterol in your blood), then
Simvastatin Viatris can:
•
help prolong your life by
reducing the risk of a heart
attack or stroke
•
reduce the need for surgery
to increase blood flow to the
legs or major organs such
as the heart
•
reduce the need for
hospitalisation due to
angina (chest pain).
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
fro

Summary of Product characteristics

Page 1 of 21
NEW ZEALAND DATA SHEET
SIMVASTATIN VIATRIS
1. PRODUCT NAME
Simvastatin Viatris 10 mg, 20 mg, 40 mg and 80 mg film coated tablets.
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Simvastatin Viatris tablet contains 10 mg, 20 mg, 40 mg or 80 mg
of simvastatin.
Excipient with known effect: lactose.
Allergen declaration: sugars as lactose.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Simvastatin Viatris 10 mg: Pinkish brown coloured, oval, biconvex,
film coated tablets with ‘BL’
debossed on one side and ‘10’ debossed on the other side.
Simvastatin Viatris 20 mg: Peach coloured, oval, biconvex, film coated
tablets with ‘BL’ debossed
on one side and ‘20’ debossed on the other side.
Simvastatin Viatris 40 mg: Dull pink coloured, oval, biconvex, film
coated tablets with ‘BL’ debossed
on one side and ‘40’ debossed on the other side.
Simvastatin Viatris 80 mg: Pink coloured, capsule shaped, biconvex,
film coated tablets with
‘80’ debossed on one side.
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);
Page 2 of 21
•
Reduce the need for peripheral and other non-coronary
revascularisation procedures;
•
Reduce t