Pravastatin Sodium

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Pravastatin sodium 10mg;  

Available from:

Viatris Limited

Dosage:

10 mg

Pharmaceutical form:

Tablet

Composition:

Active: Pravastatin sodium 10mg   Excipient: Dihydroxyaluminium sodium carbonate Iron oxide red Lactose monohydrate Sodium stearyl fumarate

Prescription type:

Prescription

Therapeutic indications:

Latest Regulatory Activity

Product summary:

Package - Contents - Shelf Life: Blister pack, cold form, OPA/Alu/PVC-Alu - 28 tablets - 36 months from date of manufacture stored at or below 25°C protect from moisture

Authorization date:

2020-06-08

Patient Information leaflet

Page 1 of 5
NEW ZEALAND CONSUMER MEDICINE INFORMATION
PRAVASTATIN SODIUM
_PRAVASTATIN SODIUM TABLET 10, 20, 40 MG _
_ _
WHAT IS IN THIS LEAFLET
Please read this leaflet carefully
before you start taking Pravastatin
Sodium.
This leaflet answers some common
questions about Pravastatin
Sodium.
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 Pravastatin
Sodium 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 PRAVASTATIN
SODIUM IS USED FOR
Pravastatin Sodium is used to treat
•
If you already have heart disease
and raised levels of cholesterol,
pravastatin will help reduce your
chances of having another heart
attack, or a stroke. It will reduce
your chances of requiring a
procedure (such as coronary
artery bypass grafting and
percutaneous transluminal
coronary angioplasty) to increase
the blood flow to your heart, and
will slow down any further
narrowing of your arteries.
•
If you do not have heart disease
but just raised levels of
cholesterol, pravastatin will help
prolong your life, reduce the risk of
you having a heart attack or
requiring a procedure to increase
the blood flow to your heart.
•
If you have a condition known as
primary hypercholesterolaemia,
pravastatin will help bring down
the cholesterol levels in your
blood.
Pravastatin Sodium contains the
active ingredient pravastatin
sodium. It belongs to a group of
medicines called HMG-CoA
reductase inhibitors (commonly
known as “statins”).
It works by lowering lipids (fats)
such as cholesterol and
triglycerides in your blood when
non-medicinal measures, such as
low-fat diet, exercise and lifestyle
changes, alone have failed.
Your doctor may have prescribed
this medicine for another reason.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT

Summary of Product characteristics

NEW ZEALAND DATA SHEET
PRAVASTATIN SODIUM
1. PRODUCT NAME
Pravastatin Sodium, 10, 20 & 40 mg, tablet.
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 10, 20 or 40 mg of pravastatin sodium.
Contains lactose.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Pravastatin Sodium 10 mg tablet: Light pink colour mottled, round,
flat bevelled tablet debossed
with “10” on one side and plain on the other side.
Pravastatin Sodium 20 mg tablet: Light yellow colour mottled, round
tablets debossed with “20” on
one side and break line on the other side.
Pravastatin Sodium 40 mg tablet: Light pink colour mottled, round
tablets debossed with “40” on
one side and break line on the other side.
Pravastatin 20 & 40 mg tablet can be divided into equal doses.
4. CLINICAL PARTICULARS
_4.1 _
_THERAPEUTIC INDICATIONS _
•
In hypercholesterolaemic patients without clinically evident coronary
heart disease, Pravastatin
Sodium is indicated as an adjunct to diet to reduce the risk of fatal
and non-fatal myocardial
infarction, need for myocardial revascularisation procedures, and to
improve survival by
reducing cardiovascular deaths.
•
Pravastatin Sodium is indicated for the reduction of elevated total
and LDL-cholesterol levels
in patients with primary hypercholesterolaemia when the response to
diet and other non-
pharmacological measures alone have been inadequate.
•
Pravastatin Sodium is indicated as an adjunct to diet to slow the
progressive course of
atherosclerosis
and
reduce
the
incidence
of
clinical
cardiovascular
events
in
hypercholesterolaemic men under 75 years of age with coronary artery
disease.
•
Coronary Artery Disease: In patients with a history of either a
myocardial infarction or unstable
angina pectoris, Pravastatin Sodium is indicated to reduce the risk
for total mortality, CHD
death,
recurrent
coronary
event
(including
myocardial
infarction),
need
for
myocardial
revascularisation procedures, and need for hospitalisation.
•
Cerebrovascular Disease: In patients wi