Pravastatin

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Pravastatin sodium 40mg

Available from:

Clinect NZ Pty Limited

INN (International Name):

Pravastatin sodium 40 mg

Dosage:

40 mg

Pharmaceutical form:

Tablet

Composition:

Active: Pravastatin sodium 40mg Excipient: Brilliant blue FCF Croscarmellose sodium Iron oxide yellow Lactose monohydrate Magnesium stearate Microcrystalline cellulose

Units in package:

Blister pack, aluminium / aluminium blister strips, 30 tablets

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

Guangdong Blue Treasure Pharmaceutical Co. Limited

Therapeutic indications:

In hypercholesterolemic patients without clinically evident coronary heart disease, pravastatin 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.

Product summary:

Package - Contents - Shelf Life: Blister pack, aluminium / aluminium blister strips - 30 tablets - 24 months from date of manufacture stored at or below 25°C - Bottle, plastic, White HDPE/white polypropylene cap - 30 tablets - 24 months from date of manufacture stored at or below 25°C protect from moisture - Bottle, plastic, White HDPE/blue polypropylene cap - 30 tablets - 24 months from date of manufacture stored at or below 25°C protect from moisture - Bottle, plastic, White HDPE/white polypropylene cap - 100 tablets - 24 months from date of manufacture stored at or below 25°C protect from moisture - Bottle, plastic, White HDPE/blue polypropylene cap - 100 tablets - 24 months from date of manufacture stored at or below 25°C protect from moisture - Bottle, plastic, White HDPE/white polypropylene cap - 500 tablets - 24 months from date of manufacture stored at or below 25°C protect from moisture - Bottle, plastic, White HDPE/blue polypropylene cap - 500 tablets - 24 months from date of manufacture stored at or below 25°C protect from moisture

Authorization date:

2008-06-16

Patient Information leaflet

PRAVASTATIN TABLETS
1
PRAVASTATIN TABLETS
_Contains the active ingredient Pravastatin sodium _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
Please read this leaflet carefully
before you start using
PRAVASTATIN.
This leaflet answers some common
questions about PRAVASTATIN. 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 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 THIS MEDICINE IS
USED FOR
PRAVASTATIN contains the active
ingredient pravastatin sodium.
This medicine belongs to a group of
medicines called HMG-CoA
reductase inhibitors. It works by
reducing the cholesterol biosynthesis
PRAVASTATIN is used to:
•
reduce the risk of heart attacks,
reduce the need for treatment
related to heart blood vessels and
to reduce deaths related to the
heart blood vessels in patients
with high cholesterol levels who
already follow an amended diet
•
treat high levels of cholesterol
where measures to diet and
lifestyle changes were not
sufficient
•
reduce the incidences of further
heart diseases in male patients
less than 75 years of age with pre-
existing diseases related to
•
the heart blood vessels when
taken in addition to dietary
amendments
•
reduce the incidences of further
heart diseases and reduce the
need for treatment related to
heart blood vessels in patients
who have had such problems
•
reduce transplant rejection and to
improve survival rates in heart or
kidney transplant patients who
are also being given
immunosuppressive medicine
Your doctor may have prescribed
PRAVASTATIN for another reason.
Cholesterol is a naturally occurring
substance in the body necessary for
normal growth. However, when you
have high levels of cholesterol it may
'stick' to the inside of your blo

Summary of Product characteristics

1
NEW ZEALAND DATA SHEET
1
PRAVASTATIN TABLETS
PRAVASTATIN 10mg tablet
PRAVASTATIN 20mg tablet
PRAVASTATIN 40mg tablet
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Pravastatin sodium 10mg
Pravastatin sodium 20mg
Pravastatin sodium 40mg
EXCIPIENT WITH KNOWN EFFECT:
Gluten: PRAVASTATIN 10mg, 20mg and 40mg tablets are gluten free.
Lactose: PRAVASTATIN 10mg, 20mg and 40mg tablets contain Lactose. If
you have been told by your doctor
that you may have intolerance to some sugars, please contact your
doctor before taking this medicinal product.
For a full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
PRAVASTATIN 10 mg tablets are light pink, round, unscored tablets,
imprinted “APO” on one side and “PRA”
over “10” on the other side.
PRAVASTATIN 20 mg tablets are off-white to light yellow, round,
unscored tablets, imprinted “APO” on one
side and “PRA” over “20” on the other side.
PRAVASTATIN 40 mg tablets are light green, round, unscored tablets,
imprinted “APO” on one side and “PRA”
over “40” on the other side.
4
CLINICAL PARTICULARS THERAPEUTIC INDICATIONS
PRAVASTATIN is indicated for:
1.
In hypercholesterolaemic patients without clinically evident coronary
heart disease, pravastatin 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.
2.
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.
3.
as an adjunct to diet to slow the progressive course of
atherosclerosis and reduce the incidence of clinical
cardiovascular events in hypercholesterolaemic men under the age of 75
with coronary artery disease.
2
4.
Coronary Artery Disease: In patients with a history of either a
myocardial infarction or unstable angina
pectoris, pravastatin is indicated to reduce the risk for total
mortalit