Pravastatin Sodium 20 mg Tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Pravastatin sodium

Available from:

Norton Waterford

ATC code:

C10AA; C10AA03

INN (International Name):

Pravastatin sodium

Dosage:

20 milligram(s)

Pharmaceutical form:

Tablet

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

HMG CoA reductase inhibitors; pravastatin

Authorization status:

Marketed

Authorization date:

2005-09-30

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
PRAVASTATIN SODIUM 10 MG, 20 MG, AND 40 MG TABLETS
PRAVASTATIN
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
•
Keep this leaflet. You may need to read it again.
•
If you have any further questions, ask your doctor or pharmacist.
•
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
•
If you get any side effects, talk to your doctor or pharmacist. This
includes any side effects not
listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1. WHAT PRAVASTATIN IS AND WHAT IT IS USED FOR
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE PRAVASTATIN
3. HOW TO TAKE PRAVASTATIN
4. POSSIBLE SIDE EFFECTS
5. HOW TO STORE PRAVASTATIN
6. CONTENTS OF THE PACK AND OTHER INFORMATION
1.
WHAT PRAVASTATIN IS AND WHAT IT IS USED FOR
Pravastatin belongs to a group of drugs called HMG-CoA reductase
inhibitors. These reduce the
amount of cholesterol and triglycerides (fatty substances) in your
blood.
Pravastatin is used:
•
to reduce your risk in the future of developing coronary heart disease
or having a heart attack or
stroke, if you have raised levels of cholesterol but do not have
coronary heart disease
•
to reduce your risk of having a further heart attack or stroke, if you
have already had a heart attack
or have unstable angina
•
to reduce increased lipid levels, if you have had an organ transplant
and are taking medication to
stop your body rejecting the transplant.
Some further information:
•
While cholesterol is vital for the normal functioning of the body, if
the level in the blood becomes
too high it can build up on the walls of the arteries. Eventually
blood vessels can become blocked.
Only a small amount of cholesterol comes from our diet, the majority
is made by our own livers.
The body produces most cholesterol at night.
•
Even though you may be on a low fat diet, your doctor has done some
bloo

Summary of Product characteristics

Health Products Regulatory Authority
24 May 2023
CRN00DJ3H
Page 1 of 11
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Pravastatin Sodium 20 mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains pravastatin sodium 20 mg.
Excipients with known effect: Each tablet contains 105.46 mg lactose.
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Tablet.
Light yellow, round, shallow convex tablet with breakline on both
sides.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
_Hypercholesterolemia_
Treatment of primary hypercholesterolemia or mixed dyslipidaemia, as
an adjunct to diet, when response to diet and other
non-pharmacological treatments (e.g. exercise, weight reduction) is
inadequate.
_Primary prevention_
Reduction of cardiovascular mortality and morbidity in patients with
moderate or severe hypercholesterolemia and at high risk
of a first cardiovascular event, as an adjunct to diet (see section
5.1).
_Secondary prevention_
Reduction of cardiovascular mortality and morbidity in patients with a
history of myocardial infarction or unstable angina
pectoris and with either normal or increased cholesterol levels, as an
adjunct to correction of other risk factors (see section 5.1).
_Post transplantation_
Reduction of post transplantation hyperlipidaemia in patients
receiving immunosuppressive therapy following solid organ
transplantation (see sections 4.2, 4.5 and 5.1).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Prior to initiating Pravastatin Tablets, secondary causes of
hypercholesterolaemia should be excluded and patients should be
placed on a standard lipid-lowering diet which should be continued
during treatment.
Pravastatin is administered orally once daily preferably in the
evening with or without food.
A total daily dose of 40 mg should not be exceeded.
_Hypercholesterolaemia_
The recommended dose range is 10-40 mg once daily. The therapeutic
response is seen within a week and the full effect of a
given dose occurs within four weeks, therefore peri