PRAVASTATIN SODIUM 10 Milligram Tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

PRAVASTATIN SODIUM

Available from:

Actavis Group PTC ehf

ATC code:

C10AA03

INN (International Name):

PRAVASTATIN SODIUM

Dosage:

10 Milligram

Pharmaceutical form:

Tablets

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

HMG CoA reductase inhibitors

Authorization status:

Authorised

Authorization date:

2013-04-26

Patient Information leaflet

PRAVASTATIN SODIUM 10 MG, 20 MG AND 40 MG TABLETS
(pravastatin sodium)
PACKAGE LEAFLET: INFORMATION FOR THE USER
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 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 possible side effects not 
listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1
   WHAT PRAVASTATIN SODIUM TABLETS ARE AND WHAT 
THEY ARE USED FOR
2
    WHAT YOU NEED TO KNOW BEFORE YOU TAKE 
PRAVASTATIN SODIUM TABLETS
3
  HOW TO TAKE PRAVASTATIN SODIUM TABLETS
4
  POSSIBLE SIDE EFFECTS
5
  HOW TO STORE PRAVASTATIN SODIUM TABLETS
6
  CONTENTS OF THE PACK AND OTHER INFORMATION
1
    WHAT PRAVASTATIN SODIUM TABLETS ARE AND WHAT 
THEY ARE USED FOR
The active substance in your medicine is called pravastatin 
sodium which belongs to a group of medicines known as statins 
or “HMG-CoA reductase inhibitors”. These work by reducing 
the amount of cholesterol and other fatty substances called 
triglycerides in your blood.
Cholesterol is important for the body to work properly but if 
cholesterol levels are too high (hypercholesterolaemia), it can 
build up on the walls of the arteries which can lead to a blockage 
of the blood vessels. This can lead to angina (crushing chest pain) 
and a heart attack.
High cholesterol in your blood may be caused by many factors, 
including a diet high in cholesterol and fats, certain existing 
diseases, inherited disease and lack of exercise.
Your doctor may have prescribed Pravastatin sodium Tablets as 
an addition to dietary measures for one of the following reasons:
•  You have h

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Pravastatin sodium 10 mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains pravastatin sodium 10 mg.
Each tablet also contains 58.65mg lactose monohydrate.
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Tablet
White to off-white, capsule shaped tablet with, "
" on one side of the tablet and “PV|10” on the other side.
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 Tablets is administered orally once daily preferably in the evening with or without food.
HYPERCHOLESTEROLAEMIA: The recommended dose range is 10-40 mg once daily.