Pravitin 40 mg Tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Pravastatin sodium

Available from:

Rowex Ltd

ATC code:

C10AA; C10AA03

INN (International Name):

Pravastatin sodium

Dosage:

40 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:

2004-05-14

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
PRAVITIN 40 MG TABLETS
pravastatin sodium
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 possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Pravitin is and what it is used for
2.
What you need to know before you take Pravitin
3.
How to take Pravitin
4.
Possible side effects
5
How to store Pravitin
6.
Contents of the pack and other information
1.
WHAT PRAVITIN IS AND WHAT IT IS USED FOR
Pravitin belongs to a group of medicines called HMG-CoA reductase
inhibitors (or statins) which
work by reducing your body’s production of “bad cholesterol” and
raising the levels of “good”
cholesterol. Cholesterol is a lipid that can cause coronary heart
disease by narrowing the vessels that
supply the heart with blood. This condition, called hardening of the
arteries or atherosclerosis, may
lead to chest pain (angina pectoris), a heart attack (myocardial
infarction) or stroke.
This medicine is used in 3 situations:
In the treatment of high levels of cholesterol and fats in the blood
Pravitin is used to lower high levels of “bad” cholesterol and to
raise the levels of “good” cholesterol
in the blood when changes to diet and exercise have failed to
adequately do this.
In the prevention of heart and blood vessel diseases
•
If you have high levels of cholesterol in your blood and risk factors
favouring these diseases (if
you smoke, are overweight, if you have high blood sugar levels or high
blood pressure, if you
take little exercise), Pravitin is used to reduce the risk of you
having heart and blood

Summary of Product characteristics

Health Products Regulatory Authority
13 September 2023
CRN00DTR5
Page 1 of 11
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Pravitin 40 mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 40 mg pravastatin sodium.
Excipients with known effect
Each tablet contains 0.2664 mmol (6.128 mg) sodium
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet.
A yellow, oval, convex, side wall scored tablet encoded P 40
The tablet can be divided into equal doses.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
HYPERCHOLESTEROLAEMIA
Treatment of primary hypercholesterolaemia 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 hypercholesterolaemia 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 (MI) 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 organ
transplantation (see sections 4.2, 4.5 and 5.1).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Prior to initiating pravastatin, 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.
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 periodic lipid determinations