Pravastatin Sodium 40 mg Tablets

Riik: Iirimaa

keel: inglise

Allikas: HPRA (Health Products Regulatory Authority)

Toimeaine:

Pravastatin sodium

Saadav alates:

Accord Healthcare Ireland Ltd.

ATC kood:

C10AA; C10AA03

INN (Rahvusvaheline Nimetus):

Pravastatin sodium

Annus:

40 milligram(s)

Ravimvorm:

Tablet

Retsepti tüüp:

Product subject to prescription which may be renewed (B)

Terapeutiline ala:

HMG CoA reductase inhibitors; pravastatin

Volitamisolek:

Marketed

Loa andmise kuupäev:

2008-09-26

Infovoldik

NL/H/4554/001-003/IA/042, version 1, Jun 2023
PACKAGE LEAFLET: INFORMATION FOR THE USER
PRAVASTATIN SODIUM 10 MG TABLETS PRAVASTATIN SODIUM 20 MG TABLETS
PRAVASTATIN SODIUM 40 MG TABLETS
PRAVASTATIN SODIUM
Read all of this leaflet carefully before you start taking this
medicine
•
Keep this leaflet. You may need to read it again.
•
If you have further questions, please ask your doctor or pharmacist.
•
This medicine has been prescribed for you. Do not pass it on to
others. It may harm
them, even if their symptoms are the same as yours.
•
If any of the side effects gets serious, or if you notice any side
effects not listed in this
leaflet, please tell your doctor or pharmacist.
IN THIS LEAFLET:
1. What Pravastatin Sodium Tablets is and what it is used for
2. 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. Further information
1. WHAT PRAVASTATIN SODIUM TABLETS IS AND WHAT IT IS USED FOR
Pravastatin Sodium Tablets belongs to a group of medicines called
statins (or HMG-CoA
reductase inhibitors). It prevents the production of cholesterol by
the liver and consequently
reduces the levels of cholesterol and other fats (triglycerides) in
your body. When there are
excessive levels of cholesterol in the blood, the cholesterol
accumulates on the walls of blood
vessels and block them. This condition is called hardening of the
arteries or atherosclerosis, may
lead to:
•
chest pain (angina pectoris), when a blood vessels in the heart is
partially blocked,
•
a heart attack (myocardial infraction), when a blood vessels in the
heart is completely
blocked,
•
a stroke (cerebrovascular accident), when a blood vessel in the brain
is completely
blocked.
This medicine is used in 3 situations:
In the treatment of high levels of cholesterol and fats in the blood
Pravastatin Sodium Tablets 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

Toote omadused

Health Products Regulatory Authority
16 June 2023
CRN00DK35
Page 1 of 11
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Pravastatin Sodium 40 mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 40 mg pravastatin sodium.
Excipient: Lactose monohydrate 286.62 mg. For a full list of
excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet.
Pravastatin Tablets 40 mg: Yellow colored, rounded rectangular shaped,
biconvex, uncoated tablets debossed ‘PDT’ on one side
and ‘40’ on the other side.
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 (eg. 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 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-patient 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 sodium 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 wee