Pravastatin Sodium 20mg Tablets

Țară: Malta

Limbă: engleză

Sursă: Medicines Authority

Ingredient activ:

PRAVASTATIN SODIUM

Disponibil de la:

Accord Healthcare Limited

Codul ATC:

C10AA03

INN (nume internaţional):

PRAVASTATIN SODIUM

Forma farmaceutică:

TABLET

Compoziție:

PRAVASTATIN SODIUM 20 mg

Tip de prescriptie medicala:

POM

Zonă Terapeutică:

LIPID MODIFYING AGENTS

Statutul autorizaţiei:

Authorised

Data de autorizare:

2009-11-19

Prospect

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 exercise have
failed to adequately do this.
In

Caracteristicilor produsului

Page 1 of 13
SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Pravastatin Sodium 20 mg Tablets
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 20 mg pravastatin sodium.
Excipient: Lactose monohydrate 143.31mg. For a full list of
excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Tablet.
Pravastatin Tablets 20 mg: Yellow colored, rounded rectangular shaped
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).
Page 2 of 13
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 weeks,
therefore periodic lipid determinations should be performed and the
dosage adjusted accordingly.
The maximum da