Pravastatin Sodium 10mg Tablets

מדינה: מלטה

שפה: אנגלית

מקור: Medicines Authority

מרכיב פעיל:

PRAVASTATIN SODIUM

זמין מ:

Accord Healthcare Ireland Ltd Euro House, Euro Business Park, Little Island Cork, T45 K857, Ireland

קוד ATC:

C10AA03

INN (שם בינלאומי):

PRAVASTATIN SODIUM 10 mg

טופס פרצבטיות:

TABLET

הרכב:

PRAVASTATIN SODIUM 10 mg

סוג מרשם:

POM

איזור תרפויטי:

LIPID MODIFYING AGENTS

מצב אישור:

Withdrawn

תאריך אישור:

2009-11-19

עלון מידע

PAGE 1 OF 6
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

מאפייני מוצר

Page 1 of 13
SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Pravastatin Sodium 10 mg Tablets
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 10 mg pravastatin sodium.
Excipient: Lactose monohydrate 71.65 mg. For a full list of
excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Tablet.
Pravastatin Tablets 10 mg: Yellow colored, rounded rectangular shaped,
biconvex, uncoated tablets
debossed ‘PDT’ on one side and ‘10’ 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).
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 l