Pravastatin Sodium 40 mg Tablets

국가: 아일랜드

언어: 영어

출처: HPRA (Health Products Regulatory Authority)

유효 성분:

Pravastatin sodium

제공처:

WPR Healthcare Limited

ATC 코드:

C10AA; C10AA03

INN (International Name):

Pravastatin sodium

복용량:

40 milligram(s)

약제 형태:

Tablet

처방전 유형:

Product subject to prescription which may be renewed (B)

치료 영역:

HMG CoA reductase inhibitors; pravastatin

승인 상태:

Authorised

승인 날짜:

2014-11-14

환자 정보 전단

_ _
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 th

제품 특성 요약

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. For a full list of excipients, see
section 6.1.
3 PHARMACEUTICAL FORM
Tablet.
_Product imported from the UK:_
Pravastatin Tablets 40 mg: Yellow coloured, rounded rectangular
shaped, biconvex, uncoated tablets debossed ‘PDT’
on one side and ‘40’ on the other side.
4 CLINICAL PARTICULARS
As per PA1390/002/003
5 PHARMACOLOGICAL PROPERTIES
As per PA1390/002/003
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
lactose monohydrate
croscarmellose sodium
magnesium stearate
light magnesium oxide
microcelac
povidone
yellow ferric oxide (E172)
6.2 INCOMPATIBILITIES
Not applicable.
6.3 SHELF LIFE
The shelf life expiry date of this product shall be the date shown on
the container and outer package of the product on
the market in the country of origin.
6.4 SPECIAL PRECAUTIONS FOR STORAGE
Keep out of the reach and sight of children.
Store below 25 °C. Store in the original package in order to protect
from light and moisture.
H
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H
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6.5 NATURE AND CONTENTS OF CONTAINER
Blister packs of 28 tablets contained in an over labelled outer
cardboard carton.
6.6 SPECIAL PRECAUTIONS FOR DISPOSAL AND