Pravastatin Sodium 10mg Tablets

Država: Malta

Jezik: angleščina

Source: Medicines Authority

Aktivna sestavina:

PRAVASTATIN SODIUM

Dostopno od:

Accord Healthcare Limited

Koda artikla:

C10AA03

INN (mednarodno ime):

PRAVASTATIN SODIUM

Farmacevtska oblika:

TABLET

Sestava:

PRAVASTATIN SODIUM 10 mg

Tip zastaranja:

POM

Terapevtsko območje:

LIPID MODIFYING AGENTS

Status dovoljenje:

Authorised

Datum dovoljenje:

2009-11-19

Navodilo za uporabo

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

Lastnosti izdelka

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