LIPOSTAT 20 Milligram Tablets

Nazione: Irlanda

Lingua: inglese

Fonte: HPRA (Health Products Regulatory Authority)

Principio attivo:

PRAVASTATIN SODIUM

Commercializzato da:

Bristol-Myers Squibb Pharmaceuticals uc

Codice ATC:

C10AA03

INN (Nome Internazionale):

PRAVASTATIN SODIUM

Dosaggio:

20 Milligram

Forma farmaceutica:

Tablets

Tipo di ricetta:

Product subject to prescription which may be renewed (B)

Area terapeutica:

HMG CoA reductase inhibitors

Stato dell'autorizzazione:

Authorised

Data dell'autorizzazione:

1997-10-31

Foglio illustrativo

PACKAGE LEAFLET: INFORMATION FOR THE USER
LIPOSTAT 10MG, 20MG AND 40MG 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 any further questions, 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 LIPOSTAT is and what it is used for
2.
Before you take LIPOSTAT
3.
How to take LIPOSTAT
4.
Possible side effects
5.
How to store LIPOSTAT
6.
Further information
1.
WHAT LIPOSTAT IS AND WHAT IT IS USED FOR
LIPOSTAT 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 blocks
them.
This condition is called hardening of the arteries or atherosclerosis
and it may lead to:

chest pain (angina pectoris), when a blood vessel in the heart is
partially blocked,

a heart attack (myocardial infarction), when a blood vessel 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
LIPOSTAT 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 the prevention of heart and blood vessel diseases

If you have high levels of cholesterol in your blood and risk factors
favouring these diseases (if
you smo

Scheda tecnica

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Lipostat 20 mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 20 mg pravastatin sodium.
Each tablet contains 129.90 mg of lactose monohydrate.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet
Yellow, capsule shaped biconvex scored tablet with a "20" engraved on
one side. The score line is only to facilitate
breaking for ease of swallowing and not to divide into equal doses.
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 (e.g. 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 (MI) 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 patients
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 Lipostat, secondary causes of
hypercholesterolaemia should be excluded and patients should be
placed on a standard lipid-lowering diet which should be continued
during treatment.
Lipostat 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 t