BELLPRAV 40 Milligram Tablets
Country: Իռլանդիա
language: անգլերեն
source: HPRA (Health Products Regulatory Authority)
SPC
(SPC)
16-04-2024
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active_ingredient:
PRAVASTATIN SODIUM
MAH:
Ranbaxy (UK) Limited
INN:
PRAVASTATIN SODIUM
dosage:
40 Milligram
pharmaceutical_form:
Tablets
prescription_type:
Product subject to prescription which may be renewed (B)
authorization_status:
Withdrawn
authorization_date:
0000-00-00
SPC
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
BellPrav 40 mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 40 mg Pravastatin Sodium.
Also includes lactose.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet
Dark yellow to yellow coloured mottled, circular, biconvex tablets debossed with “P3” on one side and a breakline on the other
side.
The tablet can be divided into equal halves.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
HYPERCHOLESTEROLEMIA
Treatment of primary hypercholesterolemia 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 hypercholesterolemia 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 patients receiving immunosupressive therapy following solid
organ transplantation (see sections 4.2, 4.5 and 5.1).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Prior to initiating Pravastatin Tablets1, 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 Tablets1 is administered orally once daily preferably in the evening with or without food.
HYPERCHOLESTEROLEMIA
The recommended dose range is
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