BYSTAT Tablets 40 Milligram

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

PRAVASTATIN SODIUM

Available from:

Helsinn Birex Therapeutics Ltd

Dosage:

40 Milligram

Pharmaceutical form:

Tablets

Authorization date:

2009-08-14

Summary of Product characteristics

License
Summary of Product Characteristics
1 NAME OF THE MEDICINAL PRODUCT
Bystat 40 mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 40 mg of pravastatin sodium.
Excipients: Each tablet contains 210.90 mg lactose.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet.
Light green, round, shallow convex tablet, with the inscription “93” on one side and “7202” on the other.
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 immunosuppressive