PRAVASTATIN SODIUM 20 Milligram Tablets
Država: Irska
Jezik: angleščina
Source: HPRA (Health Products Regulatory Authority)
Lastnosti izdelka
(SPC)
31-05-2024
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Aktivna sestavina:
PRAVASTATIN SODIUM
Dostopno od:
WPR Healthcare Limited
INN (mednarodno ime):
PRAVASTATIN SODIUM
Odmerek:
20 Milligram
Farmacevtska oblika:
Tablets
Tip zastaranja:
Product subject to prescription which may be renewed (B)
Status dovoljenje:
Authorised
Datum dovoljenje:
0000-00-00
Lastnosti izdelka
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Pravastatin Sodium 20 mg tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains Pravastatin sodium 20mg.
Excipient: Also contain lactose anhydrous.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet
_Product imported from the Netherlands:_
Yellow, round, biconvex tablets with '93' on one side and ‘7201’ on the other side
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 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 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 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
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