ALIPZA 2 Base Milligrams Film Coated Tablet
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
19-04-2024
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Active ingredient:
PITAVASTATIN CALCIUM
Available from:
Kowa Pharmaceutical Europe Co. Ltd
INN (International Name):
PITAVASTATIN CALCIUM
Dosage:
2 Base Milligrams
Pharmaceutical form:
Film Coated Tablet
Prescription type:
Product subject to prescription which may be renewed (B)
Authorization status:
Withdrawn
Authorization date:
2013-02-04
Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Alipza 2mg film-coated tablets.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains pitavastatin calcium equivalent to 2mg pitavastatin.
Excipient(s) include 126.17mg Lactose monohydrate.
For a full list of excipients see Section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
Round white film-coated tablets embossed ‘KC’ on one face and ‘2’on the reverse.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Alipza is indicated for the reduction of elevated total cholesterol (TC) and LDL-C, in adult patients with primary
hypercholesterolaemia, including heterozygous familial hypercholesterolaemia, and combined (mixed) dyslipidaemia,
when response to diet and other non-pharmacological measures is inadequate.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
For oral use only and should be swallowed whole. Alipza can be taken at any time of the day with or without food. It is
desirable that the patient takes the tablet at the same time each day. Statin therapy is generally more effective in the
evening due to the circadian rhythm of lipid metabolism. Patients should be on a cholesterol lowering diet before
treatment. It is important that patients continue dietary control during treatment.
Adults:
The usual starting dose is 1mg once daily.
Adjustment of dose should be made at intervals
of 4 weeks or more. Doses should be
individualized according to LDL-C Levels, the
goal of therapy and patient response. Most
Patients will require a 2mg dose (see Section
5.1). The Maximum daily dose is 4mg.
Elderly:
No dosage adjustment is required (see Sections
5.1 and 5.2).
Paediatric use:
Pitavastatin should not be used in children aged
below 18 years because safety and efficacy has
not been established. No data
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