EZOLETA TABLETS 10MG

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

Ezetimibe

Available from:

SINGAPORE PHARMACEUTICAL PRIVATE LIMITED

ATC code:

C10AX09

Pharmaceutical form:

TABLET

Composition:

Ezetimibe 10.00mg

Administration route:

ORAL

Prescription type:

Prescription Only

Manufactured by:

Krka, d.d., Novo mesto

Authorization status:

ACTIVE

Authorization date:

2022-01-26

Summary of Product characteristics

SmPCPIL064779_4
Page 1 of 20
EZOLETA TABLETS 10MG
1.
NAME OF THE MEDICINAL PRODUCT
Ezoleta 10 mg tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 10 mg ezetimibe.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet.
White to off white, capsule shaped tablets with bevelled edges.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
_Primary hypercholesterolemia _
Ezoleta, administered with an HMG-CoA reductase inhibitor (statin) or
alone, is indicated as
adjunctive therapy to diet for the reduction of elevated total
cholesterol (total-C), low-density
lipoprotein cholesterol (LDL-C) and apolipoprotein B (Apo B) in
patients with primary (heterozygous
familial and nonfamilial) hypercholesterolemia.
Ezoleta, administered in combination with fenofibrate, is indicated as
adjunctive therapy to diet for the
reduction of elevated total-C, LDL-C, Apo B, and non-HDL-C in patients
with mixed hyperlipidemia.
_Homozygous Familial Hypercholesterolaemia (HoFH) _
Ezoleta, administered with atorvastatin or simvastatin, is indicated
for the reduction of elevated total-C
and LDL-C levels in patients with HoFH, as an adjunct to other
lipid-lowering treatments (eg. LDL
apheresis) or if such treatments are unavailable.
_Homozygous Sitosterolemia (Phytosterolemia) _
Ezoleta is indicated as adjunctive therapy to diet for the reduction
of elevated sitosterol and
campesterol levels in patients with homozygous familial
sitosterolemia.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_ _
The patient should be on an appropriate lipid lowering diet and should
continue on this diet during
treatment with Ezoleta.
The recommended dose is one Ezoleta 10 mg tablet daily. Ezoleta can be
administered at any time of
the day, with or without food.
When Ezoleta is added to a statin, either the indicated usual initial
dose of that particular statin or the
already established higher statin dose should be continued. In this
setting, the dosage instructions for
that particular statin should be consulted.
S