EZETIMIBE MEVON TABLET 10 MG

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

Ezetimibe

Available from:

NOVEM PHARMA PRIVATE LIMITED

ATC code:

C10AX09

Pharmaceutical form:

TABLET

Composition:

Ezetimibe 10 mg

Administration route:

ORAL

Prescription type:

Prescription Only

Manufactured by:

Atlantic Pharma – Produções Farmacêuticas, S.A.

Authorization status:

ACTIVE

Authorization date:

2022-03-08

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Ezetimibe MEVON 10 mg tablets
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 10 mg of ezetimibe.
Excipient(s) with known effect:
Each tablet contains 39.01 mg of lactose monohydrate.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Tablet.
The tablets are white and oblong tablets with 8.0 mm ± 0.2 mm length
and 4.4 mm ± 0.2 mm
width.
4. CLINICAL PARTICLULARS
4.1. THERAPEUTIC INDICATIONS
Primary Hypercholesterolaemia
Ezetimibe MEVON co-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 non-familial)
hypercholesterolaemia.
Homozygous Familial Hypercholesterolaemia (HoFH)
Ezetimibe MEVON co-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 (e.g. LDL apheresis) or if such treatments
are unavailable.
Homozygous Sitosterolaemia (Phytosterolaemia)
Ezetimibe MEVON is indicated as adjunctive therapy to diet for the
reduction of elevated
sitosterol and campesterol levels in patients with homozygous familial
sitosterolaemia.
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 Ezetimibe MEVON.
The recommended dose is one Ezetimibe MEVON 10 mg tablet daily.
When Ezetimibe MEVON 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.
_ _
_Co-administration with bile acid sequestrants _
Dosing of Ezetimibe MEVON should occur either ≥ 2 hours be