EZZICAD TABLETS 10MG

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

Ezetimibe

Available from:

GLENMARK PHARMACEUTICALS SINGAPORE PTE. LTD.

ATC code:

C10AX09

Pharmaceutical form:

TABLET

Composition:

Ezetimibe 10 mg

Administration route:

ORAL

Prescription type:

Prescription Only

Manufactured by:

Glenmark Pharmaceuticals Limited

Authorization status:

ACTIVE

Authorization date:

2022-02-18

Summary of Product characteristics

For the use only of a Registered Medical Practitioners
or a Hospital or a Laboratory
SAME SIZE ARTWORK
LEAFLET SIZE : 115 mm x 560 mm
50 mm
35 mm
SPACE FOR
PHARMACODE
Ezetimibe Tablets 10 mg
PE00000 SG
Manufactured by:
B/2, Mahalaxmi Chambers,
22, Bhulabhai Desai Road,
Mumbai - 400 026, (India).
At: Plot No. 2, Phase II, Pharma Zone,
Indore Special Economic Zone, Pithampur,
Dist. Dhar (M.P), Pincode - 454775.
PRODUCT REGISTRANT:
Glenmark Pharmaceuticals Singapore Pte Ltd
6 Shenton Way, OUE Downtown #38-01
Singapore 068809
TABLET 10 MG
SAME SIZE ARTWORK
LEAFLET SIZE : 115 mm x 560 mm
35 mm
PE00000 SG
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each uncoated tablet contains: Ezetimibe10 mg
PHARMACEUTICAL FORM
Tablet
White to off-white, capsule shaped, flat, beveled edged uncoated
tablets
engraved with glenmark logo 'G' on one side and'44'on the other side.
CLINICAL PARTICULARS
_PRIMARY HYPERCHOLESTEROLAEMIA_
Ezetimibe, 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) hypercholesterolemia.
Ezetimibe, 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)_
Ezetimibe, 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 SITOSTEROLAEMIA (PHYTOSTEROLAEMIA)_ Ezetimibe is indicated
as adjunctive therapy to diet for the reduction of elevated sitosterol
and
campesterol levels in patients with homozygous familial
sitosterolaemia.
POSOLOGY AND METHOD OF ADMINISTRATION
The patient sh