ROSUZET (EZETIMIBE 10MG ROSUVASTATIN 20MG) FILM COATED TABLET

Country: Malaysia

Bahasa: Inggeris

Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Bahan aktif:

EZETIMIBE; ROSUVASTATIN CALCIUM

Boleh didapati daripada:

ORGANON MALAYSIA SDN. BHD.

INN (Nama Antarabangsa):

EZETIMIBE; ROSUVASTATIN CALCIUM

Unit dalam pakej:

30 Tablets

Dikeluarkan oleh:

HANMI PHARM. CO., LTD.

Risalah maklumat

ROSUZET
®
Ezetimibe/Rosuvastatin (10mg/10mg, 10mg/20mg)
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
Copyright 2022 Organon group of companies. All rights reserved.
1
WHAT IS IN THIS LEAFLET
1.
What RosuZet is used for
2.
How RosuZet works
3.
Before you take RosuZet
4.
How to take RosuZet
5.
While you are taking RosuZet
6.
Side effects
7.
Storage and disposal of RosuZet
8.
Product description
9.
Manufacturer
10.
Product Registration Holder
11.
Date of Revision
12.
Serial Number
WHAT ROSUZET IS USED FOR
RosuZet is a medicine used to lower
levels of total cholesterol, LDL (bad)
cholesterol, and fatty substances called
triglycerides in the blood. In addition,
RosuZet raises levels of HDL (good)
cholesterol. It is used for patients who
cannot control their cholesterol levels
by diet alone. You should stay on a
cholesterol-lowering diet while taking
this medicine.
HOW ROSUZET WORKS
RosuZet works to reduce your
cholesterol in two ways. It reduces the
cholesterol absorbed in your digestive
tract, as well as the cholesterol your
body makes by itself. RosuZet does
not help you lose weight.
BEFORE YOU TAKE ROSUZET
It is important that you continue
taking RosuZet daily as prescribed by
your doctor.
Even if you are taking medication to
treat high cholesterol, it is important to
have your cholesterol measured
regularly. You should also know your
cholesterol levels and goals.
_-_
_ _
_WHEN YOU MUST NOT TAKE IT_
Do not take RosuZet if you:
•
are hypersensitive (allergic) to
ezetimibe, rosuvastatin, or any of
the other ingredients of RosuZet
tablets
•
have active liver disease
•
are pregnant or breast-feeding,
intend to get pregnant and are
not using proper contraceptive
methods.
Pregnancy
Do not use RosuZet if you are
pregnant, trying to become pregnant
or suspect that you are pregnant. If
you become pregnant while taking
RosuZet, stop taking it and contact
your physician immediately. You
should use effective birth control
(contraception) while you are taking
RosuZet.
Breast-feeding
Do not use RosuZet if you are bre

Ciri produk

LPC-OG0653H-T-122018
ROSUZET® (EZETIMIBE 10MG/ ROSUVASTATIN 10MG) FILM COATED TABLET
(Ezetimibe 10 mg/ Rosuvastatin 10 mg)
ROSUZET® (EZETIMIBE 10MG/ ROSUVASTATIN 20MG) FILM COATED TABLET
(Ezetimibe 10 mg/ Rosuvastatin 20 mg)
CHOLESTEROL ABSORPTION INHIBITOR/ HMG-COA REDUCTASE INHIBITOR
1.
INDICATIONS AND USAGE
_PRIMARY HYPERCHOLESTEROLEMIA _
Ezetimibe + Rosuvastatin (ROSUZET) is indicated as adjunctive therapy
to diet for the
reduction of elevated total cholesterol (total-C), low-density
lipoprotein cholesterol
(LDL-C), apolipoprotein B (Apo B), triglycerides (TG), and
non-high-density lipoprotein
cholesterol (non-HDL-C), and to increase high-density lipoprotein
cholesterol (HDL-C)
in patients with primary (heterozygous familial and non-familial)
hypercholesterolemia
or mixed hyperlipidemia.
_HOMOZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA (HOFH) _
Ezetimibe + Rosuvastatin (ROSUZET) is indicated for the reduction of
elevated total-C
and
LDL-C levels in patients with HoFH. Patients may also receive
adjunctive
treatments (e.g., LDL apheresis).
2.
DOSAGE AND ADMINISTRATION
2.1
GENERAL
The patient should be on an appropriate lipid-lowering diet and should
continue on this
diet during treatment with Ezetimibe + Rosuvastatin (ROSUZET). The
dosage should
be individualized according to the baseline LDL-C level, the
recommended goal of
therapy, and the patient’s response. Ezetimibe + Rosuvastatin
(ROSUZET) can be
administered as a single dose at any time of the day, with or without
food.
2.2
ADULTS
_PRIMARY HYPERCHOLESTEROLEMIA _
The usual start dose is 10/10 mg once daily. Use Ezetimibe 10mg with
Rosuvastatin
5mg for special populations if needed. For patients with severe
hypercholesterolemia
(including heterozygous familial hypercholesterolaemia) or those with
aggressive lipid
targets, a start dose of 10/20 mg may be considered. Not all strengths
are available
locally.
_HOMOZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA _
For patients with homozygous familial hypercholesterolemia a start
dose of 10/20 mg
once a day is recommended. N