Lusefi 5mg film-coated tablet

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

Luseogliflozin Hydrate

Boleh didapati daripada:

HOE PHARMACEUTICALS SDN. BHD.

INN (Nama Antarabangsa):

Luseogliflozin Hydrate

Unit dalam pakej:

100tablet Tablets

Dikeluarkan oleh:

TAISHO PHARMACEUTICAL CO. , LTD. , OMIYA FACTORY

Risalah maklumat

LUSEFI
® FILM-COATED TABLET
Luseogliflozin (2.5mg, 5mg)
1
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
WHAT IS IN THIS LEAFLET
1.
What
_Lusefi_
_®_
is used for
2.
How
_Lusefi_
_®_
works
3.
Before you use
_Lusefi_
_®_
4.
How to use
_Lusefi_
_®_
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of
_Lusefi_
®
8.
Product Description
9.
Manufacturer
and
Product
Registration Holder
10.
Date of revision
11.
Serial number
1. WHAT _LUSEFI_
_®_ IS USED FOR
Lusefi
®
contains
the
active
substance
luseogliflozin. It belongs to a group of
medicines called “oral anti-diabetics”.

These are medicines taken by mouth
for diabetes.

They work by lowering the amount
of sugar (glucose) in your blood.
Lusefi
®
is used if your diabetes cannot be
controlled
with
other
medicines
for
diabetes, diet and exercise.
Lusefi
®
can
be
used
without
other
medicines in patients who cannot take
metformin (another diabetes medicine).
Lusefi
®
can also be used together with
glucose-lowering
medicinal
products
including
insulin
preparations
(other
medicines that your doctor may prescribe
to lower blood sugar).
It is important to continue to follow the
advice on diet and exercise given to you
by your doctor, pharmacist or nurse.
2. HOW _LUSEFI_
® WORKS
Lusefi
®
is used for a type of diabetes
called “type 2 diabetes mellitus” in adult
patients. If you have type 2 diabetes, your
pancreas does not make enough insulin or
your body is not able to use the insulin it
produces properly. This leads to a high
level of sugar in your blood.
Lusefi
®
works by removing excess sugar
from your body via your urine.
3. BEFORE YOU USE _LUSEFI_
®
-
_When you must not use it _
Do not take Lusefi
®
:

if you are allergic to luseogliflozin
or any of the other ingredients of this
medicine.
_ _
_Pregnancy and lactation _
If
you
are
pregnant
or
breast-feeding,
think you may be pregnant or are planning
to
have
a
baby,
ask
your
doctor
or
pharmacist for advice before taking this
medicine. You should stop taking this
medicine if

Ciri produk

- 1 -
Note) Use as prescribed by a doctor
FORMULATION
Brand name
Lusefi 2.5 mg
film-coated tablet
Lusefi 5 mg
film-coated tablet
Ingredient
Luseogliflozin hydrate
Content
Containing 2.5 mg as
luseogliflozin per tablet
Containing 5 mg as
luseogliflozin per tablet
Excipients
Lactose hydrate
Microcrystalline cellulose
Sodium starch glycolate
Hydroxypropylcellulose
Magnesium stearate
Hypromellose
Titanium oxide
Macrogol 400
Carnauba wax
Light anhydrous silicic acid
PRODUCT DESCRIPTION
Brand
name
Dosage
form
Appearance, size, etc.
Lusefi
2.5 mg
film-coated
tablet
White
film-coated
tablet
Front
Back
Side
Diameter
(mm)
Thickness
(mm)
Weight
(mg)
Approximately
7.1
Approximately
3.2
Approximately
144
Lusefi
5 mg
film-coated
tablet
White
film-coated
tablet
Front
Back
Side
Diameter
(mm)
Thickness
(mm)
Weight
(mg)
Approximately
8.6
Approximately
5.0
Approximately
286
- 2 -
Note) Use as prescribed by a doctor
INDICATIONS
Lusefi is indicated in the treatment of type 2 diabetes mellitus to
improve glycemic control in adults as:
Monotherapy
When diet and exercise alone do not provide adequate glycemic control
in patients for whom use of metformin is considered
inappropriate due to intolerance.
Add-on combination therapy
In combination with glucose-lowering medicinal products including
insulin preparations in adult patients with type 2 diabetes
mellitus to improve glycemic control when diet and exercise plus
monotherapy does not provide adequate glycemic control. (For
study results with respect to combinations and effects on glycemic
control see “CLINICAL STUDIES, 2. Add-on combination
therapy”)
DOSAGE AND ADMINISTRATION
Usually for adults, 2.5 mg as luseogliflozin should be orally
administered once daily before or after breakfast. When the effect is
insufficient, the dose can be increased to 5 mg once daily while
closely monitoring the clinical course.
1. PATIENTS WITH RENAL IMPAIRMENT
The efficacy of luseogliflozin is dependent on renal function, and
efficacy is reduced in patients who have moderate renal
impairment and lik