SUCRALO (Vildagliptin Tablets 50 mg)

Land: Malaysia

Sprog: engelsk

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

Aktiv bestanddel:

VILDAGLIPTIN

Tilgængelig fra:

RANBAXY (MALAYSIA) SDN. BHD.

INN (International Name):

VILDAGLIPTIN

Enheder i pakken:

10 Tablets; 10 Tablets; 3x10 Tablets; 3x10 Tablets

Fremstillet af:

Sun Pharmaceutical Industries Limited

Indlægsseddel

_Consumer Medication Information Leaflet (RiMUP)_
SUCRALO
(Vildagliptin Tablets 50 mg)
Page 1
What is in this leaflet
1. What Sucralo is used for
2. How Sucralo works
3. Before you use Sucralo
4. How to use Sucralo
5. While you are using it
6. Side effects
7. Storage and Disposal of Sucralo
8. Product Description
9. Manufacturer and Product
Registration Holder
10. Date of revision
11. Serial Number
WHAT SUCRALO IS USED FOR
Each Sucralo tablet contains 50 mg of
the active substance vildagliptin. Sucralo
is a medicine used to treat patients with
type 2 diabetes whose condition cannot
be controlled by diet and exercise alone.
It helps to control the level of sugar in
the blood. Such medicines are known as
oral antidiabetics.
Type 2 diabetes develops if the body
does not produce enough insulin or if the
insulin that your body makes does not
work as well as it should. It can also
develop if the body produces too much
glucagon.
Insulin is a substance that helps to lower
the
level
of
sugar
in
your
blood,
especially after meals. Glucagon is a
substance that triggers the production of
sugar
by
the
liver,
causing
the
blood
sugar level to rise. The pancreas makes
both of these substances.
HOW SUCRALO WORKS
Sucralo works by making the pancreas
produce more insulin and less glucagon.
Sucralo helps to control the blood sugar
level.
Your doctor will prescribe Sucralo either
alone
or
in
combination
with
other
antidiabetics
depending
on
your
condition.
It
is
important
that
you
continue
to
follow
the
diet
and/or
exercise
recommended to you while you are on
treatment with Sucralo.
Ask your doctor if you have any
questions about why this medicine has
been prescribed for you.
BEFORE YOU USE SUCRALO
Follow all instructions given to you by
your doctor or pharmacist carefully, even
if
they
differ
from
the
information
contained in this leaflet.
_- _
_When you must not use it _
If
you
are
allergic
(hypersensitive)
to
vildagliptin
or
any
of
the
other
ingredients of Sucralo.
_Pregnant women _
Tell your doctor if you are pregnant, if
you thi

Produktets egenskaber

1
_For the use of a Registered Medical Practitioner only _
PRESCRIBING INFORMATION
SUCRALO
Vildagliptin Tablets 50 mg
COMPOSITION
Each tablet contains:
Vildagliptin …50 mg
_Excipients:_
Lactose
Anhydrous,
Cellulose
Microcrystalline
(Avicel
PH
102),
Sodium
starch
glycolate,
Magnesium stearate
DESCRIPTION
White to off white colored, round tablets debossed with '50' on one
side and 'V' on other side
SUCRALO
contains Vildagliptin. Vildagliptin is a cyanopyrrolidine-based,
orally bioavailable
inhibitor of dipeptidyl peptidase 4 (DPP-4), with hypoglycemic
activity. It is described chemically
as
(2S)-1-[2-[(3-hydroxy-1-adamantyl)amino]acetyl]pyrrolidine-2-carbonitrile.
Vildagliptin
has
molecular formulae C
17
H
25
N
3
O
2
and molecular weight is 303.4. Vildagliptin has the following
structural formula:
STRUCTURAL FORMULAE OF VILDAGLIPTIN
2
PHARMACODYNAMIC AND PHARMACOKINETIC PROPERTIES

PHARMACODYNAMICS
Pharmacotherapeutic group: Drugs used in diabetes, dipeptidyl
peptidase 4 (DPP-4) inhibitors, ATC
code: A10BH02
Vildagliptin, a member of the islet enhancer class, is a potent and
selective dipeptidyl-peptidase-4
(DPP-4) inhibitor.
The administration of vildagliptin results in a rapid and complete
inhibition of DPP-4 activity,
resulting in increased fasting and postprandial endogenous levels of
the incretin hormones GLP-1
(glucagon-like peptide 1) and GIP (glucose-dependent insulinotropic
polypeptide).
By increasing the endogenous levels of these incretin hormones,
vildagliptin enhances the sensitivity
of beta cells to glucose, resulting in improved glucose-dependent
insulin secretion. Treatment with
vildagliptin 50 to 100 mg daily in patients with type 2 diabetes
significantly improved markers of
beta cell function including HOMA-

(Homeostasis Model Assesment-

), proinsulin to insulin ratio
and measures of beta cell responsiveness from the frequently-sampled
meal tolerance test. In non-
diabetic (normal glycaemic) individuals, vildagliptin does not
stimulate insulin secretion or reduce
glucose levels.
By in