Kombiglyze XR Tablet 51000mg

מדינה: מלזיה

שפה: אנגלית

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

מרכיב פעיל:

METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE

זמין מ:

ASTRAZENECA SDN. BHD.

INN (שם בינלאומי):

METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE

יחידות באריזה:

28tablet Tablets; 7tablet Tablets

תוצרת:

AstraZeneca Pharmaceuticals LP

עלון מידע

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
KOMBIGLYZE
® XR TABLET
SAXAGLIPTIN / METFORMIN HYDROCHLORIDE (5/1000 MG)
1
WHAT IS IN THIS LEAFLET
1.
What KOMBIGLYZE XR is
used for
2.
How KOMBIGLYZE XR
works
3.
Before you use
KOMBIGLYZE XR
4.
How to use KOMBIGLYZE
XR
5.
While you are using it
6.
Side effects
7.
Storage and disposal of
KOMBIGLYZE XR
8.
Product description
9.
Manufacturer
10.
Product Registration Holder
11.
Date of revision
WHAT IS KOMBIGLYZE XR
USED FOR
•
KOMBIGLYZE XR is a
prescription medicine that
contains saxagliptin and
metformin hydrochloride.
•
KOMBIGLYZE XR is used
with diet and exercise to help
control high blood sugar
(hyperglycemia) in adults with
type 2 diabetes.
_What is type 2 diabetes? _
Type 2 diabetes is a condition in
which your body does not make
enough insulin, and the insulin that
your body produces does not work
as well as it should. Your body can
also make too much sugar. When
this happens, sugar (glucose)
builds up in the blood. This can
lead to serious medical problems.
The main goal of treating diabetes
is to lower your blood sugar so that
it is as close to normal as possible.
High blood sugar can be lowered
by diet and exercise, and by certain
medicines when necessary.
HOW KOMBIGLYZE XR WORKS
•
Saxagliptin lowers blood sugar
by helping the body increase the
level of insulin after meals.
•
Metformin helps in improving
insulin sensitivity by increasing
glucose uptake and utilization in
the body.
BEFORE YOU USE KOMBIGLYZE
XR
-
_When you must not use it _
_ _
DO NOT TAKE KOMBIGLYZE XR
IF YOU:
•
have kidney problems.
•
are allergic to metformin
hydrochloride, saxagliptin, or
any of the ingredients in
KOMBIGLYZE XR. See the
end of this Patient Information
Leaflet for a complete list of
ingredients in KOMBIGLYZE
XR. Symptoms of a serious
allergic reaction to
KOMBIGLYZE XR may
include:
-
swelling of your face, lips,
throat, and other areas on your
skin
-
raised, red areas on your skin
(hives)
-
difficulty with swallowing or
breathing
-
skin rash, itching, flaking,

מאפייני מוצר

1
KOMBIGLYZE
®
XR
saxagliptin and metformin HCl extended-release tablets
INDICATIONS AND USAGE
KOMBIGLYZE XR is indicated as an adjunct to diet and exercise to
improve glycemic
control in adults with type 2 diabetes mellitus when treatment with
both saxagliptin and
metformin is appropriate [see
_Clinical Studies_
].
_ _
LIMITATION OF USE
KOMBIGLYZE XR is not indicated for the treatment of type 1 diabetes
mellitus or diabetic
ketoacidosis.
DOSAGE AND ADMINISTRATION
_ _
RECOMMENDED DOSAGE
The dosage of KOMBIGLYZE XR should be individualized on the basis of
the patient’s
current regimen, effectiveness, and tolerability. KOMBIGLYZE XR should
generally be
administered once daily with the evening meal, with gradual dose
titration to reduce the
gastrointestinal
side
effects
associated
with
metformin.
The
following
dosage
form
is
available:
•
KOMBIGLYZE XR (saxagliptin and metformin HCl extended-release) tablets
5 mg/1000
mg
In patients treated with metformin, the dosage of KOMBIGLYZE XR should
provide
metformin at the dose already being taken, or the nearest
therapeutically appropriate dose.
Following
a
switch
from
metformin
immediate-release
to
metformin
extended-release,
glycemic control should be closely monitored and dosage adjustments
made accordingly.
Patients who need 2.5 mg saxagliptin who are either metformin naive or
who require a dose
of metformin higher than 1000 mg should use the individual components.
The
maximum
daily
recommended
dosage
is
5
mg
for
saxagliptin
and
2000
mg
for
metformin extended-release.
No
studies
have
been
performed
specifically
examining
the
safety
and
efficacy
of
KOMBIGLYZE XR in patients previously treated with other
antihyperglycemic medications
and switched to KOMBIGLYZE XR. Any change in therapy of type 2
diabetes should be
undertaken with care and appropriate monitoring as changes in glycemic
control can occur.
Inform
patients
that
KOMBIGLYZE
XR
tablets
must
be
swallowed
whole
and
never
crushed, cut, or chewed.
Occasionally, the inactive ingredients of KOMBIGLYZE XR will be
e