Kombiglyze XR Tablet 2.5/1000mg

Krajina: Malajzia

Jazyk: angličtina

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

Aktívna zložka:

METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE

Dostupné z:

ASTRAZENECA SDN. BHD.

INN (Medzinárodný Name):

METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE

Počet v balení:

28tablet Tablets; 7tablet Tablets; 56tablet Tablets

Výrobca:

AstraZeneca Pharmaceuticals LP

Príbalový leták

KOMBIGLYZE
® XR TABLET
SAXAGLIPTIN / METFORMIN HYDROCHLORIDE (2.5/1000 MG, 5/500 MG & 5/1000
MG)
_CONSUMER MEDICATION _
_INFORMATION LEAFLET _
_(RIMUP)_
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

Súhrn charakteristických

1
KOMBIGLYZE ® XR
saxagliptin and metformin HCl extended -release tablets
INDICATIONS AND USAG E
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 saxagl iptin and
metformin is appropriate [s ee Clinical Studies ].
Limitation of Use
KOMBIGLYZE XR is not indicated for the treatment of type 1 diabetes mellitus or diabetic
ketoacidosis.
DOSAGE AND ADMINISTR ATION
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 forms are
available:
• KOMBIGLYZE XR (saxagliptin and metformin HCl extended -release) tablets 5 mg/500
mg
• KOMBIGLYZE XR (saxagliptin and metformin HCl extended -releas e) tablets
5 mg/1000 mg
• KOMBIGLYZE XR (saxagliptin and metformin HCl extended -release) tablets
2.5 mg/1000 mg
The recommended starting dose of KOMBIGLYZE XR in patients who need 5 mg of
saxagliptin and who are not currently treated with metformin is 5 mg saxagliptin/500 mg
metformin extended -release once daily with gradual dose escalation to reduce the
gastrointestinal side effects due to metformin.
In patients treated with metformin, the dosage of KOMBIGLYZE XR should provide
metformin at the dose alread y 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 in combination with metformin extended -release may
be treated with KOMBIGLYZE XR 2.5 mg/1000 mg. 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 indivi dual components.