Xiliarx Met 50/850mg Film-coated Tablet

Šalis: Malaizija

kalba: anglų

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

Veiklioji medžiaga:

VILDAGLIPTIN; METFORMIN HYDROCHLORIDE

Prieinama:

ALCON LABORATORIES (MALAYSIA) SDN. BHD.

INN (Tarptautinis Pavadinimas):

VILDAGLIPTIN; METFORMIN HYDROCHLORIDE

Vienetai pakuotėje:

30 Tablets; 60 Tablets

Pagaminta:

NOVARTIS PHARMA PRODUKTIONS GMBH

Pakuotės lapelis

XILIARX
®
MET
Vidagliptin and Metformin fixed combination (50mg/500mg, 50mg/850mg,
50mg/1000mg)
1
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
WHAT IS IN THIS LEAFLET
1.
WHAT XILIARX MET IS USED FOR
2.
HOW XILIARX MET WORKS
3.
BEFORE YOU USE XILIARX MET
4.
HOW TO USE XILIARX MET
5.
WHILE YOU ARE USING XILIARX MET
6.
SIDE EFFECTS
7.
STORAGE AND DISPOSAL OF XILIARX
MET
8.
PRODUCT DESCRIPTION
9.
MANUFACTURER AND PRODUCT
REGISTRATION HOLDER
10.
DATE OF REVISION
WHAT XILIARX MET
IS USED FOR
Xiliarx Met is available as tablets. Each
Xiliarx Met tablet contains two active
substances: vildagliptin and metformin
hydrochloride. Both substances belong to
a group of medicines called “oral
antidiabetics”.
Three dosage strengths are available
(vildagliptin/metformin hydrochloride)
50 mg/500 mg, 50 mg/850 mg and 50
mg/1,000 mg.
Xiliarx Met is a medicine used to treat
type 2 diabetes. It helps to control the
level of sugar in the blood. It is
prescribed together with diet and
exercise in patients who have already
received treatment with vildagliptin and
metformin hydrochloride together, or
whose diabetes is not adequately
controlled with metformin hydrochloride
or vildagliptin alone, or as a first diabetes
treatment in patients whose diabetes is
not adequately controlled by diet and
exercise alone.
Xiliarx Met is also prescribed in
combination with a sulfonylurea,
together with diet and exercise in
patients whose diabetes is not adequately
controlled with metformin and a
sulfonylurea.
Xiliarx Met is also prescribed as an add-
on to insulin, together with diet and
exercise, to improve control of blood
sugar (glycemic control) in patients when
a stable dose of insulin and metformin
alone do not provide adequate glycemic
control.
HOW XILIARX MET WORKS
Xiliarx Met works by making the
pancreas produce more insulin and less
glucagon (effect of vildagliptin) and also
by helping the body to make better use of
the insulin it produces (effect of
metformin hydrochloride). Xiliarx Met
helps to control the blood sugar level.
It is

Prekės savybės

Regulatory Affairs
XILIARX
® MET_ _
(VILDAGLIPTIN AND METFORMIN FIXED COMBINATION)
50 mg/500 mg, 50 mg/850 mg, 50 mg/1,000 mg Tablets
MALAYSIA PACKAGE INSERT (MAR 18)
(with reference to EU SmPC – 22-May-2017)
NEW INDICATION: INITIAL COMBINATION THERAPY WITH METFORMIN
Author:
AK Swain, J Evans, C. Hasenfratz
GLC approval:
30-Oct-2013, amended 03 June 2014
Effective date:
28-Nov-2016
SLC Tracking
Number:
2016-PSB/GLC-0844-s
Document status:
Final
Number of pages:
21
Novartis
Page 2
Malaysia Package Insert
28-Nov-2016
Xiliarx Met
XILIARX
 MET
COMPOSITION AND PHARMACEUTICAL FORM
Vildagliptin:
(S)-1-[2-(3-Hydroxy-adamantan-1-ylamino)acetyl]pyrrolidine-2-carbonitrile
Metformin hydrochloride: Imidodicarbinimidic, N,N-dimethyl-,
monohydrochloride
Three strengths are available. One tablet of Xiliarx Met contains:

50
mg
vildagliptin
and
500
mg
metformin
hydrochloride
(corresponding
to
390
mg
metformin).
Light
yellow,
ovaloid
bevelled
edge,
film-coated
tablet
imprinted
with
"NVR" on one side and "LLO" on the other side.

50
mg
vildagliptin
and
850
mg
metformin
hydrochloride
(corresponding
to
660
mg
metformin). Yellow, ovaloid bevelled edge, film-coated tablet
imprinted with "NVR" on
one side and "SEH" on the other side.

50 mg vildagliptin and 1,000 mg metformin hydrochloride (corresponding
to 780 mg
metformin). Dark yellow, ovaloid bevelled edge, film-coated tablet
imprinted with "NVR"
on one side and "FLO" on the other side.
Certain dosage strengths may not be available in all countries.
For a full list of excipients, see section EXCIPIENTS.
INDICATIONS
Xiliarx Met is indicated in the treatment of type 2 diabetes mellitus:

Xiliarx Met is indicated in the treatment of adult patients who are
unable to achieve
sufficient glycaemic control at their maximally tolerated dose of oral
metformin alone or
who are already treated with the combination of vildagliptin and
metformin as separate
tablets.

Xiliarx Met is indicated in combination with a sulphonylurea (i.e.
triple combination
therapy) as an adjunct t