Galvus Met 50/500mg Film-coated Tablet

Țară: Malaezia

Limbă: engleză

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

Ingredient activ:

METFORMIN HYDROCHLORIDE; VILDAGLIPTIN

Disponibil de la:

NOVARTIS CORPORATION (MALAYSIA) SDN. BHD.

INN (nume internaţional):

METFORMIN HYDROCHLORIDE; VILDAGLIPTIN

Unități în pachet:

60tablet Tablets; 10tablet Tablets; 30tablet Tablets

Produs de:

NOVARTIS SINGAPORE PHARMACEUTICAL MANUFACTURING PTD. LTD.

Prospect

GALVUS
®
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 GALVUS MET IS USED FOR
2.
HOW GALVUS MET WORKS
3.
BEFORE YOU USE GALVUS MET
4.
HOW TO USE GALVUS MET
5.
WHILE YOU ARE USING GALVUS MET
6.
SIDE EFFECTS
7.
STORAGE AND DISPOSAL OF GALVUS
MET
8.
PRODUCT DESCRIPTION
9.
MANUFACTURER AND PRODUCT
REGISTRATION HOLDER
10.
DATE OF REVISION
WHAT GALVUS MET
IS USED FOR
Galvus Met is available as tablets. Each
Galvus 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.
Galvus Met is a medicine used to treat
type 2 diabetes. It helps to control the
level of sugar in the blood. It is
prescribed as an adjunct to diet and
exercise to improve control over body
sugar levels
- as a first diabetes treatment in patients
whose diabetes is not adequately
controlled by diet and exercise alone;
- in patients who have already received
treatment with vildagliptin and
metformin hydrochloride together as
separate tablets;
- or whose diabetes is not adequately
controlled with metformin hydrochloride
or vildagliptin alone, in combination
with other medicinal products from the
treatment of diabetes, including insulin
when these do not provide adequate
glycemic control.
HOW GALVUS MET WORKS
Galvus 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). Galvus Met
helps to control the blood sugar level.
It is important that you continue to
follow the diet and/or exercise
recommended to you while you are on
treatment with Galvus Met.
Ask your doctor if you have any
questions about why this medicine has
been prescribed for you.
BEFORE YOU US

Caracteristicilor produsului

Novartis
Page 2
Malaysia Package Insert
13-Jul-2020
Galvus Met
1.
NAME OF THE MEDICINAL PRODUCT
Galvus Met 50 mg/500 mg film-coated tablets
Galvus Met 50 mg/850 mg film-coated tablets
Galvus Met 50 mg/1000 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Galvus Met 50 mg/500 mg film-coated tablets
Each film-coated tablet contains 50 mg of vildagliptin and 500 mg of
metformin hydrochloride
(corresponding to 390 mg of metformin).
Galvus Met 50 mg/850 mg film-coated tablets
Each film-coated tablet contains 50 mg of vildagliptin and 850 mg of
metformin hydrochloride
(corresponding to 660 mg of metformin).
Galvus Met 50 mg/1000 mg film-coated tablets
Each film-coated tablet contains 50 mg of vildagliptin and 1000 mg of
metformin hydrochloride
(corresponding to 780 mg of metformin).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
Galvus Met 50 mg/500 mg film-coated tablets
Light yellow, ovaloid film-coated tablet with bevelled edge, imprinted
with “NVR” on one side and
“LLO” on the other side.
Galvus Met 50 mg/850 mg film-coated tablets
Yellow, ovaloid film-coated tablet with bevelled edge, imprinted with
“NVR” on one side and “SEH”
on the other side.
Galvus Met 50 mg/1000 mg film-coated tablets
Dark yellow, ovaloid film-coated tablet with bevelled edge, imprinted
with “NVR” on one side and
“FLO” on the other side.
Novartis
Page 3
Malaysia Package Insert
13-Jul-2020
Galvus Met
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Galvus Met is indicated as an adjunct to diet and exercise to improve
glycaemic control in adults with
type 2 diabetes mellitus:
-
as initial therapy when diabetes is not adequately controlled by diet
and exercise alone
-
in patients who are inadequately controlled with metformin
hydrochloride alone
-
in patients who are already being treated with the combination of
vildagliptin and metformin
hydrochloride, as separate tablets.
-
in combination with other medicinal products for the treatment of
diabetes, inclu