GALVUMET 50/500 vildagliptin 50 mg/metformin hydrochloride 500 mg film coated tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

metformin hydrochloride, Quantity: 500 mg; vildagliptin, Quantity: 50 mg

Available from:

Novartis Pharmaceuticals Australia Pty Ltd

INN (International Name):

Metformin hydrochloride,Vildagliptin

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: hypromellose; macrogol 4000; titanium dioxide; magnesium stearate; purified talc; iron oxide yellow; iron oxide red; hyprolose

Administration route:

Oral

Units in package:

10, 120, 60, 180, 30

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

For patients with Type 2 diabetes mellitus (T2DM):,GALVUMET is indicated as an adjunct to diet and exercise to improve glycaemic control in patients whose diabetes is not adequately controlled on metformin hydrochloride alone or who are already treated with the combination of vildagliptin and metformin hydrochloride, as separate tablets. Treatment should not be initiated with this fixed-dose combination.,GALVUMET is indicated in combination with a sulfonylurea (i.e. triple combination therapy) as an adjunct to diet and exercise in patients inadequately controlled with metformin and a sulfonylurea.,GALVUMET is indicated as add-on to insulin as an adjunct to diet and exercise to improve glycaemic control in patients when stable dose of insulin and metformin alone do not provide adequate glycaemic control.

Product summary:

Visual Identification: Light yellow, ovaloid bevelled edge, film coated tablet debossed with "NVR" on one side and "LLO" on the other side.; Container Type: Blister Pack; Container Material: PA/Al/PVC/Al - polyamide-aluminium foil-polyvinylchloride/aluminium foil; Container Life Time: 18 Months; Container Temperature: Store below 30 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2010-12-13

Patient Information leaflet

GALVUMET
®
_Vildagliptin/Metformin hydrochloride_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Galvumet.
It does not contain all the available
information. It does not take the
place of talking to your doctor,
pharmacist or diabetes educator.
The information in this leaflet was
last updated on the date listed on the
final page. More recent information
on the medicine may be available.
YOU SHOULD ENSURE THAT YOU SPEAK
TO YOUR PHARMACIST OR DOCTOR TO
OBTAIN THE MOST UP TO DATE
INFORMATION ON THE MEDICINE. YOU
CAN ALSO DOWNLOAD THE MOST UP TO
DATE LEAFLET FROM
WWW.NOVARTIS.COM.AU.
Those updates may contain important
information about the medicine and
its use of which you should be aware.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking this medicine
against the benefits they expect it
will provide.
IF YOU HAVE ANY CONCERNS ABOUT THIS
MEDICINE, ASK YOUR DOCTOR OR
PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT GALVUMET IS
USED FOR
Galvumet is used to treat type 2
diabetes mellitus in people who are
already taking vildagliptin and
metformin tablets separately, or
whose diabetes cannot be controlled
by metformin alone.
Galvumet is also used with a
sulfonylurea by patients whose blood
sugar levels are not adequately
controlled when taking only
metformin and a sulfonylurea.
Galvumet is also added to insulin in
patients when a stable dose of insulin
and metformin do not provide
adequate blood sugar control.
It is prescribed by your doctor
together with diet and exercise.
Galvumet contains two ingredients:
vildagliptin, which belongs to a class
of medicines called 'islet enhancers',
and metformin, which belongs to the
'biguanide' class.
Type 2 diabetes mellitus used to be
known as 'non-insulin-dependent
diabetes mellitus (NIDDM)' or
'maturity onset diabetes'.
Type 2 diabetes develops if the body
does not produce enough insulin, or
where the insulin that your body
makes does not work as well

Summary of Product characteristics

1
AUSTRALIAN PRODUCT INFORMATION – GALVUMET
®
(VILDAGLIPTIN/METFORMIN HYDROCHLORIDE) FILM-COATED
TABLET
1
NAME OF THE MEDICINE
vildagliptin/metformin hydrochloride
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
GALVUMET film coated tablets are available in 3 strengths:
•
GALVUMET 50/500: 50 mg vildagliptin and 500 mg metformin hydrochloride
•
GALVUMET 50/850: 50 mg vildagliptin and 850 mg metformin hydrochloride
•
GALVUMET 50/1000: 50 mg vildagliptin and 1,000 mg metformin
hydrochloride
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
GALVUMET 50/500: light yellow, ovaloid bevelled edge, film-coated
tablet imprinted with
"NVR" on one side and "LLO" on the other side.
GALVUMET 50/850: yellow, ovaloid bevelled edge, film-coated tablet
imprinted with "NVR" on
one side and "SEH" on the other side.
GALVUMET 50/1000: dark yellow, ovaloid bevelled edge, film-coated
tablet imprinted with
"NVR" on one side and "FLO" on the other side.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
For patients with Type 2 diabetes mellitus (T2DM):
GALVUMET is indicated as an adjunct to diet and exercise to improve
glycaemic control in
patients whose diabetes is not adequately controlled on metformin
hydrochloride alone or who
are already treated with the combination of vildagliptin and metformin
hydrochloride, as
separate tablets. Treatment should not be initiated with this
fixed-dose combination.
GALVUMET is indicated in combination with a sulfonylurea (i.e. triple
combination therapy) as
an adjunct to diet and exercise in patients inadequately controlled
with metformin and a
sulfonylurea.
GALVUMET is indicated as add-on to insulin as an adjunct to diet and
exercise to improve
glycaemic control in patients when stable dose of insulin and
metformin alone do not provide
adequate glycaemic control.
2
4.2
D
OSE AND METHOD OF ADMINISTRATION
LIFE THREATENING LACTIC ACIDOSIS CAN OCCUR DUE TO ACCUMULATION OF
METFORMIN. THE
MAIN RISK FACTOR IS RENAL IMPAIRMENT, OTHER RISK FACTORS INCLUDE OLD
AGE