GALVUS vildagliptin 50 mg tablets blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

vildagliptin, Quantity: 50 mg

Available from:

Novartis Pharmaceuticals Australia Pty Ltd

INN (International Name):

Vildagliptin

Pharmaceutical form:

Tablet, uncoated

Composition:

Excipient Ingredients: sodium starch glycollate; magnesium stearate; lactose; microcrystalline cellulose

Administration route:

Oral

Units in package:

60 tablets, 112 tablets, 14 tablets

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Treatment of diabetes mellitus type 2 in persons 18 years of age and older, as an adjunct to diet and exercise to improve glycaemic control in patients with type 2 diabetes: - As monotherapy, in patients inadequately controlled by diet and exercise alone and for whom metformin is inappropriate due to contraindications or intolerance. - In dual combination with one of metformin, a sulfonylurea or pioglitazone when diet, exercise and the single agent do not result in adequate glycaemic control. - In triple combination with a sulfonylurea and metformin when diet and exercise plus dual therapy with these agents do not provide adequate glycaemic control. - In combination with insulin (with or without metformin) when diet, exercise and a stable dose of insulin do not result in adequate glycaemic control.

Product summary:

Visual Identification: White to light yellowish, round, flat faced, bevelled edge tablet. One side debossed with 'NVR' and the other side with 'FB'.; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius

Authorization status:

Registered

Authorization date:

2010-03-02

Patient Information leaflet

GALVUS
®
_vildagliptin_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Galvus.
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 GALVUS IS USED
FOR
Galvus is used to lower blood sugar
levels in patients with type 2 diabetes
mellitus either alone (if you are
unable to take metformin) or in
combination with certain other
medicines (metformin, or a
sulfonylurea medicine, or
pioglitazone, or metformin and a
sulfonylurea, or insulin injections),
when diet plus exercise plus the
single or dual medicines do not
provide adequate blood sugar level
control.
_TYPE 2 DIABETES MELLITUS_
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 as it
should. It can also develop if the
body produces too much glucagon.
Insulin is a substance which helps to
lower the level of sugar in your
blood, especially after meals.
Glucagon is another substance which
triggers the production of sugar by
the liver, causing the blood sugar to
rise. The pancreas makes both of
these substances.
Galvus is a member of a class of
medicines you take by mouth called
DPP-4 inhibitors (dipeptidyl
pe

Summary of Product characteristics

1
AUSTRALIAN PRODUCT INFORMATION – GALVUS
® (VILDAGLIPTIN)
TABLETS
1
NAME OF THE MEDICINE
The active ingredient of GALVUS is vildagliptin.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Vildagliptin is a white to slightly yellowish or slightly greyish
crystalline powder with a melting
point/range of approximately 150°C. It is freely soluble in water.
Each GALVUS tablet contains 50 mg vildagliptin, lactose anhydrous,
magnesium stearate,
cellulose – microcrystalline and sodium starch glycollate.
Excipients with known effect: lactose
3
PHARMACEUTICAL FORM
GALVUS (vildagliptin) is available as a 50 mg tablet.
50 mg: white to light yellowish, round flat-faced with bevelled edges,
unscored tablet. One side
is debossed with "NVR" and the other side with "FB".
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Treatment of diabetes mellitus type 2 in persons 18 years of age and
older, as an adjunct to diet
and exercise to improve glycaemic control in patients with type 2
diabetes:
•
As monotherapy, in patients inadequately controlled by diet and
exercise alone and
for whom metformin is inappropriate due to contraindications or
intolerance.
•
In dual combination with one of metformin, a sulfonylurea or
pioglitazone when
diet, exercise and the single agent do not result in adequate
glycaemic control.
•
In triple combination with a sulfonylurea and metformin when diet and
exercise
plus dual therapy with these agents do not provide adequate glycaemic
control.
•
In combination with insulin (with or without metformin) when diet,
exercise and a
stable dose of insulin do not result in adequate glycaemic control.
4.2
D
OSE AND METHOD OF ADMINISTRATION
The management of antidiabetic therapy should be individualised.
Doses greater than 100 mg are not recommended.
Vildagliptin can be administered orally with or without a meal.
The 50 mg dose should be administered once daily in the morning. The
100 mg daily dose
should be administered as two divided doses of 50 mg taken in the
morning and evening.
2
If a dose of Galvus is