Sitagliptin/Metformin Sandoz 50/850 sitagliptin (as hydrochloride monohydrate)/metformin hydrochloride 50 mg/850 mg film coated tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

metformin hydrochloride, Quantity: 850 mg; sitagliptin hydrochloride monohydrate, Quantity: 56.69 mg (Equivalent: sitagliptin, Qty mg)

Available from:

Sandoz Pty Ltd

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: hypromellose; sodium lauryl sulfate; croscarmellose sodium; povidone; sodium stearylfumarate; hyprolose; titanium dioxide; iron oxide red; triethyl citrate; purified talc; microcrystalline cellulose; iron oxide yellow

Administration route:

Oral

Units in package:

56

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Sitagliptin/Metformin Sandoz is indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus when treatment with both sitagliptin and metformin is appropriate.

Product summary:

Visual Identification: A light orange, oval, film coated tablet debossed with "SM2" on one side; Container Type: Blister Pack; Container Material: PVC/PE/PVDC/Al; Container Life Time: 2 Years; Container Temperature: Store below 30 degrees Celsius

Authorization status:

Registered

Authorization date:

2021-09-13

Patient Information leaflet

SITAGLIPTIN/METFORMIN SANDOZ
®
1
SITAGLIPTIN/
METFORMIN SANDOZ ®
_sitagliptin hydrochloride monohydrate/metformin hydrochloride _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about
Sitagliptin/Metformin Sandoz. It
does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking
Sitagliptin/Metformin Sandoz against
the benefits they expect it will have
for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT
SITAGLIPTIN/METFORMIN
SANDOZ IS USED FOR
Sitagliptin/Metformin Sandoz helps
to lower blood sugar levels in
patients with type 2 diabetes mellitus
along with diet and exercise.
Sitagliptin/Metformin Sandoz can be
used alone, or in combination with
ertugliflozin, insulin, or sulfonylurea
medicines such as glimepiride,
gliclazide and glibenclamide.
TYPE 2 DIABETES MELLITUS
Type 2 diabetes mellitus 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 resulting in
high blood sugar (hyperglycaemia).
This can lead to serious medical
problems.
The main goal of treating diabetes is
to lower your blood sugar to a
normal level. Lowering and
controlling blood sugar may help
prevent or delay complications of
diabetes, such as heart disease,
kidney disease, blindness and foot
amputation.
High blood sugar can be lowered by
diet and exercise and by certain
medicines.
_HOW SITAGLIPTIN/METFORMIN _
_SANDOZ WORKS _
Sitagliptin/Metformin Sandoz
contains two active ingredients,
sitagliptin (as hydrochloride
monohydrate) and metformin
hydrochloride. Sitagliptin belongs to
a class of medicines called DPP-4
inhibitors (dipeptidyl peptidase-4
inhibitors), and

Summary of Product characteristics

210913-sitagliptin/metformin sandoz-pi
Page 1 of 42
AUSTRALIAN PRODUCT INFORMATION
SITAGLIPTIN/METFORMIN SANDOZ
® 50/500
SITAGLIPTIN/METFORMIN SANDOZ
® 50/850
SITAGLIPTIN/METFORMIN SANDOZ
® 50/1000
(SITAGLIPTIN HYDROCHLORIDE MONOHYDRATE/METFORMIN
HYDROCHLORIDE) FILM COATED TABLET
1.
NAME OF THE MEDICINE
Sitagliptin hydrochloride monohydrate/metformin hydrochloride
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Sitagliptin/Metformin Sandoz is available for oral administration as
film-coated tablets
containing sitagliptin hydrochloride monohydrate and metformin
hydrochloride equivalent to:
50 mg sitagliptin as free base and 500 mg metformin hydrochloride
(Sitagliptin/Metformin
50/500),
850
mg
metformin
hydrochloride
(Sitagliptin/Metformin
50/850)
or
1000
mg
metformin hydrochloride (Sitagliptin/Metformin 50/1000).
For the full list of excipients, see Section 6.1 List of excipients.
3.
PHARMACEUTICAL FORM
Sitagliptin/Metformin Sandoz 50/500 - A pink, film coated tablet with
"SM 1" on one side and
plain on the other.
Sitagliptin/Metformin Sandoz 50/850 - A light orange, film coated
tablet with "SM 2" on one
side and plain on the other.
Sitagliptin/Metformin Sandoz 50/1000 - A light red, film coated tablet
with "SM 3" on one side
and plain on the other.
4.
CLINICAL PARTICULARS
4.1.
T
HERAPEUTIC INDICATIONS
Sitagliptin/Metformin
Sandoz
(sitagliptin
hydrochloride
monohydrate
and
metformin
hydrochloride) is indicated as an adjunct to diet and exercise to
improve glycaemic control in
adults with type 2 diabetes mellitus when treatment with both
sitagliptin and metformin is
appropriate.
[see Section 5.1 Pharmacodynamic properties, Clinical trials and 4.2
Dose and method of
administration].
4.2.
D
OSE AND METHOD OF ADMINISTRATION
Life-threatening lactic acidosis can occur due to accumulation of
metformin. Risk factors
include renal impairment, old age and the use of high doses of
metformin above 2000 mg
per day.
210913-sitagliptin/metformin sandoz-pi
Page 2 of 42
_Sitagliptin/Metformin _
_Sandoz _
_50/500, _
_Sitagliptin/Met