NESINA MET 12.5/850; 12.5 mg alogliptin (as benzoate) / 850 mg metformin hydrochloride film-coated tablets blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

metformin hydrochloride, Quantity: 850 mg; alogliptin benzoate, Quantity: 17 mg (Equivalent: alogliptin, Qty 12.5 mg)

Available from:

Takeda Pharmaceuticals Australia Pty Ltd

INN (International Name):

Alogliptin benzoate,Metformin hydrochloride

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: titanium dioxide; purified talc; microcrystalline cellulose; povidone; mannitol; crospovidone; hypromellose; iron oxide yellow; magnesium stearate

Administration route:

Oral

Units in package:

196, 200, 98, 28, 20, 112, 10, 14, 180, 56, 60, 120

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

NESINA MET is indicated to improve glycaemic control in adult patients (> or = 18 years old) with type 2 diabetes mellitus when diet and exercise do not provide adequate glycaemic control and treatment with both alogliptin and metformin is appropriate,,- when treatment with metformin alone does not provide adequate control; or - in combination with a thiazolidinedione or with insulin, when dual therapy does not provide adequate control.,NESINA MET can also be used to replace separate tablets of alogliptin and metformin in patients already being treated with this combination.

Product summary:

Visual Identification: Light yellow, oblong, biconvex, film-coated tablet with 12.5/850 debossed on one side and 322M debossed on the other side; Container Type: Blister Pack; Container Material: PVC/PCTFE (Aclar)/Al; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2013-10-22

Patient Information leaflet

NESINA MET
®
_Alogliptin (as benzoate)/ Metformin hydrochloride_
CONSUMER MEDICINE INFORMATION (CMI)
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Nesina Met.
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
this medicine. You can also
download the most up to date leaflet
from https://takeda.com/en-au/what-
we-do/our-products/.
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 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 NESINA MET IS
USED FOR
Nesina Met is used to lower blood
sugar levels in adults with type 2
diabetes mellitus.
Nesina Met is used when your blood
sugar cannot be adequately
controlled by diet, exercise and other
anti-diabetic medicines such as
metformin; metformin and insulin or
metformin and medicines known as
thiazolidinediones (e.g.
pioglitazone).
If you are already taking both
alogliptin and metformin as separate
tablets, Nesina Met can replace them
in one tablet.
Nesina Met is not for patients with
type 1 diabetes mellitus or diabetic
ketoacidosis (increased ketones in
blood or urine).
It is important that you continue to
follow the advice on diet and
exercise that your doctor or diabetes
educator has given you.
_TYPE 2 DIABETES MELLITUS_
Type 2 diabetes is also called non-
insulin-dependent diabetes mellitus
(NIDDM).
Type 2 diabetes develops if the body
does not make enough insulin, or if
the insulin that yo

Summary of Product characteristics

_NESINA MET PI V6.0 (CCDS V4.0)_
_ _
_ _
_1 _
AUSTRALIAN PRODUCT INFORMATION
NESINA MET
® 12.5 MG/500 MG, 12.5 MG/850 MG & 12.5 MG/1000 MG
(ALOGLIPTIN / METFORMIN HYDROCHLORIDE)
1
NAME OF THE MEDICINE
NESINA MET tablets contain 2 oral antihyperglycaemic drugs used in the
management of type 2
diabetes: alogliptin (as benzoate), a dipeptidyl peptidase 4 (DPP-4)
inhibitor, and metformin
hydrochloride, a member of the biguanide class.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
NESINA MET is available as film-coated tablets for oral administration
containing alogliptin benzoate
equivalent to 12.5 mg alogliptin free base and:
•
500 mg metformin hydrochloride (12.5 mg/500 mg) or
•
850 mg metformin hydrochloride (12.5 mg/850 mg) or
•
1000 mg metformin hydrochloride (12.5 mg/1000 mg)
Contains benzoates.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
NESINA MET is available in the following presentations:
NESINA MET 12.5/500 film-coated tablets: Pale yellow, oblong,
biconvex, film-coated tablet with
“12.5/500” debossed on one side and “322M” debossed on the
other side
NESINA MET 12.5/850 film-coated tablets: Light yellow, oblong,
biconvex, film-coated tablets with
“12.5/850” debossed on one side and “322M” debossed on the
other side.
NESINA MET 12.5/1000 film-coated tablets: Pale yellow, oblong,
biconvex, film-coated tablets with
“12.5/1000” debossed on one side and “322M” debossed on the
other side.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
NESINA MET is indicated to improve glycaemic control in adult patients
(≥ 18 years old) with type 2
diabetes mellitus when diet and exercise do not provide adequate
glycaemic control and treatment
with both alogliptin and metformin is appropriate,
•
when treatment with metformin alone does not provide adequate control;
or
•
in combination with a thiazolidinedione or with insulin, when dual
therapy does not provide
adequate control.
NESINA MET can also be used to replace separate tablets of aloglip