NESINA alogliptin (as benzoate) 6.25 mg film-coated tablet blister pack

Country: Australia

Bahasa: Inggeris

Sumber: Department of Health (Therapeutic Goods Administration)

Bahan aktif:

alogliptin benzoate, Quantity: 8.5 mg

Boleh didapati daripada:

Takeda Pharmaceuticals Australia Pty Ltd

INN (Nama Antarabangsa):

Alogliptin benzoate

Borang farmaseutikal:

Tablet, film coated

Komposisi:

Excipient Ingredients: titanium dioxide; croscarmellose sodium; magnesium stearate; mannitol; macrogol 8000; hyprolose; hypromellose; iron oxide red; microcrystalline cellulose; Shellac; ethanol absolute; iron oxide black; 1-butanol

Laluan pentadbiran:

Oral

Unit dalam pakej:

60, 30, 98, 90, 10, 7, 100, 14, 28, 56

Jenis preskripsi:

(S4) Prescription Only Medicine

Tanda-tanda terapeutik:

NESINA 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, as add on to metformin, a sulphonylurea, a thiazolidinedione, insulin (with or without metformin), or in combination with metformin and a thiazolidinedione when dual therapy does not provide adequate glycaemic control.

Ringkasan produk:

Visual Identification: Light pink, oval, biconvex, film-coated tablets with TAK and ALG-6.25 printed on one side.; Container Type: Blister Pack; Container Material: PVC/PCTFE (Aclar)/Al; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius

Status kebenaran:

Licence status A

Tarikh kebenaran:

2013-09-17

Risalah maklumat

NESINA
®
_Alogliptin (as benzoate)_
CONSUMER MEDICINE INFORMATION (CMI)
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Nesina.
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 IS USED
FOR
Nesina is used to lower blood sugar
levels in adults with type 2 diabetes
mellitus.
It must be taken together with other
antidiabetic medicines, which your
doctor will have prescribed for you,
such as sulfonylureas (e.g. glipizide,
glimepiride, glibenclamide),
metformin and/or thiazolidinediones
(e.g. pioglitazone) or insulin with or
without metformin.
Nesina is used when your blood
sugar cannot be adequately
controlled by diet, exercise and one
or more of these other antidiabetic
medicines.
It is important that you continue to
take your other antidiabetic
medication and 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 your body makes
does not work as well as it should. It
can also

Ciri produk

_NESINA PI V7.0 (CCDS 6.0)_
_ _
_ _
_1 _
AUSTRALIAN PRODUCT INFORMATION
NESINA
® (ALOGLIPTIN BENZOATE)
1
NAME OF THE MEDICINE
Alogliptin benzoate.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
NESINA is available for oral use as film-coated tablets containing
alogliptin benzoate equivalent to
6.25, 12.5 or 25 mg of free base.
Contains benzoates.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
NESINA is available in the following presentations:
NESINA 25 mg film-coated tablets: Light red, oval, biconvex,
film-coated tablets with “TAK” and
“ALG-25” printed on one side.
NESINA 12.5 mg film-coated tablets: Yellow, oval, biconvex,
film-coated tablets with “TAK” and
“ALG-12.5” printed on one side.
NESINA 6.25 mg film-coated tablets: Light pink, oval, biconvex,
film-coated tablets with “TAK” and
“ALG-6.25” printed on one side.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
NESINA 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, as add on to
metformin, a sulphonylurea, a thiazolidinedione, insulin (with or
without metformin), or in combination
with metformin and a thiazolidinedione when dual therapy does not
provide adequate glycaemic
control.
4.2
DOSE AND METHOD OF ADMINISTRATION
NESINA should be taken orally once daily with or without food. The
tablets should be swallowed
whole with water.
If a dose is missed, it should be taken as soon as the patient
remembers. A double dose should not
be taken on the same day.
ADULTS (≥ 18 YEARS OLD)
The recommended dose of NESINA is 25 mg once daily. NESINA is not
indicated for initial
combination therapy.
_NESINA PI V7.0 (CCDS 6.0)_
_ _
_ _
_2 _
When NESINA is used in combination with metformin and/or a
thiazolidinedione, the dose of
metformin
and/or
the
thiazolidinedione
should
be
maintained,
and
NESINA
administered
concomitantly.
When NESINA is used in combination with insulin or an ins