Nesina Met 12.5mg/500mg Film-Coated Tablet

Country: Malaysia

Bahasa: Inggeris

Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Bahan aktif:

METFORMIN HYDROCHLORIDE; Alogliptin benzoate

Boleh didapati daripada:

Takeda Malaysia Sdn Bhd

INN (Nama Antarabangsa):

METFORMIN HYDROCHLORIDE; Alogliptin benzoate

Unit dalam pakej:

4 x 7tablet Tablets; 8 x 7tablet Tablets

Dikeluarkan oleh:

TAKEDA PHARMACEUTICAL COMPANY LIMITED

Risalah maklumat

_Consumer Medication Information Leaflet (RiMUP) _
NESINA MET FILM-COATED TABLET
_ _ ALOGLIPTIN/METFORMIN 12.5MG/500MG AND 12.5MG/1000MG
___________________________________________________________________________
pg. 1
WHAT IS IN THIS LEAFLET
1.
What Nesina Met is used
for
2.
How Nesina Met works
3.
Before you use Nesina Met
4.
How to use Nesina Met
5.
While you are using it
6.
Side Effects
7.
Storage and Disposal of
Nesina Met
8.
Manufacturer and Product
Registration Holder
9.
Date of Revision
WHAT NESINA MET IS USED FOR
Nesina
Met
can
be
used
to
improve blood sugar levels in
adult
patients
with
type
2
diabetes in addition to diet and
exercise:
•
In combination of alogliptin
and metformin
•
In
combination
with
pioglitazone
•
In combination with insulin
HOW NESINA MET WORKS
Nesina Met is used when your
blood
sugar
cannot
be
adequately controlled by diet,
exercise and one or
more
of
these
other
oral
antidiabetic
medicines. It is important that
you continue to take your other
antidiabetic
medications,
and
continue to follow the advice
on diet and exercise that your
nurse or doctor has given you.
BEFORE YOU USE NESINA MET
-
When you must not use it
Do not take Nesina Met:
•
If
you
are
allergic
to
alogliptin
and/
or
metformin or any of the
other
ingredients
of
this
medicine.
•
If
you
have
severely
reduced kidney function.
•
If you have lactic acidosis
[too much lactic acid in
the blood (see “Risk of
lactic acidosis” below)] or
ketoacidosis.
Ketoacidosis is a
condition in which
substances called “ketone
bodies” accumulate in the
blood and which can lead
to diabetic pre-coma.
Symptoms of acidosis
may include stomach
pain, abnormal breathing
and drowsiness (if
severe).
-
Before you start to use it
Before you take Nesina Met,
tell your doctor if you
:
•
Have
type
1
diabetes
(your
body
does
not
produce insulin)
•
Have
kidney
or
liver
problems
•
Have
congestive
heart
failure
that
required
treatment with medicine
•
Older patient should not
take
Nesina
Met
unless
your
kidneys
have
been
checked
and

Ciri produk

1
D3 Proposed Package Insert
1. NAME OF THE MEDICINAL PRODUCT
Nesina Met 12. 5mg/ 5 00mg Film -Coated Tablet
Nesina Met 12. 5mg/ 1000mg Film -Coated Tablet
2. NAME AND STRENGTH OF ACTIVE SUBSTANCES
Nesina Met is available as a tablet for oral administration containing 17 mg alogliptin benzoate equivalent to 12.5 mg
alogliptin and:
• 500 mg metformin hydrochloride ( 12.5 mg/ 500 mg) or
• 1000 mg metformin hydrochloride ( 12.5 mg/ 1000 mg)
Nesina Met tablet contain the following excipients: mannitol, microcrystalline cellulose, povidone, crospovidone,
magnesium stearate, hypromellose 2910, talc, titanium dioxide and ferric oxide yellow .
3. PRODUCT DESCRIPTION
Nesina Met is supplied as tablets that are pale yellow, oblong , film -coated and are distinguished both by dose
specific imprinted markings on both side.
• 12. 5mg/5 00mg tablet – debossed with “12.5/500” on one side and “322M” on the other side
• 12.5mg/ 1000mg tablet – debossed with “ 12.5/1000” on one side and “ 322M” on the other side
4. INDICATION
Nesina Met is indicated to improve glycemic control in adult patients with type 2 diabetes mellitus (T2DM): .
• As and adjunct to diet and exercise in patients inadequately controlled on metformin or in patients already
being treated with the combination of alogliptin and metformin
• In combination with pioglitazone when diet and exercise plus dual therapy with metformin and pioglitazone
do not provide adequate glycemic control
• In combination with insulin, when insulin and metformin do not provide adequate glycemic control
5. DOSAGE AND ADMINISTRATION
5.1 Recommend ations for All Patients
• Healthcare providers should individualize the starting dose of Nesina Met based on the patient’s current
regimen.
• Nesina Met should be taken twice daily with food with gradual dose escalation to reduce the gastrointestinal
(GI) side effects due to metformin. Nesina Met tablets must not be split before swallowing.
• Dosing may be adjusted based on effectiveness and tolerabilit y