TRAJENTA DUO 2.5MG 500MG FILM-COATED TABLETS

Țară: Malaezia

Limbă: engleză

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

Ingredient activ:

METFORMIN HYDROCHLORIDE; LINAGLIPTIN

Disponibil de la:

BOEHRINGER INGELHEIM (MALAYSIA) SDN. BHD.

INN (nume internaţional):

METFORMIN HYDROCHLORIDE; LINAGLIPTIN

Unități în pachet:

60 tablets BOTTLE

Produs de:

Boehringer Ingelheim Promeco S.A. de C.V.

Prospect

TRAJENTA DUO
®
Linagliptin / Metformin hydrochloride (2.5mg/500mg, 2.5mg/850mg,
2.5mg/1000mg)
1
Consumer Medication Information Leaflet (RiMUP)
What is in this leaflet
1.
What TRAJENTA DUO is used for
2.
How TRAJENTA DUO works
3.
Before you use TRAJENTA DUO
4.
How to use TRAJENTA DUO
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of
TRAJENTA DUO
8.
Product Description
9.
Manufacturer
10. Product Registration Holder
11. Date of revision
12. Serial number
1. What TRAJENTA DUO is used for
The name of your tablet is Trajenta Duo.
It contains two different active
substances linagliptin and metformin.
•
Linagliptin belongs to a class of
medicines called DPP-4 inhibitors
(dipeptidyl peptidase-4 inhibitors).
•
Metformin belongs to a class of
medicines called biguanides.
2. How TRAJENTA DUO works
The two active substances work together
to control blood sugar levels in adult
patients with a form of diabetes called
‘type 2 diabetes mellitus’.
Type 2 diabetes mellitus is also called
non-insulin-dependent diabetes mellitus,
or NIDDM. Type 2 diabetes 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. This can lead to serious medical
problems like heart disease, kidney
disease, blindness, and amputation.
This medicine helps to improve the
levels of insulin after a meal and lowers
the amount of sugar made by your body.
Along with diet and exercise, this
medicine helps lower your blood sugar.
Trajenta Duo can be used alone or with
certain other medicines for diabetes like
sulphonylureas or insulin.
3. Before you use TRAJENTA DUO
- When you must not use it
•
if you are allergic to linagliptin or
metformin or any of the other
ingredients of this medicine (listed
in section ingredients).
•
if you have severely reduced
kidneys function.
•
if you have uncontrolled diabetes,
with, for example, severe
hyperglycaemia (h

Caracteristicilor produsului

1
TRAJENTA DUO
®
Abcd
1.
NAME OF THE MEDICINAL PRODUCT
Trajenta Duo 2.5 mg/500 mg film-coated tablets
Trajenta Duo 2.5 mg/850 mg film-coated tablets
Trajenta Duo 2.5 mg/1000 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 2.5 mg of linagliptin and 500 mg, 850 mg or 1000
mg of metformin hydrochloride.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet (tablet).
Oval, biconvex, light yellow, film-coated tablet of 16.3 mm x 8.6 mm
debossed with "D2/500" on one
side and the company logo on the other.
Oval, biconvex, light orange, film-coated tablet of 19.2 mm x 9.4 mm
debossed with "D2/850" on one
side and the company logo on the other.
Oval, biconvex, light pink, film-coated tablet of 21.1 mm x 9.7 mm
debossed with "D2/1000" on one side
and the company logo on the other.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Trajenta Duo is indicated as an adjunct to diet and exercise to
improve glycaemic control in adults with
type 2 diabetes mellitus when treatment with both linagliptin and
metformin is appropriate (see
_Posology _
_and Method of Administration _
and
_Clinical Studies_
)
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults with normal renal function (GFR≥ 90 ml/min)_
The dose of antihyperglycaemic therapy with Trajenta Duo should be
individualised on the basis of the
patient’s
current
regimen,
effectiveness,
and
tolerability,
while
not
exceeding
the
maximum
recommended daily dose of 5 mg linagliptin plus 2000 mg of metformin
hydrochloride.
_For patients currently not treated with metformin _
In
patient
currently
not
treated
with
metformin,
initiate
treatment
with
2.5mg
linagliptin/
500mg
metformin hydrochloride twice daily.
2
_For patients inadequately controlled on maximal tolerated dose of
metformin monotherapy _
For patients not adequately controlled on metformin alone, the usual
starting dose of Trajenta Duo should
provide linagliptin dosed as 2.5 mg twice daily (5 mg total daily
dose) plus the dose of met