TRAJENTAMET 2.5 mg/850 mg linagliptin 2.5 mg / metformin hydrochloride 850 mg film-coated tablet bottle

Χώρα: Αυστραλία

Γλώσσα: Αγγλικά

Πηγή: Department of Health (Therapeutic Goods Administration)

Δραστική ουσία:

linagliptin, Quantity: 2.5 mg; metformin hydrochloride, Quantity: 850 mg

Διαθέσιμο από:

Boehringer Ingelheim Pty Ltd

INN (Διεθνής Όνομα):

Linagliptin,Metformin hydrochloride

Φαρμακοτεχνική μορφή:

Tablet, film coated

Σύνθεση:

Excipient Ingredients: hypromellose; purified talc; colloidal anhydrous silica; magnesium stearate; copovidone; propylene glycol; titanium dioxide; arginine; iron oxide yellow; maize starch; iron oxide red

Οδός χορήγησης:

Oral

Μονάδες σε πακέτο:

180, 14, 60

Τρόπος διάθεσης:

(S4) Prescription Only Medicine

Θεραπευτικές ενδείξεις:

TRAJENTAMET 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, in patients inadequately controlled on metformin alone, or those already being treated and well controlled with the free combination of linagliptin and metformin. TRAJENTAMET is indicated in combination with a sulfonylurea (i.e., triple combination therapy) as an adjunct to diet and exercise in patients inadequately controlled on their maximal tolerated dose of metformin and a sulfonylurea. TRAJENTAMET is indicated in combination with an SGLT2 inhibitor (i.e. triple combination therapy) as an adjunct to diet and exercise in patients inadequately controlled on their maximum tolerated dose of metformin and an SGLT2 inhibitor. TRAJENTAMET is indicated as add-on to insulin (i.e., triple combination therapy) as an adjunct to diet and exercise to improve glycaemic control in patients when insulin and metformin alone do not provide adequate glycaemic control.

Περίληψη προϊόντος:

Visual Identification: 2.5 mg/850 mg: Light orange, oval, biconvex film coated tablets, one side debossed with the company symbol and the other side debossed with D2/850; Container Type: Bottle; Container Material: HDPE; Container Life Time: 36 Months; Container Temperature: Store below 30 degrees Celsius; Container Closure: Child resistant closure

Καθεστώς αδειοδότησης:

Licence status A

Ημερομηνία της άδειας:

2013-05-21

Φύλλο οδηγιών χρήσης

TRAJENTAMET
®
_TABLETS_
_linagliptin / metformin hydrochloride_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Trajentamet.
It does not contain all the available
information.
It does not take the place of talking to
your doctor, pharmacist or diabetes
educator.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking Trajentamet
against the benefits they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
This leaflet was last updated on the
date at the end of this leaflet. More
recent information may be available.
The latest Consumer Medicine
Information is available from your
pharmacist, doctor, or from
www.medicines.org.au and may
contain important information about
the medicine and its use of which
you should be aware.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT TRAJENTAMET IS
USED FOR
Trajentamet is used to lower blood
sugar levels in patients with type 2
diabetes mellitus.
It may be used when diet plus
exercise do not provide adequate
blood sugar level control either:
•
alone as a single medicine, or
•
in combination with certain other
anti-diabetic medicines such as:
•
sulfonylurea medicines such
as glimepiride and
glibenclamide, or
•
insulin, or
•
sodium-glucose transporter 2
inhibitor medicines such as
empagliflozin.
Type 2 diabetes mellitus is also
called non-insulin-dependent
diabetes mellitus or NIDDM. Type 2
diabetes mellitus 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.
Insulin is a substance which helps to
lower the level of sugar in your
blood, especially after meals.
When the level of sugar builds up in
your blood, this can cause damage to
the body's cells and lead to serious
problems with your heart, brain,
eyes, circulation, nerves or kidneys.
_HOW TRAJENTAMET WORKS_
Trajentamet contains two different
active substances, linagliptin a

Αρχείο Π.Χ.Π.

TRAJENTAMET PI0140-15
Page 1 of 26
AUSTRALIAN
PRODUCT
INFORMATION
–
TRAJENTAMET
(LINAGLIPTIN/METFORMIN
HYDROCHLORIDE) FILM-COATED TABLET
1 NAME OF THE MEDICINE
linagliptin and metformin hydrochloride.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
TRAJENTAMET contains two oral antihyperglycaemic drugs used in the
management of type 2
diabetes mellitus (T2DM): linagliptin (a dipeptidyl peptidase-4
(DPP-4) inhibitor) and metformin
hydrochloride.
TRAJENTAMET are film-coated tablets for oral administration:
•
TRAJENTAMET 2.5 mg/500 mg contains 2.5 mg linagliptin and 500 mg
metformin hydrochloride
•
TRAJENTAMET 2.5 mg/850 mg contains 2.5 mg linagliptin and 850 mg
metformin hydrochloride
•
TRAJENTAMET
2.5 mg/1000 mg
contains
2.5 mg
linagliptin
and
1000 mg
metformin
hydrochloride.
For the full list of excipients, see Section 6.1 List of excipients.
3 PHARMACEUTICAL FORM
TRAJENTAMET is available in three strengths:
TRAJENTAMET
2.5 mg/500 mg
-
oval,
biconvex,
light
yellow,
one
side
debossed
with
the
Boehringer Ingelheim company symbol, the other side debossed with
‘D2/500’.
TRAJENTAMET
2.5 mg/850 mg
-
oval,
biconvex,
light
orange,
one side
debossed
with the
Boehringer Ingelheim company symbol, the other side debossed with
‘D2/850’.
TRAJENTAMET 2.5 mg/1000 mg - oval, biconvex, light pink, one side
debossed with the Boehringer
Ingelheim company symbol, the other side debossed with ‘D2/1000’
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
TRAJENTAMET 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, in
patients inadequately controlled on metformin alone, or those already
being treated and well
controlled with the free combination of linagliptin and metformin.
TRAJENTAMET is indicated in combination with a sulfonylurea (i.e.,
triple combination therapy) as
an adjunct to diet and exercise in patients inadequately controlled on
their maximal tolerated dose
of metformin and a su