TRAJENTA linagliptin 5 mg film-coated tablet blister pack
Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Patient Information leaflet
(PIL)
24-08-2020
Summary of Product characteristics
(SPC)
24-08-2020
Public Assessment Report
(PAR)
29-11-2017
Active ingredient:
linagliptin, Quantity: 5 mg
Available from:
Boehringer Ingelheim Pty Ltd
INN (International Name):
Linagliptin
Pharmaceutical form:
Tablet, film coated
Composition:
Excipient Ingredients: mannitol; pregelatinised maize starch; maize starch; copovidone; magnesium stearate; titanium dioxide; hypromellose; purified talc; macrogol 6000; iron oxide red
Administration route:
Oral
Units in package:
10 tablets, 30 tablets
Prescription type:
(S4) Prescription Only Medicine
Therapeutic indications:
TRAJENTA is indicated in adult patients with type 2 diabetes mellitus to improve glycaemic control in conjunction with diet and exercise,,- as monotherapy when metformin and sulfonylureas are not tolerated, or are contraindicated, or,- as add on to metformin, sulfonylureas or metformin plus sulfonylureas, or to insulin (with or without metformin) or,- as add on to metformin plus SGLT2 inhibitors.
Product summary:
Visual Identification: Light red, round, biconvex, bevel-edged film-coated tablets, one side debossed with the BI company symbol, the other side debossed with "D5"; Container Type: Blister Pack; Container Material: PA/Al/PVC/Al - polyamide-aluminium foil-polyvinylchloride/aluminium foil; Container Life Time: 36 Months; Container Temperature: Store below 30 degrees Celsius
Authorization status:
Licence status A
Authorization date:
2011-11-01
Patient Information leaflet
TRAJENTA
®
_TABLETS_
_linagliptin_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Trajenta.
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 Trajenta
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 (Australia)
and www.medsafe.govt.nz/
Consumers/cmi/CMIForm.asp (New
Zealand) 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 TRAJENTA IS USED
FOR
Trajenta 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:
•
metformin, or
•
sulfonylurea medicines such
as glimepiride and
glibenclamide, or
•
insulin (with or without
metformin), or
•
metformin plus sulfonylurea
medicines, or
•
metformin plus 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 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 that 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, b
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Summary of Product characteristics
TRAJENTA PI0137-10
Page 1 of 16
AUSTRALIAN PRODUCT INFORMATION – TRAJENTA (LINAGLIPTIN) FILM-COATED
TABLET
1 NAME OF THE MEDICINE
linagliptin
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
TRAJENTA are film-coated tablets for oral administration containing 5
mg linagliptin.
For the full list of excipients, see Section 6.1 List of excipients.
3 PHARMACEUTICAL FORM
TRAJENTA tablets are round, light red, biconvex, bevel-edged
film-coated tablets, one side
debossed with the Boehringer Ingelheim company logo and on the other
side debossed with ‘D5’.
Each tablet contains 5 mg linagliptin.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
TRAJENTA is indicated in adult patients with type 2 diabetes mellitus
to improve glycaemic control
in conjunction with diet and exercise,
as monotherapy when metformin and sulfonylureas are not tolerated, or
are contraindicated, or
as add on to metformin, sulfonylureas or metformin plus sulfonylureas,
or to insulin (with or without
metformin) or
as add on to metformin plus SGLT2 inhibitors.
4.2 DOSE AND METHOD OF ADMINISTRATION
_Adults_: The recommended dose is 5 mg once daily.
TRAJENTA can be taken with or without a meal at any time of the day.
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.
_The elderly_: No dose adjustment is necessary.
_Children_: TRAJENTA is not recommended for use in children below 18
years due to lack of data on
safety and efficacy.
_Patients with renal impairment_
:
_ _No dosage adjustment is required for patients with renal
impairment.
_Patients with hepatic impairment_:_ _ No dosage adjustment is
required for patients with hepatic
impairment.
4.3 CONTRAINDICATIONS
Hypersensitivity to the active ingredient or to any of the excipients.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
GENERAL
TRAJENTA should not be used in patients with type 1 diabetes or for
the treatment of diabetic
ketoacidosis.
PANCREATITIS
Acute pancreatitis has been observed in patients taking linagliptin.
If pancr
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