TRAJENTA

País: Israel

Língua: inglês

Origem: Ministry of Health

Ingredientes ativos:

LINAGLIPTIN

Disponível em:

BOEHRINGER INGELHEIM ISRAEL LTD.

Código ATC:

A10BH05

Forma farmacêutica:

FILM COATED TABLETS

Composição:

LINAGLIPTIN 5 MG

Via de administração:

PER OS

Tipo de prescrição:

Required

Fabricado por:

BOEHRINGER INGELHEIM INTERNATIONAL GMBH, GERMANY

Grupo terapêutico:

LINAGLIPTIN

Área terapêutica:

LINAGLIPTIN

Indicações terapêuticas:

As an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. TRAJENTA should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis, as it would not be effective in these settings. TRAJENTA has not been studied in patients with a history of pancreatitis. It is unknown whether patients with a history of pancreatitis are at an increased risk for the development of pancreatitis while using TRAJENTA.

Data de autorização:

2018-05-31

Folheto informativo - Bula

Each film-coated tablet of Trajenta contains: 5 mg linagliptin.
Inactive ingredients and allergens in this preparation - see section 6
‘Additional
information’.
READ THE ENTIRE LEAFLET CAREFULLY BEFORE YOU START USING THE MEDICINE.
This leaflet
contains concise information about the medicine. If you have further
questions,
contact the doctor or pharmacist.
This medicine has been prescribed to treat your illness. Do not pass
it on to others.
It may harm them, even if it seems to you that their illness is
similar to yours.
1.
WHAT IS THIS MEDICINE INTENDED FOR?
In addition to diet and physical activity, Trajenta is intended to
improve control
of blood sugar levels in adults with type 2 diabetes. Trajenta can be
given as
monotherapy or in combination with additional medicinal products to
reduce
blood sugar levels.
LIMITATIONS OF USE: Do not use Trajenta to treat type 1 diabetes or
diabetic
ketoacidosis, because Trajenta is not effective with these conditions.
Trajenta has not been studied in patients who have previously had
inflammation
of the pancreas (pancreatitis). It is not known whether patients who
have
previously suffered from pancreatitis are at an increased risk of
developing
pancreatitis during the treatment with Trajenta.
THERAPEUTIC GROUP: inhibitors of the enzyme DPP-4 (dipeptidyl
peptidase-4).
2.
BEFORE USING THIS MEDICINE
DO NOT USE THE MEDICINE IF:
•
You are sensitive (allergic) to the active ingredient linagliptin or
to any of
the additional ingredients in the medicine (for a list of inactive
ingredients,
please see section 6 ‘Additional information’). Symptoms of severe
allergic
reaction to Trajenta may include skin rash, itching, flaking or
peeling of
the skin, raised red patches on your skin (hives), swelling of your
face, lips,
tongue and throat which may cause difficulty breathing or swallowing,
difficulty swallowing or breathing.
If you experience any of these symptoms, stop taking Trajenta and call
your
doctor immediately or go to the emergency room in the nearest
hospital.
SPECIAL

Características técnicas

Trajenta
Updated Prescribing Information
File coated tablets 5 mg
November 2023
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TRAJENTA
Linagliptin 5 mg
FILM COATED TABLETS
PRESCRIBING INFORMATION
1.
NAME OF THE MEDICINAL PRODUCT
Trajenta
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
The active ingredient is linagliptin 5 mg.
For the full list of excipients, see section "DESCRIPTION" below.
3.
PHARMACEUTICAL FORM
Film coated tablets.
4.
INDICATIONS AND USAGE
4.1.
Monotherapy and Combination Therapy
TRAJENTA is indicated as an adjunct to diet and exercise to improve
glycemic control in adults with type
2 diabetes mellitus _[see Clinical Studies (16.1)]. _
4.2.
Important Limitations of Use
TRAJENTA should not be used in patients with type 1 diabetes or for
the treatment of diabetic
ketoacidosis, as it would not be effective in these settings.
TRAJENTA has not been studied in patients with a history of
pancreatitis. It is unknown whether
patients with a history of pancreatitis are at an increased risk for
the development of pancreatitis while
using TRAJENTA _[see Warnings and Precautions (8.1)]. _
5.
DOSAGE AND ADMINISTRATION
5.1.
Recommended Dosing
The recommended dose of TRAJENTA is 5 mg once daily.
TRAJENTA tablets can be taken with or without food.
Trajenta
Updated Prescribing Information
File coated tablets 5 mg
November 2023
Page
2
of
26
5.2.
Concomitant Use with an Insulin Secretagogue (e.g., Sulfonylurea) or
with Insulin
When TRAJENTA is used in combination with an insulin secretagogue
(e.g., sulfonylurea) or with insulin,
a lower dose of the insulin secretagogue or insulin may be required to
reduce the risk of hypoglycemia
_[see Warnings and Precautions (8.2)]_.
6.
DOSAGE FORMS AND STRENGTHS
TRAJENTA (linagliptin) 5 mg tablets are light red, round, biconvex,
bevel-edged, film-coated tablets with
“D5” debossed on one side and the Boehringer Ingelheim logo
debossed on the other side.
7.
CONTRAINDICATIONS
TRAJENTA is contraindicated in patients with hypersensitivity to
linagliptin or any of the excipients in
Trajenta listed in section 13, re